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.
Claim(s) 1-4, 9-11,13, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZHANG et al.( CN 112675442) hereinafter ZHANG et al.(442) in view of FALCO(ES 2388930) hereinafter FALCO.
ZHANG et al.(442) teaches a boron neutron capture therapy positioning system. The positioning system including a first group of lasers; a ray source simulator(first chamber) and a first calibration device; the first calibration device is movably set in front of the ray source simulator; the height of the calibration block on the first calibration device is the same as that of the ray source simulation laser in the ray source simulator. A second group of lasers a treatment chamber collimator(second chamber) and a second calibration device; the second calibration device is movably set in front of the treatment chamber collimator; the height of the calibration block on the second calibration device is the same as that of the ray outlet of the treatment chamber collimator; four alignment lasers of the second group of lasers respectively set in front of the calibration block on the second calibration device; The structure of the first calibration device and the second calibration device are the same, comprising a calibration block and a movable base, the calibration block is set on the top of the vertical rod of the movable base. The calibration block is a cube( interpreted as a die), except the bottom surface, the other 5 surfaces are processed with a cross line ( interpreted as a mark on the cube to align with the laser cros-line). As shown in FIG. 5, the alignment laser (111, 211) is set on the laser translation stage 140, capable of translating along the axis direction of the simulation collimator 122, so as to finish the position adjustment of the alignment laser (111, 211). The laser translation stage 140 with scale, can record the displacement of the lower alignment laser (111, 211) on it and as shown in FIGS. 2 and 6, the alignment laser in the front of the treatment chamber collimator 220 is a moving cross-line indicator 240, which comprises a cross-line laser indicator 241 and a high-repeatability movable base 242; The cross-line laser indicator 241 is provided at the top of the vertical rod 243 on the high repeatability movable base 242. In one specific embodiment, as shown in FIG. 7, the first group of laser 110 and the second group of laser 210 contained in each of the alignment laser (111, 121) type and specification are the same, are provided with a pair of transverse and longitudinal beam of the laser, which has a manual fine tuning function; the positioning part 100 and the positioning part 200 of the same positioning, namely the first group of laser 110 and the second group of laser 210 included in the position and parameter of the alignment laser are set the same, ray source simulator 120 and the treatment chamber collimator 220 position parameter are the same; The position parameters of the first calibration device 130 and the second calibration device 230 are the same. In this way, it is possible to adjust the body part of the patient adjusted in the simulation room in need of treatment, and the posture is accurately reproduced in the treatment chamber.
Regarding claims 1, 9, 16 and 17, ZHANG et al.(442) teaches providing a calibration device in each of a first chamber and a second chamber; wherein the calibration device includes a calibration die, and a relative position of the calibration die of the first chamber with a relative position of the calibration die of the second chamber, and comparing a position of a first positioning mark on the calibration die of the first chamber and a position of a second positioning mark on the calibration die of the second chamber; wherein the first positioning mark is a positioning mark formed on the calibration die by a laser emitted by a first laser positioning system of the first chamber and the second positioning mark is a positioning mark formed on the calibration die by a laser emitted by a second laser positioning system of the second chamber. It is interpreted by the examiner calibrating phantom or dies with respect to two chambers or rooms results in a comparison of coordinate systems.
ZHANG et al.(442) does not specifically teach a relative position of the calibration die of the first chamber to a predetermined center point of the first chamber or a relative position of the calibration die of the second chamber to a predetermined center point of the second chamber.
FALCO teaches in the same field of endeavor an apparatus for monitoring an object (40) with respect to a first coordinate system (10), the apparatus comprising: a location system (30) calibrated with the first coordinate system (10), to locate the object (40); motion detector device (90) associated with the location system (30) to detect a displacement of an element of the location system (30); a processing system in communication with the motion detector device (90) and the location system (30) , the processing device configured to: calculate the location of the object (40) with respect to the second coordinate system (120) associated with the location system; calculate an adjustment factor based on the detected displacement; and adjust the location of the object (40) from the location with respect to the second coordinate system (120) to a location with respect to the first coordinate system (10) according to the adjustment factor. The medical device, the diagnostic device or the treatment device may be chosen, for example, from the group consisting, but not limited to, a thermal device, a radiation device, a surgical device, a mechanical device, and a device for ultrasound. [0014] In an embodiment of the invention, the first coordinate system may be defined by a plurality of lasers located in a room. The first coordinate system may be defined by a physical orientation of a medical device, a diagnostic device, a treatment device or a patient's position. The axes (x, y, z) of the Cartesian coordinate system based on the room can correspond, for example, with the floor and walls of the room, with the center of the coordinate system (for example, location 0.0, 0) being located in a corner of the room, or at some other defined point within the room. In one embodiment, the center of a Cartesian coordinate system based on a room may be located at a point established on a treatment table fixedly located within the room. Therefore, the location system can allow the user to locate a portable device precisely with respect to the treatment table, allowing an improved diagnosis and medical treatment using portable devices.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of ZHANG et al.(442) where each calibration device in each room or chamber is oriented with respect to the center of the room as taught by FALCO to allow the precise location of each calibration die in each chamber in Zhang et al.(442) to allow for an improved diagnosis and medical treatment using portable devices such as calibration dies or phantoms.
