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 .
Notice to Applicants
Claims 1-17 are currently pending.
Limitations appearing inside of {} are intended to indicate the limitations not taught by said prior art(s)/combinations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-15 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites:
wherein the processing circuitry sets a weighting for the data in the first energy bin when the second medical image is generated to be less than a weighting for the data in one or both of the second energy bin and the third energy bin when the second medical image is generated and to be less than a weighting for the data in the first energy bin when the first medical image is generated
The setting of the weighting for the data in the first energy bin appears to rely upon three conditions. Do one or all conditions need to be met in order to set the weighting, or just one, or a combination of conditions? In the second condition, it is unclear how the weighting for the data in the first energy bin can be with the second image is less than the weighting for the data in the first energy bin. In other words, how can the weighting be set if it is already set? For the purpose of examination, this limitation is interpreted as setting of weights.
Claims 2-15 are rejected as they depend from a rejected claim.
Claim 17 is similarly rejected for the same reasons as claim 1.
Claim Rejections - 35 USC § 102
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 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 –
(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.
Claims 1, 13, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Lee” (Lee, CL., Hong, K.J., Kim, N. et al. Feasibility study of portable multi-energy computed tomography with photon-counting detector for preclinical and clinical applications. Sci Rep 11, 22731 (2021). https://doi.org/10.1038/s41598-021-02210-5).
Regarding claim 1, Lee teaches a medical image processing device comprising processing circuitry configured to perform:
setting a first energy bin in a first energy range including energy of a k-absorption edge of a specific substance (interpreted as iodine, gadolinium, calcium; Specification [p 19, ln 2]) (gadolinium (K-edge energy = 50.2 keV); Lee, [p 3, §Image Acquisition, ¶1]);
setting a second energy bin in a second energy range with higher energy than the first energy range; setting a third energy bin in a third energy range with lower energy than the first energy range (bin 1: 30–50 keV, bin 2: 50–65 keV, and bin 3: 65–140 keV; Lee, [p 3, §Image Acquisition, ¶1]);
generating a first medical image (interpreted as normal CT image; Specification [p 24, ln 10-11]) and a second medical image (interpreted as k-edge emphasized image; Specification [p 24, ln 24]) in which the specific substance is more emphasized in comparison with the first medical image using data based on X-ray photons counted (interpreted as projection data; Specification [p 23, ln 20]) in each of the first energy bin, the second energy bin, and the third energy bin (See Lee Figure 4, shown below, exhibits first (i.e., Images for each energy bin) and second medical images(i.e., Decomposed image))
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outputting the first medical image and the second medical image via an output interface (Lee, See Figure 7 (c) and (d), shown below, exhibits (c) CT image (i.e., first medical image) and (d) iodine map (i.e., second medical image)),
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wherein the processing circuitry sets a weighting for the data in the first energy bin when the second medical image is generated to be less than a weighting for the data in one or both of the second energy bin and the third energy bin when the second medical image is generated and to be less than a weighting for the data in the first energy bin when the first medical image is generated (in Fig. 4, if the iodine, calcium, white matter, and gray matter were separated, a map for the four materials can be obtained by applying the model weight; Lee, [p 5, §Material decomposition using deep neural networks, ¶1]).
Regarding Claim 13, Lee teaches the medical image processing device according to claim 1. Lee further teaches wherein the processing circuitry sets a width of the third energy bin set in the third energy range to be greater than a width of the second energy bin set in the second energy range (the widths of bin 1, 2 and 3 are 20, 15 and 75, respectively “bin 1: 30–50 keV, bin 2: 50–65 keV, and bin 3: 65–140 keV” ;Lee, [p 3, §Image Acquisition]).
Claim 17 is similarly analyzed as analogous claim 1.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of “Han” (Han et al, U.S. Patent Application Publication No. US 20140105364 A1)
Regarding Claim 2, Lee teaches the medical image processing device according to claim 1. Lee does not explicitly teach wherein the processing circuitry sets the weighting for the data in the first energy bin when the second medical image is generated to zero or a minus value or does not use the data in the first energy bin when the second medical image is generated.
