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 .
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kutsuna et al. (US 20150279061 A1) in view of Najarian et al. (US 20200364859 A1) and further in view of Tsujimoto et al. (US 20200185111 A1).
Regarding claim 1, Kutsuna et al. teaches a management device comprising a processor including hardware, wherein the processor is configured to (see para [0030]; “a medical image processing apparatus 100 according to the embodiment. As illustrated in FIG. 1, the medical image processing apparatus 100 is configured by including a communication control apparatus 10”, see also para [0130-0132]; “FIGS. 18A to 18C are views for explaining a display example of the report evaluation result of the medical image processing apparatus 100..”): acquire a plurality of pieces of image information acquired through image analysis of a plurality of images (see para [0040]; “The medical image input portion 31 receives a plurality of pieces of medical image data. …A plurality of medical images each composed of a plurality of images is input into the medical image input portion 31”, see also para [0138]; “the display portion 40 switches and displays a plurality of images (slice images, for example) constituting the medical image corresponding to the position of the local structure based on the determined display order” Note: it works over many images and their derived info (position/metadata), matching the “plurality pieces of image information”); a number of captured images of each region subject to the endoscopic examination (see para [0046]; “the diagnostic reading determining portion 34 determines whether or not the check target anatomical positions listed in the diagnostic reading check information have been diagnostically read based on the anatomical position detected from the medical image”, see also para [0134]-[0135]; “The diagnostic reading chart illustrates an order of check of the check target positions and time in a bar graph…. the respective diagnostic reading time of the anatomical positions is expressed by sizes of frames indicating the anatomical positions. The anatomical positions are arranged in the order in which the diagnostic reading is completed” Note: images are mapped to position/regions, per-region status over the image set; read/not-read determination is predictable use of counting on mapped images); a first evaluation value to an evaluation result for the region (see para [0046]; “the diagnostic reading determining portion 34 determines whether or not the check target anatomical positions listed in the diagnostic reading check information have been diagnostically read based on the anatomical position detected from the medical image”, see also para [0133]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished… a report evaluation result displaying the anatomical positions which have not been diagnostically read in a list is displayed together with a message in a message window W2”, and para [0130]; “the report evaluation portion 37 evaluates a creation situation of a diagnostic reading report. ….The report evaluation portion 37 creates a report evaluation result according to the report creation situation”, Note: per-region fail/flag and notification behavior that corresponds to assigning “first evaluation value” when coverage is insufficient); and generate the evaluation result that includes the first evaluation value and the second evaluation value, based on the acquired plurality of pieces of the image information (see para [0130]-[0133]; “At ST117, the report evaluation portion 37 evaluates a creation situation of a diagnostic reading report.. creates a report evaluation result according to the report creation situation… At ST119, a report evaluation result is displayed on the display portion 40…. The report evaluation result is created by the report evaluation portion 37 when creation of the diagnostic reading is ended and displayed on the display portion 40…. an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished”). However, Kutsuna et al. does not teach captured in an endoscopic examination, derive, based on region information which identifies captured regions included in the acquired plurality of pieces of the image information, extract, from the acquired plurality of pieces of the image information, image information indicating at least one image among the plurality of images is inappropriate for observation; assign a second evaluation value to the evaluation result for each region corresponding to the extracted image information; when the derived number of captured images of each region is different from an appropriate number of captured images specified for each region.
