DETAILED ACTION
Response to Arguments
Applicant's arguments filed 11/7/2025 have been fully considered but they are not persuasive.
Applicant argues that the prior art of record does not teach or disclose (1) determination by the beam control module or the system control module determines whether there is a safety problem. Examiner disagrees as the combination of Liu in view of Hollebeek describes a controller 110 (e.g. control module) that monitors a predetermined tolerance for system parameters and/or delivery parameters of the particle beam source (see col. 15, lines 9-21). Hollebeek further teaches if the controller 110 determines the one or more system/delivery parameters is outside a clinical safely tolerance range due to mechanical issues, hardware issues and/or software issues (discussed in col. 12, lines 38-66), the delivery beam is aborted (see col. 15, lines 22-28). While the specifics of how the delivery beam is aborted are not present, a person of ordinary skill in the art would recognize that aborting the delivery beam includes preventing, by the controller 110, the charged particle beam generating apparatus from generating the charged particle beam.
Applicant further argues that the prior art of record does not teach or disclose (2 (i) or (ii) or (iii), summarized) the beam control module prevents or stops the generating the charged particle beam. Examiner disagrees as the combination of Liu in view of Hollebeek teaches when a step of determining a variety of mechanical, hardware, and software issues which affect the beam dosage being delivered is not in an ideal state (see col. 12, lines 38-66 of Hollebeek), the radiation beam delivery is aborted (see col. 15, lines 22-29) so the irradiation chamber does not receive the beam.
Regarding the arguments directed to amended independent claim 12, the amended limitations are similar to the recited amended limitations of claim 1 and are not persuasive for the same reasons above.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: beam control module, system control module, etc. in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 6-18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US PGPub 2020/0155871, hereinafter Liu) in view of Hollebeek et al. (US Pat. 10,471,279, hereinafter Hollebeek).
Regarding claim 1, Fig. 2 of Liu discloses a radiotherapy system (neutron capture therapy system, see abstract) comprising:
a first irradiation chamber (irradiation room 101B, see paragraph [0060]);
a beam generating apparatus, comprising a charged particle beam generating apparatus (accelerator 10) and a first neutron beam generating portion (neutron beam generating device 30) interacting with a charged particle beam (charged particle beam P) generated by the charged particle beam generating apparatus (accelerator 10) to generate a therapeutic neutron beam (therapeutic neutron beam N) to irradiate into the first irradiation chamber (irradiation room 101B, see paragraph [0060]);
a beam control module (control room), capable of controlling the charged particle beam generating apparatus to generate the charged particle beam (charged particle beam P) and receiving operating data of the charged particle beam generating apparatus (see paragraph [0066]); and
a system control module (control mechanism configured to control the accelerator, beam transmitting device, treatment table, and control and manage the entire irradiation process, see paragraph [0066]), capable of controlling, by the beam control module, the charged particle beam generating apparatus to generate the charged particle beam (charged particle beam P) and receiving operation data of the radiotherapy system comprising the operation data of the charged particle beam generating apparatus (see paragraph [0066]).
Liu fails to disclose the beam control module determines, according to the received operation data of the charged particle beam generating apparatus, whether there is a safely problem, the radiotherapy system is configured to prevent the charged particle beam generating apparatus from generating the charged particle beam.
Hollebeek discloses a controller 110 (e.g. control module) that monitors a predetermined tolerance for system parameters and/or delivery parameters of the particle beam source (see col. 15, lines 9-21). Hollebeek further teaches if the controller 110 determines the one or more system/delivery parameters is outside a clinical safely tolerance range due to mechanical issues, hardware issues and/or software issues (discussed in col. 12, lines 38-66), the delivery beam is aborted (see col. 15, lines 22-28). While the specifics of how the delivery beam is aborted are not present, a person of ordinary skill in the art would recognize that aborting the delivery beam includes preventing, by the controller 110, the charged particle beam generating apparatus from generating the charged particle beam.
Hollebeek modifies Liu by suggesting the beam control module determines a safety problem to control the beam and to prevent the charged particle beam generating apparatus from generating the charged particle beam when a safety problem is determined.
Since both inventions are drawn to particle therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the control module processes checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location within safety parameters as taught by Hollebeek.
