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 4/5/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 10/17/2025 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.
Claim(s) 1-3, 5, 7-9, 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kuroki et al. (US 20150036803 A1) referred to as Kuroki hereinafter and further in view of Lane et al. (US 9539441 B2) referred to as Lane hereinafter.
Regarding claim 1, Kuroki teaches A computing device comprising a display screen, (“(display unit) 29” Kuroki, para. [0019]) the computing device being configured to display on the display screen a menu listing one or more data repositories of one or more patients, (“The dose measuring unit 135 sequentially acquires dose information in accordance with imaging of an object.” Kuroki, para. [0032], object is the claimed patient)
and additionally being configured to display on the display screen a radiation timeline (“The dose graph generation unit 23 generates a dose graph indicating area doses respectively corresponding to a plurality of X-ray irradiation operations in the form of a bar graph, with the abscissa representing the number of times of imaging or the elapsed time (time series) from the start of imaging, and one ordinate representing the area doses, while indicating a total area dose from the start time of X-ray irradiation to the end time of each X-ray irradiation operation in the form of a line graph, with the other ordinate representing the total area doses.” Kuroki, para. [0043])
for each patient, patient data including one or more examination phases and radiation data thereof of a selected imaging examination, the radiation data and one or more examination phases obtained from the one or more data repositories, (“FIG. 7 is a view showing an example of dynamically increasing an area dose in each dose graph when three X-ray imaging operations are performed, with the first and third examination imaging operations being fluoroscopy and the second X-ray imaging being one-shot imaging, according to the second modification of this embodiment;” Kuroki, para. [0011])
wherein each examination phase is plotted along a horizontal axis in chronological order and a component is plotted within the radiation timeline according to a timestamp of a corresponding examination phase and a scan range of the corresponding examination phase, (“The dose graph generation unit 23 generates a dose graph indicating an area dose at the time of each of a plurality of X-ray irradiation operations and the sum of area doses (to be referred to as a total area dose hereinafter) from the start time of X-ray irradiation to the end time of each X-ray irradiation operation based on outputs from the dose measuring unit 135. The dose graph generation unit 23 calculates a total area dose by summing area doses from the start time of X-ray irradiation to the end time of each X-ray irradiation operation. That is, the dose graph generation unit 23 generates a dose graph indicating a plurality of area doses respectively corresponding to a plurality of imaging operations concerning X-ray irradiation based on dose information. In addition, the dose graph generation unit 23 sequentially updates a dose graph in accordance with the sequential acquisition of dose information.” Kuroki, para. [0042])
However, Kuroki does not teach within a graphical user interface (GUI) accessible from the menu, wherein the radiation timeline displays, and wherein the GUI is displayed while the one or more data repositories are in an un-launched state.
Lane teaches within a graphical user interface (GUI) accessible from the menu, wherein the radiation timeline displays, (“the radiation therapy system may include a Graphical Use Interface (GUI) to streamline the process of reviewing 3D patient images, 2D stereo pairs, and/or individual 2D images. The GUI may provide an efficient mechanism to visually compare images across a plurality of treatment days, making it easier to identify unusual image features that may require further investigation.” Lane, col. 4, lines 11-18)
and wherein the GUI is displayed while the one or more data repositories are in an un-launched state. (“The GUI may also allow displaying changes in spatial information over time with the image data, such as changes in offset values. The GUI may include limited floating windows that open and close, so that the user does not need to continually adjust to changing visual information. For example, the GUI may remove or decrease the discontinuity within the review of a workflow, such as when a user has to start, stop, or restart a various application or elements within the software. The discontinuity typically occurs when a user has to switch his/her attention to different patients or when a user has to switch attention between an image and graphical trend information.” Lane, col. 4, lines 18-29)
Kuroki and Lane are combinable because they are from the same field of endeavor, image processing in radiation therapy.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuroki in light of Lane’s GUI. One would have been motivated to do so because it can decrease the discontinuity within the review of a workflow. (Lane, col. 4, line 23-24)
Regarding claim 2, Kuroki teaches wherein the GUI additionally displays a second radiation timeline of examination phases without timestamps. (“FIG. 7 is a view showing an example of dynamically extending a bar indicating an area dose on a dose graph when the first and third X-ray irradiation operations of three X-ray irradiation operations are fluoroscopy, and the second X-ray irradiation is one-shot imaging. (1) in FIG. 7 indicates a display screen (11) on which a dose graph (12) is displayed before the irradiation switch is turned on (13). (2) in FIG. 7 indicates an example of a dose graph during execution of the first imaging operation (fluoroscopy)” Kuroki, para. [0088]), fig.7 does not show timestamps.
