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.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stanchev et al. (US 2024/0042240 A1, Feb. 8, 2024) (hereinafter “Stanchev”) in view of Lewis et al. (US 2021/0059631 A1, Mar. 4, 2021) (hereinafter “Lewis”).
Regarding claim 1: Stanchev discloses a medical imaging system, comprising: a radiographic imaging apparatus (imager 207, [0029]); a radiation generation apparatus (both x-ray source 206 and LINAC 204 are “radiation generation apparatus”); and an imaging control apparatus controlling the radiation generation apparatus and the radiographic imaging apparatus, wherein the imaging control apparatus includes a hardware processor that acquires imaging order information including information on positioning ([0042] - GUI and console 110 implicitly disclose a hardware processor; fig. 5, at least steps 501-507), determines whether the acquired imaging order information satisfies predetermined conditions (fig. 5, [0057] - steps 521 and 522 are performed in response to user selections or displayed elements - "predetermined conditions"),and outputs imaging support information before start of the positioning when the imaging order information satisfies the predetermined conditions (fig. 5, step 522, [0058]; [0054] - prompts for positioning the patient are displayed at step 511, indicating that the patient is not yet positioned). Stanchev further discloses a range of imaging parameters including scanning start location, scanning end location, gantry tilt, field of view, scanning energy (kV), tube current (mAs), exposure time, exposure/dose (mSv), the number of projection images acquired for the session image, patient position, patient orientation, and the like ([0039]).
Stanchev does not disclose that the imaging support information is a warning that a procedure to be performed in the imaging order information has a low imaging frequency or that an imaging direction in the imaging order information is different from a normal imaging direction.
Lewis, in the same field of endeavor, discloses a protocol manager which allows customization of an imaging protocol (including modification of imaging parameters) from a default (“normal”) protocol ([0017]) and provides a notification (“warning”) of a modification to the imaging protocol which includes information on the modification and the default item in the protocol ([0074]-[0075]). Lewis further teaches that such customization allows the healthcare site (e.g. hospital, clinic, imaging facility, etc.) to have maximum control over an image protocol ([0041]).
It would have been prima facie obvious for one having ordinary skill art prior to the effective filing date to modify the system of Stanchev to include the protocol modification and notification (“warning”) system of Lewis in order to allow the user/site to have maximum control over the imaging protocol. Since Lewis discloses that a variety of imaging settings/parameters may be modified (“…imaging systems settings such as power settings, position settings, motor speed settings, etc.”) it is further considered obvious to allow the modification/notification regarding the imaging parameters of Stanchev, where at least scanning location, gantry tilt, field of view, patient position and patient orientation comprise “an imaging direction” parameter.
Regarding claim 2: Stanchev and Lewis disclose the medical imaging system according to claim 1, wherein the imaging order information includes information on the imaging direction of the imaging site (Stanchev - fig. 6H, [0058] - imaging parameters 641; [0039] - list of possible imaging parameters for display including scanning location, gantry tilt, field of view, patient position and patient orientation - all of which comprise "information on an imaging direction of an imaging site").
Regarding claim 3: Stanchev and Lewis disclose the medical imaging system according to claim 1, wherein the imaging support information includes information for an alert related to the imaging direction of an imaging site (Lewis – [0074]-[0075]; Stanchev - [0054] - positioning prompts, step 511; fig. 6H, [0058] - imaging parameters 641).
Regarding claim 4: Stanchev and Lewis disclose the medical imaging system according to claim 1, wherein the hardware processor is capable of setting the predetermined conditions (all of the disclosed functions are performed via the processor(s) of system 100, therefore they are "capable" of performing these functions).
Regarding claim 5: Stanchev and Lewis disclose the medical imaging system according to claim 4, wherein the hardware processor is capable of setting, as the predetermined conditions, information on the imaging direction and notification necessity information as to whether to provide notification of the imaging support information in association with each other (all of the disclosed functions are performed via the processor(s) of system 100, therefore they are "capable" of performing these functions).
Regarding claim 6: Stanchev and Lewis disclose the medical imaging system according to claim 2, wherein the information on the imaging direction is an X-ray irradiation direction in a predetermined imaging direction (Stanchev - [0031]-[0032], [0039]).
Regarding claim 7: Stanchev and Lewis disclose the medical imaging system according to claim 1, further comprising: a storage that stores information on the imaging direction and notification necessity information as to whether to provide notification of the imaging support information in association with each other (Stanchev - [0061]-[0062] - memory 710, storage 730; fig. 5 and all associated description; Lewis – [0045], [0073]), wherein the hardware processor specifies the notification necessity information corresponding to the information on the imaging direction stored in the storage on a basis of the information on the imaging direction acquired as the imaging order information, determines, on the basis of the specified notification necessity information, whether the predetermined conditions are satisfied (Stanchev - fig. 5 and all associated description; Lewis – [0017], [0074]-[0075]), and outputs the imaging support information on the basis of the specified notification necessity information when the predetermined conditions are satisfied (fig. 5 and figs. 6A-H, and all associated description; Lewis – [0017], [0074]-[0075]).
