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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on11/12/2025 was being considered by the examiner.
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, 6, 7 and 10 - 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merckx (US Pub. No. 2017/0112460 A1) in view of Hu (US Pub. No. 2015/0327830 A1) and Jockel et al. (US Pub. No. 2015/0228071 A1).
With regards to claim 1, Merckx discloses a method and system for configuring an x-ray imaging system (FIG. 3). The X-ray imaging system according to FIG. 1 or FIG. 2 is obtained from a depth image or merged depth image 302 obtained from the depth cameras 101 and 102 or 201. In the depth image 302, the subject 305, a person in this example, is represented. Merckx teaches many configurations.
According to a configuration, the radiation parameters of the X-ray source 108 are configured. These parameters may comprise the current delivered to the X-ray source, the voltage delivered to the X-ray source and the exposure time [0083]. The combination of the transmission lengths and tissue type attenuation factors can also be used to calculate dose settings for a specific wanted contrast ratio [0101].
The X-ray imaging system also comprises a supporting table with ionization chambers. Each of these chambers is configured to measure the amount of radiation received from the X-ray source. The measured amount is then used for Automatic Exposure Control or AEC. If a sufficient amount of radiation is measured in the chambers underneath the object, the radiation is stopped and a sufficiently exposed X-ray image is guaranteed. In order for this to work correctly, it is necessary to only activate the chambers under the subject or the object [0045]-[0054],[0088]-[0096], [0101]-[0103] (Figures 1, 3-7).
FIG. 7 illustrates how this is performed in an automated way using the obtained depth image 702. First the table 709 is identified in the depth image 702. This may be done by image recognition or by the known current position configuration of the table. The steps performed for configuring the X-ray imaging system may further be performed iteratively. After the configuring, i.e. position configuration, resizing configuration and dose configuration, a new set of depth images may be obtained and a new configuring is then performed. The position configuration and resizing configuration may be performed first in one or more steps followed by a dose configuration in the final step [0045]-[0054],[0088]-[0096], [0101]-[0103] (Figures 1, 3-7).
Merckx fails to expressly disclose acquiring an initial exposure parameter usable by the medical device for performing exposure and updating the initial exposure parameter based on the estimated attenuation amount and finally, determining, based on the initial relative position information, the contour information, and real-time position information of the examination component. Merckx is focused on automatic configuration for depth images and on position/size corrections, and fails to make clear and explicit initial parameter acquisition as claimed.
Hu discloses a medical equipment 100 is arranged to include an X-ray source generator 1, a collimator 2, and a detector 3. The X-ray source generator I is combined with the collimator 2 and the detector 3 is arranged at a location that is spaced from the X-ray source generator 1 by a predetermined distance. Hu further includes an automatic exposure parameter control system 200 is provided and combined with the medical equipment 100, so that the automatic exposure parameter control system 200 controls various exposure parameters of the X-ray source generator 1 of the medical equipment 100. Notice how the automatic exposure parameter control system 200 according to the present invention comprises a processor unit 5, a depth camera 6, a body thickness computation unit 71, an X-ray energy computation and conversion unit 72, a data memory device 73, an X-ray energy generation unit 75, and a display device 8 [0018] – [0021].
Hu also includes a processor unit 5, upon receiving the X-ray energy output value s1 transmitted from the X-ray energy computation and conversion unit 72, generates an X-ray energy control signal s2 to the X-ray energy generation unit 75, so that the X-ray energy generation unit 75 selects and transmits, according to the X-ray energy control signal s2, one of exposure parameters s21, s22, s23 to the X-ray source generator 1 to allow the X-ray source generator 1 to generate, based on the exposure parameter, an X-ray beam 11 aiming at a selected human body portion 41 of the target human body 4 [0029] – [0031].
Jockel teaches a system and method for automatically of semi-automatically control an x-ray imaginer in combination with making adjustments to the x-ray imaging which includes an alignment and operation based on 3d image data (Abstract).
Spatial 3D (three-dimensional; contours) shape data of the object (for example a patient), anatomical body landmarks derived therefrom and a given x-ray imager geometry are together used to control i) patient-specific collimation to a desired anatomy of interest and/or ii) patient specific imager alignment (such as tube and detector orientation relative to patient) and/or exposure lock to avoid x-ray exposure during patient movement[0008] –[0012];[0014]-[0028];[0033]-[0045];[0052]-[0063];[0068]-[0080] (Figures 1-3).
In view of the utility, to reduce retakes and dose by using non-ionizing parameter selection step, it would have been obvious to a person of ordinary skill of the art at the time the invention was made to modify Merckx to include the teachings such as that taught by Hu and Jockel.
With regards to claim 6, Merckx discloses a supporting table on or against which the subject/object is positioned [0017] [0054], and thickness may be derived using that background surface (i.e. table) [0053]- [0055], [0073]- [0084], [0097],[0102],[0104]; (Figures 1-2, and 7).
