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.
Response to Amendments
Regarding the amendments to the claims filed on 09/23/2025, the amendments have been acknowledged, accepted, and entered. The claims 1-20 were previously pending. Claims 1, 4, 7, 10, 13, and 16 have been amended, claims 3, 9, and 15 have been cancelled, and claims 21 – 23 have been added. Claims 1, 2, 4 – 8, 10 – 14, and 16 - 23 are now still currently pending.
Response to Arguments
Applicant's arguments filed 09/23/2025 have been fully considered but they are not persuasive. The applicant argues that Tezuka does not teach of the “certain criterion”, used to determine a target frame image, and the “quality information”, generated regarding quality of the dynamic imaging, as being different. However, Tezuka does teach of the “certain criterion” and the “quality information” being different from each other. In [0078] of Tezuka a failure frame is determined by an irradiating condition or by the position of the subject, this irradiation condition/ position of subject represents the certain criterion used to determine a target frame image. In [0090] of Tezuka “quality information” is generated that is different than the “certain criterion”, this generated “quality information” is represented by the additional information displayed alongside the failure frame, being amount of exposure in the imaging and time of imaging, wherein this information is different from the “certain criterion” as described above.
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 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 of this title, 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, 4 - 7, 10 - 13, and 16 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tezuka; Hidetake et al. (US 20200074677 A1, hereinafter simply referred to as Tezuka.), in view of Zanca; Federica (US 20190159747 A1; hereinafter simply referred to as Zanca)
Regarding independent claim 1, Tezuka teaches:
A dynamic imaging quality control device that performs quality control of dynamic imaging (See, ¶ [8], “An object of the present invention is to be able to determine the reason for failure in the failure image of the dynamic image or the moving image”) in which a dynamic state of a subject (Subject; See ¶ 35 and 36) is imaged by irradiating the subject with radiation (See, ¶ 37 “According to the dynamic imaging of the present embodiment, in response to one imaging operation (pressing of the exposure switch 12), the imaging apparatus 2 repeats accumulating of charge and readout of the signal value a plurality of times within a short period of time (for example, 15 times in one second) to repeatedly generate a string of a plurality of sets of image data based on the radiation irradiated from the irradiating apparatus 1.”) the device comprising a hardware processor (Controller, centrally controls the operation of each unit and performs various processes, see ¶ 45, 46, Fig. 2 reference number: 31 )
determine a target frame image that meets a certain criterion (failure frame Ff decided by controller based on an irradiating condition or by the position of the subject see Fig 3C. ¶ 77, 78) as a target of quality control (quality control being reason for failure frame being chosen including but not limited to dose of radiation and movement of subject see ¶ 77, 78, 89,90 ) from among multiple frame images (plurality of frames F included in the dynamic image, see ¶ 77) constituting a dynamic image obtained by the dynamic imaging (See, ¶ 77 “the controller 31 analyzes the plurality of frames F included in the dynamic image, etc. based on the obtained data or the analyzed image data and determines whether each frame F is the failure frame Ff.,”)
generate quality information (reasoning(s) for failure frame, see ¶ 78, 86, 90) regarding quality of the dynamic imaging by using the determined target frame image (See abstract, ¶ [78] (1)(2), “the failure frame including a reason why the dynamic image or the moving image cannot be provided for diagnosis. … The position of the subject and the predetermined reference position are compared in the plurality of frames F. If the position of the subject is separated from the reference position in a predetermined distance or more, the target frame is determined to be the failure frame Ff. … the irradiating condition of the radiation is calculated from the pixel signal value and the calculated irradiating condition is compared with the predetermined reference condition in the plurality of frames F. If the irradiating condition is far from the reference condition in a predetermined value or more, the target frame is determined to be the failure frame Ff.”), and outputs the quality information (See claim 2, Figure 1, ¶ 90 “The image display apparatus according to claim 1, wherein, the hardware processor displays the failure frame on the display together with a mark indicating that the frame is the failure frame. … Here, when the amount of exposure is displayed, in addition to the amount of exposure in the certain occasion of imaging, the following items can also be displayed, for example, the contents of imaging and the amount of time of imaging performed before and after the certain occasion of imaging, whether there is failure in the imaging and the reason for failure, the amount of exposure in the imaging, and the total amount of exposure in all occasions of imaging including the certain occasion of imaging and the imaging performed before and after.”)
