DETAILED ACTION
This Office action is in response to the amendment filed on September 17th, 2025. Claims 1-19 are pending, with claims 16-19 being new.
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 .
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 7-8, 10-13, 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0051844 (Tajiri et al.) in view of US 2020/0306563 (Hara et al.).
Regarding claim 1, Tajari et al. discloses a radioactive ray irradiation system, characterized in that the radioactive ray irradiation system comprises:
a beam irradiation device generating a treatment beam and irradiating the treatment beam to an irradiated body to form an irradiated site (element 58);
a treatment plan module performing dose simulation and calculation according to parameters of the treatment beam and medical image data of the irradiated site and generating a treatment plan which determines a position of the irradiated site relative to the beam irradiation device during irradiation treatment (‘treatment plan data prepared by an unshown treatment plan device’ P 30);
a control module controlling irradiation of the beam irradiation device according to the treatment plan (element 38);
a preparation room in which simulated positioning of the irradiated body is performed according to the position of the irradiated site determined by the treatment plan, and in which a first stereoscopic vision device is arranged to collect a first image of the irradiated site, and the control module comparing the first image with the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range and determine a simulated positioning pose of the irradiated body (‘In the pre-room 25, the patient 45 is laid on the top board 5 and is then subjected to a highly accurate positioning by using a CT system or an X-ray radiographic system and by driving the actuation device 9 so that a CT image or an X-ray image is matched to a reference image for positioning (Position Information Determination Step).’ P 36); and
an irradiation room in which irradiation position of the irradiated body is performed according to the determined simulated positioning pose, and in which a second stereoscopic vision device is arranged to collect a second image of the irradiated site, the control module comparing the second image with the first image of the irradiated site corresponding to the determined simulated positioning pose or the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range, and control the beam irradiation device to start irradiation treatment of the irradiated body (‘After the positioned state is confirmed using an X-ray radiographic system and the positioned state is reproduced, the charge particle beam 31 is radiated from the irradiation nozzle 1 of the charged particle irradiation apparatus 58 to the diseased site of the patient 45.’ P 39).
Tajiri et al. does not disclose each of the first stereoscope vision device and the second stereoscopic vision device being a stereoscopic vision device comprising two or more image acquisition devices. Hara et al. discloses a radioactive ray irradiation system with a stereoscopic vision device comprising tow or more image acquisition devices in the form of two X-ray imaging systems (fig. 5A & 6, 41a & 42a comprise the first image acquisition device, and the 41b & 42b comprise the second). It would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute the two X-ray imagers of Hara et al. for the CT imagers of Tajiri et al. because the two X-ray imagers together create a stereoscopic image with a simpler design and in less time, as CT imagers require time to move through the different angles.
Regarding claim 7, Tajiri et al. in view of Hara et al. discloses the radioactive ray irradiation system of claim 1, further comprising a treatment table and a treatment table positioning device arranged in the irradiation room, the irradiated body is subject to irradiation treatment on the treatment table (element 2), and the control module controls movement of the treatment table through the treatment table positioning device (‘Actuation-device parameters of the patient table 2 that are determined from the positioning in the pre-room 25 are transferred through a network to the patent table 2 in the irradiation room 20.’ P 36).
Regarding claim 8, Tajiri et al. in view of Hara et al. discloses the claimed invention except for collecting a third image mage of the irradiated site in real time during irradiation treatment wherein the control module compares the third image with a corresponding second image of the irradiated site when the irradiation treatment is started, or the first image of the irradiated site corresponding to the determined simulated positioning pose or the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range, and control the beam irradiation device to continuously perform the irradiation treatment of the irradiated body.
Control methods for performing checks on parameters such as positioning while continuously performing irradiation except in the case of errors like positions being outside an allowable range are well known in the art. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify the beam irradiation device of Tajiri et al. to include such a control to prevent irradiation errors that could damage healthy tissue and/or result in significant missed dose to treatment areas.
