DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10, 13-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable Ji et al. (CN109124666), hereinafter referred to as ‘Ji’ and in further view of Walker et al. (US20120213326), hereinafter referred to as ‘Walker’.
Regarding Claim 1, Ji discloses a method for radiation dose management, which is implemented on a computing device including at least one processor and at least one storage device, comprising (A third aspect of the present application provides an apparatus for determining a radiation dose modulation line. The apparatus includes a storage medium and at least one processor; the storage medium includes computer instructions; and the at least one processor is configured to execute at least part of the computer instructions to implement the operations in the above method [0017]): obtaining scan information of a subject (A first aspect of the present application provides a method for determining a radiation dose modulation line, the method comprising: acquiring a three-dimensional image of an object to be scanned [0008]), wherein the scan information includes a scan mode, a scan region of the subject, and a radiation dose of the subject (In some embodiments, the method for determining radiation dose modulation lines further includes: acquiring a scout image of the object to be scanned; and determining the dose modulation line associated with the CT scan of the object to be scanned based on the scout image and the three-dimensional image [0015]); wherein the scan mode is defined by a medical device that scans the subject, and the scan mode is one of a computed tomography (CT) scan and a digital radiography (DR) scan (Medical imaging systems can be single-mode or multi-mode imaging systems. Single-mode imaging systems include PET (Positron Emission Tomography) equipment, SPECT (Single Photon Emission Computed Tomography) equipment, CT (Computed Tomography) equipment, MRI (Magnetic Resonance Imaging) equipment, and DR (Digital Radiography) equipment. [0046]); determining a record mode based on the scan mode and a relationship between the record mode and the scan mode (…determining an X-ray dose corresponding to each slice of the object to be scanned based on the three-dimensional contour of the object to be scanned; and determining a dose modulation line related to a CT scan of the object to be scanned based on the X-ray dose of each slice [0008]; For example, before operation 1310, an initial scanning protocol can be set manually by the operator (e.g., a nurse, radiologist) or automatically by the imaging system 100 for the object to be scanned. The acquisition unit 1210 can acquire the positioning image of the object to be scanned based on the initial scanning protocol, and the dose modulation line generation unit 1230 can determine the initial dose modulation line based on the positioning image and the initial scanning protocol [0151]); recording the scan region and the radiation dose based on the record mode (obtaining a mapping table containing the correspondence between X-ray dose and slice size; and searching the mapping table based on the size of the at least one slice to determine the corresponding X-ray dose [0010]), wherein the record mode refers to a presentation form of the radiation dose or a distribution of the radiation dose (obtaining a mapping table containing the correspondence between X-ray dose and slice size; and searching the mapping table based on the size of the at least one slice to determine the corresponding X-ray dose [0010]), and the record mode includes a radiation dose curve, a radiation dose model, a radiation dose table, or a radiation dose chart (obtaining a mapping table containing the correspondence between X-ray dose and slice size; and searching the mapping table based on the size of the at least one slice to determine the corresponding X-ray dose [0010]): visualizing the distribution of the radiation dose in a visualization model of at least a portion of the subject (…A general model can be trained based on multiple sample 3D images, multiple sample CT images… For example, brain-specific models can be used to generate dose modulation lines (or regional dose modulation lines elsewhere in this application) for brain regions based on 3D images and localization images. Brain-specific models can be trained using training datasets that correspond to the brain [0095]); determining or adjusting a scan protocol of a next scan of the subject based on the visualization model (Radiation dose modulation can be achieved by adjusting the tube current of the radioactive scanning source 113 based on the dose modulation line during CT scanning [0107])and performing the next scan by the medical device using the determined or adjusted scan protocol (For example, storage module 430 may store programs and/or instructions executed by the processor of processing device 140 to obtain 3D images and/or positioning images of the object to be scanned, generate dose modulation lines based on the 3D images and/or positioning images, and/or adjust the tube current of radioactive scanning source 113 based on the dose modulation lines when performing a CT scan on the object to be scanned [0073]).
Regarding Claim 2, Ji and Walker disclose the claimed invention discussed in claim 1.
Ji discloses the recording the scan region and the radiation dose based on the record mode comprises: determining a radiation dose corresponding to each position of a plurality of positions distributed along at least one direction of the scan region based on the radiation dose of the subject; and recording the radiation dose corresponding to the each position of the plurality of positions of the scan region based on the record mode (In some embodiments, the training unit 620 may obtain a training data set from a storage device (e.g., memory 150, disk 270, internal memory 360, storage module 430, external storage device). The training data set includes multiple sample CT images, multiple sample 3D images, and multiple sample positioning images. One of the plurality of sample CT images corresponds to one of the plurality of sample 3D images and one of the plurality of sample scout images. Here, the correspondence between the CT image, the 3D image, and the scout image indicates that these sample images represent the same region of the object to be scanned [0112]).
