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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/30/2026 has been entered.
Response to Amendment
The amendment filed 01/30/2026 was entered. Claims 1-12 and 14-16 were pending. Applicant amends claims 1, 3, 8, 9 and 14-16. Accordingly, claims 1-12 and 14-16 remain pending
Response to Arguments
Applicants’ arguments with respect to the independent claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 – 12 and 14 -16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seppi et al. (US Pub. No. 2005/0084073 A1) in view of Tong et al. (US Pub. No. 2004/0179651 A1) and Banks et al. (US Pub. No. 2020/0359975 A1).
With regards to claims 1, 14 and 15, Seppi discloses a control apparatus comprising (Figure 1):
An image acquisition system 10 also includes at least one processor 54 [0026] (Figure 1) that is configured to:
acquire an elapsed time from injection of a contrast medium into a subject for which a radiation image is captured by a radiography apparatus (i.e., prescribed lapsed time) [0031] [0040],
acquire a low-energy image captured by the radiography apparatus by emitting radiation having first energy to the subject into which the contrast medium has been injected and a high-energy image captured by the radiography apparatus by emitting radiation having second energy higher than the first energy to the subject into which the contrast medium has been injected (i.e., see using 1st and 2nd radiation at different levels) [0024] [0030] [0031] [0042] [0067];
the availability of breast compressed by compression plate [0006] and
generate a difference image showing a difference between the low-energy image and the high-energy image [0032], [0047], [0040], [0051] – [0056] (Figure 3B).
Additionally, Seppi teaches various forms of computer-readable media may be involved in carrying one or more sequences of one or more instructions to the processor 904 for execution. The device relates to the use of computer system 900 for collecting and processing image data [0084]. Common forms of computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, or any other magnetic medium, a CD-ROM, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read [0086].
Accordingly, Seppi teaches the processor 54 [0026], elapsed time for contrast injection into breast [0006] [0030], low/high energy acquisition [0030] – [0032], difference/composite image generation and contrast/time analysis [0030] – [0032] and [0044],
Seppi fails to expressly disclose to derive a recaptured an image or recapture timing in combination with the mammography apparatus and exciting breast, wherein the breast is compressed by a compression plate in said mammography. Specifically, Seppi fails to expressly disclose to identify whether or not to perform re-capturing of the high-energy image of the subject into which the contrast medium has been injected, based on an analysis result about a contrast amount, which is performed on the difference image, and the elapsed, in combination with the rest of the claimed limitations.
Tong discloses an automated quality control for digital radiograph allowing initiation of a retake if needed [0021] – [0023].
Banks is concerned with breast compression paddle with unique paddle features (Abstract). FIG. 1 is a schematic view of a mammography and/or tomosynthesis system 5 using a compression paddle in imaging a patient's breast with x-rays [0026].
Banks further teaches a bottom wall 204 of the compression paddle 201 includes a generally concave surface 206, which generally may correspond in shape to a breast and/or a compressed breast. Generally, the compression paddles of the present technology described herein may be more comfortable to a patient undergoing breast compression during a mammogram or other x-ray imaging of the breast, as well as provide greater technician access to the breast for proper patient positioning. The compression paddles of the present technology described herein generally require less compression force to be applied to accomplish the same tautness as that of a known flat compression paddle. The particular shapes and contours disclosed herein may reduce or eliminate discomfort during breast compression, and allow for increased access to the breast, as described further below [0029] – [0040].
In view of the utility, to ensure diagnostic adequacy of contrast-enhanced images, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Seppi to include the teaching such as that taught by Tong and Banks.
With regards to claim 2, Seppi discloses the at least one processor 904 is configured to, in a case in which the at least one processor 904 identifies that the re-capturing is to be performed, derive a timing for performing the re-capturing based on the analysis result and the elapsed time (i.e., a volumetric composite image (or composite image data) is generated for a prescribed lapsed time after the injection of the contrast agent. Additionally, steps 204 and 206 can be repeated to generate additional volumetric composite images (or composite image data) for different lapsed time after the injection of the contrast agent) [0040]. Notice how
With regards to claim 3, Seppi discloses the at least one processor is configured to perform control of causing the radiography apparatus 10 to re-capture the high-energy image at the derived timing for performing the re-capturing (i.e., a volumetric composite image (or composite image data) is generated for a prescribed lapsed time after the injection of the contrast agent. Additionally, steps 204 and 206 can be repeated to generate additional volumetric composite images (or composite image data) for different lapsed time after the injection of the contrast agent) [0032] [0040] [0041].
With regards to claim 4, Seppi discloses wherein the at least one processor 904 is configured to, in a case in which a contrast of a region of interest in the difference image is equal to or greater than a predetermined threshold value, identify that the re-capturing is not to be performed regardless of the elapsed time (i.e., a volumetric composite image (or composite image data) is generated for a prescribed lapsed time after the injection of the contrast agent. Additionally, steps 204 and 206 can be repeated to generate additional volumetric composite images (or composite image data) for different lapsed time after the injection of the contrast agent) [0008], [0030], [0040], [0044], [0052] (Figure 3B). Notice the Seppi repeatedly teaches one energy below and one above the contrast agent K-edge [0029] – [0030], [0035].