the quality information being different from the certain criterion (In [0078] of Tezuka a failure frame is determined by an irradiating condition or by the position of the subject, this irradiation condition/ position of subject represents the certain criterion used to determine a target frame image. In [0090] of Tezuka “quality information” is generated that is different than the “certain criterion”, this generated “quality information” is represented by the additional information displayed alongside the failure frame, being amount of exposure in the imaging and time of imaging, wherein this information is different from the “certain criterion” as described above.)
Tezuka does not explicitly disclose the quality control being performed periodically after the device is delivered.
However, Zanca teaches of quality control being performed periodically after the device is delivered (The quality control is performed periodically (daily) of the dynamic imaging, See ¶ 5, 13, 15, and 16) (See ¶ 15 and 16, “According to the present disclosure, one method of reducing the cost and lack of information of conventional imaging system performance analysis includes a system to track performance of imaging devices on a daily basis,” … “When the system determines that the test exam image is valid, the system measures relevant performance indicators (e.g., KPIs) of the data set, set forth by a user, a hospital, and/or medical regulations. Relevant performance indicators correspond to indicators that are relevant to imaging (e.g., indicators that correspond to the obtaining a high-quality image associated with obtaining a diagnosis for a disease with a low dose with an x-ray is used). Additionally or alternatively, relevant performance indicators may correspond to indicators that correspond to possible malfunctions of the system.”)
As taught by Zanca it is important to ensure that an imaging device is operating correctly, but the use of technicians to determine the performance is expensive and often times the measurements are not stored anywhere. (The quality control device and system as taught by Zanca ensures the imaging device is operating correctly by checking daily the performance of the imaging device while not needing a costly technician to determine the performance while also storing the measurement data of the quality control, See ¶ 3, 14, 15, and 16) (See ¶ 14 “Analyzation of test exams by technician to determine performance of an imaging device is expensive and measurements are not stored anywhere to observe trends over time.” … “Examples disclosed herein include an integrated system that solves the above problems by implementing an integrated system in a hospital information system that automatically analyzes test exams and stores results to provide (e.g., generate) reports based on imaging device functionality over time.”) As both the teachings of Tezuka and Zanca deal with the technical field of quality control of imaging devices it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tezuka with Zanca to have the quality control be performed periodically after the device is delivered as taught by Zanca in order to ensure that the imaging device is operating correctly, and save cost by not using a technician, as well as ensuring that analysis can occur of the performance over time as the quality data is stored.
Regarding dependent claim 4,Tezuka in view of Zanca teaches:
Certain criterion is that the target frame image (failure frame Ff decided by controller based on subject position or irradiation condition see Tezuka Fig 3C. ¶ 77, 78) is taken with a dose (See Tezuka ¶ [29], “In response to operation of the exposure switch 12, the generator 11 is able to apply to the radiation source 13 voltage according to the radiation irradiating condition (tube voltage, tube current, and irradiating time (mAs value), etc.))” equal to or less than a predetermined dose. (See Tezuka ¶ [78] (2), “The irradiating condition of the radiation is calculated from the pixel signal value and the calculated irradiating condition is compared with the predetermined reference condition in the plurality of frames F. If the irradiating condition is far from the reference condition in a predetermined value or more, the target frame is determined to be the failure frame Ff.”)
Regarding dependent claim 5, Tezuka in view of Zanca teaches:
Determining one frame image as the target frame image (failure frame Ff decided by controller based on image data see Tezuka Fig 3C. ¶ 77 ) (See Tezuka ¶ 79 “Then, the controller 31 displays on the display 34 the frame determined to be the failure frame Ff as the failure image.”)