Regarding Claim 3, Ji and Walker disclose the claimed invention discussed in claim 1.
Ji discloses the scan mode includes a spiral CT scan, and the determining a record mode based on the scan mode comprises: determining the record mode as the radiation dose curve based on the spiral CT scan (In some embodiments, the dose modulation line or regional dose modulation line may be discrete, including at least one discrete point, each discrete point corresponding to a radiation dose at a specific time or angle. In some embodiments, the dose modulation line or the regional dose modulation line may be a combination of at least one piecewise continuous curve, or a combination of at least one piecewise continuous curve and at least one discrete point. When a CT scan is performed on a subject to be scanned, data points of a dose modulation line or a regional dose modulation line may represent a degree of adjustment of the radiation dose (also referred to as radiation dose modulation, dose modulation, or tube current modulation). Radiation dose modulation may be achieved by adjusting the tube current of the radioactive scan source 113 based on the dose modulation line during CT scanning. For example, during a spiral CT scan, the radioactive scan source 113 may rotate in the X-Y plane as the table 115 moves along the Z axis. Radiation dose modulation can be achieved by adjusting the tube current of the radioactive scan source 113 in the X-Y plane and along the Z axis based on the dose modulation line during the spiral CT scan [0070]).
Regarding Claim 4, Ji and Walker disclose the claimed invention discussed in claim 3.
Ji discloses the recording the scan region and the radiation dose based on the record mode comprises: determining a radiation dose of each layer of a plurality of layers of the scan region (As shown in FIG9 , the dose modulation line generation model may be a convolutional neural network (CNN) model. The CNN model includes an input layer, a hidden layer, and an output layer, and each node in FIG9 can simulate a neuron. The hidden layers include multiple convolutional layers, multiple pooling layers and/or multiple fully connected layers (not shown in FIG9 ). After the CNN model is trained by, for example, the process 800 shown in FIG8 , the CNN model is configured to generate a dose modulation line in response to its input. In some embodiments, the input of the CNN includes a scout image (e.g., an AP scout image or a lateral scout image) and a 3D image of the object to be scanned [0120]); determining the radiation dose curve based on radiation doses of the plurality of layers of the scan region (In some embodiments, the dose modulation line or regional dose modulation line may be discrete, including at least one discrete point, each discrete point corresponding to a radiation dose at a specific time or angle. In some embodiments, the dose modulation line or the regional dose modulation line may be a combination of at least one piecewise continuous curve, or a combination of at least one piecewise continuous curve and at least one discrete point. When a CT scan is performed on a subject to be scanned, data points of a dose modulation line or a regional dose modulation line may represent a degree of adjustment of the radiation dose (also referred to as radiation dose modulation, dose modulation, or tube current modulation). [0070]); and recording the radiation doses corresponding to the plurality of layers of the scan region using the radiation dose curve (As shown in FIG9 , the dose modulation line generation model may be a convolutional neural network (CNN) model. The CNN model includes an input layer, a hidden layer, and an output layer, and each node in FIG9 can simulate a neuron. The hidden layers include multiple convolutional layers, multiple pooling layers and/or multiple fully connected layers (not shown in FIG9 ). After the CNN model is trained by, for example, the process 800 shown in FIG8 , the CNN model is configured to generate a dose modulation line in response to its input. In some embodiments, the input of the CNN includes a scout image (e.g., an AP scout image or a lateral scout image) and a 3D image of the object to be scanned [0120]).
Regarding Claim 5, Ji and Walker disclose the claimed invention discussed in claim 1.
Ji discloses the scan mode includes the CT scan, and the determining a record mode based on the scan mode comprises: determining the record mode as a first model including a plurality of elliptical cylinders based on the CT scan (In some embodiments, the three-dimensional outline of the object to be scanned is a cylinder, an elliptical cylinder, or a cuboid [0013]), the first model being configured to reflect radiation doses corresponding to a plurality of layers of the scan region (as discussed above).
Regarding Claim 6, Ji and Walker disclose the claimed invention discussed in claim 5.
Ji discloses the scan information further includes a thickness of each layer of the plurality of layers of the scan region (The radiation dose on each slice (each slice corresponds to a specific scanning angle) of the object to be scanned can be determined based on the properties of the 3D contour (such as thickness, width [0042]), and the recording the scan region and the radiation dose based on the record mode comprises: determining a radiation dose of the each layer of the plurality of layers of the scan region; generating the first model based on the thickness of the each layer of the plurality of layers of the scan region, and the radiation dose of the each layer of the plurality of layers of the scan region, wherein a height of each elliptical cylinder of the plurality of elliptical cylinders corresponds to a thickness of a corresponding layer of the plurality of layers of the scan region (The radiation dose on each slice (each slice corresponds to a specific scanning angle) of the object to be scanned can be determined based on the properties of the 3D contour (such as thickness, width [0042]), and a cross-sectional area of the each elliptical cylinder corresponds to a radiation dose of the corresponding layer; and recording radiation doses corresponding to the plurality of layers of the scan region using the first model (As shown in FIG9 , the dose modulation line generation model may be a convolutional neural network (CNN) model. The CNN model includes an input layer, a hidden layer, and an output layer, and each node in FIG9 can simulate a neuron. The hidden layers include multiple convolutional layers, multiple pooling layers and/or multiple fully connected layers (not shown in FIG9 ). After the CNN model is trained by, for example, the process 800 shown in FIG8 , the CNN model is configured to generate a dose modulation line in response to its input. In some embodiments, the input of the CNN includes a scout image (e.g., an AP scout image or a lateral scout image) and a 3D image of the object to be scanned [0120]).