In the same field of endeavor Najarian et al. teaches captured in an endoscopic examination (see para [0039]; “the methods of the present disclosure are applicable to many other non-surgical investigative procedures performed on human body such as, for example, upper endoscopy (esophagogastroduodenoscopy), endoscopic retrograde cholangiopancreatography (ERCP)”), derive, based on region information which identifies captured regions included in the acquired plurality of pieces of the image information (see para [0089]; “mapping frames of a colonoscopy video recording to colon segments”, see also para [0082]; “At 1502, the method 1500 builds and trains a CNN to detect frames in four distinct segments of the colon. At 1504, the method 1500 inputs the informative frames to the trained CNN to identify frames in the four colon segments…. a frame sequence belongs to a flexure of the colon”), extract, from the acquired plurality of pieces of the image information (see para [0009]; “extract other features from the converted frames to identify non-informative frames and to distinguish the non-informative frames from the informative frames. A frame is informative if the clarity of the frame is above a threshold or if the frame includes clinically relevant information about the colon”), image information indicating at least one image among the plurality of images is inappropriate for observation (see para [0075]; “At 804, control detects informative and non-informative frames in the video recording and removes the non-informative frames from the video recording (see FIG. 8 and its description for details of the model used to perform the detection and removal)”), assign a second evaluation value to the evaluation result for each region corresponding to the extracted image information (see para [0008]; “generate scores indicating severity levels of a disease for a plurality of the informative frames, estimate locations of the plurality of the informative frames in the colon, and generate an output indicating a distribution of the scores over one or more segments of the colon by combining the scores generated for the plurality of the informative frames and the estimated locations of the plurality of the informative frames in the colon”), see also para [0009]; “extract other features from the converted frames to identify non-informative frames and to distinguish the non-informative frames from the informative frames. A frame is informative if the clarity of the frame is above a threshold or if the frame includes clinically relevant information about the colon” Note: disclose a region corresponding value based on extracted image information and the primary reference Kutsuna teaches evaluation framework organized by anatomical position and generating a report evaluation result for those positions). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify a wound assessing method to check information that has been diagnostically read based on the position of the local structure detected from the medical image of Kutsuna et al. in view of the use of automated anatomic and regional location of disease features in colonoscopy videos Najarian et al. in order to facilitate objective diagnosis and disease severity measurement (see para [0039).
However, the combination of Kutsuna et al. and Najarian et al. as a whole does not teach when the derived number of captured images of each region is different from an appropriate number of captured images specified for each region.
In the same field of endeavor, Emura et a. teaches wherein the first evaluation value indicates a deduction in each of: a case where the derived number of captured images of each region is greater than an upper limit of an appropriate range of the number of captured images specified for each region; and a case where the derived number of captured images of each region is less than a lower limit of the appropriate range of the number of captured images specified for each region (see para [0032]; “acquisition unit 30 may acquire the number of captured images for each examination by checking the number of captured images stored in the examination image storage 28”, and para [0042]-[0043]; “When the average number of captured examination images in a screening examination is 40, the standard range setting unit 34 may set a standard range with a margin of 20% of the average number around the average number. Therefore, the standard range setting unit 34 sets the standard range of the number of captured images as 32 to 48…..a standard range for the number of captured images and the action time for each examination item”, see also para; [0045]-[0047]; “the implementation information storage 32 falls outside of the standard range set by the standard range setting unit 34, the examination determination unit 36 determines that the examination performed by the resident doctor is not performed properly…..The number of captured images of 100 in a screening examination with an examination ID “1” is too large compared to the standard range… the supervising doctor needs to instruct the doctor B to reduce the number of images to be captured”, and para [0054]; “When the number counted by the implementation information acquisition unit 30 exceeds the upper limit of the standard range (48 images), the examination determination unit 36 may determine that the number of captured images is not proper”, Note; the system has a set upper limit (which is 48 images in your example). If a doctor takes more images than that limit (like taking 100 images), the system flags it as "too large" and triggers a deduction in the evaluation because the examination was not performed properly). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify a wound assessing method to check information that has been diagnostically read based on the position of the local structure detected from the medical image of Kutsuna et al. in view of the use of automated anatomic and regional location of disease features in colonoscopy videos Najarian et al. and further in view of an implementation information storage that stores implementation information of an examination performed by a doctor of Tsujimoto et al. in order to determine whether or not a doctor has properly performed an examination (see para [0032).
Regarding claim 2, the rejection of claim 1 is incorporated herein.
Kutsuna et al. in the combination further teach wherein the processor is configured to sum the first evaluation value and the second evaluation value included in the evaluation result (see para [0050]; “The report evaluation portion 37 determines a diagnostic reading report creation state from the diagnostic reading check information updated in the diagnostic reading determining portion 34 during diagnostic reading and creates a report evaluation result”, see also para [0123]; “how many slice images have been checked in the slice images extracted as corresponding to the check target position can be calculated as a ratio in the total”, see also para [0131]; “At ST119, a report evaluation result is displayed on the display portion 40” Note: creates a consolidated “report evaluation result” that compiles per-position metrics and performance information ).
