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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/04/2024 has been made record of and considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "I21" and "I31" have both been used to designate the PCCT image of FIG. 7. [0071] recites “a display screen I3 of the PCCT image I21”, in reference to FIG. 7, but FIG. 7’s image is labelled as #I31. [0071] further states, “The case of FIG. 7 is the same as the case of FIG. 6.”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-14 are objected to because of the following informalities: numerous small typos/instances of awkward grammar. See claim 12, for example, spacing makes it read as “related information is DICOM files,” and should be corrected to “related information is:”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations, under their broadest reasonable interpretation, cover mental processes (concepts performed in a human mind, including as an observation, evaluation, judgment, opinion, organizing human activity and/or mathematical concepts and calculations). Independent claims 1, 13, and 14 recite acquiring count data, reconstructing images from a used first energy bin, evaluating which bins were/weren’t utilized, and storing the utilization information in association with the image/related information. This is data gathering, analyzing the information, and storing the information. In other words, a person can look at a table or chart with the relevant energies, and mentally calculate the ratio of used versus unused. See [0058]: “Specifically, all bins are bins 1 to 4, used bins are bins 1 to 3, and an unused bin is a bin 4. The energy width for all bins is 140 keV - 20 keV = 120 keV because the energy range is 20 to 140 keV. The energy width for used bins is 110 keV - 20 keV = 90 keV because the energy range is 20 to 110 keV. Therefore, the energy utilization efficiency, which is the ratio of the energy width of the used bins to the energy width of all bins, is calculated to be 90 keV/120 keV = 75%.” Further, the judicial exception is not integrated into a practical application. The claims disclose that the process is performed by a “medical information processing apparatus” in relation to PCCT, but it does not recite how the apparatus improves PCCT image reconstruction in a technical way. The additional recitation of processing circuitry and PCCT merely applies the abstract idea using generic technology and limits the idea to the field of PCCT without reciting a specific improvement to functionality or another technology. The claims do not add significantly more than the abstract idea because it merely uses generic computer components to acquire, analyze, and store information. Therefore, claims 1-14 are rejected under 35 USC 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5-11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gatayama (US 2022/0096028 A1), in further view of Noshi (US 2014/0023181 A1).
Consider claims 1, 13, and 14, Gatayama discloses a medical information processing apparatus comprising a processing circuitry (¶64-68; console 30, processing circuitry 37) configured to
[claim 14: a non-transitory computer-readable storage medium storing a program that causes a computer, when interpreted and executed by the computer, to perform the steps of ((¶64-68; console 30, memory 35, processing circuitry 37):]
acquire count data related to a plurality of energy bins, which is collected in a PCCT scan on a subject (¶32; “the X-ray CT apparatus 1 is an apparatus that counts X-ray photons having passed through a subject P”; ¶47-59; ASIC 134, counter 134e; energy bands 40a-40f, “data collection circuit 14 collects a counting result by the X-ray detector 13”; ¶148-149; “… 13 generates digital data indicating the X-ray photon counting results of the respective six energy bands 40a to 40f and outputs the generated digital data to … 14”; ¶105, 116, 147);
reconstruct one or a plurality of PCCT images based on count data related to a first energy bin of the energy bins (FIGs. 15, 17-20; ¶153-156; “reconstruction processing function 373 executes the reconstruction processing on the raw data indicating the X-ray photon counting result of the energy band determined at Step S103 out of the raw data indicating the X-ray photon counting results of the respective six energy bands 40a to 40f to reconstruct the CT image data… 373 executes the reconstruction processing on the raw data of the energy band fitting the second condition…”);
generate utilization information for evaluating a utilization degree of X-ray energy of X-rays emitted in the PCCT scan for reconstruction of the one or plurality of PCCT images based on the first energy bin used to reconstruct the one or plurality of PCCT images or a second energy bin not used to reconstruct the one or plurality of PCCT images other than the first energy bin of the energy bins (FIGs. 15, 17-20; ¶57, 116-118, 132, 147; “X-ray detector 13 sets the one energy band 40b or sets the six energy bands 40a to 40f, for example”; ¶148, 154-156; “determination function 378 first determines a condition on the energy band for the data for use in the reconstruction processing out of the data collected from the X-ray detector 13 based on the acquired imaging mode, or a second condition,… , includes the ranges of the respective energy bands, the number of energy bands, and merge information… for example, the determination function 378 determines the second condition indicating that the range of the energy band is the range of the energy value 41b or more and less than the energy value 41c and that the number of energy bands is “1”… 373 executes the reconstruction processing on the raw data of the energy band fitting the second condition out of the raw data indicating the X-ray photon counting results of the respective six energy bands 40a to 40f to reconstruct the X-ray CT image data”; ¶169-172); and
store the utilization information in a storage device in association with the one or plurality of PCCT images and/or related information of the one or plurality of PCCT images (¶67; “memory 35 stores therein the projection data and reconstructed image data … 35 stores therein an energy table 35a”; ¶72-73; “reconstruction processing function 373 stores the reconstructed X-ray CT image data in the memory 35… 373 can reconstruct the X-ray CT image data of a specific energy component… 373 can reconstruct the pieces of X-ray CT image data of a plurality of respective energy components; ¶86-89; “An optimum energy band corresponding to the imaging mode registered in the item "imaging mode” is registered in the item “energy band.””).