Regarding Claim 7, Ji and Walker disclose the claimed invention discussed in claim 1.
Ji discloses the scan mode includes the CT scan (as discussed above), the scan region includes a reference region (as discussed above), and the determining a record mode based on the scan mode comprises: determining the record mode as a second model based on the CT scan and the reference region, wherein the second model includes a cylinder with a first curved surface, and the first curved surface corresponds to the reference region (Each of the at least one region of interest corresponds to an anatomical region of the object to be scanned, such as the head, neck, chest, etc. In some embodiments, the segmentation unit 1220 may automatically segment the scout image into at least one region of interest based on an image segmentation algorithm. Exemplary image segmentation algorithms include threshold algorithms, clustering algorithms, histogram-based algorithms, region growing algorithms, etc., or any combination thereof. In some embodiments, an operator (e.g., a nurse, a radiologist) may manually segment the scout image into at least one region of interest [0142]).
Regarding Claim 8, Ji and Walker disclose the claimed invention discussed in claim 7.
Ji discloses the scan information further includes a radiation dose of the reference region, and the recording the scan region and the radiation dose based on the record mode comprises (In some embodiments, the method for determining radiation dose modulation lines further includes: acquiring a scout image of the object to be scanned; and determining the dose modulation line associated with the CT scan of the object to be scanned based on the scout image and the three-dimensional image [0015]): generating the cylinder based on the scan region and the radiation dose of the subject (The distance information of pixels in the 3D image can be used to determine the 3D contour of the object to be scanned. In some embodiments, the 3D contour includes a cylinder, an ellipsoid, a cuboid, etc. [0077]), wherein a longitudinal axis of the cylinder is perpendicular to a cross section of the subject (The workbench 115 can support an object to be scanned (e.g., a patient). The Z axis (also referred to as the Z direction) corresponds to the long axis direction of the object to be scanned. The X-Y plane (also called the cross-sectional or axial plane) corresponds to the plane perpendicular to the Z axis. During a CT scan, the radioactive scan source 113 and the detector 114 can rotate while maintaining their relative positions in the X-Y plane [0048]); generating the second model by forming, based on the radiation dose of the reference region, the first curved surface on the cylinder (The dose modulation line generation unit 630 may retrieve the dose modulation line generation model from the model library. The library includes several general and/or specialized dose modulation line generation models [0097]; In some embodiments, the dose modulation line generation model may be sent to a storage device (e.g., memory 150, disk 270, internal memory 360, storage module 430, external storage device) for storage. In some embodiments, the dose modulation line generation model may be a general model or a dedicated model. The general model can be used to generate dose modulation lines corresponding to various types of 3D images and scout images of multiple objects to be scanned or multiple regions of an object to be scanned [0095]); and recording radiation doses corresponding to a plurality of positions of the reference region using the second mode (The workbench 115 can support an object to be scanned (e.g., a patient). The Z axis (also referred to as the Z direction) corresponds to the long axis direction of the object to be scanned. The X-Y plane (also called the cross-sectional or axial plane) corresponds to the plane perpendicular to the Z axis. During a CT scan, the radioactive scan source 113 and the detector 114 can rotate while maintaining their relative positions in the X-Y plane [0048]).
Regarding Claim 9, Ji and Walker disclose the claimed invention discussed in claim 1.
Ji discloses the scan mode includes the CT scan, the scan region includes a reference region, and the determining a record mode based on the scan mode comprises (as discussed above): determining the record mode as a third model based on the CT scan and the reference region, wherein the third model includes a plurality of elliptical cylinders with a second curved surface (as discussed above), the second curved surface corresponds to the reference region, and the third model is configured to reflect radiation doses corresponding to a plurality of layers of the scan region (as discussed above).
Regarding Claim 10, Ji and Walker disclose the claimed invention discussed in claim 9.