Regarding claim 3, the rejection of claim 2 is incorporated herein.
Kutsuna et al. in the combination further teach wherein the processor is configured to determine whether a conducted endoscopic examination was good or bad, based on the sum total of the first evaluation value and the second evaluation value (see para [0133]; “a report evaluation result in which an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished”, see also para [0135]; “The shaded portion may display a portion whose check result changes from “needs attention” to “favorable”” and para [0131]; “a report evaluation result is displayed on the display portion 40”, Note: the chart shows performance transitions such as” needs attention” to “favorable”).
Regarding claim 4, the rejection of claim 1 is incorporated herein.
Kutsuna et al. in the combination further teach wherein, even when a number of captured images of a region is larger than the appropriate number of captured images, if a lesion is present in the region, the processor is configured not to assign the first evaluation value to the evaluation result for the region (see para [0102]; “The diagnostic reading determining portion 34 may make determination based on a key image or an input content of finding when a diagnostic reading report is compiled”, see also para [0135]; “The anatomical positions are arranged in the order in which the diagnostic reading is completed, and a label is displayed at the anatomical position at which a key image or finding has been input”).
Regarding claim 5, the rejection of claim 1 is incorporated herein.
Kutsuna et al. in the combination further teach wherein the processor is configured to create a guidance document for a doctor based on the evaluation result (see para [0130]; “The report evaluation portion 37 creates a report evaluation result according to the report creation situation”, see also para [0133]; “a report evaluation result displaying the anatomical positions which have not been diagnostically read in a list is displayed together with a message in a message window W2”).
Regarding claim 6, the rejection of claim 1 is incorporated herein.
Kutsuna et al. in the combination further teach wherein, when the endoscopic examination starts++++, the processor is configured to perform notification of advice based on the evaluation result (see para [0133]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed ….,” see also para [0136]; “a user can be prompted for a final check of the diagnostic reading report … and feedback for the subsequent work can be made. By accumulating the procedure of the diagnostic reading work as above as a database, diagnostic reading methods of a skilled user can be shared with the others. In addition, by recording the diagnostic reading procedure, a missed site in diagnostic reading can be easily found, and when the diagnostic reading is resumed, duplicated work can be avoided, and improvement of efficiency and labor saving of the diagnostic reading work can be realized”). Note: notifications/visual prompts tied to evaluation both during and after reading).
Regarding claim 7, the rejection of claim 1 is incorporated herein.
Kutsuna et al. in the combination further teach wherein, when the number of captured images of a region is smaller than the appropriate number of captured images of the region, the processor is configured to notify a doctor conducting the endoscopic examination that the number of captured images of the region is insufficient (see para [0133]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished. In the example in FIG. 18A, a report evaluation result displaying the anatomical positions which have not been diagnostically read in a list is displayed together with a message in a message window W2 to confirm that diagnostic reading has been performed”).
Regarding claim 8, the rejection of claim 1 is incorporated herein.
Kutsuna et al. in the combination further teach the processor is configured to perform notification of the image being inappropriate (see para [0133]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed”).
Najarian et al. in the combination further teach wherein, when the image information includes information indicating that an image is inappropriate (see para [0009]; “identify non-informative frames and to distinguish the non-informative frames from the informative frames”).
Regarding claim 9, the scope of claim 9 is fully encompassed by the scope of claim 1, accordingly, the rejection of claim 1 is fully applicable here.
Regarding claim 10, the rejection of claim 9 is incorporated herein.