Regarding claim 2, Liu discloses the charged particle beam generating apparatus comprises a charged particle beam generating portion (accelerator 10) and a beam transmission portion comprising a beam direction switching component (switch electromagnet) (see paragraph [0061]), and the charged particle beam generating portion (accelerator 10) generates the charged particle beam (charged particle beam P) to selectively interact with the first neutron beam generating portion (neutron beam generating device 30) through the beam direction switching component (switch electromagnet), to generate the therapeutic neutron beam (therapeutic neutron beam N) to irradiate into the first irradiation chamber (irradiation room 101B) (see paragraphs [0060-0061]).
Regarding claim 3, Liu discloses the beam generating apparatus (accelerator 10) irradiates the neutron beam (neutron beam N) into the first irradiation chamber (irradiation room 101B) and the beam control module (control room) or the system control module is capable of controlling, through the beam control module (control room), the beam direction switching component (switch electromagnet) to switch the neutron beam away from the first irradiation chamber (see paragraph [0061]).
Liu fails to disclose the beam control module determines, according to the received operation data of the charged particle beam generating apparatus, whether there is a safely problem, the radiotherapy system is configured to control the charged particle beam generating apparatus to switch the neutron beam away from the first irradiation chamber.
Hollebeek discloses a particle therapy system (see abstract). Hollebeek teaches that if a measured dose of the incident beam does not match the expected dose, the treatment plan is not approved for use. Hollebeek further teaches that a variety of failures may be monitored or detected as the source for the treatment plan to not be approved for use. Such examples may be mechanical issues (e.g. device damaged/deformed/warped, radiation beam is blocked), hardware issues (e.g. components reach end of life cycle, failing components need recalibration/replacement), or software issues (e.g. error conditions, software bugs), all of which lead to safety problems that need to be addressed before the treatment plan can be approved and continued (see col. 12, lines 38-66). Hollebeek further discloses if the system parameter cannot be adjusted, the radiation delivery is aborted (see col. 15, lines 22-29).
Hollebeek modifies Liu by suggesting the beam control module determines a safety problem to control the beam.
Since both inventions are drawn to particle therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the control module processes checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location within safety parameters as taught by Hollebeek.
Regarding claim 4, Liu discloses the operation data of the charged particle beam generating apparatus comprises operation data of the charged particle beam generating portion (accelerator 10) or operation data of the beam transmission portion comprising operation data of the beam direction switching component (switch electromagnet, see paragraph [0061]).
Regarding claim 6, Liu discloses a charged particle beam generating chamber (accelerator room 1021) accommodating the charged particle beam generating portion (accelerator 10), a beam transmission chamber (beam transmission room 1022) accommodating the beam direction switching component (switch electromagnet), a shielding door (shielding door D4) of the charged particle beam generating chamber (accelerator room 1021) and a shielding door (shielding door D6) of the beam transmission chamber (beam transmission room 1022), the operation data of the radiotherapy system further comprises operation data of the shielding door (shielding door D4) of the charged particle beam generating chamber (accelerator room 1021) or operation data of the shielding door (shielding door D6) of the beam transmission chamber (beam transmission room 1022, see paragraph [0063]).
Regarding claim 7, Liu discloses the charged particle beam generating apparatus comprises a charged particle beam monitoring component (current monitor), and the operation data of the charged particle beam generating apparatus comprises operation data of the charged particle beam monitoring component (current monitor, see paragraph [0062]).
Regarding claim 8, Liu fails to disclose the beam generating apparatus further comprises a neutron beam monitoring component, and the operation data of the radiotherapy system comprises operation data of the neutron beam monitoring component.
Hollebeek discloses a particle therapy system (see abstract). Hollebeek teaches that if a measured dose of the incident beam does not match the expected dose, the treatment plan is not approved for use. Hollebeek further teaches that a variety of failures may be monitored or detected as the source for the treatment plan to not be approved for use. Such examples may be mechanical issues (e.g. device damaged/deformed/warped, radiation beam is blocked), hardware issues (e.g. components reach end of life cycle, failing components need recalibration/replacement), or software issues (e.g. error conditions, software bugs), all of which lead to safety problems that need to be addressed before the treatment plan can be approved and continued (see col. 12, lines 38-66). Hollebeek further discloses if the system parameter cannot be adjusted, the radiation delivery is aborted (see col. 15, lines 22-29).