Ji discloses the scan information further includes a thickness of each layer of the plurality of layers of the scan region, and a radiation dose of the reference region, and the recording the scan region and the radiation dose based on the record mode comprises (The radiation dose on each slice (each slice corresponds to a specific scanning angle) of the object to be scanned can be determined based on the properties of the 3D contour (such as thickness, width [0042]): determining a radiation dose of the each layer of the plurality of layers of the scan region (In some embodiments, the object to be scanned may be divided into a plurality of slices along the Z axis. [0072]); generating the plurality of elliptical cylinders based on the thickness of the each layer of the plurality of layers of the scan region (In some embodiments, the three-dimensional outline of the object to be scanned is a cylinder, an elliptical cylinder, or a cuboid [0013]), and the radiation dose of the each layer of the plurality of layers of the scan region (as discussed above), wherein a longitudinal axis of the each elliptical cylinder of the plurality of elliptical cylinders is located on a same straight line, the longitudinal axis of the each elliptical cylinder of the plurality of elliptical cylinders is perpendicular to a cross section of the subject (The scanning device 110 includes a gantry 111, a 3D depth camera 112, a radioactive scanning source 113, a detector 114 and a workbench 115. A three-dimensional Cartesian coordinate system is shown in FIG1 . The workbench 115 can support an object to be scanned (e.g., a patient). The Z axis (also referred to as the Z direction) corresponds to the long axis direction of the object to be scanned. The X-Y plane (also called the cross-sectional or axial plane) corresponds to the plane perpendicular to the Z axis. During a CT scan, the radioactive scan source 113 and the detector 114 can rotate while maintaining their relative positions in the X-Y plane [0048]), a height of the each elliptical cylinder of the plurality of elliptical cylinders corresponds to a thickness of a corresponding layer of the plurality of layers of the scan region, and a cross-sectional area of the each elliptical cylinder corresponds to a radiation dose of the corresponding layer (A pixel in a 3D image contains information related to a corresponding point on the object to be scanned. For example, a pixel in a 3D image includes information related to the distance from the 3D depth camera to a corresponding point on the object to be scanned, the grayscale value or color of the corresponding point, or any combination thereof. The distance information of pixels in the 3D image can be used to determine the 3D contour of the object to be scanned. In some embodiments, the 3D contour includes a cylinder, an ellipsoid, a cuboid, etc. The 3D profile includes surface structure or shape size information of the object to be scanned, such as width, thickness, etc., or any combination thereof [0077]); generating the third model by forming, based on the radiation dose of the reference region (The dose modulation line generation unit 630 may retrieve the dose modulation line generation model from the model library. The library includes several general and/or specialized dose modulation line generation models [0097]), the second curved surface on the plurality of elliptical cylinders; and recording radiation doses corresponding to the plurality of layers of the scan region and a plurality of positions of the reference region using the third model (Each of the at least one region of interest corresponds to an anatomical region of the object to be scanned, such as the head, neck, chest, etc. In some embodiments, the segmentation unit 1220 may automatically segment the scout image based on an image segmentation algorithm. Exemplary image segmentation algorithms include threshold algorithms, clustering algorithms, histogram-based algorithms, region growing algorithms, etc., or any combination thereof. In some embodiments, an operator (e.g., nurse, radiologist) can manually segment the scout image. In some embodiments, the scout image can be segmented semi-automatically, for example, the segmentation unit 1220 first automatically performs rough segmentation and then the operator manually adjusts it, or the operator first makes a preliminary manual selection and then the segmentation unit 1220 accurately segments it [0148]).
Regarding Claim 13, Ji and Walker disclose the claimed invention discussed in claim 1.
Ji discloses causing a terminal device to display the subject model (The functions of the terminal 130 can be implemented on the mobile device 300 . As shown in FIG3 , mobile device 300 includes a communication platform 310 , a display 320 , a graphics processing unit (GPU) 330 , a central processing unit (CPU) 340 , and I/O 350, a memory 360 , and a storage 390 . In some embodiments, any other suitable components, including but not limited to a system bus or a controller (not shown), may also be included in the mobile device 300 [0063]).
However, Ji does not explicitly disclose obtaining one or more historical scan regions of the subject, one or more historical radiation doses of the subject, and one or more historical record modes; generating a subject model representing the subject (as discussed above) ; and causing a terminal device to display the subject model, the one or more historical scan regions and the one or more historical radiation doses according to the one or more historical record modes.
Nevertheless, Walker discloses obtaining one or more historical scan regions of the subject, one or more historical radiation doses of the subject, and one or more historical record modes; generating a subject model representing the subject (A policy generator 218 generates scan policies, including, but not limited to one or more policies 216 in the policy bank 214. The illustrated policy generator 218 can generate scan policies based on various input, including, but not limited to, a policy template (e.g., a policy template 220 in a template bank 222), rules (e.g., a rule from a rules bank 232), historical radiation dose information for the patient and/or facility, historical policy adherence for the patient and/or facility, operator input (e.g., patient identification, demographics, etc.), and/or other information [0038]), the one or more historical scan regions and the one or more historical radiation doses according to the one or more historical record modes (A policy generator 218 generates scan policies, including, but not limited to one or more policies 216 in the policy bank 214. The illustrated policy generator 218 can generate scan policies based on various input, including, but not limited to, a policy template (e.g., a policy template 220 in a template bank 222), rules (e.g., a rule from a rules bank 232), historical radiation dose information for the patient and/or facility, historical policy adherence for the patient and/or facility, operator input (e.g., patient identification, demographics, etc.), and/or other information [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ji, in view of Walker to obtain one or more historical scan regions of the subject, one or more historical radiation doses of the subject, and one or more historical record modes; generating a subject model representing the subject, the one or more historical scan regions and the one or more historical radiation doses according to the one or more historical record modes to generate scan policies based on various output, rules, and historical radiation dose information for the patient and to improve radiation dosage.