Regarding claim 3, Kuroki teaches wherein the GUI additionally displays a radiation dose element that comprises one or more dosage bars indicating an amount of irradiation at various scan ranges, the one or more dosage bars displayed aligned according to the various scan ranges. (“The dose graph generation unit 23 generates a dose graph indicating an area dose at the time of each of a plurality of X-ray irradiation operations and the sum of area doses (to be referred to as a total area dose hereinafter) from the start time of X-ray irradiation to the end time of each X-ray irradiation operation based on outputs from the dose measuring unit 135.” Kuroki, para. [0042])
Regarding claim 5, Kuroki teaches wherein the one or more examination phases include one or more of scout acquisitions, image series acquisitions, and injected agent administrations. (“in X-ray imaging using an X-ray diagnostic apparatus, exposure information (dose information) of an object is stored as additional information together with an acquired image. Acquired images and exposure doses accompanying the acquired images are often managed upon being linked to each other. In addition, acquired images and exposure doses accompanying the acquired images are sometimes sent to an external server or the like. At this time, the server manages dose information concerning each object.” Kuroki, para. [0003])
Regarding claim 7, Kuroki teaches wherein the component is a scan range bar when the corresponding examination phase is an image series acquisition and the scan range bar is displayed within the radiation timeline along a vertical axis based on a scan range of the image series acquisition. (“Referring to FIG. 12, each bar indicating an area dose associated with fluoroscopy is indicated by oblique lines extending from the upper right to the lower left. Referring to FIG. 12, each bar indicating an area dose associated with one-shot imaging is indicated by oblique lines extending from the upper left to the lower right. Note that on a dose graph indicating total area doses corresponding to the items of X-ray irradiation regions, the upper limit value of a dose up to which X-ray irradiation is permitted (to be referred to as an upper dose limit value hereinafter) may be displayed for each X-ray irradiation region. A plurality of upper dose limit values respectively correspond to a plurality of X-ray irradiation regions.” Kuroki, para. [0060])
Regarding claim 8, Kuroki teaches wherein the one or more data repositories include a plurality of imaging systems, wherein each of the plurality of imaging systems stores in memory radiation data for each examination phase, the radiation data including amount of irradiation delivered for each examination phase. (“The control unit 31 temporarily stores, in the memory (not shown), information such as instructions, X-ray conditions including imaging conditions and fluoroscopy conditions which are sent from the input unit 27. The control unit 31 controls the respective units (e.g., the high voltage generation unit 11, the X-ray beam limiting unit 133, and the driving unit 19) of the X-ray diagnostic apparatus 1 to execute X-ray imaging (one-shot imaging and fluoroscopy) in accordance with operator instructions, fluoroscopy and imaging positions, X-ray conditions, and the like stored in the memory.” Kuroki, para. [0065])
Regarding claim 9, Kuroki teaches A method, comprising: accessing one or more data repositories; (“FIG. 7 is a view showing an example of dynamically increasing an area dose in each dose graph when three X-ray imaging operations are performed, with the first and third examination imaging operations being fluoroscopy and the second X-ray imaging being one-shot imaging, according to the second modification of this embodiment;” Kuroki, para. [0011])
retrieving radiation dose data from the one or more data repositories; (“The dose graph generation unit 23 may generate a dose report concerning each of a plurality of X-ray imaging operations. A dose report is numerical information corresponding to a dose graph. The dose graph generation unit 23 outputs the generated dose graph and dose report to the output unit 29 and the storage unit 25.” Kuroki, para. [0047])
performing period segmentation to the radiation dose data to segment the radiation dose data into a plurality of examination phases for a selected imaging examination; (“The dose graph generation unit 23 generates a dose graph indicating an area dose at the time of each of a plurality of X-ray irradiation operations and the sum of area doses (to be referred to as a total area dose hereinafter) from the start time of X-ray irradiation to the end time of each X-ray irradiation operation based on outputs from the dose measuring unit 135. The dose graph generation unit 23 calculates a total area dose by summing area doses from the start time of X-ray irradiation to the end time of each X-ray irradiation operation. That is, the dose graph generation unit 23 generates a dose graph indicating a plurality of area doses respectively corresponding to a plurality of imaging operations concerning X-ray irradiation based on dose information. In addition, the dose graph generation unit 23 sequentially updates a dose graph in accordance with the sequential acquisition of dose information.” Kuroki, para. [0042])
generating a radiation timeline that displays one or more components for each of the plurality of examination phases, the radiation timeline displaying the one or more components according to time and scan range; (“The dose graph generation unit 23 generates a dose graph indicating area doses respectively corresponding to a plurality of X-ray irradiation operations in the form of a bar graph, with the abscissa representing the number of times of imaging or the elapsed time (time series) from the start of imaging, and one ordinate representing the area doses, while indicating a total area dose from the start time of X-ray irradiation to the end time of each X-ray irradiation operation in the form of a line graph, with the other ordinate representing the total area doses.” Kuroki, para. [0043]) and (“(display unit) 29” Kuroki, para. [0019])
However, Kuroki does not teach and displaying the radiation timeline in a graphical user interface (GUI).
