DETAILED ACTION
This office action is in response to the communication received on September 30, 2025 concerning application No. 17/645,460 filed on December 22, 2021.
Claims 1, 4-6, 8-10, 15-25, and 27-28 are currently pending.
Claim 10 is currently withdrawn
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 filed 09/30/2025 regarding the 35 USC 112b rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112b rejection of claims 4-6, 8-9, 18-19, 21, and 23-25. Examiner notes the amendments have led to further 112b issues.
Applicant’s arguments with respect to claim(s) 1, 5, 17, and 20 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.
Applicant's arguments filed 09/30/2025 regarding the prior art rejection have been fully considered but they are not persuasive. In response to applicant’s arguments that the prior art of record fails to teach the newly amended claim limitations of claim 25, examiner respectfully disagrees. See the rejection of claim 25 below for further details on how Reiner is being applied to teach the new claim limitations.
In response to the applicant’s arguments regarding claim 6, the amendments to the claims in combination with applicant’s arguments have been entered and overcome the 35 USC 103 rejection of claim 6 previously set forth.
In response to applicant’s arguments on pgs. 32-36 regarding claim 16, that the prior art fails to teach “modifying at least part of prior information of a selected candidate subject based on a body shape difference between a candidate subject and the target subject; and designating the modified prior information as the target prior information of the target subject”, examiner respectfully disagrees. As set forth in previous office action [0025] and [0028] disclose “the virtual mathematical phantom may be generated by deforming an existing mathematical phantom to better match the size, shape, and/or organ positions of a patient being exposed to radiation in a CT scan”, where the existing phantom is considered the prior information of the candidate subject. The resulting hybrid phantom is then used in a dose simulation. Examiner further draws attention to [0047] which further clarifies the geometry and body shape of the mathematical model imaging phantom selected corresponds to the size, shape, and organ positions of an actual person having a CT procedure. As the claim is currently written it does not provide specific details on what is considered prior information and who exactly is considered the candidate subject. Therefore the broadest reasonable interpretation of the claim encompasses the candidate subject being a mathematical model imaging phantom that corresponds to the size, shape, and organ positions of an actual person. Further, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the prior information is a multi-dimensional collection of information (historical imaging scan parameter values, historical image reconstruction parameter values, historical scan data., etc.)” and “the ‘modifying’ can be multifaceted, for example, targeting different parameters in the prior information”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, in response to applicant’s arguments that the technologies of Couch and Reiner have completely different objects, examiner respectfully disagrees. Both Couch and Reiner relate to the determination of an optimal radiation dose, where the determination of a radiation dose of Couch corresponds to the determination of a scan parameter (radiation dose) of Reiner. For at least these reasons the combination of Reiner in view of Couch teaches the argued limitation recited above.
Regarding applicant’s arguments to claims 8-9, 21, and 27, as discussed above the rejection relies on a new reference to teach the claim amendments of claim 1, therefore the rejections of claims 8-9 and 27 stand. Examiner further notes that the Han and Reiner ‘834 references are not being relied upon for teaching limitations of claim 1.
In response to applicant’s argument that Reiner does not teach the limitations of new claim 28, examiner respectfully disagrees. See the rejection of claim 28 below for how the teachings of Reiner are being applied to teach the limitations of new claim 28.
Response to Amendment
The amendments to the claims have been entered. However, examiner notes the amendments made in claims 1, 17, and 20, specifically, the “a” in lines 21, 23, and 20 respectively, should be underlined as it was not previously present in the claims.
Claim Objections
Claims 1, 4, 8, 17, 19, 20, and 27 are objected to because of the following informalities:
Claim 1, line 14, “a value of a procedure” should read “the value of the procedure”,
Claim 1, line 28, “plurality of the candidate” should read “the plurality of candidate”,
Claim 4, lines 5-6, “ a value of a procedure” should read “the value of the procedure”,
Claim 8, line 4, “a prior information” should read “the prior information”,
Claim 17, line 17, “a value of a procedure” should read “the value of the procedure”,
Claim 1, lines 10-11, “plurality of the candidate” should read “the plurality of candidate”,
Claim 19, lines 2-3, “a plurality of simulation values…a plurality of simulation values” should read “the plurality of simulation values…the plurality of simulation values”,
Claim 20, line 13, “a value of a procedure” should read “the value of the procedure”,
Claim 20, line 27, “plurality of the candidate” should read “the plurality of candidate”,
Claim 27, line 3, “a prior information” should read “the prior information”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1, 4-6, 8-9, 15-25, and 27-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 17, and 20 recite the limitation “obtaining scan data…based on a value of the imaging scan parameter; generating an image of the target subject based on…a value of the image reconstruction parameter”, which is considered indefinite. It is not clear to the examiner whether the value of the imaging scan parameter and value of the image reconstruction parameter being used are one of the simulated parameter values or if they are values included within the procedure parameter. For the purpose of examination and this office action it is being interpreted that the value of the imaging scan parameter and the value of the image reconstruction parameter being used are the values that are included as part of the determined value of the procedure parameter.