Gatayama fails to explicitly disclose: store the utilization information in a storage device in association with the one or plurality of PCCT images.
In related art, Noshi explicitly discloses a medical information processing apparatus comprising a processing circuitry Noshi ¶34-36; image processing apparatus 12) configured to
[claim 14: a non-transitory computer-readable storage medium storing a program that causes a computer, when interpreted and executed by the computer, to perform the steps of (Noshi ¶40-46; storage unit 44, main control unit 45):]
acquire count data related to a plurality of energy bins, which is collected in a PCCT scan on a subject (Noshi 47-49; energy classifying unit; ¶71-72; “an energy distribution represented by the counts of photons”);
reconstruct one or a plurality of PCCT images based on count data related to a first energy bin of the energy bins (Noshi ¶50; “Any energy bin including an insufficient number of photons would cause the noise level of the corresponding energy bin image in FIG. 3 to be high”; ¶67; generate energy bin images);
generate utilization information for evaluating a utilization degree of X-ray energy of X-rays emitted in the PCCT scan for reconstruction of the one or plurality of PCCT images (Noshi ¶73-79; “53 superimposes an image (e.g., a character information image) 61 indicating the corresponding energy level EL and energy width EW on each of the initial image and the extended energy bin image.”); and
store the utilization information in a storage device in association with the one or plurality of PCCT images and/or related information of the one or plurality of PCCT images (Noshi ¶73-80, 102; “storage unit 44 to store a predetermined number of energy bin images generated by the image generating unit 53… storage unit 44 to store an extended energy bin image generated by the image
generating unit 53 and determined by a user, in association with additional information being the energy level EL and energy width EW corresponding to the extended energy bin image… store the extended energy bin image in association with additional information. As a result, an operator … confirm the extended energy bin image and the additional information for the extended energy bin image through a display unit 81 of the interpretation apparatus 80.).
Noshi further states: “Any energy bin including an insufficient number of photons would cause the noise level of the corresponding energy bin image in FIG. 3 to be high. As a result, an image displayed as an initial image may have low user visibility. To address this, on the basis of information on the photons of the multiple energy bins, the X-ray CT apparatus using photon counting 10 according to the present embodiment generates an extended energy bin image having an energy level EL set by the setting unit 55 and an energy width EW of some of the predetermined number of energy bins. As a result, because of an increased number of photons, the extended energy bin image may have a lower noise level than that of each energy bin image generated based on information on photons assigned to a single energy bin (Noshi ¶50-51).” Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the associated PCCT image storage of Noshi into the energy bin information processing method of Gatayama to predictably store/display the utilization information in association with the one or plurality of PCCT images and/or related information of the one or plurality of PCCT images. Further, “an operator … can confirm the extended energy bin image and the additional information for the extended energy bin image through a display unit 81(Noshi ¶80).”
Consider claim 2, Gatayama, as modified by Noshi, discloses the claimed invention wherein the energy utilization information includes: an identifier and/or an energy range of the first energy bin or the second energy bin (Gatayama ¶55-58, 154);
an energy utilization efficiency representing a ratio of the energy range of the first energy bin to the energy ranges of the energy bins (Gatayama FIGs. 4, 9-10, 16, ¶57-58, 116-118, 154); and/or
an energy non-utilization efficiency representing a ratio of the energy range of the second energy bin to the energy ranges of the energy bins (Gatayama FIGs. 4, 21, ¶57-58, 116-118, 154).
Consider claim 5, Gatayama, as modified by Noshi, discloses the claimed invention wherein the processing circuitry is configured to: input a comment with respect to the utilization information (Gatayama ¶65; Noshi ¶75-76; 94; “an instruction to modify the energy level EL and the energy width EW is input by the user”); and
store the comment in the storage device together with the utilization information (Noshi FIGs. 1-2 and 7, ¶56, 61-62, 65, 81-82; Gatayama ¶65, 77, 91, 168, 192).
Consider claim 6, Gatayama, as modified by Noshi, discloses the claimed invention wherein the processing circuitry is configured to input the comment in a case where the utilization degree does not satisfy a predetermined condition (Noshi ¶75, 94).
Consider claim 7, Gatayama, as modified by Noshi, discloses the claimed invention wherein the processing circuitry is configured to input the comment in a free input format or a format selected from fixed phrases (Gatayama ¶65, 91, 185, 186, 192; Noshi ¶36, 75-76, 79, 90, 94-95, 100,).