Regarding claim 10, Tajiri et al. discloses a control method for a radioactive ray irradiation system, characterized in that the radioactive ray irradiation system comprises a beam irradiation device generating a treatment beam and irradiating the treatment beam to an irradiated body to form an irradiated site, a treatment plan module, a control module, a preparation room and an irradiation room in which a first stereoscopic vision device and a second stereoscopic vision device are arranged respectively, the control method comprising:
performing, by the treatment plan module, dose simulation and calculation according to parameters of the treatment beam generated by the beam irradiation device and medical image data of the irradiated site, and generating, by the treatment plan module, a treatment plan which determines a position of the irradiated site relative to the beam irradiation device during irradiation treatment and a corresponding irradiation time (‘treatment plan data prepared by an unshown treatment plan device’ P 30);
retrieving, by the control module, a current treatment plan corresponding to the irradiated body from the treatment plan module (‘The irradiation management device 38 controls the irradiation position of the charged particle beam 31 in the diseased site of the patient 45 on the basis of treatment plan data’ P 30);
performing simulated positioning of the irradiated body in the preparation room according to the position of the irradiated site determined by the treatment plan (‘In the pre-room 25, the patient 45 is laid on the top board 5 and is then subjected to a highly accurate positioning’ P 36);
collecting, by the first stereoscopic vision device, a first image of the irradiated site, and comparing, by the control module, the first image with the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range and determine a simulated positioning pose of the irradiated body (‘In the pre-room 25, the CT system or the X-ray radiographic system is placed. Using a CT image of the CT system or an X-ray image of the X-ray radiographic system, the patient is subjected to the positioning by driving motors for making settings in respective directions of axes of the actuation device 9 so that the image is matched to the diseased site in a reference CT image used when a treatment plan was prepared.’ P 36);
performing irradiation positioning of the irradiated body in the irradiation room according to the determined simulated positioning pose (‘Thereafter, the actuation device 9 acquires the actuation-device parameters of the patient table 2 used in the pre-room 25 for positioning. The actuation device 9 drives the motors for making settings in the respective directions of the axes so that the top board 5 and the patient 45 are reproduced into their positional condition having been highly accurately positioned in the pre-room 25.’ P 39);
collecting, by the second stereoscopic vision device, a second image of the irradiated site, and comparing, by the control module, the second image with the first image of the irradiated site corresponding to the determined simulated positioning pose or the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range, and control the beam irradiation device to start irradiation treatment of the irradiated body (‘After the positioned state is confirmed using an X-ray radiographic system and the positioned state is reproduced, the charge particle beam 31 is radiated from the irradiation nozzle 1 of the charged particle irradiation apparatus 58 to the diseased site of the patient 45.’ P 39); and
in response to reaching irradiation time determined by the treatment plan, controlling, by the control module, the beam irradiation device to stop irradiation of the irradiated body (‘The irradiation management device 38 controls the irradiation … on the basis of treatment plan data’ P 30).
Tajiri et al. does not disclose each of the first stereoscope vision device and the second stereoscopic vision device being a stereoscopic vision device comprising two or more image acquisition devices. Hara et al. discloses a radioactive ray irradiation system with a stereoscopic vision device comprising two or more image acquisition devices in the form of two X-ray imaging systems (fig. 5A & 6, 41a & 42a comprise the first image acquisition device, and the 41b & 42b comprise the second). It would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute the two X-ray imagers of Hara et al. for the CT imagers of Tajiri et al. because the two X-ray imagers together create a stereoscopic image with a simpler design and in less time, as CT imagers require time to move through the different angles.
Regarding claim 11, Tajiri et al. in view of Hara et al. discloses the claimed invention except for further comprising: after the beam irradiation device starts the irradiation treatment of the irradiated body, collecting, by the second stereoscopic vision device, a third image of the irradiated site in real time during the irradiation treatment, and comparing, by the control module, the third image with a corresponding second image of the irradiated site when the irradiation treatment is started, or the first image of the irradiated site corresponding to the determined simulated positioning pose or the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range, and control the beam irradiation device to continuously perform the irradiation treatment of the irradiated body.
