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 .
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.
Claims 1, 4-7, 9-10 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Bottura (US 20210187328 A1) in view of Ishiyama (US 20160107001 A1).
Regarding claim 1, Bottura teaches a particle therapy system comprising:
A particle accelerator (accelerator extraction line, [0121]) configured to output a particle beam at a predefined maximum energy (beam energy, [0049]); and
A toroidal gantry (100, fig. 1) comprising magnets in an interior thereof, the magnets comprising first magnets (10b, fig. 1) and one or more second magnets (10a), the first magnets being arranged around a hole (formed by cylinder 500, fig. 18) of the toroidal gantry containing a treatment position (patient, fig. 1), each of the first magnets being configured to bend the particle beam toward the treatment position, the one or more second magnets being between the first magnets and the particle accelerator, where a second magnet of the one or more second magnets is configured to direct the particle beam at the predefined maximum energy to a first magnet of the first magnets (fig. 1, magnets 10a bend beam towards magnets 10b which bend it towards the treatment position).
Bottura does not teach one or more motors that are configured to move one or more of the first magnets relative to the treatment position.
Ishiyama teaches a gantry system having actuators (claim 2) configured to move a magnet relative to a treatment position ([0012]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to have motors for moving the first magnets relative to the treatment positions, in order to allow fine adjustment of the magnet position to correct for small deviations as described by Ishiyama with no unexpected result.
Regarding claim 4, Bottura teaches that the first magnets are spaced apart and are each located in a different circumferential sector of the toroidal gantry (fig. 12, each of magnets 10a and 10b comprises multiple separate magnet coils in different circumferential sectors of the gantry).
Regarding claim 5, Bottura teaches that the toroidal gantry comprises between six and twenty first magnets (sixteen magnets as part of magnet 10, fig. 12; second magnet 10b in arrangement of fig. 1 would have this structure).
Regarding claim 6, Ishiyama teaches that the one or more motors are configured to move the magnets relative to other magnets (so that in the system of Bottura they would move a first magnet relative to other magnets of the first magnet).
Regarding claim 7, Bottura teaches that the first magnets are configured to bend the particle beam by at least 90 degrees (fig. 19), and the first magnets are superconducting magnets ([0022-0023]).
Regarding claim 9, Bottura and Ishiyama do not teach that the distance between the first magnet and the treatment position is 2m or less.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Bottura by adjusting the distance between the first magnet and the treatment position to be within the claimed range, as a matter of adjusting the size of parts of the invention (or adjusting the patient position using a movable couch) to optimize the irradiation with no unexpected result.
Regarding claim 10, Ishiyama teaches that the one or more motors are configured to rotate the first magnets relative to the treatment position (by moving deformation prevention mechanisms 10, fig. 4A-4B).
Regarding claim 40, Bottura and Ishiyama do not teach that the distance between each of the first magnet and the treatment position is 1m or less.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Bottura by adjusting the distance between the first magnet and the treatment position to be within the claimed range, as a matter of adjusting the size of parts of the invention (or adjusting the patient position using a movable couch) to optimize the irradiation with no unexpected result.
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.
Claims 2-3, 8, 11-13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bottura in view of Ishiyama and in further view of Zwart (US 10,675,487 B2).
Regarding claim 2, Bottura and Ishiyama teach all the limitations of claim 1 as described above. Bottura does not teach that the particle accelerator and the toroidal gantry are in the same treatment space.
Zwart teaches a system having a particle accelerator (synchrocyclotron 604) in the same treatment space as a gantry (605, fig. 29).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to have a particle accelerator in the treatment space as taught by Zwart, as a matter of selecting a particle accelerator and arranging the parts of the invention in order to provide a compact system which can provide particle beam directly to the patient without requiring an external routing device (Zwart, [0113]).
Regarding claim 3, Bottura does not teach that the particle accelerator is a fixed-energy particle accelerator, or that the particle therapy system comprises an energy degrader that is movable within a space between each of the first magnets and the treatment position, the energy degrader to change an energy of the particle beam before the particle beam reaches the treatment position.