Regarding dependent claim 6, Tezuka in view of Zanca teaches:
The concept of a receiver (operator that is operated by a user via clicks or touchscreen see Tezuka ¶ 60 ) that receives information regarding the target frame image (failure frame Ff decided by controller based on image data see Tezuka Fig 3C. ¶ 77) from a user, wherein the hardware processor (Controller which centrally controls the operation of each unit and performs various processes see Tezuka ¶ 45, 46, Fig. 2 reference number: 31 ) determines the target frame image, based on the information received by the receiver. (See Tezuka, ¶ [60], FIG. 3, claim 6 “The frame is specified as follows. The user checks whether the body of the subject moved or whether the irradiating condition of the radiation is suitable while watching the dynamic image, etc. based on the image data or the analyzed image data displayed on the image display screen 51 of the display 34. At the timing when the user believes the desired dynamic image, etc. is not obtained, for example, the subject is moving, the image is too dark (too bright), or there is a large amount of scattered radiation and the contrast is low, the user operates the operator 35 (clicks or touches the image) to specify the frame displayed at this point as the failure frame Ff. … The image display apparatus according to claim 1, wherein the hardware processor sets the frame specified by the user from among the plurality of frames as the failure frame, and displays the frame set as the failure frame on the display.”)
Regarding independent claim 7, claim 7 is a non-transitory computer-readable storage medium claim corresponding to claim 1. Please see the discussion of claim 1 above. Furthermore Tezuka teaches of a non-transitory computer-readable storage medium storing a dynamic imaging quality control program for a dynamic imaging quality control device to perform quality control of dynamic imaging (See, ¶ [8], [46], [48], [77], [78], [90] “The controller 31 centrally controls the operation of each unit of the image display apparatus 3 with the CPU, RAM, etc. Specifically, based on the operation signal input from the operator 35 and the various signals and data received from the imaging apparatus 2, various process programs stored in the storage 33 are read out and deployed in the RAM. The controller 31 performs various processes according to the process programs and controls the contents displayed on the display 34. … The storage 33 includes a HDD (Hard Disk Drive), a semiconductor memory, and the like, and stores various process programs and parameters and files necessary to perform the programs.” … “An object of the present invention is to be able to determine the reason for failure in the failure image of the dynamic image or the moving image” … “the controller 31 analyzes the plurality of frames F included in the dynamic image, etc. based on the obtained data or the analyzed image data and determines whether each frame F is the failure frame Ff.,”))
Regarding dependent claim 10, claim 10 is considered to be a non-transitory computer readable medium claim corresponding to claim 4. Please see the discussion for claim 4 above.
Regarding dependent claim 11, claim 11 is considered to be a non-transitory computer readable medium claim corresponding to claim 5. Please see the discussion for claim 5 above.
Regarding dependent claim 12, claim 12 is considered to be a non-transitory computer readable medium claim corresponding to claim 6. Please see the discussion for claim 6 above.
Regarding independent claim 13, claim 13 is considered to be a method claim corresponding to claim 1. Please see the discussion of claim 1 above.
Regarding dependent claim 16, claim 16 is considered to be a method claim corresponding to claim 4. Please see the discussion for claim 4 above.
Regarding dependent claim 17, claim 17 is considered to be a method claim corresponding to claim 5. Please see the discussion for claim 5 above.
Regarding dependent claim 18, claim 18 is considered to be a method claim corresponding to claim 6. Please see the discussion for claim 6 above.
Regarding dependent claim 19, Tezuka in view of Zanca teaches:
The target frame image is at least one image selected by the user from the multiple frame images, (The target frame being the failure frame that is selected by the user is chosen from a plurality of frame images, See Tezuka ¶ 59) (See Tezuka ¶ 59 “According to the present embodiment, among the plurality of frames F, the frame specified by the user (the person who images the subject or the person confirming the obtained frame F (the person who images the subject, the person interpreting the image, doctor, etc.)) is set as the failure frame Ff.”)