Regarding Claim 14, Ji and Walker disclose the claimed invention discussed in claim 13.
Ji discloses the causing a terminal device to display the subject model (The functions of the terminal 130 can be implemented on the mobile device 300 . As shown in FIG3 , mobile device 300 includes a communication platform 310 , a display 320 , a graphics processing unit (GPU) 330 [0063]), the one or more historical scan regions, and the one or more historical radiation doses according to the one or more historical record modes comprises: generating target image data by mapping the one or more historical scan regions and the one or more historical radiation doses on the subject model according to the one or more historical record modes; and causing the terminal device to display the target image data (In some embodiments, the dose modulation lines may display the relationship between radiation dose and time during a scan [0087]).
However, Ji does not explicitly disclose the one or more historical scan regions, and the one or more historical radiation doses according to the one or more historical record modes comprises: generating target image data by mapping the one or more historical scan regions and the one or more historical radiation doses on the subject model according to the one or more historical record modes.
Nevertheless, Walker discloses the one or more historical scan regions, and the one or more historical radiation doses according to the one or more historical record modes comprises: generating target image data by mapping the one or more historical scan regions and the one or more historical radiation doses on the subject model according to the one or more historical record modes ( A dose calculator 228 calculates or estimates patient radiation dose for a patient based on the scan parameters. The calculated dose can be stored in a radiation dose storage 230, which can be local and/or remote memory. The radiation dose information can be stored on an individual scan basis for the patient, aggregated over a time period such as per year, lifetime, etc. for the patient, combined with radiation dose information from one or more other procedures or modalities (e.g., for radiation therapy planning), combined with radiation dose information for another patient(s), for example, to determine radiation dose for a particular facility, an average radiation dose for a procedure for one or more facilities, and/or otherwise. The generated radiation dose information includes the historical radiation dose information used by the policy generator 218 for generating policies such as radiation dose based policies [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ji, in view of Walker to include the one or more historical scan regions, and the one or more historical radiation doses according to the one or more historical record modes comprises: generating target image data by mapping the one or more historical scan regions and the one or more historical radiation doses on the subject model according to the one or more historical record modes to generate scan policies based on various output, rules, and historical radiation dose information for the patient and to improve radiation dosage.
Regarding Claim 15, Ji and Walker disclose the claimed invention discussed in claim 14.
However, Ji does not explicitly disclose the one or more historical scan regions are displayed in the subject model in different colors, or one or more colors of the one or more historical scan regions correspond to the one or more historical radiation doses of the one or more historical scan regions.
Nevertheless, Walker discloses the one or more historical scan regions are displayed in the subject model in different colors, or one or more colors of the one or more historical scan regions correspond to the one or more historical radiation doses of the one or more historical scan regions (A policy generator 218 generates scan policies, including, but not limited to one or more policies 216 in the policy bank 214. The illustrated policy generator 218 can generate scan policies based on various input, including, but not limited to, a policy template (e.g., a policy template 220 in a template bank 222), rules (e.g., a rule from a rules bank 232), historical radiation dose information for the patient and/or facility, historical policy adherence for the patient and/or facility, operator input (e.g., patient identification, demographics, etc.), and/or other information [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ji, in view of Walker to the one or more historical scan regions, and the one or more historical radiation doses according to the one or more historical record modes comprises: generating target image data by mapping the one or more historical scan regions and the one or more historical radiation doses on the subject model according to the one or more historical record modes to generate scan policies based on various output, rules, and historical radiation dose information for the patient and to improve radiation dosage.
Regarding Claim 17, Ji and Walker disclose the claimed invention discussed in claim 1.
Ji discloses the visualizing the scan region and the radiation dose using the model comprises (as discussed above): displaying a current distribution of an accumulative radiation dose corresponding to the at least one historical scan of the subject in the model.
However, Ji does not explicitly disclose the scan information includes historical scan information of at least one historical scan of the subject and displaying a current distribution of an accumulative radiation dose corresponding to the at least one historical scan of the subject in the model.