Zwart teaches a therapy system having a fixed-energy particle accelerator (105; fixed-energy, col. 24 lines 52-53) and an energy degrader (110) that is movable between a gantry and a treatment position to change an energy of the particle beam (fig. 30, col. 12 lines 9-13).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Bottura to have the fixed-energy accelerator and energy degrader of Zwart, in order to easily change the energy of the beam (to alter the beam depth and reach different layers of the patient) without changing the beam trajectory in the gantry.
Regarding claim 8, Bottura teaches that the patient is at a treatment position within the hole of the toroidal gantry (fig. 12; patient is inside gantry, implicitly at treatment position).
Bottura does not teach that the patient is held on a movable treatment couch.
Zwart teaches a radiation system having a movable treatment couch for positioning a patient (col. 23 lines 55-57).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to have the movable treatment couch of Zwart as this is a known common means of restraining and moving a patient during an therapy process.
Regarding claims 11-13, Bottura teaches all the limitations of claim 1 as described above. Bottura teaches that the particle accelerator is configured to operate at two energies (E1 and E2, fig. 1) one of the two energies being greater than another of the two energies.
Bottura does not teach that the particle accelerator is a synchrocyclotron or synchrotron.
Zwart teaches a system having a particle accelerator which is a synchrocyclotron or synchrotron (col. 10 lines 28-39).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to have the particle accelerator be a synchrocyclotron or synchrotron as taught by Zwart, as a matter of selecting a known equivalent type of accelerator used in the particle therapy art with no unexpected result.
Regarding claim 19, Bottura teaches all the limitations of claim 1 as described above. Bottura does not teach that the particle accelerator comprises main superconducting coils to generate a magnetic field for accelerating particles to produce the particle beam, and active return coils to conduct current in an opposite direction as the main superconducting coils.
Zwart teaches a particle therapy system having a particle accelerator comprising main superconducting coils to generate a magnetic field for accelerating particles to produce the particle beam, and active return coils to conduct current in an opposite direction to the main coils (col. 10 lines 40-60 , col. 11 lines 33-44).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to have the superconducting and return coils of Zwart, as a matter of substituting a known equivalent type of accelerator with a compact structure as described by Zwart with no unexpected result.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bottura in view of Ishiyama and in further view of Rigney (WO 2005018734 A2).
Regarding claim 15, Bottura and Ishiyama teach all the limitations of claim 1 as described above. Bottura and Ishiyama do not teach a first nozzle configured for movement around the toroidal gantry, the nozzle to align to the first magnet to output the particle beam to a treatment position.
Rigney teaches a nozzle (104) configured for movement around the gantry (figs. 1A-1B; gantry includes magnets in combination with Bottura, above, for alignment with nozzle) the nozzle for outputting the particle beam to the treatment position.
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to have the movable nozzle attached to the gantry of Rigney, in order to aim the beam at a desired point in a known manner with no unexpected result.
Regarding claim 14, Rigney teaches an imaging device (imagers 112) mounted to a gantry (102) and configured for movement around the gantry (figs. 1A-1B).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to mount an imaging device to the gantry of Bottura, in order to determine the position of a target tissue and proper targeting of the irradiation region as taught by Rigney (p. 2 lines 12-23).
Regarding claim 16, Rigney teaches a control system programmed to control movement of the one or more imaging devices and to control movement of the nozzle, the control system being programmed to prevent collision between the nozzle and the one or more imaging devices (collision avoidance system 270, p. 21 lines 23-33).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to have the collision avoidance system of Rigney, in order to prevent damage to the system from collisions in a known manner with no unexpected result.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bottura in view of Ishiyama and Rigney and in further view of Pelizzari (US 20060113482 A1).
Regarding claim 17, Bottura, Ishiyama and Rigney teaches all the limitations of claim 15 as described above. Bottura, Ishiyama and Rigney do not teach that the nozzle is configured to rotate around a first track in the toroidal gantry and the one or more imaging devices are configured to rotate around a second inner track in the toroidal gantry, the first inner track and the second inner track being at different locations of the toroidal gantry.