Consider claim 8, Gatayama, as modified by Noshi, discloses the claimed invention wherein the processing circuitry is configured to display the utilization information on a display device (Noshi ¶50-51, 73-79, FIGs. 3-5).
Consider claim 9, Gatayama, as modified by Noshi, discloses the claimed invention wherein the display device displays the utilization information together with the one or plurality of PCCT images (Noshi ¶50-51, 73-79, FIGs. 3-5).
Consider claim 10, Gatayama, as modified by Noshi, discloses the claimed invention wherein the processing circuitry is configured to extract information related to the first energy bin and/or the second energy bin from bin setting information set before performing the PCCT scan (Gatayama ¶80-105, 116; Noshi ¶82, 104).
Consider claim 11, Gatayama, as modified by Noshi, discloses the claimed invention wherein the processing circuitry is configured to set information related to the first energy bin and/or the second energy bin after performing the PCCT scan (Noshi ¶90-100).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Gatayama, in view of Noshi, as applied to claims 1, 2, 5-11, 13, and 14 above, and further in view of Kojima (US 2020/0323502 A1).
Consider claim 3, Gatayama, as modified by Noshi, fails to explicitly disclose wherein the processing circuitry is configured to calculate a ratio of an energy width of the first energy bin used for reconstructing the one PCCT image to energy widths of the energy bins as the energy utilization efficiency of the one PCCT image.
In related art, Kojima supports wherein the processing circuitry is configured to calculate a ratio of an energy width of the first energy bin used for reconstructing the one PCCT image to energy widths of the energy bins as the energy utilization efficiency of the one PCCT image (Kojima ¶114-115).
In ¶57, Gatayama states: “In the first embodiment, the widths of the respective six energy bands 40a to 40f are fixed values.” So, it would have been obvious to one of ordinary skill in the art, if only the first band was used for reconstruction, that the ratio would be 1/6. Kojima discloses normalizing the widths based on the counts of each bin, so that each width has the same number of counts (Kojima ¶114-115).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the ratio calculation of Kojima into the information processing method of Gatayama, as modified by Noshi, to calculate a ratio as the energy efficiency.
Consider claim 4, Gatayama, as modified by Noshi, fails to explicitly disclose wherein the processing circuitry is configured to calculate a ratio of an energy width of the first energy bin used for reconstructing any one of the plurality of PCCT images to energy widths of the energy bins as the energy utilization efficiency of the plurality of PCCT images.
In related art, Kojima supports wherein the processing circuitry is configured to calculate a ratio of an energy width of the first energy bin used for reconstructing any one of the plurality of PCCT images to energy widths of the energy bins as the energy utilization efficiency of the plurality of PCCT images (Kojima ¶114-115).
In ¶57, Gatayama states: “In the first embodiment, the widths of the respective six energy bands 40a to 40f are fixed values.” So, it would have been obvious to one of ordinary skill in the art, if only the first band was used for reconstruction, that the ratio would be 1/6. Kojima discloses normalizing the widths based on the counts of each bin, so that each width has the same number of counts (Kojima ¶114-115).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the ratio calculation of Kojima into the information processing method of Gatayama, as modified by Noshi, to calculate a ratio as the energy efficiency of the plurality of images.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gatayama, in view of Noshi, as applied to claims 1, 2, 5-11, 13, and 14 above, and further in view of Wikipedia (“DICOM”).
Consider claim 12, Gatayama, as modified by Noshi, discloses the claimed invention wherein the related information is DICOM files of the one or plurality of PCCT images (Noshi ¶80),
performed scan information related to the PCCT scan (Gatayama ¶86-87, 91; Noshi ¶80) and/or
order information for the PCCT scan (Gatayama ¶86-87, 91).
In related art, Wikipedia confirms that DICOM files are typical in the art for storing medical images with associated additional data. Wikipedia states: “Digital Imaging and Communications in Medicine (DICOM) is a technical standard for the digital storage and transmission of medical images and related information… The primary purpose of the standard is to facilitate communication between the software and hardware entities involved in medical imaging, especially those that are created by different manufacturers. Entities that utilize DICOM files include components of picture archiving and communication systems (PACS), such as imaging machines (modalities), radiological information systems (RIS), scanners, printers, computing servers, and networking hardware… DICOM is used worldwide to store, exchange, and transmit medical images. DICOM has been central to the development of modern radiological imaging: DICOM incorporates standards for imaging modalities such as radiography, ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI), and radiation therapy.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the well-known DICOM file structure into the information processing method of Gatayama, as modified by Noshi, to accurately and efficiently store, exchange, and transmit medical images (Wikipedia Applications).
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0220979 A1 discloses a photon counting CT device.
US 2021/0239856 A1 discloses TTOT processing for a photon-counting x-ray detector.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY HYTREK whose telephone number is (703)756-4562. The examiner can normally be reached M-F 9:00-5:00.
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/ASHLEY HYTREK/ Examiner, Art Unit 2665
/Stephen R Koziol/ Supervisory Patent Examiner, Art Unit 2665
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