Claim 5, recites the limitation “wherein the initial value is an expected value of an imaging scan parameter determined manually by a medical system” which is considered indefinite. It is not clear to the examiner how a medical system can manually determine a value of a parameter since the system is an electronic component and electronic components cannot perform manual determination. For the purpose of examination and this office action the claim is being interpreted as the medical system determines the value of the parameter electronically.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4-5, 15, 17-20, 22-25, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable by Reiner (US 20110270623) in view of Xia et al. (US 20220130520, hereinafter Xia).
Regarding claims 1 and 20, Reiner teaches a method for imaging (Abstract), implemented on a computing device (system 100 in fig. 1) having one or more processors (the electronic circuitry of system 100 in fig. 1. Also see [0036] “client computer 101”) and one or more storage devices ([0040] “memory 109” and “secondary storage devices 113”), and a non-transitory computer readable medium, comprising executable instructions that, when executed by at least one processor, direct the at least one processor to perform a method for imaging ([0044] discloses the processor 106 accesses the memory 109 which includes a stored sequency of code instructions for performing the operations), the method comprising:
obtaining feature information of a target subject ([0147] discloses in step 202, patient biometric information is inputted into the computer system. The biometric information is considered the feature information);
obtaining target prior information of the target subject based on the feature information of the target subject and a prior information database ([0147] discloses in step 203 the patient’s prior clinical, lab and image data is retrieved using the biometrics from at least one database), wherein the prior information database includes prior information of a plurality of candidate subjects ([0123] discloses the database includes exams from the patient as well as comparable exams from other patients); and
determining, based on the target prior information of the target subject, a value of a procedure parameter that relates to a procedure of the target subject using a medical device ([0123] discloses “based upon this multi-institutional analysis, optimal exposure parameters are presented by the program 110 to the technologist”, the exposure parameters are considered the value of a procedure parameter. [0123] further teaches the exposure parameter is related to a CT procedure), the procedure parameter including an imaging scan parameter at least relates to a radiation dose and an image reconstruction parameter ([0094] discloses the exposure parameter corresponds to a radiation dose, which is considered an imaging scan parameter. [0082] discloses the optimal peak signal-to-noise ratio (SNR) is determined, the SNR is considered the image reconstruction parameter), and the determining, based on the target prior information of the target subject, a value of a procedure parameter comprising:
determining, based on the target prior information of the target subject, a plurality of simulation values of the imaging scan parameter ([0083]-[0084] disclose an approach where an appearance of the image from the prior examination is simulated to generate images that simulate lower dose exposure studies, the parameters that simulate the lower radiation dose in each of the simulated images are considered the plurality of simulation values of the imaging scan parameter that relate to a radiation dose) and a plurality of simulation values of the image reconstruction parameter ([0083]-[0084] disclose an approach where an appearance of the image from the prior examination is simulated using various noise level values, the noise level values used for obtaining the simulated images are considered the simulation values);
determining a plurality of simulated images based on the plurality of simulation values of the imaging scan parameter and the plurality of simulation values of the image reconstruction parameter ([0083] discloses simulated images are obtained that represent the appearance of the prior image with the lower dose values and calculated noise level); and
determining the value of the procedure parameter based on the plurality of simulated images ([0084] discloses the values are used to generate simulated images which are used to determine an optimal dose, the optimal dose is considered the procedure parameter that is determined based on the simulated images), wherein the prior information database is established based on at least one of: simulation values of the imaging scan parameters of plurality of the candidate subjects, simulation values of the image reconstruction parameters of the plurality of candidate subject, simulation scan data of the plurality of candidate subject, simulated images of the plurality of candidate subject, or recommended values of procedure parameters of the plurality of candidate subjects ([0123] discloses the database includes optimal exposure parameters relied upon in previous exams which can be relied upon for determining the exposure parameters of the present exam. Therefore the database includes at least recommended values of procedure parameters of the plurality of candidate subjects that can be used for the current procedure parameters);
obtaining scan data of the target subject by causing the medical device to scan the target subject based on a value of the imaging scan parameter ([0223] discloses a CT image is acquired using the acquisition parameters determined from the database); and
generating an image of the target subject based on the scan data and a value of the image reconstruction parameter ([0315] discloses the technologist applied the noise reduction filter to decrease noise and enhance contrast resolution of the imaging data).
Reiner does not specifically teach the image reconstruction parameter includes a parameter of a reconstruction algorithm, the plurality of simulation values of the image reconstruction parameter are associated with different reconstruction algorithms, determining a plurality of simulated images based on the plurality of simulation values of the imaging scan parameter and the plurality of simulation values of the image reconstruction parameter associated with the different reconstruction algorithm, and using the image reconstruction parameter associated with the reconstruction algorithm to generate an image of the target subject.
