DETAILED ACTION
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 on 04/10/2025 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 § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tsubota et al (US PAP 2016/0199018 A1) in view of De Man et al. (US PAP 2014/0185575 A1) and Vandroux et al. (US PAP 2021/0228176 A1).
With respect to claim 1, Tsubota et al. teaches a medical system (10), comprising (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15):
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an X-ray generating device (1) including an X-ray tube (1); a detector (4) for detecting X-rays irradiated from the X-ray generating device (1); and one or more processors (20) executing instructions to: calculate a characteristic value of the X-rays irradiated from the X-ray generating device based on data on the X-rays detected by the detector (4), every time a prescribed scan is executed; and determine whether to output an alert based on change in the characteristic value over time (see Figs. 6 and 7). Tsubota et al. fails to explicitly mention that the prescribed scan is a calibration scan.
De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) discloses a system/method for X-ray medical imaging
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which explicitly teaches one or more processors (26) executing instructions to: calculate a characteristic value of the X-rays irradiated from the X-ray generating device (12) based on data on the X-rays detected by the detector (36), every time a prescribed calibration scan is executed (see paragraphs 0046-0048 and 0053-0057) providing user with capabilities to estimate projection-based dose in real time with instructions for controlling the X-ray medical imaging (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057).
Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) discloses a system/method for X-ray medical imaging, which explicitly teaches one or more processors (216) executing instructions to:
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calculate a characteristic value of the X-rays irradiated from the X-ray generating device (106) based on data on the X-rays detected by the detector (108), every time a prescribed calibration scan is executed (see paragraph 0038) providing user with capabilities to collect data of the attenuated X-ray beams to estimate projection-based dose in real time with instructions for controlling the X-ray medical imaging (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117).
Tsubota et al., De Man et al. and Vandroux et al. disclose related methods/apparatuses for X-ray medical imaging.
It 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 to provide teachings of the prescribed calibration scan as suggested by De Man et al. and Vandroux et al. in the apparatus of Tsubota et al., since such a modification would provide user with the capabilities to estimate projection-based dose in real time with instructions for controlling the X-ray medical imaging.
It would have been obvious to treat Tsubota et al., De Man et al. and Vandroux et al. as related art whereby an improvement on one of the systems/methods would readily be apparent as an improvement on either of the systems.
The Examiner’s conclusion that claim 1 would have been obvious is based on the fact that all the claimed elements were known in the prior art, that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and that the combination teaches nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. 398, 82 USPQ2d at 1385 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim 2, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 1, wherein the medical system periodically executes the prescribed calibration scan while alternately switching a tube voltage between a first tube voltage and a second tube voltage, and the characteristic value includes an absorption coefficient of a first reference substance and an absorption coefficient of a second reference substance (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 3, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 2, wherein the one or more processors further execute instructions to calculate the absorption coefficient of the first reference substance and the absorption coefficient of the second reference substance every time the prescribed calibration scan is executed (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 4, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 3, wherein the one or more processors further executes instructions to: calculate a first reference absorption coefficient serving as a criterion for determining whether to output an alert; calculate a first difference between the first reference absorption coefficient and the absorption coefficient of the first reference substance; and compare the first difference with a first threshold value and determining whether to output an alert based on a comparison result thereof (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 5, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 3, wherein the one or more processors further executes instructions to: calculate a second reference absorption coefficient serving as a criterion for determining whether to output an alert; calculate a second difference between the second reference absorption coefficient and the absorption coefficient of the second reference substance; and compare the second difference with a second threshold value and determining whether to output an alert based on a comparison result thereof (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 6, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 5, wherein every time the prescribed calibration scan is executed, the one or more processors further executes instructions to: calculate the first reference absorption coefficient based on the absorption coefficient of the first reference substance obtained by a previously executed prescribed calibration scan; or calculate the second reference absorption coefficient based on the absorption coefficient of the second reference substance obtained by a previously executed prescribed calibration scan (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 7, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 6, wherein the first reference substance is water and the second reference substance is iodine or calcium (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 8, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 2, wherein when the alert is output, the medical system sends data indicating a time change in the absorption coefficient to a back office (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 9, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system of claim 2, wherein the absorption coefficient of the first reference substance and the absorption coefficient of the second reference substance are calculated for each channel of each row of the detector (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 10, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 1, wherein the medical system periodically executes the prescribed calibration scan while alternately switching a tube voltage between a first tube voltage and a second tube voltage, and the characteristic value includes a first representative value of a first X-ray spectrum corresponding to the first tube voltage and a second representative value of a second X-ray spectrum corresponding to the second tube voltage (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 11, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 10, wherein every time the prescribed calibration scan is executed, the one or plurality of processors calculates a first representative value of the first X-ray spectrum and a second representative value of the second X-ray spectrum (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 12, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 3, wherein the one or more processors further executes instructions to: calculate a first energy reference value serving as a criterion for determining whether to output an alert; calculate a first difference between the first energy reference value and the first representative value; and compare the first difference with a first threshold value and determining whether to output an alert based on a comparison result thereof (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 13, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 3, wherein the one or more processors further executes instructions to: calculate a second energy reference value serving as a criterion for determining whether to output an alert; calculate a second difference between the second energy reference value and the second representative value; and compare the second difference with a second threshold value and determining whether to output an alert based on a comparison result thereof (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 14, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 5, wherein every time the prescribed calibration scan is executed, the one or more processors further executes instructions to: calculate the first difference based on a first representative value of the first X-ray spectrum obtained by a previously executed prescribed calibration scan; or calculate the second difference based on a second representative value of the second X-ray spectrum obtained by a previously executed prescribed calibration scan (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 15, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 10, wherein the first representative value is an average energy value or an integral energy value of the first X-ray spectrum, and the second representative value is an average energy value or an integral energy value of the second X-ray spectrum (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
With respect to claim 16, Tsubota et al. (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15) as modified by De Man et al. (see abstract; Figs. 1-12; paragraphs 0001-0005, 0019-0028, 0037-0041, 0046-0048 and 0053-0057) and Vandroux et al. (see abstract; Figs. 1-17; paragraph 0002-0005, 0020-0028, 0036-0038, 0043-0048, 0078-0081 and 0115-0117) teaches the medical system according to claim 1, wherein the medical system executes a plurality of calibration scans, and one calibration scan of the plurality of calibration scans is executed as the prescribed calibration scan (see abstract; Figs. 1-7; paragraphs 0001-0009, 0017-0031, 0038-0040, 0044-0049, 0051, 0057-0063, 0071-0074 and 0076; claims 1-15).
Conclusion
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Irakli Kiknadze
/IRAKLI KIKNADZE/
Primary Examiner, Art Unit 2884
/I.K./ August 20, 2026