Regarding dependent claim 20, Tezuka in view of Zanca teaches:
The target frame image is at least one frame image except the first image and a last frame image, (The user selects any of the plurality of frames that they deem as the failure frame, as seen in figure 4 the failure frame is neither the first nor the last frame, any of the frames can be chosen, See Tezuka ¶ 59, 60, Figures 3 and 4) (See Tezuka ¶ 60, “The frame is specified as follows. The user checks whether the body of the subject moved or whether the irradiating condition of the radiation is suitable while watching the dynamic image, etc. based on the image data or the analyzed image data displayed on the image display screen 51 of the display 34. At the timing when the user believes the desired dynamic image, etc. is not obtained, for example, the subject is moving, the image is too dark (too bright), or there is a large amount of scattered radiation and the contrast is low, the user operates the operator 35 (clicks or touches the image) to specify the frame displayed at this point as the failure frame Ff ”)
Claims 2, 8, 14 and 21 – 23 are rejected under 35 U.S.C. 103 as being anticipated by Tezuka; Hidetake et al. (US 20200074677 A1, hereinafter simply referred to as Tezuka.), in view of Zanca; Federica (US 20190159747 A1; hereinafter simply referred to as Zanca), further in view of Hao; Xin (US 20190139275 A1, herein simply referred to as Hao), further in view of Nakayama; Osamu (JP4346379B2, hereinafter simply referred to as Nakayama) and further in view of Kuchii; Toshimasa (TW200846648A; hereinafter simply referred to as Kuchii).
Regarding dependent claim 2, Tezuka in view of Zanca does not teach:
The quality information including at least one of a piece of information indicating a low contrast resolution of the dynamic image, a piece of information indicating streaks, and a piece of information indicating unevenness; however;
Hao teaches of the quality information including at least one of a piece of information indicating a low contrast resolution of the dynamic image; (See ¶ [73], “In some embodiments, the judgment module 506 may determine whether there is a pulsatile artifact in the reconstructed cardiac image based on one or more image quality parameters. The one or more image quality parameters may include an image uniformity, a high contrast resolution, a low contrast resolution, a signal noise ratio (SNR), a CT number linearity, or the like, or any combination thereof. For example, if at least one image quality parameter is less than a predetermined quality threshold, the judgment module 506 may determine that there is the pulsatile artifact in the reconstructed cardiac image.”).
As taught by Hao, an image shown with low contrast resolution can result in an Xray image of poor/low quality. (Low contrast resolution can lead to determination of an artifact See ¶ 73) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hao with Tezuka in view of Zanca in order to include the quality information including at least one of a piece of information indicating a low contrast resolution of the dynamic image; in order for the user to identify the image as poor, if it has low contrast resolution.
Tezuka in view of Zanca and Hao does not teach of a piece of information indicating streaks or a piece of information indicating unevenness; however;
Nakayama teaches of a piece of information indicating streaks; (See ¶ [5], “The invention according to claim 2 is a defect inspection method for detecting a defect of an inspection object by imaging the inspection object with an imaging device and processing image data of the obtained inspection object. The main feature is a defect inspection method in which an inspection feature image having the feature value of each pixel as the luminance value of each pixel is created and the connectivity of each pixel of the inspection feature image is evaluated to determine whether the inspection object is good or bad. According to the second aspect of the present invention, it is possible to determine whether the inspection object is good or not, and to detect streak-like defects generated”).
As taught by Nakayama, an image shown with streaks can result in an Xray image of poor/low quality. (Streak-like defects indicate poor quality ¶ 3,4) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nakayama with Tezuka in view of Zanca and Hao in order to include the quality information including at least one of a piece of information indicating streaks of the dynamic image; in order for the user to identify the image as poor, if it has streaks.
Tezuka in view of Zanca, Hao, and Nakayama does not teach of a piece of information indicating unevenness; however;
Kuchii teaches of a piece of information indicating unevenness; (See at least Kuchii ¶ [3], “the defect detecting device according to the present invention detects a region in which a pixel value changes unevenly from a region around itself in a digital image, that is, a defect region”)
As taught by Kuchii, an image shown with unevenness can result in an Xray image of poor/low or bad quality. (Unevenness indicates a defect in an image see ¶ 1,3) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kuchii with Tezuka in view of Zanca, Hao and Nakayama in order to include the quality information including at least one of a piece of information indicating unevenness of the dynamic image; in order for the user to identify the image as poor, if it has unevenness.