However,
Xia in a similar field of endeavor teaches determining an image reconstruction parameter that includes a parameter of a reconstruction algorithm ([0046] discloses determining reconstruction parameters based on a variety of patient-specific factors), determining a plurality of simulation values of the image reconstruction parameter, the plurality of simulation values of the image reconstruction parameter are associated with different reconstruction algorithms ([0069] discloses using a variety of theoretical image reconstruction parameters that are adjustable, which include, reconstruction method, reconstruction kernel, noise reduction filter, slice thickness, and a system matrix that simulates the scanning process. Each of the reconstruction parameter types is considered its own reconstruction algorithm), determining a plurality of simulated images based on the plurality of simulation values of the imaging scan parameter and the plurality of simulation values of the image reconstruction parameter associated with the different reconstruction algorithm ([0069] discloses reconstructing the simulated 2D CT image based on the variety of image reconstruction parameters), and using the image reconstruction parameter associated with the reconstruction algorithm to generate an image of the target subject ([0056] discloses the optimal image reconstruction parameter is implemented within a full CT scan of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Reiner to have the image reconstruction parameter include a parameter of a reconstruction algorithm, the plurality of simulation values of the image reconstruction parameter are associated with different reconstruction algorithms, determining a plurality of simulated images based on the plurality of simulation values of the imaging scan parameter and the plurality of simulation values of the image reconstruction parameter associated with the different reconstruction algorithm, and using the image reconstruction parameter associated with the reconstruction algorithm to generate an image of the target subject in order to maximize image quality for diagnosis while minimizing radiation exposure to the patient, as recognized by Xia ([0043]).
Regarding claim 17, Reiner teaches a system for imaging (Abstract), comprising:
at least one storage device including a set of instructions ([0040] “memory 109 with a program 110”, the program is considered the set of instructions); and
at least one processor configured to communicate with the at least one storage device (([0044] discloses the processor 106 accesses the memory 109 which includes a stored sequency of code instructions for performing the operations), wherein when executing the set of instructions, the at least one processor is configured to direct the system to perform operations including:
obtaining feature information of a target subject ([0147] discloses in step 202, patient biometric information is inputted into the computer system. The biometric information is considered the feature information);
obtaining target prior information of the target subject based on the feature information of the target subject and a prior information database ([0147] discloses in step 203 the patient’s prior clinical, lab and image data is retrieved using the biometrics from at least one database), wherein the prior information database includes prior information of a plurality of candidate subjects ([0123] discloses the database includes exams from the patient as well as comparable exams from other patients); and
determining, based on the target prior information of the target subject, a value of a procedure parameter that relates to a procedure of the target subject using a medical device ([0123] discloses “based upon this multi-institutional analysis, optimal exposure parameters are presented by the program 110 to the technologist”, the exposure parameters are considered the value of a procedure parameter. [0123] further teaches the exposure parameter is related to a CT procedure), wherein the procedure parameter includes an imaging scan parameter at least relates to a radiation dose and an image reconstruction parameter ([0094] discloses the exposure parameter corresponds to a radiation dose, which is considered an imaging scan parameter. [0082] discloses the optimal peak signal-to-noise ratio (SNR) is determined, the SNR is considered the image reconstruction parameter), and the determining, based on the target prior information of the target subject, a value of a procedure parameter comprises:
determining, based on the target prior information of the target subject, a plurality of simulation values of the imaging scan parameter ([0083]-[0084] disclose an approach where an appearance of the image from the prior examination is simulated to generate images that simulate lower dose exposure studies, the parameters that simulate the lower radiation dose in each of the simulated images are considered the plurality of simulation values of the imaging scan parameter that relate to a radiation dose) and a plurality of simulation values of the image reconstruction parameter ([0083]-[0084] disclose an approach where an appearance of the image from the prior examination is simulated using various noise level values, the noise level values used for obtaining the simulated images are considered the simulation values);
determining a plurality of simulated images based on the plurality of simulation values of the imaging scan parameter and the plurality of simulation values of the image reconstruction parameter ([0083] discloses simulated images are obtained that represent the appearance of the prior image with the lower dose values and calculated noise level);and
determining the value of the procedure parameter based on the plurality of simulated images ([0084] discloses the values are used to generate simulated images which are used to determine an optimal dose, the optimal dose is considered the procedure parameter that is determined based on the plurality simulated images), wherein the prior information database is established based on at least one of: simulation values of the imaging scan parameters of plurality of the candidate subjects, simulation values of the image reconstruction parameters of the plurality of candidate subject, simulation scan data of the plurality of candidate subject, simulated images of the plurality of candidate subject, or recommended values of procedure parameters of the plurality of candidate subjects ([0123] discloses the database includes optimal exposure parameters relied upon in previous exams which can be relied upon for determining the exposure parameters of the present exam. Therefore the database includes at least recommended values of procedure parameters of the plurality of candidate subjects that can be used for the current procedure parameters);
obtaining scan data of the target subject by causing the medical device to scan the target subject based on a value of the imaging scan parameter ([0223] discloses a CT image is acquired using the acquisition parameters determined from the database); and
generating an image of the target subject based on the scan data and a value of the image reconstruction parameter ([0315] discloses the technologist applied the noise reduction filter to decrease noise and enhance contrast resolution of the imaging data).
