[OPINION WITH AMENDMENT]

1. Premise of the Opinion

With respect to the grounds for rejection identified in the Notice of Submission of Opinion dated July 14, 2026, the applicant has amended, by the amendment filed on the same date, the background art, the detailed description for carrying out the invention, the drawings, and claims 1 through 4, and hereby submits the following opinion.

This opinion is based on the amended claims. Accordingly, the determination of the disclosure requirements and inventive step of the present invention should not be based on unclear expressions or unorganized descriptions before amendment, but on the configurations actually recited in the amended claims, the relationships among those configurations, and their operational effects.

The amendment is intended to clarify the corresponding relationships between the X-ray emission module and the X-ray detection module, between the gamma-ray emission module and the gamma-ray detection module, and within the composite-image acquisition structure; to arrange reference numerals 410 and 420 in Figure 2 so that they indicate the actual detection modules; to add publication numbers of prior-art documents; and to specifically incorporate into the claims the core features of the present invention, namely a plurality of distributed irradiation channels arranged around an open gantry, sequential movement through a plurality of irradiation sections, and selective control for each irradiation section.

Therefore, any subsequent determination must be made on the basis of the entire combined structure of the amended claims, and the present invention as a whole should not be considered readily derivable merely because some individual elements were separately known.

2. Summary of the Opinion

The applicant cannot agree with the ground for rejection asserting that the amended present invention could be readily made by a person skilled in the art from Cited Inventions 1 through 3.

The amended present invention is not a parallel combination of a simple C-arm, a simple vertical movement device, a simple image-brightness-based dose-control device, or a simple CT/PET/SPECT combined apparatus.

The amended present invention has an organically combined structure in which a plurality of radiation irradiation channels and corresponding detection channels are distributed around a C-shaped or U-shaped open gantry arranged along a portion of the circumference of the subject’s body; the gantry is sequentially moved to positions corresponding to a plurality of irradiation sections set along the longitudinal direction of the subject’s body; and irradiation position, irradiation intensity, irradiation direction, irradiation timing, the open state of the irradiation channels, and the asymmetric aperture shape of an iris-type shielding unit are selectively controlled for each irradiation section according to body information and irradiation history, thereby acquiring radiation projection data or detection data and reconstructing an internal image.

Further, the composite-image acquisition structure of claim 3 has been clearly amended so that it is not a structure that simply mixes X-rays and gamma rays into one physical radiation. Rather, a structural image based on X-ray projection data and a functional image based on gamma-ray projection data or gamma-ray detection data are separately acquired and then registered or combined to generate a composite internal-structure image.

Accordingly, inventive step should be determined not by whether individual elements were known, but by whether the overall operating structure formed by combining the above elements is specifically disclosed or suggested in the cited inventions, whether a person skilled in the art had a concrete motivation and direction to make such a combination, and whether the effects resulting from the combination were predictable.

3. Purpose of the Amendment and Subject Matter for Determination

To overcome the insufficiency of disclosure under Article 42(3)(1) of the Patent Act identified in the Notice of Submission of Opinion, the applicant clarified the emission and detection of X-rays and gamma rays and the data flow of the composite image.

(a) It was clarified that the X-ray detection module 410 corresponding to the X-ray emission module 310 detects X-rays transmitted through or scattered by the subject’s body and generates X-ray projection data.

(b) The corresponding relationship between the gamma-ray emission module 320 and the gamma-ray detection module 420 was clarified, as was the fact that the gamma-ray detection module may detect gamma-ray signals emitted from a radioactive tracer present inside the subject’s body.

(c) Composite-radiation or composite-image acquisition was organized to include separately acquiring X-ray projection data and gamma-ray projection data or gamma-ray detection data and registering or combining a structural image and a functional image to generate a composite internal-structure image.

(d) Figure 2 was corrected so that reference numerals 410 and 420 indicate actual X-ray and gamma-ray detection modules rather than merely directions of radiation travel.

(e) To overcome the ground for rejection under Article 42(3)(2) of the Patent Act, publication numbers and publication dates of the cited prior-art documents were added to the background art.

(f) Claims 1 through 3 now clearly reflect a plurality of radiation irradiation channels distributed around the open gantry, corresponding detection channels, sequential movement through a plurality of irradiation sections, channel selection for each irradiation section, and control of overlapping irradiation regions.

Therefore, any subsequent determination must be based on the actual wording of the amended claims.

