CTNF 18/908,808 CTNF 79579 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) submitted on 10/8/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 1, 2, 4-6, 9, 10, 15 and 16 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Kitano (US 2021/0378617 A1) . Regarding claims 1, 15 and 16, Kitano discloses a radiation irradiation apparatus and method thereof (Figs.1, 6 and 7), including: a) a radiation source 40 that irradiates an object P with radiation; b) a distance measurement camera 32 that is attached to the radiation source 40, the distance measurement camera 32 generates a distance image 55 in which each pixel value represents a distance, where the distance image 55 includes the object P in a field of view (Fig.6); and c) a processor that transforms the distance image 55 into a 3D point cloud and calculates a distance from a radiation focus F to the object P based on the transformed 3D point cloud (Fig.7, the x-ray focus F is a known, fixed distance away from the camera 32, Fig.1, and par.0053). Examiner’s Note: while there is an art-recognized distinction between a distance image and a corresponding 3D point cloud, the differences are limited to the fact that a 3D point cloud provides an intuitive visualization when displayed to a human. The datasets are mathematically identical, where each point from each dataset contains the exact same length, width, and height values from a common origin, and any analysis performed on one dataset will produce identical results on the other dataset. Further, no “transformation” of the data consistent with the legal definition within patent law has taken place. The claim merely requires a replotting of the identical data, nothing more than simply looking at a distance image edge-on from the side and plotting the pixel values on an axis perpendicular to the image plane. Therefore, as broadly as claimed, the distance image, and the 3D point cloud generated therefrom, are considered to be mathematically and functionally identical, where either is anticipatory of the other. With respect to claim 2, Kitano further discloses that the processor: d) searches for a closest point SP, which is a point closest to the radiation focus F, in the 3D point cloud along an irradiation direction of the radiation from the radiation focus (pars.0062 and 0065, the line L is considered to be directly under the x-ray focus, and the closest point SP is the point with the smallest distance D2 from the x-ray focus); and e) calculates a distance D2 from the radiation focus to the closest point detected by the search. With respect to claim 4, Kitano further discloses that the object is a subject P, and the processor calculates a first distance D2, which is a distance from the radiation focus F to a surface of the subject P (Figs.1 and 7, par.0056). With respect to claim 5, Kitano further discloses: d) the object is a surface of a member 20 that is in contact with a subject P and that is disposed at a position farther from the radiation source 40 than the subject P (Fig.6); and e) the processor calculates a second distance D1, which is a distance from the radiation focus F to the surface of the member 20 (Fig.7; pars.0053 and 0062-0063). With respect to claim 6, Kitano further discloses that the member 20 is an imaging table 20. With respect to claim 9, Kitano further discloses: d) the object includes a subject P and a surface of a member 20 that is in contact with the subject P and that is disposed at a position farther from the radiation source 40 than the subject P (Fig.6); and the processor: e) performs a calculation of a first distance D2, which is a distance from the radiation focus F to a surface of the subject P, and calculation of a second distance D1, which is a distance from the radiation focus F to a surface of the member 20 (pars.0053 and 0062); and f) calculates a difference between the first distance D2 and the second distance D1 as a body thickness BT of the subject (Fig.7; pars.0063-0064). With respect to claim 10, Kitano further discloses that the processor corrects an imaging condition defined by a tube voltage and a tube current-time product based on the body thickness BT (Fig.23) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA 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. 07-21-aia AIA Claim s 3, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kitano (US 2021/0378617 A1) in view of Sundheimer (US 2016/0343124 A1) . With respect to claim 3, Kitano, as applied to claim 1 above: d) sets a region of interest including the region directly under the x-ray focus F in an irradiation direction of the radiation (par.0065, search of all pixels having depth values smaller than D1); e) searches for a closest point SP, which is a point closest to the radiation focus F, from the point cloud included in the region of interest in the 3D point cloud (Fig.7); and f) calculates a distance D2 from the radiation focus F to the closest point SP detected by the search. Further with respect to claim 3, Kitano does not specify a particular shape for the region of search. Sundheimer teaches the practice of assigning a shape of the search region suitable to the distance being calculated. In this case, since the 3D point cloud is plotted in polar coordinates (Fig.5), the search region for acquiring the height of the roof of the tank is defined as a region within the walls of the tank (pars.0068 and 0073, in polar coordinates, the region of interest is a circle). The skilled artisan appreciates the fact that the search of all points with values less than the expected value of D1, would include extraneous regions such as the arms of the patient (Fig.6), while the concerns about the skin dose and image quality are known to be based on the body thickness being imaged directly under the x-ray source, which is a region that is much thicker than the arms (pars.0130 and Fig.7). As such, the skilled artisan, when considering the teachings of Sundheimer, would set a smaller region, such as a square or rectangle consistent with the coordinate system of the distance image, in order to limit the search to the relevant portions of the patient. It would have been obvious to one of ordinary skill in the art at the time of the invention for Kitano to set a simple shaped sub-region for analyzing only the points within the distance image/3D point cloud that are relevant to the desired depth information, as recommended by Sundheimer, in order to efficiently determine the desired parameters. Examiner’s Note: as noted above with respect to claim 1, since the distance image and the corresponding 3D point cloud are identical, then there is no distinction between searching within a square on the distance image, or searching within the parallelepiped of the corresponding 3D point cloud. It is the same projection of the same data, and therefore the two analyses will produce identical results every time. With respect to claim 7, Kitano further discloses that the second distance D1 is calculated from a region centered on a center position of the radiation (Fig.6). Further with respect to claim 7, Kitano does not specifically disclose using a histogram to determine the second distance D1. Kitano does teach that the data is generally