Reiner does not specifically teach the image reconstruction parameter includes parameters of a reconstruction algorithm, the plurality of simulation values of the image reconstruction parameter are associated with different reconstruction algorithms, determining a plurality of simulated images based on the plurality of simulation values of the imaging scan parameter and the plurality of simulation values of the image reconstruction parameter associated with the different reconstruction algorithm, and using the image reconstruction parameter associated with the reconstruction algorithm to generate an image of the target subject.
However,
Xia in a similar field of endeavor teaches determining an image reconstruction parameter that includes parameters of a reconstruction algorithm ([0046] discloses determining reconstruction parameters based on a variety of patient-specific factors), determining a plurality of simulation values of the image reconstruction parameter, the plurality of simulation values of the image reconstruction parameter are associated with different reconstruction algorithms ([0069] discloses using a variety of theoretical image reconstruction parameters that are adjustable, which include, reconstruction method, reconstruction kernel, noise reduction filter, slice thickness, and a system matrix that simulates the scanning process. Each of the reconstruction parameter types is considered its own reconstruction algorithm), determining a plurality of simulated images based on the plurality of simulation values of the imaging scan parameter and the plurality of simulation values of the image reconstruction parameter associated with the different reconstruction algorithm ([0069] discloses reconstructing the simulated 2D CT image based on the variety of image reconstruction parameters), and using the image reconstruction parameter associated with the reconstruction algorithm to generate an image of the target subject ([0056] discloses the optimal image reconstruction parameter is implemented within a full CT scan of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Reiner to have the image reconstruction parameter include parameters of a reconstruction algorithm, the plurality of simulation values of the image reconstruction parameter are associated with different reconstruction algorithms, determining a plurality of simulated images based on the plurality of simulation values of the imaging scan parameter and the plurality of simulation values of the image reconstruction parameter associated with the different reconstruction algorithm, and using the image reconstruction parameter associated with the reconstruction algorithm to generate an image of the target subject in order to maximize image quality for diagnosis while minimizing radiation exposure to the patient, as recognized by Xia ([0043]).
Regarding claim 4, Reiner in view of Xia teaches the method of claim 1, as set forth above. Reiner further teaches a first modality corresponding to the scan data obtained by the medical device is the same as a second modality corresponding to the target prior information ([0072] discloses the acquisition parameters for a previous examination stored in the database can be used for the current examination, meaning the first modality and second modality are the same. Also see [0081]), the target prior information includes a candidate value of the imaging scan parameter of the target subject ([0072] discloses the acquisition parameters are displayed as optimized acquisition parameters to be used by the tech, the optimized acquisition parameters are considered the candidate value of the imaging scan parameter. [0081] also discloses determined optimized imaging parameters based on the prior examination), and the determining, based on the target prior information of the target subject, a value of a procedure parameter comprises:
determining the plurality of simulation values of the imaging scan parameter based on a candidate value of the imaging scan parameter ([0083]-[0084] disclose an approach where an appearance of the image from the prior examination is simulated using various noise level values, the noise level values used for obtaining the simulated images are considered the simulation values), wherein the candidate value of the imaging scan parameter of the target subject is obtained based on the target prior information ([0084] discloses the noise level in the standard image is defined as x (candidate value) and is therefore determined from the standard image which represents the target prior information);
for each simulation value of the plurality of simulation values of the imaging scan parameter, determining simulation scan data based on candidate scan data, the candidate value of the imaging scan parameter, and the simulation value of the imaging scan parameter ([0084] discloses the synthesized images are based on “standard” image (candidate scan data), the calculated parameter value x (candidate value) and the simulated value using the created noise levels), wherein the candidate scan data is obtained based on the target prior information ([0084] discloses the data is determined from the standard image which represents the target prior information); and
for each simulation value of the plurality of simulation values of the image reconstruction parameter, generating a simulated image of the plurality of simulated images based on the simulation scan data and the simulation value of the image reconstruction parameter ([0083] discloses simulated images are obtained that represent the appearance of the prior image with the lower dose values and calculated noise levels. The noise level is considered the image reconstruction parameter); and
determining the value of the procedure parameter based on the plurality of simulated images ([0084] discloses the simulated images are used to determine an optimal dose, the optimal dose is considered the procedure parameter).