Control methods for performing checks on parameters such as positioning while continuously performing irradiation except in the case of errors like positions being outside an allowable range are well known in the art. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify the control method of Tajari et al. to include such a control to prevent irradiation errors that could damage healthy tissue and/or result in significant missed dose to treatment areas.
Regarding claim 12, Tajiri et al. in view of Hara et al. discloses the control method of claim 10, further comprising: defining the same irradiation coordinate system in the preparation room and the irradiation room (‘Here, the positioning by the patient table 2 in the pre-room 25 is performed with reference to an isocenter of the patient table 2 in the irradiation room 20.’ P 37); converting, by the treatment plan module, the medical image data of the irradiated site into a voxel prosthesis tissue model (inherent in treatment planning); and converting, by the treatment plan module, the position of the irradiated site determined by the treatment plan into a coordinate matrix of the voxel prosthesis tissue model of the irradiated site in the irradiation coordinate system (obvious to convert to irradiation coordinate system to make positioning easier).
Regarding claim 13, Tajiri et al. in view of Hara et al. discloses the claimed method except for converting, by the control module, the first image and the second image into the irradiation coordinate system, for comparison. Conversion to a single coordinate system is a common practice in image analysis. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to include such a conversion step to make the position matching step easier.
Regarding claim 16, Tajiri et al. in view of Hara et al. discloses the control method of claim 10, wherein each of the first stereoscopic vision device and the second stereoscopic vision device is a binocular stereoscopic vision device (Hara et al., fig. 5A & 6, elements 41 & 42).
Regarding claim 17, Tajiri et al. in view of Hara et al. discloses the control method of claim 16, wherein the binocular stereoscopic vision device is formed by two charge coupled device (CCD) cameras (Hara et al., ‘the X-ray detector 42 may be a CCD area image sensor,’ P 85).
Regarding claim 18, Tajiri et al. in view of Hara et al. discloses the radioactive ray irradiation system of claim 1, wherein each of the first stereoscopic vision device and the second stereoscopic vision device is a binocular stereoscopic vision device (Hara et al., fig. 5A & 6, elements 41 & 42).
Regarding claim 19, Tajiri et al. in view of Hara et al. discloses the radioactive ray irradiation system of claim 18, wherein the binocular stereoscopic vision device is formed by two charge coupled device (CCD) cameras (Hara et al., ‘the X-ray detector 42 may be a CCD area image sensor,’ P 85).
Claim(s) 1-9 & 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/11678 (the ‘678 publication) in view of US 2009/0154645 (Lifshitz et al.) and US 2020/0306563 (Hara et al.).
Regarding claim 1, the ‘678 publication discloses a radioactive ray irradiation system, characterized in that the radioactive ray irradiation system comprises:
a beam irradiation device generating a treatment beam and irradiating the treatment beam to an irradiated body to form an irradiated site (fig. 1, elements 5, 8, and 11);
a treatment plan module performing dose simulation and calculation according to parameters of the treatment beam and medical image data of the irradiated site and generating a treatment plan which determines a position of the irradiated site relative to the beam irradiation device during irradiation treatment (‘First, a treatment plan (first version) using a CT image is created (S01). … In the treatment plan, the position of the focus of the patient Q suitable for the irradiation of the neutron beam N is set.’);
a control module controlling irradiation of the beam irradiation device according to the treatment plan (‘Thereafter, the neutron beam N is irradiated to the patient Q based on the treatment plan (S06).’);
a preparation room in which simulated positioning of the irradiated body is performed according to the position of the irradiated site determined by the treatment plan, and in which a first stereoscopic vision device is arranged to collect a first image of the irradiated site, and the control module comparing the first image with the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range and determine a simulated positioning pose of the irradiated body (fig. 1, elements 20 & 30); and
an irradiation room in which irradiation position of the irradiated body is performed according to the determined simulated positioning pose, and in which (fig. 1, room 3).