Lane teaches and displaying the radiation timeline in a graphical user interface (GUI). (“The GUI may also allow displaying changes in spatial information over time with the image data, such as changes in offset values. The GUI may include limited floating windows that open and close, so that the user does not need to continually adjust to changing visual information. For example, the GUI may remove or decrease the discontinuity within the review of a workflow, such as when a user has to start, stop, or restart a various application or elements within the software. The discontinuity typically occurs when a user has to switch his/her attention to different patients or when a user has to switch attention between an image and graphical trend information.” Lane, col. 4, lines 18-29)
Kuroki and Lane are combinable because they are from the same field of endeavor, image processing in radiation therapy.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuroki in light of Lane’s GUI. One would have been motivated to do so because it can decrease the discontinuity within the review of a workflow. (Lane, col. 4, line 23-24)
Regarding claim 13, Kuroki teaches wherein the one or more data repositories comprise one or more of a picture archiving and communication system (PACS), (“Note that the storage unit 25 can also output a dose graph together with a single projection image or a plurality of associated projection images to an external medical image archiving apparatus or the like via an interface unit and a network” Kuroki, para. [0104]) one or more imaging systems, and a radiology information system (RIS), the one or more imaging systems comprising one or more of a computed tomography (CT), mammography, interventional radiology, a positron emission tomography (PET) system, a multi-modality system, a magnetic resonance imaging (MRI) system, an x-ray system, and a radio fluoroscopy (RF) system. (“FIG. 1 shows the arrangement of an X-ray diagnostic apparatus 1 according to the first embodiment.” Kuroki, para. [0019])
Regarding claim 14, Kuroki teaches wherein the plurality of examination phases comprise one or more of scout acquisitions, image series acquisitions, injected agent administrations, and monitoring steps. (“in X-ray imaging using an X-ray diagnostic apparatus, exposure information (dose information) of an object is stored as additional information together with an acquired image. Acquired images and exposure doses accompanying the acquired images are often managed upon being linked to each other. In addition, acquired images and exposure doses accompanying the acquired images are sometimes sent to an external server or the like. At this time, the server manages dose information concerning each object.” Kuroki, para. [0003])
Regarding claim 15, Kuroki teaches wherein performing period segmentation on the radiation dose data further comprises segmenting data without timestamps from data with timestamps. (“The monitor displays the projection image generated by the image generation unit 21. The monitor displays a dose graph together with a dose report. FIG. 4 is a view showing an example of displaying a dose graph together with a dose report. Referring to the dose graph shown in FIG. 4, the abscissa represents the number of times of imaging. Note that the abscissa of the dose graph may represent time. Referring to the dose graph shown in FIG. 4, the left ordinate represents area dose. On the dose graph, area doses corresponding to the number of times of imaging are indicated by vertical bars (bars). Referring to FIG. 4, each bar representing an area dose associated with fluoroscopy is indicated by oblique lines extending from the upper right to the lower left in a vertical bar like a histogram bar. Referring to FIG. 4, each bar representing an area dose associated with one-shot imaging is indicated by oblique lines extending from the upper left to the lower right in a vertical bar like a histogram bar.” Kuroki, para. [0057])
Regarding claim 16, Lane teaches further comprising displaying the data without timestamps in a secondary timeline within the GUI. (“FIG. 4 illustrates an exemplary graphical representation of offset trends. In FIG. 4, trend graph 400 includes information (e.g., 402) about the treatment site for which the offsets have been calculated, as well as the patient geometry at the time of treatment. Trend graph 400 includes multiple subgraphs (e.g., 404, 406, 408), depicting each of the different components of the offset. The components of the offset that are depicted include the superior, lateral, and anterior translation components (shown in the front tab “Planar Graphs”), as well as sagittal, coronal, and transverse rotational components (hidden in the background tab “Rotational Graphs”).” Lane, col. 6, lines 11-22)