Regarding claim 5, Reiner in view of Xia teaches the method of claim 1, as set forth above. Reiner further teaches the determining based on the target prior information of the target subject, a plurality of simulation values of the imaging scan parameter and a plurality of simulation values of the image reconstruction parameter comprises:
obtaining an initial value of the imaging scan parameter ([0083]-[0084] discloses obtaining an initial acquisition parameter value x);
obtaining an initial image corresponding to the initial value of the imaging scan parameter from a dose simulation model ([0083]-[0084] disclose a prior image is obtained that is based on the initial acquisition value x and the initial dose (candidate level) using the program 110 (dose simulation model)); and
determining at least one of the plurality of simulation values of the imaging scan parameter based on the initial image and the initial value of the imaging scan parameter ([0084] discloses the simulation values used are based on the prior image (initial image) and the calculate parameter level x (initial value)).
Xia further teaches obtaining an initial value of the imaging scan parameter, wherein the initial value is an expected value of an imaging scan parameter determined manually by a medical system ([0048] discloses using an initial set of scan acquisition parameters the system determined based on previous sets of scan acquisition parameters);
inputting the initial value of the imaging scan parameter, a candidate value of the imaging scan parameter, and an image corresponding to the candidate value of the imaging scan parameter into a dose simulation model ([0048] discloses the system uses the initial scan acquisition parameter and scout scan data (image corresponding to the candidate value) to generate a simulated image. [0046] discloses a fraction of a radiation dose (candidate value) is used to generate the scout scan data. The electronic circuitry of the system that generates the simulated image is considered the dose simulation model),
obtaining an initial image corresponding to the initial value of the imaging scan parameter from the dose simulation model ([0048] discloses generating a simulated image based on the initial scan acquisition parameter), wherein the candidate value of the imaging scan parameter of the target subject is obtained based on the target prior information ([0046] discloses the dose used for generating the scout data is a fraction of a full dose (target prior information)), and
determining at least one of the plurality of simulation values of the imaging scan parameter based on the initial image and the initial value of the imaging scan parameter ([0056] and fig. 1 disclose generating the optimized imaging protocol parameters based on the simulated image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Reiner in view of Xia to have the determining based on the target prior information of the target subject, a plurality of simulation values of the imaging scan parameter and a plurality of simulation values of the image reconstruction parameter comprises: obtaining an initial value of the imaging scan parameter, wherein the initial value is an expected value of an imaging scan parameter determined manually by a medical system; inputting the initial value of the imaging scan parameter, a candidate value of the imaging scan parameter, and an image corresponding to the candidate value of the imaging scan parameter into a dose simulation model, obtaining an initial image corresponding to the initial value of the imaging scan parameter from the dose simulation model, wherein the candidate value of the imaging scan parameter of the target subject is obtained based on the target prior information, and determining at least one of the plurality of simulation values of the imaging scan parameter based on the initial image and the initial value of the imaging scan parameter in order to maximize image quality for diagnosis while minimizing radiation exposure to the patient, as recognized by Xia ([0043]).
Regarding claim 15, Reiner in view of Xia teaches the method of claim 1, as set forth above. Reiner further teaches the target prior information includes a recommended value of the procedure parameter ([0072] discloses the database includes acquisition parameters from comparable examinations, which are considered recommended values of the procedure parameter), and the determining, based on the target prior information of the target subject, a value of a procedure parameter comprises:
determining whether the recommended value of the procedure parameter satisfies a scan condition of the target subject ([0072] discloses the acquisition parameters with the highest recorded image quality are identified, the identification of the acquisition parameters with the highest image quality is considered the determination that the recommended value satisfies a scan condition of the target subject); and
in response to determining that the recommended value of the procedure parameter satisfies the scan condition, determining the value of the procedure parameter based on the recommended value of the procedure parameter ([0072] discloses the optimized acquisition parameters are determined and provided to the technologist from the identified acquisition parameters, meaning the value of the procedure parameter is based on the recommended value of the procedure parameter).
Regarding claim 18, Reiner in view of Xia teaches the system of claim 17, as set forth above. Reiner further teaches a first modality corresponding to scan data obtained by the medical device is the same as a second modality corresponding to the target prior information ([0072] discloses the acquisition parameters for a previous examination stored in the database can be used for the current examination, meaning the first modality and second modality are the same. Also see [0081]), and the target prior information includes a candidate value of the imaging scan parameter of the target subject ([0072] discloses the acquisition parameters are displayed as optimized acquisition parameters to be used by the tech, the optimized acquisition parameters are considered the candidate value of the imaging scan parameter. [0081] also discloses determined optimized imaging parameters based on the prior examination).