The ‘678 publication does not disclose a second stereoscopic vision device in the irradiation room to collect a second image of the irradiated site, the control module comparing the second image with the first image of the irradiated site corresponding to the determined simulated positioning pose or the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range, and control the beam irradiation device to start irradiation treatment of the irradiated body
Lifshitz et al. discloses a radioactive ray irradiation system including a preparation room and an irradiation room, wherein the irradiation room in which a second stereoscopic vision device is arranged to collect a second image of the irradiated site (fig. 1, element 60), the control module comparing the second image with the first image of the irradiated site taken in the preparation room and corresponding to the determined simulated positioning pose or the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range, and control the beam irradiation device to start irradiation treatment of the irradiated body (fig. 5, steps 1060-1080). It would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify the system of the ‘678 publication to include an imager in the irradiation room and the related control programming so that the final positioning can occur at the same location as the irradiation, reducing the chance that errors occur.
The ‘678 publication and Lifshitz et al. do not disclose each of the first stereoscope vision device and the second stereoscopic vision device being a stereoscopic vision device comprising two or more image acquisition devices. Hara et al. discloses a radioactive ray irradiation system with a stereoscopic vision device comprising tow or more image acquisition devices in the form of two X-ray imaging systems (fig. 5A & 6, 41a & 42a comprise the first image acquisition device, and the 41b & 42b comprise the second). It would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute the two X-ray imagers of Hara et al. for the CT imager of the ‘678 publication because the two X-ray imagers together create a stereoscopic image with a simpler design and in less time, as CT imagers require time to move through the different angles.
Regarding claim 2, the ‘678 publication in view of Lifshitz et al. and Hara et al. and Hara et al. discloses the radioactive ray irradiation system of claim 1, wherein the beam irradiation device comprises a beam outlet at least partially arranged in the irradiation room (‘an irradiation room provided with an irradiation port for irradiating neutron rays;’), the preparation room is provided with a simulated beam outlet which is the same as the beam outlet (‘a simulated irradiation port 40 simulating an irradiation port of the neutron beam N described later are provided in the simulation room 20’), a positional relationship of the simulated beam outlet and the first stereoscopic vision device is the same as that of the beam outlet and the second stereoscopic vision device (obvious to make the same so the images are can be easily correlated), the preparation room and the irradiation room define the same irradiation coordinate system therein, and the control module is capable of converting each of the first image and the second image into a coordinate matrix of the irradiated site in the irradiation coordinate system (obvious to convert the images to the same coordinate system so they can be matched).
Regarding claim 3, the ‘678 publication in view of Lifshitz et al. and Hara et al. discloses the claimed invention except for wherein the treatment plan module performs dose simulation and calculation by using a Monte Carlo simulation program, the treatment plan module converts the medical image data of the irradiated site into a voxel prosthesis tissue model required by the Monte Carlo simulation program, the medical image data of the irradiated site comprises a coordinate matrix of the irradiated site in a medical image coordinate system, and the treatment plan module or the control module is capable of acquiring a coordinate conversion matrix of the medical image coordinate system and the irradiation coordinate system.
Monte Carlo simulation programs are well known, as are programs for converting medical image data into voxel prosthesis tissue models. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to include such programs in the treatment plan module to provide for the calculations needed to generate a treatment plan. It would further have been obvious to perform the claimed coordinate conversions so that the output could be put in a form useable by the irradiation system.
Regarding claim 4, the ‘678 publication in view of Lifshitz et al. and Hara et al. discloses the radioactive ray irradiation system of claim 2, wherein the irradiated site is provided with a feature pattern made of a material which is capable of being developed by a medical image and being recognized by the first stereoscopic vision device and the second stereoscopic vision device, each of the first stereoscopic vision device and the second stereoscopic vision device collects an image of the irradiated site by collecting an image of the feature pattern (Lifshitz et al., ‘In one embodiment, imager 60 may further comprise one or more markers, transmitters, or a combination thereof inserted about or at the target tissue. These markers, transmitters, or a combination thereof are used to identify the areas on the patient to be imaged.’), and the control module converts the image of the feature pattern into the coordinate matrix of the irradiated site in the irradiation coordinate system according to a position of the feature pattern in a medical image of the irradiated site (obvious to convert to the same coordinate system).