segmented between the uniform depth areas which are presumed to correspond to the imaging table, and all smaller depth values are presumed to correspond to the patient (Figs.5-7, pars.0062-0065 and 0155). Sundheimer teaches the practice of acquiring an accurate measurement of the height of a substantially flat object by applying a histogram (Fig.6) to a region of a distance image that includes the region to be measured (Fig.5) and selecting the height as the value bin having the most pixels in order to accurately determine the height of the object (par.0073). It would have been obvious to one of ordinary skill in the art at the time of the invention for Kitano to use a histogram in order to improve the precision in determining the distance D1, as taught by Sundheimer, in order to improve the precision of determining the patient thickness for safer and higher-quality imaging, as suggested by Kitano. With respect to claim 8, Kitano, as modified by Sundheimer, does not specifically disclose adjusting the size of the region in accordance with the size of the surface of the member. However, the skilled artisan recognizes that either a region can be adjusted in order to focus on the surface of the member in the histogram, or the whole region may be plotted in the histogram. The accuracy remains unchanged, insofar as a larger region would have a bimodal distribution, where one maximum would be a mean height of the patient, and the other would be the height of the table (see at least the profile of line L in Fig.6, and consider a histogram of that profile). It would have been obvious to one of ordinary skill in the art at the time of the invention for Kitano to adjust the size of the region in accordance with the size of the surface of the member in order to simplify the analysis, as recognized by one of ordinary skill in the art . 07-21-aia AIA Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kitano, as applied to claim 9 above, in view of Cheng (US 2024/0358345 A1; also see the attached foreign priority document TW 202443109 A for establishing an earlier effective filing date for the US document) . With respect to claim 11, Kitano does not specifically disclose displaying the thickness to the operator. Given the generalities of the disclosure, the skilled artisan is left to assume that the parameter selection is performed automatically (Fig.23). Cheng teaches the practice of providing the calculated thickness of the patient from a distance image to an operator for either automated or manual adjustments of the imaging parameters, as desired for optimal image quality (pars.0022-0023). It would have been obvious to one of ordinary skill in the art at the time of the invention for Kitano to give notification information on the body thickness by using a notification device, and corrects an imaging condition defined by a tube voltage and a tube current-time product in accordance with an input instruction received by an operation device, as taught by Cheng, as a routine means of providing for operator expertise over generic settings, as known in the art . 07-21-aia AIA Claim s 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kitano, as applied to claim 1 above, in view of Ancar (US 2021/0338368 A1) . With respect to claim 12, Kitano discloses an x-ray collimator; however, Kitano does not specifically disclose an optical camera that generates an optical image of the patient for setting the field of view of the x-ray collimator. Ancar teaches the practice of providing an optical camera 537 in addition to an optical-based distance measurement device 536, in an x-ray imaging system (Fig.5, pars.0013 and 0064), where: d) the optical camera 537 is attached to the radiation source and generates an optical image 800 including the object; and e) a display device 511 that displays the optical image 800; where f) the radiation source includes a collimator 538 that limits an irradiation field of the radiation; and where g) the processor displays one or both of a center position of the radiation or the irradiation filed in a superimposed manner on the optical image 800 (Figs.8A-8D). In this manner, the field of view of the x-ray collimator relative to the patient is intuitively and unambiguously conveyed to the operator for manual or automated adjustment of the collimator prior to imaging for improved safety to the patient (pars.0012 and 0089). It would have been obvious to one of ordinary skill in the art at the time of the invention for Kitano to provide an optical camera attached to the radiation source for generating an optical image of the patient, where the processor displays one or both of a center position of the radiation or the irradiation field in a superimposed manner on the optical image, as taught by Ancar, in order to provide a clear and intuitive interface for the operator to safely operate the x-ray device. With respect to claim 13, Ancar further teaches that, when aperture information of the collimator is included, the processor determines a size of the irradiation field on the optical image based on the aperture information (Figs.8A-8D). It would have been obvious to one of ordinary skill in the art at the time of the invention for Kitano for the processor to determine a size of the irradiation field on the optical image based on aperture information, as taught by Ancar, in order to provide a clear and intuitive interface for the operator to safely operate the x-ray device. With respect to claim 14, Ancar further teaches that, when aperture information of the collimator is not included, the processor determines a size of the irradiation field on the optical image based on the aperture information (Figs.8A-8D). It would have been obvious to one of ordinary skill in the art at the time of the invention for Kitano for the processor to determine a size of the irradiation field on the optical image based on aperture information, as taught by Ancar, in order to provide a clear and intuitive interface for the operator to safely operate the x-ray device . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : Cheng (cited above) further teaches an angular offset correction for the unavoidable differences between the camera 100 and the x-ray focus 311 (Figs.4-5B); CN patent document to Zhou et al. teaches the practice of establishing all of the linear and angular offset corrections for correlating the depth camera data to the x-ray focus for more precise patient thickness calculations (Figs.2-3) and CN patent document to Shen et al. teaches the practice of using the image from a depth camera for optical alignment, collimator aperture setting, and patient thickness calculations. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS R ARTMAN whose telephone number is (571)272-2485. The examiner can normally be reached Monday-Thursday 10am-6:30pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Makiya can be reached on 571.272.2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. THOMAS R. ARTMAN Primary Examiner Art Unit 2884 /THOMAS R ARTMAN/ Primary Examiner, Art Unit 2884 Application/Control Number: 18/908,808 Page 2 Art Unit: 2884 Application/Control Number: 18/908,808 Page 3 Art Unit: 2884
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