However, Han teaches wherein the processing circuitry sets the weighting for the data in the first energy bin when the second medical image is generated to zero or a minus value or does not use the data in the first energy bin when the second medical image is generated (In the case of setting an energy bin using a photon counting detector (PCD), the spectrum estimation apparatus may determine that an area excluding the set energy bin is "zero"; HAN, ¶[0061])
Lee and Han are analogous art because they are from the same field of endeavor of separating an optimal spectrum and estimating a spectrum using a photon counting detector (PCD).. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include not using data in an energy bin as taught by Han to the invention of Lee. The motivation to do so would be to perform highly accurate estimation by narrowing the range of a sampling point.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of “Lu” (Lu, U.S. Patent Application Publication No. US 20200234471 A1).
Regarding Claim 3, Lee teaches the medical image processing device according to claim 1. Lee further teaches wherein the processing circuitry performs preprocessing on count data indicating the number of X-ray photons counted for each energy bin and generates projection data from the count data (The PCD counts the X-ray photons transmitted through the patient and sorts the counts in the three energy bins. The three bins of count data are processed to produce three sets of uncorrected raw data (low-, middle-, and high-energy), which are used as inputs to the CT reconstruction algorithm, Lee [p 3, §Spectral CT System Design, ¶1]; The projection images acquired from the multi-energy phantom were reconstructed for each energy bin; Lee, [p 4, §Material decomposition using deep neural networks, ¶1]), {and wherein the processing circuitry adjusts the weighting for the projection data}. Lee does not explicitly teach wherein the processing circuitry adjusts the weighting for the projection data.
However, Lu teaches wherein the processing circuitry adjusts the weighting for the projection data (regarding “input images representing a plurality of energy-resolved projection images that are resolved according to a plurality of energy bins” … “updating of the weighting coefficients” ;Lu, ¶[0147])
Lee and Lu are analogous art because they are from the same field of endeavor of photon-counting detectors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include weighting projection data as taught by Lu to the invention of Lee. The motivation to do so would be for noise balance.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of “Tkaczyk” (Tkaczyk et al., US Patent Application Publication No. US 20070076842 A1).
Regarding Claim 4, Lee teaches the medical image processing device according to claim 1. Lee further teaches wherein the processing circuitry performs preprocessing on count data indicating the number of X-ray photons counted for each energy bin and generates projection data from the count data, wherein the processing circuitry performs a reconstruction process on the projection data in the first energy bin and generates a first spectral image (interpreted as k-edge emphasized image; Specification, [p24 , ln 17-18]),
wherein the processing circuitry performs the reconstruction process on the projection data in the second energy bin and generates a second spectral image,
wherein the processing circuitry performs the reconstruction process on the projection data in the third energy bin and generates a third spectral (The PCD counts the X-ray photons transmitted through the patient and sorts the counts in the three energy bins. The three bins of count data are processed to produce three sets of uncorrected raw data (low-, middle-, and high-energy), which are used as inputs to the CT reconstruction algorithm, Lee [p 3, §Spectral CT System Design, ¶1]; The projection images acquired from the multi-energy phantom were reconstructed for each energy bin; Lee, [p 4, §Material decomposition using deep neural networks, ¶1]),
{wherein the processing circuitry generates the first medical image and the second medical image by combining the first spectral image, the second spectral image, and the third spectral image, and wherein the processing circuitry adjusts the weighting for each of the first spectral image, the second spectral image, and the third spectral image}.
Lee does not explicitly disclose wherein the processing circuitry generates the first medical image and the second medical image by combining the first spectral image, the second spectral image, and the third spectral image, and wherein the processing circuitry adjusts the weighting for each of the first spectral image, the second spectral image, and the third spectral image.
However, Tkaczyk teaches wherein the processing circuitry generates the first medical image and the second medical image by combining the first spectral image, the second spectral image, and the third spectral image (the weighted image data associated with each of the first and second regions of the pixel may then be combined to generate composite image data; Tkaczyk, ¶[0048]), and
wherein the processing circuitry adjusts the weighting for each of the first spectral image, the second spectral image, and the third spectral image (Optimal energy weighting (OEW) of the different energy bins may be used to enhance further the contrast to noise level for the iodine signal; Tkaczyk, ¶[0038]).