Regarding claim 5, the ‘678 publication in view of Lifshitz et al. and Hara et al. discloses the claimed invention except for providing each of the preparation room and the irradiation room with the same laser positioning device having the same positional relationship, and the treatment plan module is capable of simulating a position of a laser generated by the laser positioning device hitting the irradiated site.
Such laser positioning devices are well-known in the art, and it would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify the irradiation system of the ‘678 publication in view of Lifshitz et al. and Hara et al. to include such devices to serve as visual guides to positioning.
Regarding claim 6, the ‘678 publication in view of Lifshitz et al. and Hara et al. discloses the claimed invention except for wherein the laser generated by the laser positioning device determines a position consistent with central axes of the beam outlet and the simulated beam outlet. It would been obvious to a person having ordinary skill in the art at the time the application was filed to use the laser for this purpose since the isocenter is along this axis and all other positioning will relay on the isocenter being correctly placed.
Regarding claim 7, the ‘678 publication in view of Lifshitz et al. and Hara et al. discloses the radioactive ray irradiation system of claim 1, further comprising a treatment table and a treatment table positioning device arranged in the irradiation room, the irradiated body is subject to irradiation treatment on the treatment table (element 2, also Lifshitz, element 90), and the control module controls movement of the treatment table through the treatment table positioning device (‘The treatment table 2 is movable in the Y direction’).
Regarding claim 8, the ‘678 publication in view of Lifshitz et al. and Hara et al. discloses the radioactive ray irradiation system of claim 1,wherein the second stereoscopic vision device collects a third image of the irradiated site in real time during irradiation treatment, and the control module compares the third image with a corresponding second image of the irradiated site when the irradiation treatment is started, or the first image of the irradiated site corresponding to the determined simulated positioning pose or the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range, and control the beam irradiation device to continuously perform the irradiation treatment of the irradiated body (Lifshitz, ‘In the event that additional irradiation positions are prescribed, the patient can be rotated and translated in the treatment area to additional irradiation positions. In some embodiments, imaging and fine adjustment is performed for each irradiation position and irradiation is accomplished in accordance with stage 1080.’ P 84).
Regarding claim 9, the ‘678 publication in view of Lifshitz et al. and Hara et al. discloses the radioactive ray irradiation system of claim 1, wherein the radioactive ray irradiation system is a neutron capture therapy system, the beam irradiation device comprises: a neutron generation device comprising an accelerator and a target (fig. 1, elements 5 & 11, also fig. 2, element T), the accelerator accelerating charged particles to generate a charged particle line which acts with the target to generate a neutron line (‘As shown in FIG. 2, the neutron beam generation unit 11 is irradiated with the charged particle beam P to generate a neutron beam N, and a target T for decelerating the generated neutron beam N (reducing energy).’); a beam shaping body capable of adjusting the neutron line generated by the neutron generation device to a preset beam quality (fig. 2, elements 17 & 18); and a treatment table on which the irradiated body is irradiated by the neutron line generated by the neutron generation device through the beam shaping body (element 2).
Regarding claim 18, the ‘678 publication in view of LifShitz et al. and Hara et al. discloses the radioactive ray irradiation system of claim 1, wherein each of the first stereoscopic vision device and the second stereoscopic vision device is a binocular stereoscopic vision device (Hara et al., fig. 5A & 6, elements 41 & 42).
Regarding claim 19, the ‘678 publication in view of LifShitz et al. and Hara et al. discloses the radioactive ray irradiation system of claim 18, wherein the binocular stereoscopic vision device is formed by two charge coupled device (CCD) cameras (Hara et al., ‘the X-ray detector 42 may be a CCD area image sensor,’ P 85).
