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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/03/2026 has been entered.
Claim Rejections - 35 USC § 112
Claims 2-7, 11-12, and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The phrase “imaging direction” and associated limitation(s) have been removed from independent claims 1, 8, 13, and 14. However, the dependent claims 2-7, 11-12, and 17-19 still make reference to “information on the imaging direction” and “the imaging direction.” It is not clear what “the imaging direction” in the dependent claims is meant to refer to in the absence of these limitations in the parent claims. For the purposes of further examination, all references to “the imaging direction” will be interpreted to mean the selected imaging protocol.
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 Nakatsugawa et al. (US 2011/0158385 A1, Jun. 31, 2011) (hereinafter “Nakatsugawa”).
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 predetermined condition is that a procedure to be performed in the imaging order information has a low imaging frequency, or that the imaging support information is a warning that a procedure to be performed in the imaging order information has low imaging frequency.
Nakatsugawa, in the same field of endeavor, discloses a control console which is configured to determine if the planned frame rate for an imaging order is too low (“has low imaging frequency”) based on the minimum irradiated amount that is necessary to capture quality images ([0019], [0123]). Nakatsugawa further discloses that if the frame rate is too low, a warning (“imaging support information”) is issued (fig. 10, [0312]-[0313]).
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 low frame rate (“low imaging frequency”) warning of Nakatsugawa in order to ensure that quality images are acquired.
Regarding claim 2: Stanchev and Nakatsugawa 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 Nakatsugawa 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 (Stanchev - [0054] - positioning prompts, step 511; fig. 6H, [0058] - imaging parameters 641).
Regarding claim 4: Stanchev and Nakatsugawa 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 Nakatsugawa 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 Nakatsugawa 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 Nakatsugawa 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), 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); 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).
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 predetermined condition is that a procedure to be performed in the imaging order information has a low imaging frequency, or that the imaging support information is a warning that a procedure to be performed in the imaging order information has low imaging frequency.
Nakatsugawa, in the same field of endeavor, discloses a control console which is configured to determine if the planned frame rate for an imaging order is too low (“has low imaging frequency”) based on the minimum irradiated amount that is necessary to capture quality images ([0019], [0123]). Nakatsugawa further discloses that if the frame rate is too low, a warning (“imaging support information”) is issued (fig. 10, [0312]-[0313]).
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 low frame rate (“low imaging frequency”) warning of Nakatsugawa in order to ensure that quality images are acquired.
Regarding claim 9: Stanchev and Nakatsugawa 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 Nakatsugawa 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 Nakatsugawa 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 Nakatsugawa 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 predetermined condition is that a procedure to be performed in the imaging order information has a low imaging frequency, or that the imaging support information is a warning that a procedure to be performed in the imaging order information has low imaging frequency.
Nakatsugawa, in the same field of endeavor, discloses a control console which is configured to determine if the planned frame rate for an imaging order is too low (“has low imaging frequency”) based on the minimum irradiated amount that is necessary to capture quality images ([0019], [0123]). Nakatsugawa further discloses that if the frame rate is too low, a warning (“imaging support information”) is issued (fig. 10, [0312]-[0313]).
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 low frame rate (“low imaging frequency”) warning of Nakatsugawa in order to ensure that quality images are acquired.
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 predetermined condition is that a procedure to be performed in the imaging order information has a low imaging frequency, or that the imaging support information is a warning that a procedure to be performed in the imaging order information has low imaging frequency.
Nakatsugawa, in the same field of endeavor, discloses a control console which is configured to determine if the planned frame rate for an imaging order is too low (“has low imaging frequency”) based on the minimum irradiated amount that is necessary to capture quality images ([0019], [0123]). Nakatsugawa further discloses that if the frame rate is too low, a warning (“imaging support information”) is issued (fig. 10, [0312]-[0313]).
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 low frame rate (“low imaging frequency”) warning of Nakatsugawa in order to ensure that quality images are acquired.
Regarding claim 15: Stanchev and Nakatsugawa 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 Nakatsugawa 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 Nakatsugawa 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 Nakatsugawa 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 Nakatsugawa 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
Applicant’s arguments with respect to prior art rejection of claims 1-19, filed 06/03/2026 have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
Prosecution Insights