Nevertheless, Walker discloses the scan information includes historical scan information of at least one historical scan of the subject (as discussed above) and displaying a current distribution of an accumulative radiation dose corresponding to the at least one historical scan of the subject in the model (as discussed above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ji, in view of Walker to incorporate the scan information includes historical scan information of at least one historical scan of the subject and displaying a current distribution of an accumulative radiation dose corresponding to the at least one historical scan of the subject in the model to generate scan policies based on various output, rules, and historical radiation dose information for the patient and to improve radiation dosage.
Regarding Claim 18, Ji and Walker disclose the claimed invention discussed in claim 17.
Ji discloses the scan information further includes current scan information of a current scan of the subject, and the visualizing the scan region and the radiation dose using the model comprises (as discussed above).
However, Ji does not explicitly discloses displaying an estimated distribution of an accumulative radiation dose corresponding to the at least one historical scan of the subject and the current scan of the subject in the model.
Nevertheless, Walker discloses displaying an estimated distribution of an accumulative radiation dose corresponding to the at least one historical scan of the subject and the current scan of the subject in the model (as discussed above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ji, in view of Walker to display an estimated distribution of an accumulative radiation dose corresponding to the at least one historical scan of the subject and the current scan of the subject in the model to generate scan policies based on various output, rules, and historical radiation dose information for the patient and to improve radiation dosage.
Regarding Claim 19, Ji discloses a method for radiation dose management, which is implemented on a computing device including at least one processor and at least one storage device, comprising (A third aspect of the present application provides an apparatus for determining a radiation dose modulation line. The apparatus includes a storage medium and at least one processor; the storage medium includes computer instructions; and the at least one processor is configured to execute at least part of the computer instructions to implement the operations in the above method [0017]): the method is performed before a CT scan is performed by a CT device, which includes a radiation source and a collimator (In this application, tube voltage refers to the peak energy (e.g., in kilovolts) of X-ray photons in the X-ray energy spectrum. In this application, the pitch refers to the ratio of the stage translation (in centimeters, stage feed amount for 360° gantry rotation) in a spiral CT to the total nominal collimated X-ray beam width in the Z direction [0071]), the method comprises: generating a rendered 3D model of a subject based on historical scan regions and historical radiation doses of the subject (The dose modulation line generation unit 630 can generate a dose modulation line based on the 3D image and localization image acquired by the acquisition unit 610 and the dose modulation line generation model trained by the training unit 620 [0096]), wherein the historical scan regions are displayed in the rendered 3D model in different colors, each of the different colors corresponding to one of the historical radiation doses of the historical scan regions (A pixel in a 3D image contains information related to a corresponding point on the object being scanned. For example, a pixel in a 3D image contains information related to the distance from the 3D depth camera to a corresponding point on the object being scanned, the grayscale value or color of that corresponding point, or any combination thereof. Distance information of pixels in a 3D image can be used to determine the 3D contour of the object to be scanned [0077]); determining at least one of an execution order and a position of the collimator for different scan regions of the subject based on the rendered 3D model of the subject (In this application, tube voltage refers to the peak energy (e.g., in kilovolts) of X-ray photons in the X-ray energy spectrum. In this application, the pitch refers to the ratio of the stage translation (in centimeters, stage feed amount for 360° gantry rotation) in a spiral CT to the total nominal collimated X-ray beam width in the Z direction [0071]), obtaining scan information of the subject (as discussed above); determining, based on the scan information (A first aspect of the present application provides a method for determining a radiation dose modulation line, the method comprising: acquiring a three-dimensional image of an object to be scanned [0008]), determining, based on the scan information, a distribution of a radiation dose in at least one dimension of one of the different scan regions of the subject (A general model can be trained based on multiple sample 3D images, multiple sample CT images, and multiple sample localization images associated with different regions of a certain type of object to be scanned. In some embodiments, multiple sample 3D images, multiple sample CT images, and multiple sample localization images used for training can collectively cover the entire human body or the entire upper body. [0095]); and displaying the distribution of the radiation dose (In some embodiments, the method for determining radiation dose modulation lines further includes: acquiring a scout image of the object to be scanned; and determining the dose modulation line associated with the CT scan of the object to be scanned based on the scout image and the three-dimensional image [0015]); A second aspect of the present application provides a system for determining radiation dose modulation lines, the system comprising: an acquisition unit configured to acquire a three-dimensional image of an object to be scanned; a three-dimensional contour determination unit configured to determine a three-dimensional contour of the object to be scanned based on the three-dimensional image; and a dose modulation line generation unit configured to: determine an X-ray dose corresponding to each slice of the object to be scanned based on the three-dimensional contour of the object to be scanned; and determine a dose modulation line associated with a CT scan of the object to be scanned based on the X-ray dose of each slice [0016]).