4. Core Configuration of the Present Invention

The core of the amended present invention is as follows.

First, body information such as the subject’s height, body type, body outline, posture, movement, or distance from the open gantry is acquired, and a reference irradiation position and a plurality of irradiation sections are established.

Second, a plurality of radiation irradiation channels and corresponding detection channels are distributed at different positions around a C-shaped or U-shaped open gantry arranged along a portion of the circumference of the subject’s body.

Third, while the open gantry is sequentially moved to positions corresponding to a plurality of irradiation sections, such as the head, neck, torso, pelvis, legs, or another examination region, set along the longitudinal direction of the subject’s body, radiation projection data or detection data is acquired for each section.

Fourth, an AI-based controller determines irradiation position, irradiation intensity, irradiation direction, irradiation timing, irradiation duration, number of irradiations, and the open state of the irradiation channels based on the body part, cross-sectional body shape, examination purpose, and irradiation history of each irradiation section, and controls the asymmetric aperture shape of the iris-type shielding unit.

Fifth, when an overlapping irradiation region exists between a preceding irradiation section and a current irradiation section, the irradiation channel corresponding to that region is blocked or the irradiation intensity or duration is reduced, thereby reducing unnecessary repeated irradiation and cumulative exposure.

Sixth, a structural image is generated in an X-ray image-acquisition mode, a radioactive-tracer distribution or functional image is generated in a gamma-ray image-acquisition mode, and the two images are registered or combined in a composite-image acquisition mode to generate a composite internal-structure image.

This is not a mere parallel listing of components, but a continuous and organic operating structure of: acquisition of body information → setting of irradiation sections → sequential gantry movement → channel and shielding control for each irradiation section → acquisition of projection data → control of overlapping irradiation → reconstruction of an internal image.

5. Current Recitations of the Claims

Amended claim 1 is not a simple C-arm X-ray imaging apparatus.

Amended claim 1 recites a plurality of X-ray emission modules or X-ray irradiation channels distributed at different positions around the circumference of an open gantry, corresponding X-ray detection modules or detection channels, sequential movement through a plurality of irradiation sections along the longitudinal direction of the body, setting of irradiation sections based on body information, channel control for each irradiation section, asymmetric aperture control, and blocking of channels corresponding to overlapping irradiation regions.

Amended claim 2 does not merely name a gamma-ray emission unit and gamma-ray detection unit. It specifically recites the relationship in which the gamma-ray detection module detects gamma rays transmitted through or scattered by the subject’s body, or gamma-ray signals emitted from a radioactive tracer, generates gamma-ray projection data or gamma-ray detection data, and reconstructs a functional image using the data.

Amended claim 3 does not simply mix X-rays and gamma rays as a single radiation. It clearly recites a data flow in which the X-ray image-acquisition mode and the gamma-ray image-acquisition mode are performed selectively or in coordination, and an X-ray structural image and a gamma-ray functional image are registered or combined to reconstruct a composite internal-structure image.

Amended claim 4 recites a dependent control structure that reflects contrast-agent response information, radioactive-tracer distribution information, or temporal image-change information in the irradiation conditions or image-acquisition conditions for each irradiation section.

Because the amended claims specifically recite the relationships among radiation emission, detection, data generation, and image reconstruction, the insufficiency-of-disclosure determination based on unclear expressions before amendment has been overcome.

6. Corresponding Configurations in the Cited Inventions

Cited Invention 1 places one radiation irradiation unit and one image-acquisition unit at opposite ends of a C-arm and adjusts tube voltage, tube current, or irradiation duration according to brightness information of continuous images or a subject region.

However, Cited Invention 1 does not disclose a plurality of radiation irradiation channels distributed at different positions around the circumference of an open gantry and a plurality of detection channels corresponding to the respective irradiation channels.

Further, the vertical movement of the C-arm in Cited Invention 1 concerns positional adjustment for aligning the spatial position and angle of the C-arm with the target region. It differs from the scanning-movement structure of the present invention, which sequentially moves through a plurality of irradiation sections set along the longitudinal direction of the subject’s body and acquires projection data under different irradiation conditions and channel states in each section.

Cited Invention 1 does not set a plurality of irradiation sections such as the head, neck, torso, pelvis, and legs by using body information, determine the open state of the irradiation channels and asymmetric aperture for each irradiation section, or automatically block a channel corresponding to an overlapping region between a previous and current irradiation section.