Regarding claim 19, Reiner in view of Xia teaches the system of claim 17, as set forth above. Reiner further teaches the determining based on the target prior information of the target subject, a plurality of simulation values of the imaging scan parameter and a plurality of simulation values of the image reconstruction parameter comprises:
obtaining an initial value of the imaging scan parameter ([0083]-[0084] discloses obtaining an initial acquisition parameter value x);
obtaining an initial image based on the initial value of the imaging scan parameter and a candidate value of the imaging scan parameter using a dose simulation model ([0083]-[0084] disclose a prior image is obtained that is based on the initial acquisition value x and the initial dose (candidate level) using the program 110 (dose simulation model)), wherein the candidate value of the imaging scan parameter of the target subject is obtained based on the target prior information ([0084] discloses the noise level in the standard image is defined as x (candidate value) and is therefore determined from the standard image which represents the target prior information); and
determining at least one of the plurality of simulation values of the imaging scan parameter based on the initial image and the initial value of the imaging scan parameter ([0084] discloses the simulation values used are based on the prior image (initial image) and the calculate parameter level x (initial value)).
Regarding claim 22, Reiner in view of Xia teaches the method of claim 1, as set forth above. Reiner further teaches capturing image data of the target subject by an image capturing device ([0230] discloses in step 311 a full study according the exam order is performed on the patient. [0220]-[0221] discloses the examination includes a CT exam which includes capturing a CT image of the patient using a CT scanner (image capturing device)); and
determining the feature information of the target subject based on the image data according to an image analysis algorithm ([0231] discloses in step 312 the program calculates an exam radiation dose (feature information) from the exam and records the dose in a database).
Regarding claim 23, Reiner in view of Xia teaches the method of claim 4, as set forth above. Reiner further teaches determining simulation scan data based on the candidate scan data, the candidate value of the imaging scan parameter, and the simulation value of the imaging scan parameter ([0083]-[0084] discloses the synthesized images are based on “standard” image (candidate scan data), the calculated parameter value x (candidate value) and the simulated value using the created noise levels) comprising:
determining the simulation scan data corresponding to the simulation value of the imaging scan parameter by adding noise in the candidate scan data based on the candidate value of the imaging scan parameter, the simulation value of the imaging scan parameter, and a statistical distribution function of the noise ([0083]-[0084] discloses “progressively higher noise images would be generated by the program 110 introducing noise into the image to simulate lower exposure studies”, the sequential noise levels used are a statistical distribution function of the calculated noise level of the image as shown in [0084]. The varying levels of noise are considered the simulated values of the imaging scan parameter).
Regarding claim 24, Reiner in view of Xia teaches the method of claim 4, as set forth above. Reiner further teaches determining simulation scan data based on the candidate scan data, the candidate value of the imaging scan parameter, and the simulation value of the imaging scan parameter ([0083]-[0084] discloses the synthesized images are based on “standard” image (candidate scan data), the calculated parameter value x (candidate value) and the simulated value using the created noise levels) comprising:
generating the simulation scan data based on the candidate scan data according to a statistical correlation between the simulation scan data corresponding to a relatively low radiation dose and the candidate scan data corresponding to a relatively high radiation dose using a low-dose simulation algorithm ([0083]-[0084] disclose generating progressively higher noise images using a percentage of the calculated noise level from the standard image (candidate scan data) to simulate lower exposure radiation doses using the program 110 (low-dose simulation algorithm). The radiation dose of the standard image is considered the relatively high radiation dose and the simulated images correspond to simulation scan data with a relatively low radiation dose).
Regarding claim 25, Reiner in view of Xia teaches the method of claim 23, as set forth above. Reiner further teaches determining simulation scan data based on the candidate scan data, the candidate value of the imaging scan parameter, and the simulation value of the imaging scan parameter comprising:
determining the simulation scan data based on the candidate scan data, the candidate value of the imaging scan parameter, and the simulation value of the imaging scan parameter, according to a low-dose simulation algorithm ([0083]-[0084] discloses using program 110 to synthesize images that are based on “standard” image (candidate scan data), the calculated parameter value x (candidate value) and the simulated value using the created noise levels. The program 110 is considered the low-does simulation algorithm); and
optimizing a low-dose simulation algorithm based on prior information in the prior information database ([0185]-[0216] discloses the program 110 utilizes historical imaging data in order to determine the optimal radiation dose for the patient. by utilizing historical data the program is being optimized based on prior information in the prior information database), including:
determining and/or adjusting empirical parameters of the low-dose simulation algorithm based on historical data corresponding to a first imaging scan parameter and historical data corresponding to a second imaging scan parameter, wherein a value of the first imaging scan parameter is greater than a value of the second imaging scan parameter ([0201]-[0204] disclose low dose (second imaging parameter) and ultra-low dose (first imaging parameter) radiation doses are used to optimize the program 110).