Hollebeek modifies Liu by suggesting the beam control module monitors the beam.
Since both inventions are drawn to particle therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the control module processes checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location within safety parameters as taught by Hollebeek.
Regarding claim 9, Liu discloses a shielding door (shielding door D2) of the first irradiation chamber (irradiation room 101B, see paragraph [0063]).
A difference between Liu and the claim invention is a radiation monitoring component arranged in the first irradiation chamber. Liu fails to disclose the beam generating apparatus further comprises a beam monitoring component, and the operation data of the radiotherapy system comprises operation data of the beam monitoring component.
Hollebeek discloses a particle therapy system (see abstract). Hollebeek teaches that if a measured dose of the incident beam does not match the expected dose, the treatment plan is not approved for use. Hollebeek further teaches that a variety of failures may be monitored or detected as the source for the treatment plan to not be approved for use. Such examples may be mechanical issues (e.g. device damaged/deformed/warped, radiation beam is blocked), hardware issues (e.g. components reach end of life cycle, failing components need recalibration/replacement), or software issues (e.g. error conditions, software bugs), all of which lead to safety problems that need to be addressed before the treatment plan can be approved and continued (see col. 12, lines 38-66). Hollebeek further discloses if the system parameter cannot be adjusted, the radiation delivery is aborted (see col. 15, lines 22-29).
Hollebeek modifies Liu by suggesting the beam control module monitors the beam.
Since both inventions are drawn to particle therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the control module processes checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location within safety parameters as taught by Hollebeek.
Regarding claim 10, while Liu does not explicitly disclose a patient state monitoring component, Hollebeek discloses a particle therapy system (see abstract). Hollebeek teaches that if a measured dose of the incident beam does not match the expected dose, the treatment plan is not approved for use. Hollebeek further teaches that a variety of failures may be monitored or detected as the source for the treatment plan to not be approved for use. Such examples may be mechanical issues (e.g. device damaged/deformed/warped, radiation beam is blocked), hardware issues (e.g. components reach end of life cycle, failing components need recalibration/replacement), or software issues (e.g. error conditions, software bugs), all of which lead to safety problems that need to be addressed before the treatment plan can be approved and continued (see col. 12, lines 38-66). In view of such teaching, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the processing checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location as taught by Hollebeek.
Regarding claim 11, Liu discloses a treatment plan module (treatment plan) and the operation data of the radiotherapy system comprises treatment plan data retrieved by the system control module (control room) from the treatment plan module (see paragraph [0066]).
Regarding claim 12, Liu discloses a method for controlling safety interlock of a radiotherapy system (neutron capture therapy system, see abstract) comprising:
providing the radiotherapy system comprising:
a first irradiation chamber (irradiation room 101B, see paragraph [0060]);
a beam generating apparatus, comprising a charged particle beam generating apparatus (accelerator 10) and a first neutron beam generating portion (neutron beam generating device 30) interacting with a charged particle beam (charged particle beam P) generated by the charged particle beam generating apparatus (accelerator 10) to generate a therapeutic neutron beam (therapeutic neutron beam N) to irradiate into the first irradiation chamber (irradiation room 101B, see paragraph [0060]);
a system control module (control mechanism configured to control the accelerator, beam transmitting device, treatment table, and control and manage the entire irradiation process, see paragraph [0066]), capable of controlling, by the beam generating apparatus to generate the charged particle beam (charged particle beam P) and receiving operation data of the radiotherapy system comprising the operation data of the charged particle beam generating apparatus (see paragraph [0066]); and
a beam control module (control room), capable of controlling the charged particle beam generating apparatus to generate the charged particle beam (charged particle beam P) and receiving operating data of the charged particle beam generating apparatus (see paragraph [0066]).
Liu fails to disclose the beam control module determines, according to the received operation data of the charged particle beam generating apparatus, whether there is a safely problem, the radiotherapy system is configured to prevent the charged particle beam generating apparatus from generating the charged particle beam.