With regards to claim 5, Seppi discloses the at least one processor is configured to, in a case in which a contrast of a region of interest in the difference image is smaller than a predetermined threshold value and the elapsed time is equal to or longer than a threshold value time, identify that the re-capturing is not to be performed (i.e., a volumetric composite image (or composite image data) is generated for a prescribed lapsed time after the injection of the contrast agent. Additionally, steps 204 and 206 can be repeated to generate additional volumetric composite images (or composite image data) for different lapsed time after the injection of the contrast agent) [0040] [0028] [0029] [0035] - [0041] [0046] [0061].
With regards to claim 6, Seppi discloses the at least one processor is configured to, in a case in which a contrast of a region of interest in the difference image is smaller than a predetermined threshold value and the elapsed time is shorter than a threshold value time, identify that the re-capturing is to be performed (i.e., a volumetric composite image (or composite image data) is generated for a prescribed lapsed time after the injection of the contrast agent. Additionally, steps 204 and 206 can be repeated to generate additional volumetric composite images (or composite image data) for different lapsed time after the injection of the contrast agent) [0040] [0028] [0029] [0035] - [0041] [0046] [0061].
With regards to claim 7, Seppi discloses the threshold value time is a time according to at least one of a type of the contrast medium, a blood flow of the subject, a height of the subject, a weight of the subject, or a type of an object of interest (i.e., a volumetric composite image (or composite image data) is generated for a prescribed lapsed time after the injection of the contrast agent. Additionally, steps 204 and 206 can be repeated to generate additional volumetric composite images (or composite image data) for different lapsed time after the injection of the contrast agent) [0030], [0040]. See steps 204 - 206 repeated for different lapsed times (Figure 2).
With regards to claim 8, Seppi discloses the subject is a breast, and the threshold value time is a time according to a mammary gland mass of the breast [0028] -[0030], [0035] - [0041] [0046] [0061].
With regards to claim 9, Seppi modified discloses at least one processor 904 is configured to: acquire the high-energy image by the radiography apparatus 10, and generate a difference image showing a difference between the low-energy image (i.e., notice how steps 204 and 206 can be repeated) [0030] [0040].
Seppi fails to expressly disclose a re-captured high-energy image in combination with the acquiring energy imaging.
Tong acquires additional images during retake procedures [0009], [0021] – [0023]. Tony teaches that a signal display unit 34 and operator control unit 35 are connected to signal control unit 32. Signal display unit 34, which acts in response to signaling from the signal control unit 32 for displaying to an operator that a radiographic image is unacceptable and for allowing initiation of a re-image, may be a bank of gauges or indicators, a computer monitor on which messages can be displayed, or a speaker through which sounds are produced, or any combination thereof [0017] – [0019], [0021] – [0024]
In view of the utility, to ensure diagnostic adequacy of contrast-enhanced images by including re-capturing to generate new images, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Seppi to include the teaching such as that taught by Tong.
With regards to claim 10, Seppi modified discloses in a case in which the at least one processor 904 identifies that the re-capturing is to be performed, the at least one processor 904 is configured to: also identify that re-capturing of the low-energy image is to be performed, and generate a re-captured difference image showing a difference between the re-captured low-energy image and the re-captured high-energy image (i.e., notice how steps 204 and 206 can be repeated) [0030] [0040]. Also see the rejection of claim 9.
With regards to claim 11, Seppi modified discloses the at least one processor 904 is configured to: perform the same image processing of enhancing a region of interest on the difference image and the re-captured difference image, and display the difference image and the re-captured difference image which have been subjected to the image processing (i.e., Seppi teaches that when it is desired to capture image data from the image elements 508, control signals are sent to a gate driver to "select" the gate(s) of transistors. Electrical signals from the photodiodes "selected" by the gate driver are then sent to charge amplifiers, which outputs image signals/data for further image processing/display) [0056] [0083]. Also see the rejection of claim 9.
With regards to claim 12, the method version reads on the same teachings as the processor in combination with the display teachings. As such, see the rejection of claim 9.
With regards to claim 13, Seppi discloses the subject is a breast, and the radiography apparatus is a mammography apparatus [0037].
With regards to claim 15, Seppi discloses the claimed invention according to claims 1 and 14 and additionally that common forms of computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, or any other magnetic medium, a CD-ROM, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read [0086]. Various forms of computer-readable media may be involved in carrying one or more sequences of one or more instructions to the processor 904 for execution [0081] – [0087].
With regards to claim 16, Seppi discloses the claimed invention according to claim 1, absent some degree of criticality, the recitations of wherein the at least one processor is configured to automatically identify whether or not to perform re-capturing of the high-energy image of the subject into which the contrast medium has been injected is considered only a matter of design choice involving routine skill of the art
For example, Tong et al. A digital radiographic system in which a digital detector captures digital radiographic image data based on exposure of a patient to x-ray energy from an x-ray source, and assesses the acceptability of the digital radiographic image data at a time before the radiographic protocol has otherwise ended. Additionally, the digital radiographic system signals whether the digital radiographic image data is unacceptable based on the assessment, and allows for the initiation of a retake. The assessment may be made based on acceptability of the exposure and/or based on the acceptability of motion artifacts in the image. If the image is unacceptable, the technologist is alerted that a re-image is needed, with the alert being made in real-time immediately after the image is captured (Abstract) [0021] –[0023].
Conclusion
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/DJURA MALEVIC/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884