Kutsuna et al. in the combination further teach comprising: summing the first evaluation value and the second evaluation value included in the evaluation result (see para [0050]; “The report evaluation portion 37 determines a diagnostic reading report creation state from the diagnostic reading check information updated in the diagnostic reading determining portion 34 during diagnostic reading and creates a report evaluation result”, see also para [0123]; “how many slice images have been checked in the slice images extracted as corresponding to the check target position can be calculated as a ratio in the total”, see also para [0131]; “At ST119, a report evaluation result is displayed on the display portion 40” Note: creates a consolidated “report evaluation result” that compiles per-position metrics and performance information ); and determining whether a conducted endoscopic examination was good or bad, based on the sum total (see para [0133]; “a report evaluation result in which an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished”, see also para [0135]; “The shaded portion may display a portion whose check result changes from “needs attention” to “favorable”” and para [0131]; “a report evaluation result is displayed on the display portion 40”, Note: the chart shows performance transitions such as” needs attention” to “favorable”).
Regarding claim 11, the rejection of claim 9 is incorporated herein.
Kutsuna et al. in the combination further teach comprising: not assigning the first evaluation value to the evaluation result for a region, if a lesion is present in the region (see para [0133]- [0134]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished. In the example in FIG. 18A, a report evaluation result displaying the anatomical positions which have not been diagnostically read… From the diagnostic reading chart, … portion may display a portion whose check result changes from “needs attention” to “favorable””, see also para [0135]; “a label is displayed at the anatomical position at which a key image or finding has been input” Note: it already ties finding to specific regions. Model labels a region when a key image or findings is present, so the system knows which anatomical position contains findings (lesion) and mark them in the evaluation).
Tsujimoto et al. in the combination further teach even when the number of captured images of the region is larger than the appropriate number of captured images (see para [0054]; “When the number counted by the implementation information acquisition unit 30 exceeds the upper limit of the standard range (48 images), the examination determination unit 36 may determine that the number of captured images is not proper”, se also para [0046]; “The examination determination unit 36 determines that the number of captured images (100) falls outside the standard range (32 to 48) set by the standard range setting unit 34 in a screening examination performed by a doctor B with an examination ID “1””).
Regarding claim 12, the rejection of claim 9 is incorporated herein.
Kutsuna et al. in the combination further teach comprising: creating a guidance document for a doctor, based on the evaluation result (see para [0045]; “At ST117, the report evaluation portion 37 evaluates a creation situation of a diagnostic reading report”, see also para [0133]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished. In the example in FIG. 18A, a report evaluation result displaying the anatomical positions which have not been diagnostically read in a list is displayed together with a message in a message window W2”).
Regarding claim 13, the rejection of claim 9 is incorporated herein.
Kutsuna et al. in the combination further teach comprising: performing notification of advice based on the evaluation result when the endoscopic examination starts (see para [0133]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed ….,” see also para [0136]; “a user can be prompted for a final check of the diagnostic reading report … and feedback for the subsequent work can be made. By accumulating the procedure of the diagnostic reading work as above as a database, diagnostic reading methods of a skilled user can be shared with the others. In addition, by recording the diagnostic reading procedure, a missed site in diagnostic reading can be easily found, and when the diagnostic reading is resumed, duplicated work can be avoided, and improvement of efficiency and labor saving of the diagnostic reading work can be realized”).
Regarding claim 14, the scope of claim 14 is fully encompassed by the scope of claim 1,
accordingly, the rejection of claim 1 is fully applicable here. Kutsuna et al. further teaches a medical system comprising a storage device and a processor including hardware (see para [0034]; “When a program stored in the storage portion 20 is executed by a processor of the main control portion 30, the medical image processing apparatus 100”), the storage device retains an appropriate number of captured images of each region subject (see para [0046]; “the diagnostic reading determining portion 34 determines whether or not the check target anatomical positions listed in the diagnostic reading check information have been diagnostically read based on the anatomical position detected from the medical image” Note: stored per-position standard for completed is the practical threshold and it would encode as the appropriate number (at least one quantifying image per region, i.e. 1,2,3..). Encoding that as a number in storage is an obvious implementation);
Regarding claim 15, the rejection of claim 14 is incorporated herein.
Kutsuna et al. in the combination further teach wherein the processor is configured to sum the first evaluation value and the second evaluation value included in the evaluation result (see para [0050]; “The report evaluation portion 37 determines a diagnostic reading report creation state from the diagnostic reading check information updated in the diagnostic reading determining portion 34 during diagnostic reading and creates a report evaluation result”, see also para [0123]; “how many slice images have been checked in the slice images extracted as corresponding to the check target position can be calculated as a ratio in the total”, see also para [0131]; “At ST119, a report evaluation result is displayed on the display portion 40” Note: creates a consolidated “report evaluation result” that compiles per-position metrics and performance information).