Regarding claim 2, ZHANG et al.(442) in view of FALCO teaches adjusting the first laser positioning system and/or the second laser positioning system when there is a deviation between the position of the first positioning mark on the calibration die and/or the position of the second positioning mark on the calibration die.
It is noted that there are a limited number of choices available to a person of ordinary skill in the art for calibrating two moveable objects within two coordinate systems. Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to try in the device of ZHANG et al.(442) as modified by FALCO adjusting the first laser positioning system and/or the second laser positioning system when there is a deviation between the position of the first positioning mark on the calibration die and/or the position of the second positioning mark on the calibration and thus choosing from a finite number of identified, predictable solutions, with a reasonable expectation of successfully calibrating the two dies within two coordinate systems. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claims 3, 4, 10, and 11, ZHANG et al.(442) teaches wherein the calibration device further includes a support frame and wherein the support frame includes a mounting bracket and a support plate mounted on the mounting bracket for supporting the calibration die; wherein mounting the support frame includes: mounting the mounting bracket in a predetermined position in the second chamber or the first chamber and adjusting angle and/or height of the support plate relative to the mounting bracket. As shown in FIG. 7, the first calibration device 130 and the second calibration device 230 have the same structure, comprising a calibration block (131, 231) and a movable base (132, 232); the calibration block (131, 231) is set on the movable base (132, 232) of the vertical rod (133, 233).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZHANG et al.( CN 112675442) hereinafter ZHANG et al.(442) in view of FALCO(ES 2388930) hereinafter FALCO and further in view of Gunzert-Marx et al.( US 20080210853) hereinafter Gunzert-Marx et al.
ZHANG et al.(442) in view of FALCO does not specifically teach wherein the mounting bracket is provided with an adjusting structure located below the support plate, the support plate is provided with a positioning structure on a lower surface of the support plate which cooperates with the adjusting structure, and the angle and/or height of the support plate relative to the mounting bracket are adjusted by adjusting the adjusting structure.
Gunzert-Marx et al. teaches in the same field of endeavor a radiation therapy device, includes both an examination table that can be positioned at an isocenter and an optical coordinate display system. The optical coordinate display system has at least one radiation source, in particular a laser emitter, that is intended for emitting a test beam. Simplified and more-objective checking of the positioning accuracy of the examination table is effected via a test body for beam detection. The test body includes at least one photoelectric line, constructed of a row of photoelectric cells, the position of the line being coordinated with that of the examination table. The test body(calibration die) is a separate geometric object, which is positioned separately from the examination table at the isocenter via an adjusting device, for example, a robot arm, of the examination table. The correct coordinates of the test body relative to the isocenter are stored in memory, so that the examination table may be moved at any time later with the adjusting device into a defined position relative to the isocenter. In an alternative embodiment, the separate test body is mounted on the examination table. A direct correlation is set up between the separate test body coordinates and those of the examination table. In another embodiment, the test body is part of the examination table and includes a plurality of elements. The plurality of elements may be secured at different positions of the examination table or are integrated with the examination table. [0016] The test body may be coupled at a coupling point to an adjusting device, for example, a robot arm, of the examination table. The test body may be coupled directly to the adjusting device via a tool-changing unit. After the positioning of the test body at the isocenter and the storage of the coordinates of the isocenter in memory, the test body may be exchanged for the examination table with the aid of the tool-changing unit, and the table may be moved into a defined position relative to the isocenter. [0033] The test body 16 serves to check the positioning accuracy of an examination table 18 of the medical device 2 in the coordinate display system 10. In one exemplary embodiment, the test body 16 is a separate object. The test body 16 may be detachably connected to the examination table 18 and movable indirectly via an adjusting device 20 of the table 18. The positioning of the test body 16 on the examination table 18 is precise and replicable. An unambiguous correlation between the position of the test body 16 and that of the examination table 18 in the coordinate display system 10 may be assured.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in ZHANG et al.(442) as modified by FALCO where the position of the calibration die may be adjusted via a mounting plate or bracket and adjusting structure as taught by Gunzert-Marx et al. to allow for better alignment of the calibration die in each chamber or room.