Lee and Tkaczyk are analogous art because they are from the same field of endeavor of enhancing image quality and providing tissue composition information by analysis of energy discrimination data in photo-counting CT imaging.. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include combining spectral image and automatically adjusting weights as taught by Tkaczyk to the invention of Lee. The motivation to do so would be to enhance further the contrast to noise level for the contrast signal.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Tkaczyk, and further in view of “Han” (Han et al., US Patent Application Publication No. US 20140105364 A1).
Regarding claim 5, the combination of Lee and Tkaczyk teach the medical image processing device according to claim 4. Tkaczyk further teaches wherein the processing circuitry sets the weighting for the first spectral image (Optimal energy weighting (OEW) of the different energy bins may be used to enhance further the contrast to noise level for the iodine signal; Tkaczyk, ¶[0038]) {when the second medical image is generated to zero or a minus value}. The combination does not explicitly disclose when the second medical image is generated to zero or a minus value.
However, Han teaches when the second medical image is generated to zero or a minus value (In the case of setting an energy bin using a photon counting detector (PCD), the spectrum estimation apparatus may determine that an area excluding the set energy bin is "zero"; HAN, ¶[0061]).
Lee and Han are analogous art because they are from the same field of endeavor of separating an optimal spectrum and estimating a spectrum using a photon counting detector. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include generating an image to zero value as taught by Han to the combined invention of Lee and Tkaczyk. The motivation to do so would be to perform highly accurate estimation by narrowing the range of a sampling point.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of “Kato” (Kato et al., US Patent Application Publication No. US 20190353822 A1).
Regarding claim 14, Lee teaches the medical image processing device according to claim 1. Lee further teaches wherein the processing circuitry generates a {difference} image {between the first medical image and the second medical image}, {and wherein the processing circuitry outputs the difference image via the output interface} (images of the three energy levels (bins 1, 2 and 3) were used to generate the images of the separated iodine (Fig. 6e), calcium (Fig. 6f), white matter (Fig. 6g), and gray matter (Fig. 6h); Lee, [p 6, § Results, Multi‑energy CT imaging, ¶1]). Lee does not explicitly disclose the difference between the first medical image and the second medical image.
However, Kato teaches wherein the processing circuitry generates a difference image between the first medical image and the second medical image (by subtracting the first image data from the second image data, the image reconstructing unit 36 generates difference image data; Kato, ¶[0055]), and wherein the processing circuitry outputs the difference image via the output interface (the controlling unit 38 exercises control so that the various types of image data stored in the image storage unit 37 are displayed on the display device 32; Kato, ¶[0051]).
Lee and Kato are analogous art because they are from the same field of endeavor of photon counting CT to generate images using discrimination the individual photons so as to be divided into the energy components.. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include difference images as taught by Kato to the invention of Lee. The motivation to do so would be to enable the operator to recognize the region in which the contrast agent is distributed.
Regarding claim 15, Lee teaches the medical image processing device according to claim 1. Kato further teaches wherein the output interface includes a display (See Lee Fig 5 “display window”), {wherein the medical image processing device further comprises an input interface which is able to be operated by a user and wherein the processing circuitry displays the second medical image in a region of interest which is a region designated by the user on a screen of the display and displays the first medical image in a region other than the region of interest when a region in which the second medical image is displayed is designated by the user using the input interface}. Lee does not explicitly disclose wherein the medical image processing device further comprises an input interface which is able to be operated by a user and wherein the processing circuitry displays the second medical image in a region of interest which is a region designated by the user on a screen of the display and displays the first medical image in a region other than the region of interest when a region in which the second medical image is displayed is designated by the user using the input interface.
