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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/10/2026 has been entered.
Response to Amendment
The amendment filed 08/19/2026 was entered. Claims 1, 3, 17, and 18 have been amended. No claims have been added or cancelled. As such, claims 1-14 and 17-19 remain pending and under examination
Response to Arguments
Applicants’ arguments with respect to claim(s) 08/19/2026 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, 2, 8, 10, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shea et al. (US 2023/0013818 A1) in view of Franco et al. (US 2016/0223706 A1) and He et al. (EP 1 024 356 B1).
With regards to claim 1, Shea teaches a method using an imaging X-ray device for a patient/examination subject having an X-ray source, a two-dimensional X-ray detector, and a collimator/beamformer configured to adjust the shape and position of the radiation beam. Shea selectively exposes a primary/center detector region while one or more detector shadow regions are blocked from direct radiation and receive scattered radiation. Shea further teaches frame-by-frame image acquisition and processing, including a measured image having primary and secondary/shadow image portions, with the measured image being approximately equal to the scatter component in the blocked region. Shea also teaches dynamic beam collimation for region-of-interest (ROI) imaging and other beamformer window shapes/configurations, Shea [0074] - [0093], [0129] - [0131], [0158] - [0166], (Figures 3 - 8 & 16 - 17).
Shea, however, does not expressly teach “wherein the collimator shadow surrounds a central region of the X-ray detector corresponding to the region of interest” in the closed surrounding relationship now claimed.
He teaches the missing surrounding-shadow relationship by blocking an outer portion of a transmitted X-ray beam while allowing a center portion through a center bore, thereby producing a local-minimum detector shadow region surrounding the central beam-incidence region. He expressly teaches that the attenuator creates a local minimum intensity region on the detection surface that surrounds the beam-incidence region; minimum-intensity points surrounding the center define a boundary surrounding that region; and Figure 4 shows a bright central spot surrounded by a ring of shadow, He [0007] - [0010], [0014] - [0019], [0021] - [0023], (Figures 2 - 5B); claims 2 and 19.
In view of the utility of He’s closed-loop beam-obstruction geometry for providing a readily detectable shadow boundary surrounding a central directly exposed detector region, it would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify Shea’s expressly variable beamformer/collimator window to employ the closed surrounding geometry taught by He. Shea expressly permits different beamformer window shapes and other collimator configurations, so the modification predictably preserves Shea’s shadow-based scatter acquisition while providing a shadow that surrounds the central detector region.
Shea modified, however, does not expressly teach evaluating the single two-dimensional scattered-radiation image to ascertain material information pertaining to a material present in the region of interest.
Franco teaches the missing material-information evaluation by determining a selected object/location from X-ray image information, positioning collimation to irradiate the selected item/location, detecting scatter scan data from the selected item, generating a diffraction/coherent-scatter signature, and using scatter information together with density and/or effective atomic number to identify or classify material of interest. Franco further teaches targeting alarming/segmented regions for CXS material classification and comparing CXS signatures with stored threat signatures, Franco [0029], [0046] - [0048], [0076] - [0083], [0101] - [0103], [0154] - [0166], [0177] - [0183], [0195] - [0209], (Figures 4C - 5D & 7 - 12).
In view of the utility of Franco’s localized scatter-based material evaluation for determining material information at a selected inspection location, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to further modify Shea modified by He so that the single two-dimensional scatter information acquired for the selected ROI is evaluated for material information, such as taught by Franco, thereby predictably obtaining material-specific information for the ROI while retaining Shea’s medical X-ray and shadow-scatter acquisition architecture.
With regards to claim 2, Shea modified teaches the claimed invention according to claim 1, and Shea further teaches a segmentation process in a two-dimensional image data set by segmenting an input image frame into primary and secondary regions and using an imaging mask to operate on a sub-region of the image data, Shea [0129] - [0131], [0158] - [0166], (Figures 6 - 10).
Shea modified, however, does not expressly teach that the location of the region of interest is determined from that segmentation process.
Franco teaches determining the location of an object or region of interest from X-ray image information and using that location for subsequent targeted inspection, Franco [0029], [0081], [0101] - [0103], [0160], [0173] - [0178]. Under the recited “and/or” alternative, the segmentation-based determination is sufficient when Shea’s segmentation is applied to Franco’s ROI-localization workflow.
In view of the utility of image segmentation for automatically identifying and operating on a selected image sub-region, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Shea to use the segmentation process in the ROI-localization workflow taught by Franco, thereby predictably determining the ROI location from previously acquired image data for targeted acquisition.