Claim(s) 10-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0154645 (Lifshitz et al.) in view of WO 2019/11678 (the ‘678 publication) and US 2020/0306563 (Hara et al.).
Regarding claim 10, Lifshitz et al. discloses a control method for a radioactive ray irradiation system, characterized in that the radioactive ray irradiation system comprises a beam irradiation device generating a treatment beam and irradiating the treatment beam to an irradiated body to form an irradiated site, a treatment plan module, a control module, a preparation room and an irradiation room in which a first stereoscopic vision device and a second stereoscopic vision device are arranged respectively, the control method comprising:
retrieving, by the control module, a current treatment plan corresponding to the irradiated body (inherent in the following steps, in which control module uses the treatment plan);
performing simulated positioning of the irradiated body in the preparation room according to the position of the irradiated site determined by the treatment plan (fig. 5, step 1030);
collecting, by the first stereoscopic vision device, a first image of the irradiated site body, and comparing, by the control module, the first image with the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range and determine a simulated positioning pose of the irradiated (‘In one embodiment, imaging is performed in the preparation room 20. The imaging is used to make fine adjustments to the treatment position.’ P 45);
performing irradiation positioning of the irradiated body in the irradiation room according to the determined simulated positioning pose (fig. 5, step 1050);
collecting, by the second stereoscopic vision device, a second image of the irradiated site, and comparing, by the control module, the second image with the first image of the irradiated site corresponding to the determined simulated positioning pose or the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range, and control the beam irradiation device to start irradiation treatment of the irradiated body (fig. 5, steps 1060-1080, wherein ‘In yet another embodiment, upon arrival of the patient in the treatment area 50, the patient is imaged with imager 60. Fine adjustments to the presentation position are made in response to the image if necessary.’ P 47); and
in response to reaching irradiation time determined by the treatment plan, controlling, by the control module, the beam irradiation device to stop irradiation of the irradiated body (fig. 5, step 1090).
Lifshitz et al. does not disclose performing, by the treatment plan module, dose simulation and calculation according to parameters of the treatment beam generated by the beam irradiation device and medical image data of the irradiated site, and generating, by the treatment plan module, a treatment plan which determines a position of the irradiated site relative to the beam irradiation device during irradiation treatment and a corresponding irradiation time.
The ‘678 publication discloses a control method for a radioactive ray irradiation system performing, by the treatment plan module, dose simulation and calculation according to parameters of the treatment beam generated by the beam irradiation device and medical image data of the irradiated site, and generating, by the treatment plan module, a treatment plan which determines a position of the irradiated site relative to the beam irradiation device during irradiation treatment and a corresponding irradiation time (‘First, a treatment plan (first version) using a CT image is created (S01). … In the treatment plan, the position of the focus of the patient Q suitable for the irradiation of the neutron beam N is set.’).
It would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify the control method of Lifshitz et al. to include the treatment planning steps of the ‘678 publication in order to generate the treatment plan used by the rest of the method.
Lifshitz et al. and the ‘678 publication do not disclose each of the first stereoscope vision device and the second stereoscopic vision device being a stereoscopic vision device comprising two or more image acquisition devices. Hara et al. discloses a radioactive ray irradiation system with a stereoscopic vision device comprising tow or more image acquisition devices in the form of two X-ray imaging systems (fig. 5A & 6, 41a & 42a comprise the first image acquisition device, and the 41b & 42b comprise the second). It would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute the two X-ray imagers of Hara et al. for the CT imager of the ‘678 publication because the two X-ray imagers together create a stereoscopic image with a simpler design and in less time, as CT imagers require time to move through the different angles. do not disclose each of the first stereoscope vision device and the second stereoscopic vision device being a stereoscopic vision device comprising two or more image acquisition devices. Hara et al. discloses a radioactive ray irradiation system with a stereoscopic vision device comprising tow or more image acquisition devices in the form of two X-ray imaging systems (fig. 5A & 6, 41a & 42a comprise the first image acquisition device, and the 41b & 42b comprise the second). It would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute the two X-ray imagers of Hara et al. for the CT imager of the ‘678 publication because the two X-ray imagers together create a stereoscopic image with a simpler design and in less time, as CT imagers require time to move through the different angles.