Hollebeek discloses a controller 110 (e.g. control module) that monitors a predetermined tolerance for system parameters and/or delivery parameters of the particle beam source (see col. 15, lines 9-21). Hollebeek further teaches if the controller 110 determines the one or more system/delivery parameters is outside a clinical safely tolerance range due to mechanical issues, hardware issues and/or software issues (discussed in col. 12, lines 38-66), the delivery beam is aborted (see col. 15, lines 22-28). While the specifics of how the delivery beam is aborted are not present, a person of ordinary skill in the art would recognize that aborting the delivery beam includes preventing, by the controller 110, the charged particle beam generating apparatus from generating the charged particle beam.
Hollebeek modifies Liu by suggesting the beam control module determines a safety problem to control the beam.
Since both inventions are drawn to particle therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the control module processes checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location within safety parameters as taught by Hollebeek.
Regarding claim 13, Liu discloses the charged particle beam generating apparatus comprises a charged particle beam generating portion (accelerator 10) and a beam transmission portion comprising a beam direction switching component (switch electromagnet), and the charged particle beam generating portion generates the charged particle beam (charged particle beam P) to selectively interact with the first neutron beam generating portion (neutron beam generating device 30) to irradiate into the first irradiation chamber (irradiation room 101B) (see paragraph [0060]), and the controlling, by the beam control module (control room) the charged particle beam (charged particle beam P) generated by the charged particle beam generating apparatus to stop interacting with the first neutron beam generating portion (neutron beam generating device 30), by the beam control module (control room), the beam direction switching component (switch electromagnet) to switch the neutron beam away from the first irradiation chamber (irradiation room 101B) (see paragraph [0061]).
Regarding claim 14, Liu discloses the radiotherapy system further comprises a second irradiation chamber (irradiation room 101C, see paragraph [0060]), further comprising before controlling, by the beam control module (control room), the beam direction switching component (switch electromagnet) to switch the neutron beam (therapeutic neutron beam N) away from the first irradiation chamber (irradiation room 101B) (see paragraph [0060]),
wherein the controlling, by the beam control module (control room) the beam direction switching component (switch electromagnet), the beam direction switching component to switch the neutron beam (therapeutic neutron beam N) away from the first irradiation chamber comprises:
controlling, by the beam control module (control room), the beam direction switching component to switch the neutron beam from the first irradiation chamber (irradiation room 101B) to the second irradiation chamber (irradiation room 101C) (see paragraphs [0060-0061]).
Liu fails to disclose the beam control module determines, according to the received operation data of the charged particle beam generating apparatus, whether there is a safely problem.
Hollebeek discloses a particle therapy system (see abstract). Hollebeek teaches that if a measured dose of the incident beam does not match the expected dose, the treatment plan is not approved for use. Hollebeek further teaches that a variety of failures may be monitored or detected as the source for the treatment plan to not be approved for use. Such examples may be mechanical issues (e.g. device damaged/deformed/warped, radiation beam is blocked), hardware issues (e.g. components reach end of life cycle, failing components need recalibration/replacement), or software issues (e.g. error conditions, software bugs), all of which lead to safety problems that need to be addressed before the treatment plan can be approved and continued (see col. 12, lines 38-66). Hollebeek further discloses if the system parameter cannot be adjusted, the radiation delivery is aborted (see col. 15, lines 22-29).
Hollebeek modifies Liu by suggesting the beam control module determines a safety problem to control the beam and to prevent the charged particle beam generating apparatus from generating the charged particle beam when a safety problem is determined.
Since both inventions are drawn to particle therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the control module processes checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location within safety parameters as taught by Hollebeek.
Regarding claim 15, Liu discloses the radiotherapy system further comprises a beam collecting apparatus (beam dump), wherein the controlling, by the beam control module (control room), the beam direction switching component (switch electromagnet) to switch the neutron beam (therapeutic neutron beam N) away from the first irradiation chamber (irradiation room 101B) (see paragraph [0060]), comprises:
controlling, by the beam control module (control room), the beam direction switching component (switch electromagnet) to switch the neutron beam (therapeutic neutron beam N) from the first irradiation chamber (irradiation room 101B) to the beam collecting apparatus (beam dump) (see paragraph [0061]).