Even if Cited Invention 2 discloses a gantry module movable vertically and horizontally, it does not disclose a specific structure combining the movement unit with a plurality of distributed irradiation channels around an open gantry, sequential scanning of a plurality of irradiation sections, channel selection for each section, and control of overlapping irradiation regions.

Cited Invention 3 relates to a multimodal radiation imaging apparatus including CT, PET, and SPECT functions in one device, but it does not disclose a structure combining a plurality of distributed channels around an open gantry, sequential movement through a plurality of irradiation sections along the body, and channel blocking based on irradiation history.

Some general elements of the present invention may exist individually in the cited inventions, but no specific configuration corresponding to the entire core combined structure of the amended claims is presented.

7. Determination of Differences

The substantive differences between the amended present invention and the cited inventions are as follows.

First, Cited Invention 1 has a single radiation source and a single detector at opposite ends of a C-arm, whereas the present invention distributes a plurality of irradiation channels and corresponding detection channels at several positions around an open gantry.

Second, the vertical movement in Cited Inventions 1 and 2 is positional adjustment for matching an imaging position, whereas the movement unit of the present invention is a scanning-movement structure that sequentially moves through a plurality of irradiation sections set along the longitudinal direction of the subject’s body and acquires data for each section.

Third, the present invention sets a reference irradiation position and a plurality of irradiation sections based on body information such as height, body type, body outline, posture, and distance from the gantry, whereas Cited Invention 1 mainly adjusts irradiation conditions based on image brightness or the subject region.

Fourth, the present invention determines opening and blocking of irradiation channels, irradiation direction, and irradiation timing for each section and controls an asymmetric opening of a plurality of shielding blades according to the body’s cross-sectional shape. The cited inventions do not disclose such coordinated control of multiple channels and asymmetric shielding for each section.

Fifth, the present invention performs irradiation-history-based control by determining an overlapping region between a previous and current irradiation section and blocking a corresponding channel or reducing irradiation intensity or time. The cited inventions contain no such structure.

Sixth, amended claim 3 combines generation of a composite internal-structure image, obtained by separately acquiring and registering or combining a structural image and a functional image, with the above multi-channel, section-by-section movement and selective-control structure. This entire combined structure is not derivable from the general CT/PET/SPECT multimodal structure of Cited Invention 3 alone.

The present invention is substantively different from the cited inventions in the organic combination of distributed irradiation/detection channels, sequential scanning through multiple irradiation sections, channel and shielding control for each section, blocking of overlapping irradiation regions, and composite-image reconstruction.

8. Motivation to Combine

To conclude that the amended present invention could be derived by combining multiple cited inventions, a concrete motivation, suggestion, or necessity that would have led a person skilled in the art to make such a combination at the filing date must be shown.

The purpose of Cited Invention 1 is to secure image quality while reducing or maintaining dose according to brightness of continuous radiation images and whether the subject is fixed.

The purpose of Cited Invention 2 is to support a gantry module of a radiation imaging apparatus so that it can move vertically or horizontally.

The purpose of Cited Invention 3 is to integrate CT, PET, and SPECT imaging functions into one apparatus.

The purposes and operating principles of these documents differ, and none of them suggests a direction of combination requiring distribution of multiple irradiation/detection channels around an open gantry, sequential movement through multiple irradiation sections along the body, and control of channels and asymmetric apertures for each section based on body information and irradiation history.

The mere fact that a C-arm, vertical movement, artificial intelligence, or multimodal imaging was individually known does not provide the motivation and direction for proceeding to the specific overall combined structure of the present invention.

Only the abstract possibility of combining the cited inventions has been asserted; a concrete motivation and direction leading to the core combined structure of the present invention have not been sufficiently shown.

9. Predictability of Operational Effects

The effects of the amended present invention are not limited to moving a C-arm or controlling dose according to image brightness.

By distributing multiple irradiation channels around an open gantry and selectively operating only necessary channels, the output burden concentrated on a single irradiation source can be distributed and projection data can be acquired in the direction needed for each irradiation section.

By setting irradiation sections such as the head, neck, torso, pelvis, and legs using body information and forming an asymmetric aperture corresponding to the cross-sectional body shape of each section, unnecessary irradiation outside the body or in non-examination regions can be reduced.

By blocking channels corresponding to overlapping regions between previous and current irradiation sections, or reducing output and duration, repeated irradiation and cumulative exposure of the same area can be reduced.

By separately acquiring and registering or combining an X-ray structural image and a gamma-ray functional image, a composite internal-structure image reflecting both structural and functional information can be generated.