With regards to claim 8, Shea modified teaches the claimed invention according to claim 1, and Shea further teaches that the single two-dimensional scattered-radiation image is acquired without an anti-scatter grid by obtaining scatter measurements from collimator-shadow detector regions and estimating scatter without requiring a detector-side anti-scatter grid; Shea expressly discusses flat-panel CBCT configurations without anti-scatter grids, Shea [0029] - [0033], [0077] - [0093].
With regards to claim 10, Shea modified teaches the claimed invention according to claim 1, but fails to expressly teach that “the material information comprises an effective atomic number, a density of the material, a classification as one of at least two candidate materials, or a combination thereof.”
Franco teaches the additional material-information limitation through density, effective atomic number, scatter/diffraction signatures, and material classification, Franco [0016] - [0026], [0046], [0076], [0157] - [0158], [0190] - [0209].
In view of the utility of Franco’s localized scatter-based material evaluation for determining material information at a selected inspection location, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to further modify Shea with Franco.
With regards to claim 17, Shea modified teaches the corresponding X-ray-device implementation of the claimed invention according to claim 1. Shea teaches the X-ray source, detector, collimator/beamformer, controller/processor, patient/ROI imaging, and scatter-image processing, Shea [0034] - [0041], [0074] - [0096], [0129] - [0131], [0158] - [0166], (Figures 1 - 6 & 16 - 17). He teaches the surrounding-shadow geometry, He [0007] - [0010], [0014] - [0022], (Figures 3 - 5A). Franco teaches the localized material-information evaluation, Franco [0154] - [0166], [0174] - [0183], [0194] - [0209], (Figures 4C - 5D & 8 - 12). Refer to the rejection of claim 1.
With regards to claim 18, Shea modified teaches the claimed invention according to claim 1, and Shea further teaches the corresponding non-transitory computer-readable-medium implementation through processors, memory, software, frame-by-frame image processing, and scatter-image generation, Shea [0034] - [0041], [0129] - [0131], [0158] - [0166].
He further teaches software instructions stored in a local storage medium for processing a single detection frame, He [0020] - [0021].
In view of the utility of storing the previously addressed acquisition and evaluation operations as executable instructions for repeatable processor-controlled operation, it would have been obvious to a person of ordinary skill in the art at the time of the invention was made to implement those operations in a non-transitory computer-readable medium, thereby predictably enabling automated execution of the combined imaging process.
With regards to claim 19, Shea modified teaches the claimed invention according to claim 1, and Shea further teaches that the examination subject is a patient and repeatedly relates detector measurements to a patient or associated patient ROI, Shea [0074] - [0076], [0094] - [0096], (Figures 1 - 2 & 5).
Claims 3 - 5 are rejected under 35 U.S.C. §103 as being unpatentable over Shea in view of Franco and He, as applied to claim 1 above, and further in view of Kok et al. (WO 2018/037128 A1) and Annis et al. (US 4,825,454).
With regard to claim 3, Shea modified teaches the claimed invention according to claim 1, but fails to expressly teach that the X-ray imaging device further comprises an anti-scatter grid on a detector side and actuating an adjustment device to align a focus of the anti-scatter grid onto the region of interest.
Kok teaches an anti-scatter device arranged at an X-ray detector and having a variable-focus anti-scatter grid comprising X-ray-absorbing slats/lamellae. Kok further teaches an adjustment mechanism in which application of voltage changes the geometry/spacing of the slats and changes the focusing distance of the anti-scatter grid, Kok pp. 2 - 7, 10 - 14, (Figures 3A - 4B).
Kok modified, however, does not expressly teach directing the adjustable grid focus onto a selected internal region of interest so that scatter originating from that region is preferentially detected.
Annis teaches the missing internal-region focusing principle. Annis teaches a focused collimator whose scatter-transmitting pathways originate in a common region of the examined object, and expressly teaches focusing the detector view onto a small volumetric element so that radiation scattered from the desired focal volume reaches the detector while scatter originating from other regions is blocked, Annis col. 3, l. 6 - col. 4, l. 20; col. 7, l. 1 - col. 8, l. 20, (Figures 1 & 2).
In view of the utility of Annis’s internal-volume focusing arrangement for spatially localizing detected scatter to a desired examination region while suppressing scatter originating outside that region, it would have been obvious to a person of ordinary skill in the art before the effective filing date to configure Kok’s already-adjustable detector-side anti-scatter grid so that its adjustable focus is directed to the selected region of interest. The modification predictably applies a known adjustable scatter-rejection structure to the known scatter-localization function taught by Annis.