However, Kato teaches wherein the medical image processing device further comprises an input interface which is able to be operated by a user (the display device 32 displays an input-purpose GUI 300 used by the operator to input a parameter; Kato, ¶[0108]), and
wherein the processing circuitry displays the second medical image in a region of interest which is a region designated by the user on a screen of the display and displays the first medical image in a region other than the region of interest when a region in which the second medical image is displayed is designated by the user using the input interface (first image data 101 from projection data corresponding to a counting result of “C(ER4)+C(ER5)”, according to an instruction from the controlling unit 38 or the operator. Further, for example, as illustrated in FIG. 7, the image reconstructing unit 36 reconstructs second image data 102 from projection data corresponding to a counting result of “C(ER6)+C(ER7)”, according to an instruction from the controlling unit 38 or the operator; Kato, ¶[0085], and See Fig 7, shown below)
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a GUI as taught by Kato to the invention of Lee. The motivation to do so would be to enable the operator to perform operations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a displaying first medical image without the region of interest and a second medical image with the region of interest as taught by Kato to the invention of Lee. The motivation to do so would be to enable the operator to arbitrarily change conditions referring to the image data.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of “Tsukerman” (Tsukerman, U.S. Patent Application Publication No. US 20110129132 A1).
Regarding claim 6, Lee teaches the medical image processing device according to claim 1. Lee does not explicitly disclose wherein the processing circuitry determines a range of the first energy bin on the basis of a size of a region of an examinee irradiated with X-rays.
However, Tsukerman discloses wherein the processing circuitry determines a range of the first energy bin on the basis of a size of a region of an examinee irradiated with X-rays (the localization radiopharmaceutical may be used to localize and position the ROI 66 within the FOV of the detectors 54 using the display 72 as a virtual view finder. It should be noted that in the persistence phase of imaging the imaging system 50 is set to cover an energy range, namely to define an energy window for detection by the detectors 54; Tsukerman, ¶[0033]).
Lee and Tsukerman are analogous art because they are from the same field of endeavor of photon-counting detectors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include determining range based on size of region of the patient as taught by Tsukerman to the invention of Lee. The motivation to do so would be to optimize for the localization radiopharmaceutical.
Claim 16 is similarly analyzed as analogous claim 1. Lee does not explicitly teach wherein the processing circuitry determines a range of the first energy bin on the basis of a region of an examinee irradiated with X-rays.
However, Tsukerman teaches wherein the processing circuitry determines a range of the first energy bin on the basis of a region of an examinee irradiated with X-rays (the localization radiopharmaceutical may be used to localize and position the ROI 66 within the FOV of the detectors 54 using the display 72 as a virtual view finder. It should be noted that in the persistence phase of imaging the imaging system 50 is set to cover an energy range, namely to define an energy window for detection by the detectors 54; Tsukerman, ¶[0033]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Tsukerman and further in view of “Zou” (Zou, U.S. Patent No. US 9836859 B2).
Regarding claim 7, The combination of Lee and Tsukerman teach the medical image processing device according to claim 6. The combination does not explicitly disclose wherein the processing circuitry narrows the range of the first energy bin as the size of the region decreases and broadens the range of the first energy bin as the size of the region increases.
However, Zou further teaches wherein the processing circuitry narrows the range of the first energy bin as the size of the region decreases and broadens the range of the first energy bin as the size of the region increases (step 502, a kV and mA waveform is designed to optimize (i.e., narrow or broaden) the quality of the scan for a given patient using personal information, such as age, size, gender, and the diagnostic task; Zou, [Col 6: 38-41]).
Lee and Zou are analogous art because they are from the same field of endeavor of photon-counting detectors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include determining range based on size of region of the patient as taught by Zou to the combined invention of Lee and Tsukerman. The motivation to do so would be to optimize the quality of the scan.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of “Zou” (Zou, U.S. Patent No. US 9836859 B2).
Regarding claim 8, Lee teaches the medical image processing device according to claim 1. Lee does not explicitly disclose wherein the processing circuitry determines a range of the first energy bin on the basis of attributes of an examinee irradiated with X-rays.
However Zou teaches wherein the processing circuitry determines a range of the first energy bin on the basis of attributes (interpreted as for example age, physical constitution (such as height, weight, and BMI), sex, medical history, and hospitalization days, Specification [p 20, ln 15-18]) of an examinee irradiated with X-rays (step 502, a kV and mA waveform is designed to optimize the quality of the scan for a given patient using personal information, such as age, size, gender, and the diagnostic task; Zou, [Col 6: 38-41)]).