These effects are not naturally predictable merely by arranging in parallel the brightness-based dose control of Cited Invention 1, the simple movement structure of Cited Invention 2, and the general multimodal imaging function of Cited Invention 3.

The effects of the present invention arise from the organic combination of distributed channels, section-by-section movement, body-information-based control, asymmetric shielding, and irradiation-history-based overlap control.

10. State of the Art at the Filing Date

Inventive step must be determined based on the state of the art at the filing date, not at the examination date.

The fact that radiation imaging apparatuses, AI image processing, and composite-imaging technologies were individually known does not mean that the entire structure of the amended present invention was common general knowledge to a person skilled in the art at the filing date.

In particular, to establish that it was common general knowledge at the filing date to organically perform, in one system, distribution of multiple irradiation/detection channels around an open gantry, sequential movement through multiple irradiation sections, body-information-based section setting, asymmetric-aperture control, and irradiation-history-based blocking of overlapping channels, specific documents or technical materials must be presented.

Absent a specific basis showing that the entire combined structure of the amended claims was common general knowledge at the filing date, inventive step cannot be denied merely because some individual elements were known.

11. Hindsight Reasoning

Inventive step must not be determined by learning the present invention first and then selecting individual elements from the cited inventions and reassembling them to resemble the present invention.

The present invention has the concrete flow: acquisition of body information → setting of a reference irradiation position and multiple irradiation sections → sequential movement of the open gantry → control of multiple channels and asymmetric apertures for each section → blocking of overlapping irradiation regions → acquisition of projection data → reconstruction of a structural image, functional image, or composite image.

Where the cited inventions themselves do not present such a direction of combination, extracting the C-arm and image-based dose control from Cited Invention 1, the movement structure from Cited Invention 2, and the multimodal imaging function from Cited Invention 3 and combining them into the same structure as the present invention risks reverse reconstruction after learning the present invention.

If the elements of each document were selected based on the configuration of the present invention rather than the technical problem and combination direction of the cited inventions themselves, the determination risks constituting hindsight reasoning.

12. Omitted Determinations

In the element-by-element comparison of the Notice of Submission of Opinion, the specific configuration and paragraph of Cited Invention 1 corresponding to the “plurality of X-ray emission modules or irradiation channels arranged around the circumference of the open gantry” in claim 1 were not clearly identified.

The comparison table also marked the element including the iris-type shielding unit and movement unit as a “difference,” but the subsequent determination identified only the vertical movement unit as the difference, and did not sufficiently provide a separate determination regarding the plurality of shielding blades that form an asymmetric opening according to the body’s cross-sectional shape.

Specific determinations are also difficult to identify for the following core configurations:

(a) a plurality of distributed irradiation channels and corresponding detection channels around the open gantry;
(b) setting of a reference irradiation position and a plurality of irradiation sections using body information;
(c) determination of irradiation direction, irradiation timing, and channel-open state for each irradiation section;
(d) asymmetric iris-aperture control according to the body’s cross-sectional shape;
(e) blocking of a channel corresponding to an overlapping region between a previous and current irradiation section; and
(f) the effects of customized irradiation for each section and reduction of overlapping exposure arising from the combination of the above elements.

If these core configurations and effects were not specifically evaluated and the invention was assessed only by reference to a general C-arm, movement, artificial intelligence, or multimodal technology, the determination of the overall combined structure of the present invention is insufficient.

13. Absence of Supporting Basis

To conclude that a person skilled in the art could readily make the amended present invention, the specific paragraphs, drawings, embodiments, or technical means of the cited inventions corresponding to each core configuration of the amended claims, the specific motivation to combine the cited inventions, and the predictability of the resulting effects must be presented.

However, merely stating that the cited inventions are similar in technical field, purpose, or some elements is insufficient to establish that a structure combining multiple distributed channels around an open gantry, sequential movement through multiple irradiation sections, section-by-section channel and shielding control, and blocking of overlapping irradiation could be readily derived.

In particular, there must be a concrete explanation of why the single-source/single-detector C-arm of Cited Invention 1 would be changed into the multiple distributed irradiation/detection channel structure of the present invention; why the movement unit of Cited Invention 2 would be linked to sequential scanning through multiple irradiation sections; and why the multimodal function of Cited Invention 3 would be combined with the multiple-channel, section-by-section control structure of the present invention.