Regarding Claim 20, Ji discloses a method for radiation dose management, which is implemented on a computing device including at least one processor and at least one storage device, comprising (A third aspect of the present application provides an apparatus for determining a radiation dose modulation line. The apparatus includes a storage medium and at least one processor; the storage medium includes computer instructions; and the at least one processor is configured to execute at least part of the computer instructions to implement the operations in the above method [0017]): obtaining scan information of a subject; determining, based on the scan information (A first aspect of the present application provides a method for determining a radiation dose modulation line, the method comprising: acquiring a three-dimensional image of an object to be scanned [0008]), and displaying the current distribution of the accumulative radiation dose in a visualization model of the subject (In some embodiments, the method for determining radiation dose modulation lines further includes: acquiring a scout image of the object to be scanned; and determining the dose modulation line associated with the CT scan of the object to be scanned based on the scout image and the three-dimensional image [0015]); A second aspect of the present application provides a system for determining radiation dose modulation lines, the system comprising: an acquisition unit configured to acquire a three-dimensional image of an object to be scanned; a three-dimensional contour determination unit configured to determine a three-dimensional contour of the object to be scanned based on the three-dimensional image; and a dose modulation line generation unit configured to: determine an X-ray dose corresponding to each slice of the object to be scanned based on the three-dimensional contour of the object to be scanned; and determine a dose modulation line associated with a CT scan of the object to be scanned based on the X-ray dose of each slice [0016]).
However, Ji does not explicitly disclose a current distribution of an accumulative radiation dose corresponding to the plurality of historical scans in at least one dimension of the subject.
Nevertheless, Walker discloses the plurality of historical scans in at least one dimension of the subject (as discussed above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ji, in view of Walker to a current distribution of an accumulative radiation dose corresponding to the plurality of historical scans in at least one dimension of the subject to generate scan policies based on various output, rules, and historical radiation dose information for the patient and to improve radiation dosage.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ji and Walker, and further in view of Leghissa et al. (US20190274649) hereinafter referred to as ‘Leghissa’.
Regarding Claim 11, Ji and Walker disclose the claimed invention discussed in claim 1.
Ji discloses the scan mode includes a beam limited scan mode (The scanning protocol is related to the anatomical region of the subject to be scanned, such as the head, neck, chest, etc. For example, the scan protocol may include a head scan protocol, a neck scan protocol, a chest scan protocol, and the like. In some embodiments, the scan protocol includes scan parameters such as voltage of the radioactive scan source 113 , tube current-time product, beam width, gantry rotation time, reconstruction kernel, etc., or any combination thereof [0082]), and the determining a record mode based on the scan mode comprises: determining the record mode as a fourth model based on the beam limited scan mode, wherein the fourth model includes a frustum (Each of the at least one region of interest corresponds to an anatomical region of the object to be scanned, such as the head, neck, chest, etc. In some embodiments, the segmentation unit 1220 may automatically segment the scout image based on an image segmentation algorithm. Exemplary image segmentation algorithms include threshold algorithms, clustering algorithms, histogram-based algorithms, region growing algorithms, etc., or any combination thereof. In some embodiments, an operator (e.g., nurse, radiologist) can manually segment the scout image. In some embodiments, the scout image can be segmented semi-automatically, for example, the segmentation unit 1220 first automatically performs rough segmentation and then the operator manually adjusts it, or the operator first makes a preliminary manual selection and then the segmentation unit 1220 accurately segments it [0148]).
However, Ji does not explicitly disclose the determining a record mode based on the scan mode comprises: determining the record mode as a fourth model based on the beam limited scan mode, wherein the fourth model includes a frustum.
Nevertheless, Walker discloses the determining a record mode based on the scan mode (as discussed above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ji, in view of Walker to determine a record mode based on the scan mode to estimate and/or regulate dose for subsequent imaging procedures by the same or different patient and improve management/accuracy of radiation dosage.
However, the combination does not explicitly disclose the fourth model includes a frustum.
Nevertheless, Leghissa discloses the model includes a frustum ((In particular in the case of "measurement radiation" (for example X-ray radiation, CT radiation and the like), the model conformity of the radiation phantom device preferably relates to the conformity in the region of a detector means and/or to the conformity in a region in the form of an axially positioned disc and/or (especially in the case of a cone beam geometry) to the conformity in a cone-shaped (frustum-shaped) region [0018]), and a height of the frustum corresponds to the radiation dose of the subject (In particular in the case of "measurement radiation" (for example X-ray radiation, CT radiation and the like), the model conformity of the radiation phantom device preferably relates to the conformity in the region of a detector means and/or to the conformity in a region in the form of an axially positioned disc and/or (especially in the case of a cone beam geometry) to the conformity in a cone-shaped (frustum-shaped) region [0018])).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ji and Walker, in view of Leghissa to incorporate the fourth model includes a frustum to relate to the region of a detector and to improve radiation dosage.
Regarding Claim 12, Ji and Walker disclose the claimed invention discussed in claim 11.