Regarding claim 9, the combination of Lee and Zou teach the medical image processing device according to claim 8.
Zou further teaches wherein the attributes include a physical constitution (interpreted as physical constitution (such as height, weight, and BMI); Specification [p 20, ln 15-18]) of the examinee, and wherein the processing circuitry narrows the range of the first energy bin as the physical constitution decreases and broadens the range of the first energy bin as the physical constitution increases (step 502, a kV and mA waveform is designed to optimize the quality of the scan for a given patient using personal information, such as age, size, gender, and the diagnostic task; Zou, [Col 6: 38-41)]).
Regarding claim 10, the combination of Lee and Zou teach the medical image processing device according to claim 8. Zou further teaches wherein the attributes include an age of the examinee, and wherein the processing circuitry narrows the range of the first energy bin as the age decreases and broadens the range of the first energy bin as the age increases (step 502, a kV and mA waveform is designed to optimize (i.e., narrow or broaden) the quality of the scan for a given patient using personal information, such as age, size, gender, and the diagnostic task; Zou, [Col 6: 38-41)]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lee, in view of “Oh” (Oh et al., U.S. Patent Application Publication No. US 20140254757 A1).
Regarding claim 11, Lee teaches the medical image processing device according to claim 1. Lee does not explicitly teach wherein the processing circuitry determines a range of the first energy bin on the basis of an energy resolution of an X-ray CT scanner irradiating an examinee with X-rays.
However, Oh teaches wherein the processing circuitry determines a range of the first energy bin on the basis of an energy resolution of an X-ray CT scanner irradiating an examinee with X-rays (The range and number of the separated X-ray energy bands may be determined in consideration of the resolution or definition of a desired image and/or one or more properties of the subject; Oh, ¶[0133]).
Lee and Oh are analogous art because they are from the same field of endeavor of X-ray imaging apparatus which may acquire respective phase-contrast image-signals having different properties on a per energy band basis at a single time by using a photon counting detector that separates detected X-rays on a per energy band basis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include resolution as a basis for energy ranges as taught by Oh to the invention of Lee. The motivation to do so would be to generate a phase contrast image of the subject using the phase contrast image signals which have been acquired on a per energy band basis.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lee, in view of Oh and further in view of “Iniewski” (Iniewski et al., U.S. Patent Application Publication No. US 20210022695 A1).
Regarding claim 12, the combination of Lee and Iniewski teach medical image processing device according to claim 11.
Iniewski further teaches wherein the processing circuitry narrows the range of the first energy bin as the energy resolution increases and broadens the range of the first energy bin as the energy resolution decreases (X-rays emitted at the specific energy X-ray emission exhibit a narrow range of energies (broadened due to thermal and quantum effects). Thus, if the detector exhibited very high energy resolution, the detector would record a very narrow range of energies centered about the specific energy of the X-ray emission. The finite energy resolution of detectors may be due to several factors, but the net result is a broadening of the measured energies about the specific energy of the X-ray emission. Thus in operation 1302, a measure of the energy resolution of the detector may be made by determining the width or range of photon energies recorded by the detector at a count-rate in the measure photon energy spectrum that is half way between zero and the maximum counts at or near the specific energy of the X-ray emissions of the isotope; Iniewski, ¶[0090]).
Lee and Iniewski are analogous art because they are from the same field of endeavor of X-ray photon detectors and methods of operating such detectors that compensate for charge sharing effects. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include narrowing/broadening energy range based on increased/decreased resolution as taught by Iniewski to the combined invention of Lee and Oh. The motivation to do so would be to determine the percentage of charge sharing events occurring in the detector.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Flohr et al., US 20160242727 A1, teaches automated determination of an adjusted setting for signal analysis parameters of an x-ray detector.
Solf et al., US 20250327939 A1, teaches, a photon counting detector with multiple energy bins and use of energy thresholds separating the multiple energy bins, that dynamically adapt, per photodetector pixel or group of photodetector pixels, the energy thresholds for use in a subsequent iteration based on information.
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/CHANDHANA PEDAPATI/Examiner, Art Unit 2669
/CHAN S PARK/Supervisory Patent Examiner, Art Unit 2669