Without specific corresponding configurations and reasons for combination, a mere conclusion of “readily derivable” or “simple design modification” cannot provide a sufficient basis for denying inventive step of the entire combined structure of the amended present invention.

14. Specific Determinations Required if the Rejection Is Maintained

To maintain a determination denying inventive step of the amended present invention, at least the following matters must be specifically presented.

First, specific paragraphs, drawings, or embodiments of a cited invention corresponding to the plurality of irradiation channels distributed around the circumference of the open gantry and the corresponding plurality of detection channels must be identified.

Second, a specific configuration corresponding to sequential movement through a plurality of irradiation sections set along the longitudinal direction of the subject’s body while acquiring projection data in each section must be identified.

Third, the corresponding relationships for setting irradiation sections using body information, controlling channel-open states and asymmetric apertures for each irradiation section, and blocking channels corresponding to overlapping irradiation regions must be identified.

Fourth, a specific motivation, suggestion, or necessity existing at the filing date for combining Cited Inventions 1 through 3 into the above entire combined structure must be presented.

Fifth, specific reasons must be given as to why the combination would have made predictable the present invention’s effects of customized irradiation by section, reduction of overlapping irradiation, limitation of unnecessary irradiation regions, and generation of a structural-functional composite image.

Sixth, with respect to the generation of gamma-ray detection data and the registration or combination relationship between the structural and functional images, which are clearly recited in amended claims 2 and 3, the amended overall structure must be evaluated rather than simply relying on the fact that PET, SPECT, and CT exist in a single apparatus.

A mere conclusion of ready derivation without such specific determinations cannot be regarded as a sufficient determination of the differences, motivation to combine, operational effects, and exclusion of hindsight reasoning.

15. Comprehensive Opinion

The amended present invention is not a simple radiation imaging apparatus, a simple movable C-arm, or a simple multimodal imaging apparatus.

The amended present invention is an overall operating structure that sets a reference irradiation position and a plurality of irradiation sections from acquired body information; sequentially moves a plurality of irradiation/detection channels distributed around an open gantry to each irradiation section along the body; coordinately controls irradiation conditions, channel-open states, asymmetric shielding apertures, and overlapping irradiation regions for each section; and then uses acquired data to generate a structural image, functional image, or composite internal-structure image.

Cited Invention 1 concerns a C-arm with a single radiation source and a single detector and dose control based on image brightness. Cited Invention 2 concerns a gantry movement structure. Cited Invention 3 concerns CT/PET/SPECT multimodal imaging.

However, the cited inventions neither disclose nor suggest the organically combined structure of the present invention comprising multiple distributed irradiation/detection channels, sequential scanning through multiple irradiation sections, body-information-based section setting, section-by-section channel and asymmetric-aperture control, and irradiation-history-based blocking of overlapping channels.

Further, the amendment has clarified the emission, detection, and data flow of X-ray, gamma-ray, and composite-image acquisition, the correspondence of drawing reference numerals, and the publication numbers of prior-art documents. Therefore, the grounds for rejection under Article 42(3)(1) and (2) of the Patent Act have been overcome.

Accordingly, the amended present invention cannot be regarded as readily made by a person skilled in the art from the cited inventions, and the ground for rejection under Article 29(2) of the Patent Act should also be reconsidered.

16. Conclusion

As described above, by the amendment the applicant has addressed the insufficiency of disclosure in the description and drawings, omission of prior-art document information in the background art, and the inventive-step grounds for rejection against claims 1 through 4 identified in the Notice of Submission of Opinion.

The amended claims clearly recite the core configurations of the present invention and the relationships among them, and clearly organize the relationships between the X-ray emission and detection units, between the gamma-ray emission and detection units, and between the structural and functional images.

The amended present invention differs from the cited inventions in configuration and operational effect and cannot be regarded as readily derivable by a person skilled in the art from Cited Inventions 1 through 3.

In particular, to again deny inventive step, the examination must clearly identify specific cited configurations corresponding to each core configuration of the amended claims, specific reasons for combining the cited inventions, and the predictability of the operational effects resulting from such combination.

The applicant has submitted all necessary amendments and opinions in response to the identified grounds for rejection. The applicant therefore asserts that the grounds for rejection have been overcome and respectfully requests reexamination on the basis of the amended claims and a decision to grant a patent.

In addition, because the present invention is being prepared for actual commercialization and implementation by the applicant and an early determination of the rights is required, the applicant respectfully requests prompt examination and decision.