Regarding claim 16, the rejection of claim 15 is incorporated herein.
Kutsuna et al. in the combination further teach wherein the processor is configured to determine whether a conducted endoscopic examination was good or bad, based on the sum total of the first evaluation value and the second evaluation value (see para [0133]; “a report evaluation result in which an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished”, see also para [0135]; “The shaded portion may display a portion whose check result changes from “needs attention” to “favorable”” and para [0131]; “a report evaluation result is displayed on the display portion 40”, Note: the chart shows performance transitions such as” needs attention” to “favorable”).
Regarding claim 17, the rejection of claim 14 is incorporated herein.
Kutsuna et al. in the combination further teach if a lesion is present in the region (see also para [0135]; “The anatomical positions are arranged in the order in which the diagnostic reading is completed, and a label is displayed at the anatomical position at which a key image or finding has been input”), the processor is configured not to assign the first evaluation value to the evaluation result for the region see para [0133]- [0134]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished. In the example in FIG. 18A, a report evaluation result displaying the anatomical positions which have not been diagnostically read… From the diagnostic reading chart, … portion may display a portion whose check result changes from “needs attention” to “favorable””).
Tsujimoto et al in the combination further teach wherein, even when the number of captured images of the region is larger than the appropriate number of captured images (see para [0054]; “When the number counted by the implementation information acquisition unit 30 exceeds the upper limit of the standard range (48 images), the examination determination unit 36 may determine that the number of captured images is not proper”, se also para [0046]; “The examination determination unit 36 determines that the number of captured images (100) falls outside the standard range (32 to 48) set by the standard range setting unit 34 in a screening examination performed by a doctor B with an examination ID “1””).
Regarding claim 18, the rejection of claim 14 is incorporated herein.
Kutsuna et al. in the combination further teach wherein the processor is configured to create a guidance document for a doctor based on the evaluation result (see para [0045]; “At ST117, the report evaluation portion 37 evaluates a creation situation of a diagnostic reading report”, see also para [0133]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished. In the example in FIG. 18A, a report evaluation result displaying the anatomical positions which have not been diagnostically read in a list is displayed together with a message in a message window W2”).
Regarding claim 19, the rejection of claim 14 is incorporated herein.
Kutsuna et al. in the combination further teach wherein, when a doctor starts an endoscopic examination, the processor is configured to perform notification of advice based on the evaluation result (see para [0133]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed ….,” see also para [0136]; “a user can be prompted for a final check of the diagnostic reading report … and feedback for the subsequent work can be made. By accumulating the procedure of the diagnostic reading work as above as a database, diagnostic reading methods of a skilled user can be shared with the others. In addition, by recording the diagnostic reading procedure, a missed site in diagnostic reading can be easily found, and when the diagnostic reading is resumed, duplicated work can be avoided, and improvement of efficiency and labor saving of the diagnostic reading work can be realized”).
Regarding claim 20, the rejection of claim 14 is incorporated herein.
Kutsuna et al. in the combination further teach, the processor is configured to notify a doctor conducting the endoscopic examination that the number of captured images of the region is insufficient (see para [0046]; “the diagnostic reading determining portion 34 determines whether or not the check target anatomical positions listed in the diagnostic reading check information have been diagnostically read”, see also para [0133]; “an alarm message is described when there is an anatomical position determined by the diagnostic reading determining portion 34 that diagnostic reading has not been completed when diagnostic reading is finished. In the example in FIG. 18A, a report evaluation result displaying the anatomical positions which have not been diagnostically read in a list”).
Tsujimoto et al. in the combination further teach wherein, when the number of captured images of a region is smaller than the appropriate number of captured images of the region (see para [0046]; “the examination determination unit 36 determines that the number of captured images (20) falls outside the standard range (8 to 12)”).
Conclusion
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/WINTA GEBRESLASSIE/Examiner, Art Unit 2677
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