Regarding claim 8: Stanchev discloses an imaging control apparatus, comprising: a hardware processor that acquires imaging order information including information on positioning ([0042] - GUI and console 110 implicitly disclose a hardware processor; fig. 5, at least steps 501-507), determines whether the acquired imaging order information satisfies predetermined conditions (fig. 5, [0057] - steps 521 and 522 are performed in response to user selections or displayed elements - "predetermined conditions"), and outputs imaging support information before start of the positioning when the imaging order information satisfies the predetermined conditions (fig. 5, step 522, [0058]; [0054] - prompts for positioning the patient are displayed at step 511, indicating that the patient is not yet positioned). Stanchev further discloses a range of imaging parameters including scanning start location, scanning end location, gantry tilt, field of view, scanning energy (kV), tube current (mAs), exposure time, exposure/dose (mSv), the number of projection images acquired for the session image, patient position, patient orientation, and the like ([0039]).
Stanchev does not disclose that the imaging support information is a warning that a procedure to be performed in the imaging order information has a low imaging frequency or that an imaging direction in the imaging order information is different from a normal imaging direction.
Lewis, in the same field of endeavor, discloses a protocol manager which allows customization of an imaging protocol (including modification of imaging parameters) from a default (“normal”) protocol ([0017]) and provides a notification (“warning”) of a modification to the imaging protocol which includes information on the modification and the default item in the protocol ([0074]-[0075]). Lewis further teaches that such customization allows the healthcare site (e.g. hospital, clinic, imaging facility, etc.) to have maximum control over an image protocol ([0041]).
It would have been prima facie obvious for one having ordinary skill art prior to the effective filing date to modify the apparatus of Stanchev to include the protocol modification and notification (“warning”) system of Lewis in order to allow the user/site to have maximum control over the imaging protocol. Since Lewis discloses that a variety of imaging settings/parameters may be modified (“…imaging systems settings such as power settings, position settings, motor speed settings, etc.”) it is further considered obvious to allow the modification/notification regarding the imaging parameters of Stanchev, where at least scanning location, gantry tilt, field of view, patient position and patient orientation comprise “an imaging direction” parameter.
Regarding claim 9: Stanchev and Lewis disclose the imaging control apparatus according to claim 8, wherein the hardware processor outputs the predetermined notification to an external device (Stanchev - at least remote console 110 or screens 101 on system 100 which includes imagers 207, [0061-[0064]).
Regarding claim 10: Stanchev and Lewis disclose the imaging control apparatus according to claim 9, wherein the external device is an imaging apparatus (Stanchev - at least remote console 110 or screens 101 on system 100 which includes imagers 207, [0061-[0064]).
Regarding claim 11: Stanchev and Lewis disclose the imaging control apparatus according to claim 8, wherein the hardware processor is capable of setting the predetermined conditions, and the hardware processor is capable of setting, as the predetermined conditions, information on the imaging direction and notification necessity information as to whether to provide notification of the imaging support information in association with each other (all of the disclosed functions are performed via the processor(s) of system 100, therefore they are "capable" of performing these functions).
Regarding claim 12: Stanchev and Lewis disclose the imaging control apparatus according to claim 8, wherein the imaging order information includes information on an imaging direction, and the information on the imaging direction is an irradiation direction of radiation in a predetermined imaging direction (Stanchev - [0054] - positioning prompts, step 511; fig. 6H, [0058] - imaging parameters 641; [0039] - list of possible imaging parameters for display including scanning location, gantry tilt, field of view, patient position and patient orientation - all of which comprise "information on an imaging direction of an imaging site"; [0031]-[0032], [0039]).
Regarding claim 13: Stanchev discloses a medical imaging method causing a hardware processor to perform: acquiring imaging order information including information on positioning ([0042]; fig. 5, at least steps 501-507); determining whether the acquired imaging order information satisfies predetermined conditions (fig. 5, [0057] - steps 521 and 522 are performed in response to user selections or displayed elements - "predetermined conditions"); and outputting imaging support information before start of the positioning when the imaging order information satisfies the predetermined conditions (fig. 5, step 522, [0058]; [0054] - prompts for positioning the patient are displayed at step 511, indicating that the patient is not yet positioned). Stanchev further discloses a range of imaging parameters including scanning start location, scanning end location, gantry tilt, field of view, scanning energy (kV), tube current (mAs), exposure time, exposure/dose (mSv), the number of projection images acquired for the session image, patient position, patient orientation, and the like ([0039]).
Stanchev does not disclose that the imaging support information is a warning that a procedure to be performed in the imaging order information has a low imaging frequency or that an imaging direction in the imaging order information is different from a normal imaging direction.
