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 Objections
Applicant is advised that should claim 10 be found allowable, claim 40 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Amending claim 40 to depend on claim 32 would overcome the objection. In the following rejection claim 40 is assumed to depend on claim 32.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-7, 32 and 35-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bottura (US 20210187328 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 a first magnet proximate to an output of the particle accelerator (10a, fig. 1) and second magnets (10b) proximate to a treatment position, the first magnet being configured to direct the particle beam to a second magnet, the second magnet being configured to bend the particle at the predefined maximum energy towards the treatment position (patient position, fig. 1).
Regarding claim 4, Bottura teaches that the second 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 second 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, Bottura teaches that the second magnets are stationary on the toroidal gantry (“magnet is substantially stationary in use”, [0010]).
Regarding claim 7, Bottura teaches that the second magnets are configured to bend the particle beam by at least 90 degrees (fig. 19).
Regarding claim 32, Bottura teaches a gantry (toroidal gantry 100) for use in a particle therapy system, the gantry comprising:
A toroidal structure that is connectable to a particle accelerator ([0121]), the toroidal structure comprising first magnets (coils 1a-1p, fig. 12) arranged in sectors around a circumference of the toroidal structure, the first magnets for bending a particle beam originating at the particle accelerator by at least 90 degrees towards a treatment position (fig. 19);
An enclosure (vector magnet 20) connecting the toroidal structure to the particle accelerator, the enclosure comprising second magnets (22, fig. 20(b)), the second magnets for receiving the particle beam and for directing the particle beam towards the first magnets; and
A rotatable structure within the enclosure (rotatable magnet, [0086]) configured for mounting radiation delivery components (magnets 22).
Regarding claim 35, 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 36, Bottura teaches that the toroidal gantry comprises between six and twenty first magnets (sixteen, fig. 12).
Regarding claim 37, Bottura teaches that the second magnets are stationary on the toroidal gantry ([0010]).
Regarding claim 38, Bottura teaches that the second magnets are configured to bend the particle beam by at least 90 degrees (fig. 19).
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, 19 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Bottura in view of Zwart (US 10,675,487 B2).
Regarding claims 2 and 33, Bottura teaches all the limitations of claims 1 and 32 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 claims 3 and 34, 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 between each of the second 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 a 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 9-10 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Bottura.
Regarding claims 9-10 and 39-40, Bottura teaches all the limitations of claims 1 and 32 as described above. Bottura does not teach that the distance between the second magnet and the treatment position is 2m or less, or 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 second 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.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bottura in view of Rigney (WO 2005018734 A2).
Regarding claim 14, Bottura teaches all the limitations of claim 1 as described above. Bottura does not teach one or more imaging devices mounted to the toroidal gantry, the one or more imaging devices being configured for movement around the toroidal gantry.
Rigney teaches a therapy system having imaging devices (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 15, Rigney teaches a nozzle (104) configured for movement around the gantry (figs. 1A-1B; gantry is toroidal in combination with Bottura, above) 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 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 Rigney and in further view of Pelizzari (US 20060113482 A1).
Regarding claim 17, Bottura teaches all the limitations of claim 15 as described above. Bottura 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.
Claims 18 and 44 is rejected under 35 U.S.C. 103 as being unpatentable over Bottura in view of Fahrig (US 10,806,950 B2).
Regarding claims 18 and 44, Bottura teaches that the second 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 Khuntia (US 20200286601 A1).
Regarding claim 20, Bottura teaches all the limitations of claim 1 as described above. Bottura does not teach that the particle beam is delivered to the patient 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]).
Claims 22-31 are rejected under 35 U.S.C. 103 as being unpatentable over Bottura in view of Zwart and in further view of Fahrig.
Regarding claim 22, Bottura teaches a particle therapy system comprising:
A gantry (toroidal gantry 100) configured to deliver radiation to the patient;
A particle accelerator ([0121]) connected to the gantry to output the radiation towards the gantry.
Bottura does not teach that the gantry is a multi-sectored gantry, each sector being configured to deliver radiation to a patient from a different position on the multi-sectored gantry.
Fahrig teaches a particle therapy system having a multi-sectored gantry, each sector being configured to deliver radiation to a patient from a different position on the multi-sectored gantry (multi-beamline structure, fig. 13A).
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 multi-sectored gantry of Fahrig, in order to perform irradiation from multiple angles in order to effectively treat a patient as described by Fahrig.
Zwart teaches a system having a particle accelerator (synchrocyclotron 604) in the same treatment space as a gantry (605, fig. 29) and not separated by shielding external to the gantry or the particle accelerator.
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, in order to provide a particle beam directly to the patient without requiring an external routing device or extended beamline (Zwart, [0113]).
Regarding claim 23, Zwart teaches that the multi-sectored gantry and the particle accelerator are in a same treatment space (fig. 29).
Regarding claim 24, Bottura teaches that each sector comprises a magnet configured to direct the radiation towards the patient (magnets 10a-10p, fig. 12; send radiation towards patient, fig. 1b).
Regarding claim 25, Bottura teaches that each magnet is substantially D-shaped (fig. 12).
Regarding claim 26, Bottura teaches that each magnet is configured to bend the particle beam by at least 90 degrees (fig. 19).
Regarding claim 27, Bottura teaches that the gantry is toroidal in shape; and
The multi-sectored gantry comprises a second magnet (magnet coils, fig. 12 forming magnet 10) in each sector and a first magnet (vector magnet 20) between the second magnet and the particle accelerator, the first magnet for directing the particle beam to a second magnet in a target sector.
Regarding claim 28, Bottura teaches that the first magnet is configured to direct the particle beam to different sectors.
Regarding claims 29-31, Bottura, Fahrig and Zwart teaches all the limitations of claim 22 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.
Allowable Subject Matter
Claims 41-43 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 a statement of reasons for the indication of allowable subject matter: 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.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at 22293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID E SMITH/ Examiner, Art Unit 2881