Merckx already teaches a table/bed relation and adjustability [0082], but fails to expressly disclose the examination component further comprises an examination table, the initial relative position information of the test subject relative to the examination component including initial relative position information of the test subject relative to the examination table.
Jockel table/bed-based x-ray arrangements [0033] [0068]. Jockel defines imager geometry/alignment data to include patient bed position [0025] – [0028].
In view of the utility, to use the same contour/position workflow when a patient lies on an examination table rather than standing, it would have been obvious to a person of ordinary skill of the art at the time the invention was made to modify Merckx to include the teachings such as that taught by Hu and Jockel.
With regards to claim 7, Merckx discloses the claimed invention according to claim 1 and further obtaining one or more depth images of the subject and determines size/thickness/position from those images [0011] – [0017], [0086] - [0096].
Merckx fails to disclose acquiring an initial image of the test subject located in the medical device. Notice that Merckx initial depth-image acquisition is substantially the same in function [0012] - [0018], [0086] - [0096].
Jockel teaches different approaches are envisaged to detect the anatomic landmarks to so realize a patient-adaptive X-ray collimation. For example, patient's chest portion is expected in front of the detector with source-detector distance SID known which helps to identify, solely based on the shape information in the received 3D data, relevant body landmarks like shoulders and left and right torso flanks by means of the depth image. For example, 3D analyzer iterates row by row through depth values of 3D image data supplied by camera RC and once a significant change is registered the torso's flanks are assumed to have been found [0053] – [0063].
In view of the utility, to use the same contour/position workflow to coordinate anatomic landmarks with initial depth-image acquisition (i.e., the first data set being first-acquired depth), it would have been obvious to a person of ordinary skill of the art at the time the invention was made to modify Merckx to include the teachings such as that taught by Jockel.
With regards to claim 10, Merckx discloses non-transitory computer-readable storage medium with an executable program stored thereon, that when executed, causes a processor to perform the method of claim 1 [0089], [0104], [0105].
With regards to claim11, Merckx discloses a computer program product, embodied on a non-transitory computer-readable storage medium, and including a computer program that when executed by a processor, causes the processor to perform the method as claimed in claim 1 [0089], [0104], [0105].
With regards to claim 12, see the rejection of claims 1, 10 and 11. Claim 12 is directed to an apparatus that mirrors method claim 1.
With regards to claim 13, see the rejection of claim 1. Claim 13 is the processor/memory implementation of claim 1. As far as the claimed processor and memory in communicative connection with the processor and a storing computer program, Mercky teaches that all steps performed in the controller 850 may be implemented in software that can be compiled to processor instructions. These instructions then run on a processor 850 in the controller upon execution. Automated steps for configuring the X-ray imaging system according to the FIGS. 3 to 7 are performed on a controller 850 as illustrated in FIG. 8. The controller 850 as part of the X-ray imaging system 800 receives one or more depth images from the depth camera(s) 801 [0103] - [0105].
Claim(s) 2 - 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merckx (US Pub. No. 2017/0112460 A1), Hu (US Pub. No. 2015/0327830 A1) and Jockel et al. (US Pub. No. 2015/0228071 A1) in view of Zhang et al. (CN 103462628 A).
With regards to claim 2, Merckx discloses the claimed invention according to claim 1 and further teaches determining thickness/transmission length through the object form depth images and using that information in exposure configuration [0011] –[0017], [0045]-[0054],[0096]-[0101].
Merckx fails to expressly disclose more specific step of determining size information of a part of the test subject lying in a ray path from the radiation source until received by a detector in addition to determining the attenuation amount base on the ray-path size data.
Zhang discloses calculates thickness along the ray path using known source-detector, source to surface and detector to surface distances at different projection projections [0035] – [0037], source to detector distance and measured source to object and detector to object distance [0030] –[0032],[0035]-[0037] and to resolve the attenuation [0035] –[0037],[0045]-[0050] (Claim 9)(Claim 18)(Figure 4),( Figures 9-10).
In view of the utility, to seek more accurate attenuation estimation and lower dose by enhanced matching exposure to actual path length of X-rays through the subject, it would have been obvious to a person of ordinary skill of the art at the time the invention was made to modify Merckx to include the teachings such as that taught by Zhang
With regards to claim 3, Merckx discloses the claimed invention according to claim 2 and further teaches sensed depth/thickness and position to scale an anatomic model using the scaled model to calculate approximate transmission lengths [0093]-[0096], [0101]-[0103].
Merckx does not by itself state the virtual system model in exact claimed language requiring both a virtual subject model and a virtual component model corresponding to the examination component.
Jockel uses 3D data plus current geometry/alignment data and queried geometry to compute desired geometry and generalized 3D body model fitted/scaled to the sensed patient body shape [0025] – [0028], [0058], [0060]- [0063], [0071]- [0078].
In view of the utility, to improve anatomical localization and exposure accuracy, it would have been obvious to a person of ordinary skill of the art at the time the invention was made to modify Merckx to include the teachings such as that taught by Jockel.