Lewis, in the same field of endeavor, discloses a protocol manager which allows customization of an imaging protocol (including modification of imaging parameters) from a default (“normal”) protocol ([0017]) and provides a notification (“warning”) of a modification to the imaging protocol which includes information on the modification and the default item in the protocol ([0074]-[0075]). Lewis further teaches that such customization allows the healthcare site (e.g. hospital, clinic, imaging facility, etc.) to have maximum control over an image protocol ([0041]).
It would have been prima facie obvious for one having ordinary skill art prior to the effective filing date to modify the method of Stanchev to include the protocol modification and notification (“warning”) system of Lewis in order to allow the user/site to have maximum control over the imaging protocol. Since Lewis discloses that a variety of imaging settings/parameters may be modified (“…imaging systems settings such as power settings, position settings, motor speed settings, etc.”) it is further considered obvious to allow the modification/notification regarding the imaging parameters of Stanchev, where at least scanning location, gantry tilt, field of view, patient position and patient orientation comprise “an imaging direction” parameter.
Regarding claim 14: Stanchev discloses a non-transitory computer readable recording medium storing a program causing a computer to perform: acquiring imaging order information including information on positioning ([0042]; fig. 5, at least steps 501-507); determining whether the acquired imaging order information satisfies predetermined conditions (fig. 5, [0057] - steps 521 and 522 are performed in response to user selections or displayed elements - "predetermined conditions");and outputting imaging support information before start of the positioning when the imaging order information satisfies the predetermined conditions (fig. 5, step 522, [0058]; [0054] - prompts for positioning the patient are displayed at step 511, indicating that the patient is not yet positioned). Stanchev further discloses a range of imaging parameters including scanning start location, scanning end location, gantry tilt, field of view, scanning energy (kV), tube current (mAs), exposure time, exposure/dose (mSv), the number of projection images acquired for the session image, patient position, patient orientation, and the like ([0039]).
Stanchev does not disclose that the imaging support information is a warning that a procedure to be performed in the imaging order information has a low imaging frequency or that an imaging direction in the imaging order information is different from a normal imaging direction.
Lewis, in the same field of endeavor, discloses a protocol manager which allows customization of an imaging protocol (including modification of imaging parameters) from a default (“normal”) protocol ([0017]) and provides a notification (“warning”) of a modification to the imaging protocol which includes information on the modification and the default item in the protocol ([0074]-[0075]). Lewis further teaches that such customization allows the healthcare site (e.g. hospital, clinic, imaging facility, etc.) to have maximum control over an image protocol ([0041]).
It would have been prima facie obvious for one having ordinary skill art prior to the effective filing date to modify the CRM of Stanchev to include the protocol modification and notification (“warning”) system of Lewis in order to allow the user/site to have maximum control over the imaging protocol. Since Lewis discloses that a variety of imaging settings/parameters may be modified (“…imaging systems settings such as power settings, position settings, motor speed settings, etc.”) it is further considered obvious to allow the modification/notification regarding the imaging parameters of Stanchev, where at least scanning location, gantry tilt, field of view, patient position and patient orientation comprise “an imaging direction” parameter.
Regarding claim 15: Stanchev and Lewis disclose the recording medium according to claim 14, wherein the program causes the computer to output the predetermined notification to an external device (Stanchev - at least remote console 110 or screens 101 on system 100 which includes imagers 207, [0061-[0064]).
Regarding claim 16: Stanchev and Lewis disclose the recording medium according to claim 15, wherein the external device is an imaging apparatus (Stanchev - at least remote console 110 or screens 101 on system 100 which includes imagers 207, [0061-[0064]).
Regarding claim 17: Stanchev and Lewis disclose the recording medium according to claim 14, wherein the program enables the computer to set the predetermined conditions, and the program enables the computer to set, as the predetermined conditions, information on a imaging direction and notification necessity information as to whether to provide notification of the imaging support information in association with each other (all of the disclosed functions are performed via the processor(s) of system 100, therefore they are "enabled" of performing these functions).
Regarding claim 18: Stanchev and Lewis disclose the recording medium according to claim 14, wherein the imaging order information is information on an imaging direction, and the information of the imaging direction is an irradiation direction of radiation in a predetermined imaging direction (Stanchev - [0054] - positioning prompts, step 511; fig. 6H, [0058] - imaging parameters 641; [0039] - list of possible imaging parameters for display including scanning location, gantry tilt, field of view, patient position and patient orientation - all of which comprise "information on an imaging direction of an imaging site"; [0031]-[0032], [0039).
Regarding claim 19: Stanchev and Lewis disclose the medical imaging system according to claim 1, wherein the hardware processor determines whether the acquired imaging order information satisfies predetermined conditions based on the imaging site and the imaging direction in the acquired imaging order information (fig. 5 and all associated description; [0057] - steps 521 and 522 are performed in response to user selections or displayed elements - "predetermined conditions").
Response to Arguments
Objection to claims 1 and 8 is withdrawn in light of the amendment to claim 1.
Applicant’s arguments with respect to prior art rejection of claims 1-18, filed 12/23/2025, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799