With regards to claim 4, Shea modified further in view of Kok and Annis teaches the claimed invention according to claim 3, and Kok further teaches adjustable X-ray-absorbing slats/lamellae on which the adjustment mechanism acts by changing the cover-element/slat geometry so as to change the grid focusing distance, Kok pp. 3 - 7, 10 - 14, (Figures 3A - 4B). In the combination stated for claim 3, that adjustment is used to obtain at least partial alignment of the grid focus with the selected region of interest.
With regards to claim 5, Shea modified further in view of Kok and Annis teaches the claimed invention according to claim 4, and Kok further teaches that the adjustable X-ray-absorbing elements may be slats, lamellae, bars, and/or strip-shaped elements, Kok pp. 2 - 4, 10 - 14.
Claims 6 - 7 are rejected under 35 U.S.C. §103 as being unpatentable over Shea in view of Franco and He, as applied to claim 1 above, further in view of Kok and Annis, as applied to claim 3 above, and further in view of Farbizio et al. (US 2016/0022230 A1).
With regards to claim 6, Shea modified further in view of Kok and Annis teaches the claimed invention according to claim 3 but fails to expressly teach changing a position of the anti-scatter grid along a direction of the central beam by an adjustment component.
Farbizio teaches a medical X-ray imaging system having an anti-scatter grid and a motor/actuator arrangement for moving the anti-scatter grid relative to the X-ray source/detector, including movement along an axis toward or away from the X-ray source, Farbizio [0039], [0051] – [0058], (Figures 1A - 1B & 5 - 8).
In view of the utility of Farbizio’s actuator-controlled grid positioning for adapting grid geometry/position to the selected imaging geometry, it would have been obvious to a person of ordinary skill in the art at the time of the invention was made to provide the adjustable grid of the Shea-Kok-Annis combination with such an axial positioning component, thereby permitting the grid position along the central-beam direction to be changed as needed to obtain the desired focal alignment with the selected region of interest.
With regards to claim 7, Shea modified further in view of Kok, Annis, and Farbizio teaches the claimed invention according to claim 6.
Kok further teaches a focused anti-scatter grid having a nominal/base focusing distance and an adjustable focusing distance.
Annis teaches that the focused scatter-selection structure is focused at an internal volumetric element and expressly teaches that focal length is principally dictated by the depth of the selected slice within the object, Annis col. 9, ll. 1 - 39, (Figure 5).
Farbizio teaches physically shifting the anti-scatter grid relative to the source/detector. In the combined system, shifting the grid from its source-focused base position according to the separation between the source focal spot and selected internal focal region is a predictable geometric consequence of aligning the grid focus with that internal region.
In view of the utility of maintaining the desired focal relationship as the selected internal focal region changes in depth relative to the X-ray source, it would have been obvious to a person of ordinary skill in the art at the time of the invention was made to control the axial grid displacement in accordance with the source-to-selected-region geometry, thereby predictably positioning the focused grid for the selected region of interest.
Claim 9 is rejected under 35 U.S.C. §103 as being unpatentable over Shea in view of Franco and He, as applied to claim 1 above, and further in view of DeFreitas.
With regard to claim 9, Shea modified teaches the claimed invention according to claim 8, but does not expressly teach that “the anti-scatter grid is removed from a beam path for the acquiring of the single two-dimensional scattered radiation image.”
DeFreitas teaches a scatter-reducing grid selectively movable between a position in the imaging-beam path and a position outside that path, including automatic withdrawal for magnification imaging, DeFreitas [0010] - [0012], [0018] - [0020], (Figures 1 & 2).
In view of the utility of selectively removing a scatter-reducing grid when the selected imaging mode would otherwise be impeded by the grid, it would have been obvious to further modify the Shea-Franco-He system to move the anti-scatter grid out of the beam path for the claimed scatter-image acquisition, such as taught by DeFreitas, thereby predictably avoiding grid interference with the selected acquisition.
Claims 11 and 12 are rejected under 35 U.S.C. §103 as being unpatentable over Shea in view of Franco and He, as applied to claim 1 above, and further in view of Xu.
With regards to claim 11, Shea modified teaches the claimed invention according to claim 1, and Shea further teaches model-based scatter estimation and identifies convolutional neural networks as a scatter-model option, Shea [0129] - [0131], [0158] - [0166].