Regarding dependent claim 8, claim 8 is considered to be a non-transitory computer readable medium claim corresponding to claim 2. Please see the discussion for claim 2.
Regarding dependent claim 14, claim 14 is considered to be a method claim corresponding to claim 2. Please see the discussion for claim 2.
Regarding dependent claim 21, Tezuka in view of Zanca does not teach:
The quality information including at least one of a piece of information indicating a low contrast resolution of the dynamic image, a piece of information indicating streaks, and a piece of information indicating unevenness; however;
Hao teaches of the quality information including at least one of a piece of information indicating a low contrast resolution of the dynamic image; (See ¶ [73], “In some embodiments, the judgment module 506 may determine whether there is a pulsatile artifact in the reconstructed cardiac image based on one or more image quality parameters. The one or more image quality parameters may include an image uniformity, a high contrast resolution, a low contrast resolution, a signal noise ratio (SNR), a CT number linearity, or the like, or any combination thereof. For example, if at least one image quality parameter is less than a predetermined quality threshold, the judgment module 506 may determine that there is the pulsatile artifact in the reconstructed cardiac image.”).
As taught by Hao, an image shown with low contrast resolution can result in an Xray image of poor/low quality. (Low contrast resolution can lead to determination of an artifact See ¶ 73) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hao with Tezuka in view of Zanca in order to include the quality information including at least one of a piece of information indicating a low contrast resolution of the dynamic image; in order for the user to identify the image as poor, if it has low contrast resolution.
Tezuka in view of Zanca and Hao does not teach of a piece of information indicating streaks or a piece of information indicating unevenness; however;
Nakayama teaches of a piece of information indicating streaks; (See ¶ [5], “The invention according to claim 2 is a defect inspection method for detecting a defect of an inspection object by imaging the inspection object with an imaging device and processing image data of the obtained inspection object. The main feature is a defect inspection method in which an inspection feature image having the feature value of each pixel as the luminance value of each pixel is created and the connectivity of each pixel of the inspection feature image is evaluated to determine whether the inspection object is good or bad. According to the second aspect of the present invention, it is possible to determine whether the inspection object is good or not, and to detect streak-like defects generated”).
As taught by Nakayama, an image shown with streaks can result in an Xray image of poor/low quality. (Streak-like defects indicate poor quality ¶ 3,4) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nakayama with Tezuka in view of Zanca and Hao in order to include the quality information including at least one of a piece of information indicating streaks of the dynamic image; in order for the user to identify the image as poor, if it has streaks.
Tezuka in view of Zanca, Hao, and Nakayama does not teach of a piece of information indicating unevenness; however;
Kuchii teaches of a piece of information indicating unevenness; (See at least Kuchii ¶ [3], “the defect detecting device according to the present invention detects a region in which a pixel value changes unevenly from a region around itself in a digital image, that is, a defect region”)
As taught by Kuchii, an image shown with unevenness can result in an Xray image of poor/low or bad quality. (Unevenness indicates a defect in an image see ¶ 1,3) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kuchii with Tezuka in view of Zanca, Hao and Nakayama in order to include the quality information including at least one of a piece of information indicating unevenness of the dynamic image; in order for the user to identify the image as poor, if it has unevenness.
Regarding dependent claim 22, claim 22 is considered to be a non-transitory computer readable medium claim corresponding to claim 21. Please see the discussion for claim 21 above.
Regarding dependent claim 23, claim 23 is considered to be a method claim corresponding to claim 21. Please see the discussion for claim 21 above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEJANDRO HERNANDEZ whose telephone number is (703)756-1876. The examiner can normally be reached M-F 8 am - 5 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John M Villecco can be reached on (571) 272-7319. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEJANDRO HERNANDEZ/Examiner, Art Unit 2661
/AARON W CARTER/Primary Examiner, Art Unit 2661