Pelizzari teaches a system having separate tracks for radiation nozzles and at least some imaging devices at different locations of a gantry (rings 122a, 122b [0049]),
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to have the separate tracks for nozzles and imaging devices as described by Pelizzari, in order to allow independent movement of the nozzles and the image devices for optimized imaging (e.g. PET imaging during radiotherapy, Pelizzari [0046]) with no unexpected result.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bottura in view of Ishiyama and in further view of Fahrig (US 10,806,950 B2).
Regarding claim 18, Bottura teaches that the first magnets are spaced apart and are each located in a different circumferential sector of the toroidal gantry (fig. 12, magnets are spaced circumferentially).
Bottura does not teach that each of the sectors comprise a nozzle for outputting the particle beam to the treatment position.
Fahrig teaches a system having a gantry (50) with multiple circumferentially spaced nozzles (35, fig. 13A) for irradiating a treatment position.
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to have the multiple nozzles of Fahrig, each in one sector of the gantry, in order to emit particles from multiple angles as described by Fahrig for efficient treatment of any desired target area.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bottura in view of Ishimura and in further view of Khuntia (US 20200286601 A1).
Regarding claim 20, Bottura and Ishimura teach all the limitations of claim 1 as described above. Bottura and Ishimura do not teach that the particle beam is output at FLASH doses.
Khuntia teaches a system which delivers radiation to a patient at FLASH doses ([0005]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to modify the system of Bottura to operate at FLASH doses as taught by Khuntia, as a matter of adjusting the beam intensity of the system Bottura in order to perform fast treatment which prevents damage to normal tissue as described by Khuntia.
Regarding claim 21, Khuntia teaches that the dose exceeds 20 Gray-per-second for a duration of less than 5 seconds ([0005]).
Allowable Subject Matter
Claims 22-39, 41 and 43-44 are allowed.
The following is a statement of reasons for allowance:
Regarding claims 22-31, the prior art does not disclose or make obvious a particle therapy system with a stationary multi-sectored gantry, each sector configured to output radiation toward a treatment position from a different angle, a stationary particle accelerator comprising a monoenergetic particle beam, and a vault containing the gantry, the accelerator and the treatment position, therein the treatment position is not shielded from the gantry or the particle accelerator by shielding of the vault that is external to the gantry or particle accelerator.
Regarding claims 32-39, 41 and 43-44, the prior art does not disclose or make obvious a particle therapy system having a toroidal structure with first magnets arranged in sectors around a circumference of the toroidal structure, an enclosure connecting the toroidal structure to a particle accelerator, the enclosure comprising second magnets, the second magnet for receiving the particle beam and for directing the particle beam toward the first magnets; and a rotatable structure within the enclosure configured for mounting imaging components or nozzles for outputting the particle beam for movement around the toroidal structure.
In the prior art, Bottura teaches a toroidal gantry having magnets, but does not teach an enclosure with second magnets AND a rotatable structure within the enclosure for mounting imaging components and/or a nozzle for movement around the toroidal gantry. Bottura teaches “second magnets” that are either be the vector magnets (22), which are part of an enclosure which cannot contain imaging components or a nozzle, or the bending magnets 10a which are part of the toroidal gantry. Amending Bottura to meet the limitations of claims 41-43 would require removing the magnets 10a from the toroidal gantry and adding them to a separate enclosure as well as a rotational structure within the enclosure for holding nozzles and imaging devices around the toroidal gantry, which one of ordinary skill in the art would not be motivated to do without benefit of the applicant’s disclosure.
Response to Arguments
Applicant’s arguments with respect to claim 1 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 DAVID E SMITH whose telephone number is (571)270-7096. The examiner can normally be reached M to F 8:30 AM-5:00 PM.
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/DAVID E SMITH/ Examiner, Art Unit 2881
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