Regarding claim 11, Lifshitz et al. in view of the ‘678 publication and Hara et al. disclose the control method of claim 10, further comprising: after the beam irradiation device starts the irradiation treatment of the irradiated body, collecting, by the second stereoscopic vision device, a third image of the irradiated site in real time during the irradiation treatment, and comparing, by the control module, the third image with a corresponding second image of the irradiated site when the irradiation treatment is started, or the first image of the irradiated site corresponding to the determined simulated positioning pose or the position of the irradiated site determined by the treatment plan, to ensure that the comparison result is in an allowable difference range, and control the beam irradiation device to continuously perform the irradiation treatment of the irradiated body (Lifshitz, ‘In the event that additional irradiation positions are prescribed, the patient can be rotated and translated in the treatment area to additional irradiation positions. In some embodiments, imaging and fine adjustment is performed for each irradiation position and irradiation is accomplished in accordance with stage 1080.’ P 84).
Regarding claim 12, Lifshitz et al. in view of the ‘678 publication and Hara et al. disclose the control method of claim 10, further comprising: defining the same irradiation coordinate system in the preparation room and the irradiation room (obvious to make image matching easier); converting, by the treatment plan module, the medical image data of the irradiated site into a voxel prosthesis tissue model (inherent in treatment planning); and converting, by the treatment plan module, the position of the irradiated site determined by the treatment plan into a coordinate matrix of the voxel prosthesis tissue model of the irradiated site in the irradiation coordinate system (obvious to convert to irradiation coordinate system to make positioning easier).
Regarding claim 13, Lifshitz et al. in view of the ‘678 publication and Hara et al. disclose the control method of claim 12, further comprising: converting, by the control module, the first image and the second image into the irradiation coordinate system, for comparison (obvious to convert to irradiation coordinate system to make matching easier).
Regarding claim 14, Lifshitz et al. in view of the ‘678 publication and Hara et al. disclose the control method of claim 10, further comprising: providing a feature pattern on the irradiated site, and collecting a position of the feature pattern in a medical image of the irradiated site (‘In one embodiment, imager 60 may further comprise one or more markers, transmitters, or a combination thereof inserted about or at the target tissue. These markers, transmitters, or a combination thereof are used to identify the areas on the patient to be imaged.’).
Regarding claim 15, Lifshitz et al. in view of the ‘678 publication and Hara et al. disclose the control method of claim 14, further comprising: collecting, by the first stereoscopic vision device and the second stereoscopic vision device, images of the feature pattern and transmitting, by the first stereoscopic vision device and the second stereoscopic vision device, the images to the control module; and converting, by the control module, the images into coordinate matrices of the irradiated site in the irradiation coordinate system through the position of the feature pattern in the medical image of the irradiated site, for comparison (well-known method of correlating images).
Regarding claim 16, Lifshitz et al. in view of the ‘678 publication and Hara et al. discloses the control method of claim 10, wherein each of the first stereoscopic vision device and the second stereoscopic vision device is a binocular stereoscopic vision device (Hara et al., fig. 5A & 6, elements 41 & 42).
Regarding claim 17, Lifshitz et al. in view of the ‘678 publication and Hara et al. discloses the control method of claim 16, wherein the binocular stereoscopic vision device is formed by two charge coupled device (CCD) cameras (Hara et al., ‘the X-ray detector 42 may be a CCD area image sensor,’ P 85).
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ELIZA W OSENBAUGH-STEWART whose telephone number is (571)270-5782. The examiner can normally be reached 10am - 6pm Pacific Time M-F.
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/ELIZA W OSENBAUGH-STEWART/Primary Examiner, Art Unit 2881