Allowable Subject Matter
Claims 5-8, 12,14, 15, and 18-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The prior art of record teaches a calibration phantom or die located in each of two rooms and may be calibrated with a laser system based on the position of the die or phantom within each room. Where the calibration die or phantom includes markings on the surface of the die and where the die may be mounted on an adjustable and movable support system within the room.
The prior art of record does not reasonably teach alone or in combination where the wherein the support plate is provided with a first scale in a first direction and a second scale in a second direction perpendicular to the first direction; and providing the calibration die at the predetermined position on the support frame includes: placing the calibration die at a predetermined scale position on the support plate according to the first scale and the second scale or wherein each of the first chamber and the second chamber is provided with a collimator and a collimator mounting structure for mounting the collimator; the calibration device includes a support frame, and the support frame of the calibration device is mounted on the collimator mounting structure, a predetermined center point of each of the first chamber and the second chamber corresponds to the collimator in position relationship, and is exactly consistent in spatial dimension.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
ZHANG et al.( CN 201175531) teaches a patient fixing bed-plate for accurately insuring tumor focus of radiation treatment equipment in the treatment bed of radiation treatment machine; the CT room, the bed plate 1 placed on the examining table of CT machine, then using laser calibration device, the bed plate 1 four side face of the scale line, correcting the position of the bed board, then the bed plate 1 is relatively fixed with the detecting bed. Radiotherapy room, the same bed plate with the CT room 1 placed on the treatment bed, using laser calibration device, the bed plate 1 four side face of the scale line, the correction position of the bed plate 1, then the bed is relatively fixed with the therapy bed.
CHEN et al.( CN 112089991) teaches a patient guiding swing and target displacement real-time monitoring and correcting system and method, wherein it comprises the following steps: 1) in the simulation chamber of the heavy ion treatment device and the treatment chamber building patient guide swing and target displacement real-time monitoring and correction system, and obtaining the patient tumour target area calibration data under the central coordinate system of treatment in the simulation chamber; 2) according to the obtained calibration data of patient tumor target area under the central coordinate system of the treatment chamber, guiding the patient to swing and carrying out the swing verification; 3) real-time monitoring the patient tumor target area displacement, and according to the patient tumor target area displacement real-time monitoring result and the preset threshold value, the patient tumor target area position for online correction.
MEAD et al.( CN 111132730) teaches a method calibrating monitoring system (10, 14), wherein the calibration phantom (70) is located to the centre about the treatment device (16) arranged to image-directing radiation through the treatment chamber at the centre, wherein the calibration phantom (70) closest to the monitoring system (10, 14) of the capturing image surface of the device (72) relative to the monitoring system of the capturing camera plane inclined by about 45 degrees. Then, using an image capture device (72) captures an image of the calibration phantom (70), model processing these images to generate the imaged surface of the calibration phantom. after the generated model of the imaged surface of the calibration phantom (70) for identifying the centre of the image of the calibration phantom (70) to capture the relative position of camera plane of the device (72), which is then used to determine the image capture camera plane and treatment chamber device and so the centre of relative position.
DE 202011104321 teaches uality assurance phantom for checking the accuracy of patient positioning in percutaneous radiation therapy consisting of a PMMA cuboid with a central plate, characterized in that this cuboid contains test markers of different materials arranged at defined geometric distances from one another.
MAEZAWA(JP 2010178989) teaches a calibration phantom for a radiation therapy equipment, in which the radiograph of a subject is taken with the calibration phantom kept placed on the subject's bed, and this makes it easy to determine if the working axes of a radiation therapy equipment in operation are out of position.
KIKUCHI(WO 2014132501) teaches a neutron capture therapy system with which irradiation-chamber preparation time can be shortened. This neutron capture therapy system (100) irradiates a patient (S) with a neutron beam (N). The neutron capture therapy system (100) is provided with: irradiation chambers (30A, 30B) which are each provided with a chamber interior capable of having the patient (S) disposed therein in order to irradiate the patient (S) with the neutron beam (N), and which are surrounded by shielding walls (W1) for blocking chamber-exterior-bound radiation of the neutron beam (N) from the chamber interiors; a neutron beam generation unit (10) which is capable of irradiating the chamber interiors of the irradiation chambers (30A, 30B) with the neutron beam (N); and a treatment table (80) upon which the patient (S) is placed, and which is configured so as to be capable of moving between chamber exteriors and the chamber interiors of the irradiation chambers (30A, 30B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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