With regards to claim 4, Merckx discloses the claimed invention according to claim 4 and further teaches model based, patient-specific estimation of transmission lengths and exposure parameters after geometric reconfiguration [0045]-[0054],[0101]-[0103].
Merckx fails to disclose constructing the virtual subject model relative to a pre-stored virtual component model and updating that virtual component model based on real-time position information of the examination component.
Jockel defines image geometry/alignment data as the coordinated description of the tube, detector collimator, sensor and patient bed in space [0025]- [0028], [0033]-[0040],[0060]-[0063]. Jockel fitted body model identifies anatomy from the model [0058].
In view of the utility, to improve anatomical localization and exposure accuracy especially for the exact patient -specific geometry, it would have been obvious to a person of ordinary skill of the art at the time the invention was made to modify Merckx to include the teachings such as that taught by Jockel.
With regards to claim 5, Merckx discloses the claimed invention according to claim 4 and further teaches using an anatomical model scaled t the sensed patient to compute approximate transmission lengths through tissue types and to derive patient specific exposure parameters [0101].
Merckx fails to disclose constructing the virtual subject model relative to the virtual component model comprises: constructing the virtual subject model relative to the virtual component model based on the initial relative position information, the contour information of the test subject, and a virtual organ model, the virtual organ model being a virtual model pre-stored in the medical device and useable to determine an absorption characteristic for rays of the part of the test subject that lies in the ray path; and determining the size information of the part of the test subject comprises: determining size information and an absorption characteristic for the rays of the part of the test subject based on the virtual system model.
Joclel teaches a generalized 3Dvody model with segmented and annotated organs [0058].
Zhang discloses calculates thickness along the ray path using known source-detector, source to surface and detector to surface distances at different projection projections [0035] – [0037], source to detector distance and measured source to object and detector to object distance [0030] –[0032],[0035]-[0037] and to resolve the attenuation [0035] –[0037],[0045]-[0050] (Claim 9)(Claim 18)(Figure 4)( Figures 9-10).
In view of the utility, to improve patient specific attenuation estimates, it would have been obvious to a person of ordinary skill of the art at the time the invention was made to modify Merckx to include the teachings such as that taught by Jockel and Zhang.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merckx (US Pub. No. 2017/0112460 A1), Hu (US Pub. No. 2015/0327830 A1) and Jockel et al. (US Pub. No. 2015/0228071 A1) in view of Jan et al. (US Pub. No. 2018/0116622 A1) and Popescu et al. (US Pub. 2004/0062341).
With regards to claim 8, Merckx discloses the claimed invention according to claim 1 and further teaches estimating attenuation from depth to derived thickness/transmission data and determining exposure parameters from that estimate [0045]-[0054], [0096]-[0103].
Merckx fails to expressly disclose causing the medical device to use the updated initial exposure parameter to perform exposure, so as to obtain a medical image; determining an actual attenuation amount of the test subject based on an image parameter of the medical image; and determining whether to again update the updated initial exposure parameter based on the estimated attenuation amount and the actual attenuation amount.
Jan performs X-ray imaging according to the imaging exposure parameters estimated form depth and parameter database and further measures an average ROI pixel value after X-ray projection and compares against a pre-measurement value [0031]-[0035],[0048]-[0049],[0055]-[0063],[0071]-[0075],[0079].
Jan uses threshold feedback from the measured image data [0071]-[0075],[0079].
Popescu calculates an actual attenuation profile form detector side signals representing attenuated X-rays and further repeatedly calculates attenuation profiles and adjust tube current and operating parameters [0027]-[0033],[ 0039]-[0040]..
In view of the utility, to improve or refine operating parameters when measured results deviates from prediction as needed, it would have been obvious to a person of ordinary skill of the art at the time the invention was made to modify Merckx to include the teachings such as that taught by Jan and Popescu.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merckx (US Pub. No. 2017/0112460 A1), Hu (US Pub. No. 2015/0327830 A1) and Jockel et al. (US Pub. No. 2015/0228071 A1) in view of Toth et al. (US Pub. 20050185759 A).
With regards to claim 9, Merckx discloses the claimed invention according to claim 1 and further teaches determining dose/exposure parameters for thickness/transmission/tissue [0045]-[0054],[0101]-[0103].
Merckx fails to expressly disclose a preset exposure curve describing an exposure parameter of each exposure point during operation or updating according to that curve.
Toth teaches an ideal tube-current modulation waveform /profile developed from scout scant data and then sampled at multiple points while providing the mechanism of applied by point-by-point profile during acquisition [0010]-[0011],-[0034]-[0055].
In view of the utility, to improve anatomical localization and exposure accuracy using scout scans, it would have been obvious to a person of ordinary skill of the art at the time the invention was made to modify Merckx to include the teachings such as that taught by Toth.
Conclusion
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/DJURA MALEVIC/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
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