Ji discloses the scan information further includes a shape of a beam limiter of a medical device (In this application, tube voltage refers to the peak energy of an X-ray photon in the X-ray energy spectrum (e.g., in kilovolts). In this application, pitch refers to the ratio of the table translation (in centimeters, the table feed for 360° gantry rotation) to the total nominal collimated X-ray beam width in the Z direction in spiral CT [0071]), and the recording the scan region and the radiation dose based on the record mode comprises: generating the fourth model based on the shape of the beam limiter and the radiation dose of the subject (Each of the at least one region of interest corresponds to an anatomical region of the object to be scanned, such as the head, neck, chest, etc. In some embodiments, the segmentation unit 1220 may automatically segment the scout image based on an image segmentation algorithm. Exemplary image segmentation algorithms include threshold algorithms, clustering algorithms, histogram-based algorithms, region growing algorithms, etc., or any combination thereof. In some embodiments, an operator (e.g., nurse, radiologist) can manually segment the scout image [0148]), and recording the radiation dose of the subject using the fourth model (Each of the at least one region of interest corresponds to an anatomical region of the object to be scanned, such as the head, neck, chest, etc. In some embodiments, the segmentation unit 1220 may automatically segment the scout image based on an image segmentation algorithm. Exemplary image segmentation algorithms include threshold algorithms, clustering algorithms, histogram-based algorithms, region growing algorithms, etc., or any combination thereof. In some embodiments, an operator (e.g., nurse, radiologist) can manually segment the scout image [0148]).
However, Ji does not explicitly disclose wherein an axis of the frustum is perpendicular to a coronal plane of the subject, a shape of a surface of the frustum corresponds to the shape of the beam limiter, and a height of the frustum corresponds to the radiation dose of the subject; and recording the radiation dose of the subject using the fourth model.
Nevertheless, Leghissa discloses wherein an axis of the frustum is perpendicular to a coronal plane of the subject, a shape of a surface of the frustum corresponds to the shape of the beam limiter (FIG. 3 shows a magnet unit 20 forming a funnel 24 as a first region. The funnel 24 is in particular formed by the first housing 26 of the magnet unit 20. In this example embodiment, the funnel 24 is embodied in a prism shape with a rectangular base. However, the funnel 24 can also be embodied in a prism shape with a base of a different shape or as a pyramid frustum or cone frustum. In particular, it is possible for the funnel 24 to be cylindrical. The design of the funnel 24 can in particular take account of the necessary stability of the magnet unit 20 and the geometric shape of the beam path of the radiation 32 from the first radiation unit 30. In the example embodiment, the funnel 24 is filled with air. However it is also possible to fill the funnel 24 with another material which can be penetrated by the radiation emitted by the first radiation unit 30 [0079]); and recording the radiation dose of the subject using the fourth model.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ji, in view of Walker , Leghissa to an axis of the frustum is perpendicular to a coronal plane of the subject, a shape of a surface of the frustum corresponds to the shape of the beam limiter to relate to the region of a detector and to improve radiation dosage
Response to Arguments
35 USC § 101
Applicant’s arguments, filed 12/24/2025, with respect to claims 1-15 and 17-20 have been fully considered and are persuasive. The rejection of claims 1-15 and 17-20 has been withdrawn.
35 USC § 103
Applicant' s arguments with respect to claims 1-15 and 17-20 have been considered but are moot in view of new grounds of rejection.
With regards to disclosing “Ji does not disclose the relationship between the record mode and the scan mode, the determination of the record mode based on the scan mode, and related features”.
Ji discloses the record mode, i.e. “a presentation form of the radiation dose or a distribution of the radiation dose, and the record mode includes a radiation dose curve, a radiation dose model, a radiation dose table, or a radiation dose chart”, the scan mode, i.e., “a computed tomography (CT) scan and a digital radiography (DR) scan” as discussed above, and the relationship between the record mode and the scan mode according to the specification [0105], is set by a user .
With regards to disclosing “Applicant respectfully submits that Leghissa does not remedy the deficiencies of Ji and Walker set forth above with respect to claim 1. Specifically, Leghissa does not disclose "determining a record mode based on the scan mode based on a relationship between the record mode and the scan mode; recording the scan region and the radiation dose based on the record mode wherein the record mode refers to a presentation form of the radiation dose or distribution of the radiation dose, and the record mode includes a radiation dose curve, a radiation dose model, a radiation dose table, or a radiation dose chart; visualizing the distribution of the radiation dose in a visualization model of at least a portion of the subject; determining or adjusting a scan protocol of a next scan of the subject based on the visualization model; and performing the next scan by the medical device using the determined or adjusted scan protocol”.
Leghissa was a secondary reference and was primarily used to address “… a frustum” and according to MPEP 2145, “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871(CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant' s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).”
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARAH ZAAB whose telephone number is (571)272-4973. The examiner can normally be reached Monday - Friday 7:00 am - 4:30 pm.
/SHARAH ZAAB/Examiner, Art Unit 2857
/Catherine T. Rastovski/Supervisory Primary Examiner, Art Unit 2863