Regarding claim 28, Reiner in view of Xia teaches the method of claim 1, as set forth above. Reiner further teaches the obtaining the target prior information of the target subject based on the feature information of the target subject and the prior information database comprises:
determining whether the prior information database includes a recommended radiation dose of the target subject ([0222] discloses the determining whether prior on-site imaging studies were performed), and
in response to determining that the prior information database does not include the recommended radiation dose of the target subject ([0222]-[0229] discloses in response to a lack of prior on-site imaging studies (no recommended radiation dose) performing the steps by the program 110):
obtaining the target prior information of the target subject based on the feature information of the target subject and the prior information database ([0223] discloses acquiring a sample test CT image from the region of interest of the subject).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reiner in view of Xia as applied to claim 1 above, and further in view of Han (US 20190362522).
Regarding claim 8, Reiner in view of Xia teaches the method of claim 1, as set forth above. Reiner further teaches a first modality of the medical device is different from a second modality corresponding to the target prior information ([0124] discloses the previous obtained radiographs (second modality) are used for determined the optimal exposure parameters for the current CT image (first modality). Also see [0150], [0165] which disclose historical radiograph image studies and current CT studies).
Reiner in view of Xia does not specifically teach the obtaining target prior information of the target subject based on the feature information of the target subject and a prior information database comprises: inputting a second image of the second modality and a value of procedure parameter corresponding to the second image into a trained modality model; and outputting, by the trained modality model, a first image of the first modality and a value of the procedure parameter corresponding to the first image, the value of the procedure parameter corresponding to the first image including the candidate value of the imaging scan parameter, wherein the candidate value of the imaging scan parameter of the target subject is obtained based on the target prior information.
However,
Han in a similar field of determining proper radiation does teaches inputting a second image of the second modality and a value of procedure parameter corresponding to the second image into a trained modality model; and outputting, by the trained modality model, a first image of the first modality and a value of the procedure parameter corresponding to the first image ([0040] “the software program 44 may include image processing programs to train a predictive model for converting a medical image 46 in one modality (e.g., an MRI image) into a synthetic image of a different modality (e.g., a pseudo CT image)”. [0043] disclose generating updated parameters (value of the procedure parameters corresponding to the first image) which include radiation dosage based on the medical image 46 and a previously used radiation dosage), the value of the procedure parameter corresponding to the first image including a candidate value of the imaging scan parameter, wherein the candidate value of the imaging scan parameter of the target subject is obtained based on the target prior information ([0043]-[0044] and [0088] disclose using the synthetic image to determine a radiation therapy plan. The determined radiation therapy treatment plan includes a radiation dose to be used. The radiation dose used for the synthetic image is considered the candidate value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Reiner to have the obtaining target prior information of the target subject based on the feature information of the target subject and a prior information database comprises: inputting a second image of the second modality and a value of procedure parameter corresponding to the second image into a trained modality model; and outputting, by the trained modality model, a first image of the first modality and a value of the procedure parameter corresponding to the first image, the value of the procedure parameter corresponding to the first image including the candidate value of the imaging scan parameter, wherein the candidate value of the imaging scan parameter of the target subject is obtained based on the target prior information in order to determine the radiation therapy plan without exposing a patient to ionizing radiation, as recognized by Han ([0088]).
Regarding claim 9, Reiner in view of Xia and Han teaches the method of claim 8, as set forth above. Reiner further teaches the first modality or the second modality includes at least one of an ultrasound imaging, an X-ray imaging, a computed tomography (CT), a magnetic resonance imaging (MRI), a single photon emission computed tomography (SPECT), or a positron emission tomography (PET) ([0223] discloses the acquired image is a CT image, which corresponds to the first modality. [0124] discloses the previously acquired image are radiographs, which corresponds to X-ray imaging and the second modality).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reiner in view of Xia and Han as applied to claim 8 above, and further in view of Eriksson et al. (US 20200254277, hereinafter Eriksson).
Regarding claim 21, Reiner in view of Xia and Han teaches the method of claim 8, as set forth above. Reiner further teaches the trained modality model is obtained according to a process including:
obtaining a plurality of training samples ([0071] discloses recording image quality data into a database to be used by the program 110 for training); each of which includes a sample value of the imaging scan parameter ([0072] discloses the database includes comparable acquisition parameters used on previous examinations, the comparable acquisition parameters are considered the sample imaging scan parameter), and
determining the trained modality model by training a preliminary model based on the plurality of training samples ([0071] discloses the image quality data is used by the program 110 for training, the program 110 that is generated after training is considered the dose simulation model and the program before training is considered the preliminary model).
Reiner in view of Xia and Han does not specifically teach each of the plurality of training samples includes a sample image corresponding to the sample value of the imaging scan parameter, a reference value of the imaging scan parameter, and a reference image corresponding to the reference value of the imaging scan parameter.