Shea modified, however, does not expressly teach “applying at least one trained function to the single two-dimensional scattered radiation image as input data and/or with the material information as output data.”
Xu teaches the missing trained-function limitation by applying trained neural-network functions to X-ray scatter information, with imaging information as input and scatter information as output, Xu [0021] - [0024], [0038] - [0041], [0045] - [0047], (Figures 1 & 8).
In view of the utility of a trained scatter-estimation function for rapidly and repeatably extracting scatter-related information from X-ray image data, it would have been obvious to apply such a trained function to the single two-dimensional scatter image of the Shea-Franco-He system and use the resulting scatter representation in Franco’s material-evaluation workflow, thereby predictably automating the claimed evaluation.
With regard to claim 12, Shea modified further in view of Xu teaches the claimed invention according to claim 11, and Xu further teaches that training images annotated with a ground truth are used for training the trained function and that simulations of an imaging process for two-dimensional scattered-radiation images are performed to determine training data for specified examination subjects through supervised training using simulated scatter profiles and Monte Carlo simulation as ground truth, Xu [0027], [0038], [0045] - [0048], (Figure 8).
In view of the utility of simulation-derived ground truth for training a scatter-estimation function without requiring exhaustive physical measurements, it would have been obvious to train the function using simulated ROI/material conditions, thereby predictably improving robustness across examination subjects.
Claim 13 is rejected under 35 U.S.C. §103 as being unpatentable over Shea in view of Franco and He, as applied to claim 1 above, and further in view of Loxley et al. (US 2020/0237333 A1).
With regard to claim 13, Shea modified teaches the claimed invention according to claim 1, but does not expressly teach that “similarity measures of the single two-dimensional scattered radiation image to comparison images of different comparison material information are determined and the material information is ascertained based on at least one of the similarity measures.”
Loxley teaches the missing comparison methodology by obtaining observed X-ray images with a pixelated detector, building a simulator database of simulated scatter kernels/patterns for different materials and thicknesses, comparing observed-image parameters with parameters of simulator-created images, identifying simulator inputs giving the closest match, and iterating until a match is obtained. Loxley further teaches that material type and/or thickness information can result from the scatter-processing method, Loxley, [0067], [0068], (Figures 1A - 2); claims 1 and 9.
In view of the utility of Loxley’s material-dependent simulated-image comparison for distinguishing among material/thickness hypotheses, it would have been obvious to a person of ordinary skill in the art before the effective filing date to apply Loxley’s image/simulation matching technique to the single two-dimensional scattered-radiation image of Shea modified, using comparison scatter images corresponding to different candidate material information and selecting material information based on the resulting similarity/closest-match measure. This predictably applies a known material-dependent image-matching technique to the spatial scatter image already acquired by the base combination.
Claim 14 is rejected under 35 U.S.C. §103 as being unpatentable over Shea in view of Franco and He, as applied to claim 1 above, and further in view of Loxley, as applied to claim 13 above, and Scott et al. (US 2021/0307714 A1).
With regard to claim 14, Shea modified further in view of Loxley teaches the claimed invention according to claim 13, but does not expressly teach that “the comparison images are determined at least in part by simulation of an imaging process of the single two-dimensional scattered radiation image for a model of the examination subject, and wherein a material of the respective comparison material information is inserted in the model in the region of interest.”
Scott teaches a spatial model of the examination sample in which respective pixel/voxel locations carry material-composition and thickness values; simulation of the X-ray imaging process from that model to generate simulated image data including a scatter image; evaluation of the simulated image data against acquired image data using an error/similarity measure; and iteration among material-composition models. Scott further teaches considering material combinations for each voxel and simulating the X-ray image arising from those combinations, Scott, [0013], [0018], s (Figures 2 - 5B & 7A - 8B); claims 2 - 5, 10, 13, 15, and 18.
In view of the utility of Scott’s location-specific material-composition model for predicting the scatter image associated with a material hypothesis, it would have been obvious to a person of ordinary skill in the art at the time of the invention was made to implement Loxley’s material-dependent comparison simulations using Scott’s spatial subject model and assign the respective candidate material composition to the model location or locations corresponding to Franco’s selected ROI before simulating the comparison scatter image.
The predictable result is a comparison image representing the candidate material at the ROI that can be tested against the acquired scatter image.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Djura Malevic whose telephone number is 571.272.2975. The examiner can normally be reached M-F (9-5).
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/DJURA MALEVIC/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
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