Regarding claim 17, Kuroki teaches A radiation dose management system, (“A medical dose information management” Kuroki, abstract) comprising: one or more processors; and memory storing instructions executable by the one or more processors to (“Note that the storage unit 25 may store a dose information generation program concerning each type of function, e.g., a function of generating a dose graph and a dose report, executed by the dose graph generation unit 23. Furthermore, the storage unit 25 may store a program (dose graph generation program) for executing dose graph generation processing.” Kuroki, para. [0053])
Refer to the explanation of claims 1 and 9 for rest of claim 17.
Regarding claim 18, Lane teaches wherein the radiation timeline further includes one or more selectable elements that when selected trigger display of a pop-up window displaying additional information relating to the selected element. (“To group the rows according to data contained in the columns, the user may click on the header (e.g., 112) of a particular column according to which the rows are to be grouped. When the rows are grouped, the grouping headers (e.g., 114) allow the collection of grouped rows to be expanded and collapsed. Each grouping header includes summary information about the collection of rows within the group, including, for example, the count of rows within the group (e.g., image count) and statistics about columns within the group such as oldest image acquisition date and time. Selection of a particular row in table 100 makes the image represented by the row available to be loaded for review.” Lane, col. 4, lines 60-67, col. 5, lines 1-5)
Claim(s) 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kuroki and Lane as mentioned above and further in view of Anderson et al. (US 7970624 B2).
Regarding claim 19, the combination of Kuroki and Lane does not teach wherein the one or more selectable elements comprise one or more of over-irradiation alerts, isotope activity elements, and practice issue alerts.
However, Anderson teaches wherein the one or more selectable elements comprise one or more of over-irradiation alerts, isotope activity elements, and practice issue alerts. (“Workflow engine 10 provides alert messages to a clinician that are triggered by acquired patient parameters or treatment device parameters that are outside of predetermined tolerance limit values. The alert messages enable an oncology clinician, for example to more quickly identify subtle changes in treatment, outcome and patient clinical status enabling the clinician to adjust a treatment process to the needs of a particular patient.” Anderson, col. 4, lines 65-67, col. 5, lines 1-4)
Kuroki, Lane, and Anderson are combinable because they are from the same field of endeavor, image processing in radiation therapy.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuroki and Lane in light of Anderson’s over-irradiation alerts. One would have been motivated to do so because it can result in a positive treatment outcome. (Anderson, col. 3, line 17)
Regarding claim 20, Anderson teaches wherein the one or more examination phases are plotted as icons along a horizontal axis of the radiation timeline, the icons each being selectable to launch a pop-up window displaying additional information about a corresponding examination phase. (“Image area 309 presents information indicating treatment delivered or to be delivered for a currently selected corresponding phase of treatment indicated in a currently selected row of rows 320, 323, and 326, selected in response to user activation of a corresponding button 330, 332 and 335. Treatment administration events are shown in image area 309 in a reverse chronological timeline 375 along the left side of image area 309. A selected treatment administration event 355 is indicated by white boldface text. Image area 309 includes one or more bar charts such as bar charts 363, 365 and 367. Bar charts 363, 365 and 367 individually compare a cumulative treatment dose administered to three corresponding different target anatomical sites with a total dose prescribed to be administered to the three target anatomical sites.” Anderson, col. 4, lines 17-30)
Allowable Subject Matter
Claims 4, 6, 10-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/PARDIS SOHRABY/ Examiner, Art Unit 2664
/JENNIFER MEHMOOD/ Supervisory Patent Examiner, Art Unit 2664