However,
Eriksson in a similar field of endeavor teaches training a dose simulation model using a plurality of training samples that include a sample image corresponding to the sample value of the imaging scan parameter ([0047] discloses the training data includes image data and [0055] discloses the images disclose the dose distribution, meaning they correspond to values of the imaging scan parameter), a reference value of the imaging scan parameter ([0084] discloses the training data includes radiation dose levels, the radiation dose level used is considered the reference value), and a reference image corresponding to the reference value of the imaging scan parameter ([0046] further discloses the training data includes the particular dose that is applied to a patient and [0047] discloses the training database includes image data, therefore the training data includes a reference image corresponding to the reference value of the imaging scan parameter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Reiner in view of Xia and Han to have each of the plurality of training samples includes a sample image corresponding to the sample value of the imaging scan parameter, a reference value of the imaging scan parameter, and a reference image corresponding to the reference value of the imaging scan parameter in order to verify that the model correctly simulates the delivery of a dose that matches the calculated dose, thereby ensuring that the model is outputting the most accurate dose recommendations, as recognized by Eriksson ([0056]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reiner in view of Xia as applied to claim 1 above, and further in view of Couch et al. (US 20120148131, hereinafter Couch).
Regarding claim 16, Reiner in view of Xia teaches the method of claim 1, as set forth above. Reiner in view of Xia does not specifically teach modifying at least part of prior information of a selected candidate subject based on a body shape difference between a candidate subject and the target subject; and designating the modified prior information as the target prior information of the target subject.
However,
Couch in a similar field of endeavor teaches modifying at least part of prior information of a selected candidate subject based on a body shape difference between a candidate subject and the target subject ([0025] “the virtual mathematical phantom may be generated by deforming an existing mathematical phantom to better match the size, shape, and/or organ positions of a patient being exposed to radiation in a CT scan”, the existing mathematical phantom is considered the prior information); and
designating the modified prior information as the target prior information of the target subject ([0028] “the resulting hybrid phantom provides a much more accurate mathematical representation of a particular patient to use in a dose simulation”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Reiner in view of Xia to have modified at least part of prior information of a selected candidate subject based on a body shape difference between a candidate subject and the target subject; and designating the modified prior information as the target prior information of the target subject in order to obtain a more accurate radiation dose determination, as recognized by Couch ([0028]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reiner in view of Xia as applied to claim 1 above, and further in view of Reiner (US 20080103834, hereinafter Reiner ‘834).
Regarding claim 27, Reiner in view of Xia teaches the method of claim 1, as set forth above. Reiner in view of Xia does not specifically teach the obtaining target prior information of the target subject based on the feature information of the target subject and a prior information database comprises: determining degree of similarity between the plurality of candidate subjects and the target subject based on the feature information of the target subject and feature information of the plurality of candidate subjects; selecting a candidate subject with a highest degree of similarity to the target subject among the plurality of candidate subjects in the prior information database; and designating prior information of the selected candidate subject as the target prior information of the target subject.
However,
Reiner ‘834 in a similar field of endeavor teaches the obtaining target prior information of the target subject based on the feature information of the target subject and a prior information database ([0277]—[0278] disclose obtaining target prior information from a prior information database 113, 114) comprises:
determining degree of similarity between the plurality of candidate subjects and the target subject based on the feature information of the target subject and feature information of the plurality of candidate subjects ([0278] discloses “the program 110 would identify those comparable exams (e.g., low dose chest CT), performed on patients with similar body habitus…from this list of database candidates, the program 110 would than identify those exams performed for similar clinical indications and on comparable technology”);
selecting a candidate subject with a highest degree of similarity to the target subject among the plurality of candidate subjects in the prior information database ([0278] discloses identifying the candidate with similar clinical indications that used comparable technology, thereby identifying the candidate that is most similar to the current target subject); and
designating prior information of the selected candidate subject as the target prior information of the target subject ([0279] the program 110 then derives optimized acquisition parameters based on the exam determined from the database).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Reiner in view of Xia to have the obtaining target prior information of the target subject based on the feature information of the target subject and a prior information database comprises: determining degree of similarity between the plurality of candidate subjects and the target subject based on the feature information of the target subject and feature information of the plurality of candidate subjects; selecting a candidate subject with a highest degree of similarity to the target subject among the plurality of candidate subjects in the prior information database; and designating prior information of the selected candidate subject as the target prior information of the target subject in order to maximize image quality and reduce radiation dose, as recognized by Reiner ‘834 ([0277]).
Allowable Subject Matter
Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record fails to reasonably teach or in combination ender obvious the following limitations when the claims taken as a whole to include, “the dose simulation model is obtained according to a process including: obtaining a plurality of training samples each of which includes a sample value of the imaging scan parameter, a sample image corresponding to the sample value of the imaging scan parameter, a reference value of the imaging scan parameter, and a reference image corresponding to the reference value of the imaging scan parameter; and determining the dose simulation model by training a preliminary model based on the plurality of training samples”. Where the dose simulation model is a model that outputs an initial image from an initial value of the imaging scan parameter, a candidate value of the imaging scan parameter, and an image corresponding to the candidate value of the imaging scan parameter that are input into the model.
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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/ANDREW W BEGEMAN/Examiner, Art Unit 3798