Regarding claim 16, Liu discloses the charged particle beam generating apparatus further comprises a charged particle beam monitoring component (current monitor), and the operation data of the charged particle beam generating apparatus further comprises operation data of the charged particle beam monitoring component (current monitor) (see paragraph [0062]).
Regarding claim 17, Liu fails to disclose the beam control module comprises a beam monitoring component.
Hollebeek discloses a particle therapy system (see abstract). Hollebeek teaches that if a measured dose of the incident beam does not match the expected dose, the treatment plan is not approved for use. Hollebeek further teaches that a variety of failures may be monitored or detected as the source for the treatment plan to not be approved for use. Such examples may be mechanical issues (e.g. device damaged/deformed/warped, radiation beam is blocked), hardware issues (e.g. components reach end of life cycle, failing components need recalibration/replacement), or software issues (e.g. error conditions, software bugs), all of which lead to safety problems that need to be addressed before the treatment plan can be approved and continued (see col. 12, lines 38-66). Hollebeek further discloses if the system parameter cannot be adjusted, the radiation delivery is aborted (see col. 15, lines 22-29).
Hollebeek modifies Liu by suggesting the beam control module determines a safety problem to control the beam and to prevent the charged particle beam generating apparatus from generating the charged particle beam when a safety problem is determined.
Since both inventions are drawn to particle therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the control module processes checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location within safety parameters as taught by Hollebeek.
Hollebeek discloses a particle therapy system (see abstract). Hollebeek teaches that if a measured dose of the incident beam does not match the expected dose, the treatment plan is not approved for use. Hollebeek further teaches that a variety of failures may be monitored or detected as the source for the treatment plan to not be approved for use. Such examples may be mechanical issues (e.g. device damaged/deformed/warped, radiation beam is blocked), hardware issues (e.g. components reach end of life cycle, failing components need recalibration/replacement), or software issues (e.g. error conditions, software bugs), all of which lead to safety problems that need to be addressed before the treatment plan can be approved and continued (see col. 12, lines 38-66). Hollebeek further discloses if the system parameter cannot be adjusted, the radiation delivery is aborted (see col. 15, lines 22-29).
Hollebeek modifies Liu by suggesting the beam control module determines a safety problem to control the beam and to prevent the charged particle beam generating apparatus from generating the charged particle beam when a safety problem is determined.
Since both inventions are drawn to particle therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the control module processes checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location within safety parameters as taught by Hollebeek.
Regarding claim 18, Liu discloses the radiotherapy system further comprises a shielding door (shielding door D2) of the first irradiation chamber (irradiation room 101B) (see paragraph [0063]) and a treatment plan module (treatment plan) (see paragraph [0066]).
Liu fails to disclose the beam control module determines, according to the received operation data of the charged particle beam generating apparatus, whether there is a safely problem, the radiotherapy system is configured to prevent the charged particle beam generating apparatus from generating the charged particle beam.
Hollebeek discloses a particle therapy system (see abstract). Hollebeek teaches that if a measured dose of the incident beam does not match the expected dose, the treatment plan is not approved for use. Hollebeek further teaches that a variety of failures may be monitored or detected as the source for the treatment plan to not be approved for use. Such examples may be mechanical issues (e.g. device damaged/deformed/warped, radiation beam is blocked), hardware issues (e.g. components reach end of life cycle, failing components need recalibration/replacement), or software issues (e.g. error conditions, software bugs), all of which lead to safety problems that need to be addressed before the treatment plan can be approved and continued (see col. 12, lines 38-66). Hollebeek further discloses if the system parameter cannot be adjusted, the radiation delivery is aborted (see col. 15, lines 22-29).
Hollebeek modifies Liu by suggesting the beam control module determines a safety problem to control the beam and to prevent the charged particle beam generating apparatus from generating the charged particle beam when a safety problem is determined.
Since both inventions are drawn to particle therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu with the control module processes checks of all the systems, whether mechanical or software in nature, to ensure the treatment plan is implemented as expected for the purpose of delivering a precise dosage in the intended location within safety parameters as taught by Hollebeek.
Regarding claim 21, Liu discloses a second irradiation chamber, wherein the radiotherapy system is configured to control, by the beam control module, the beam direction switching component to switch the neutron beam away from the first irradiation chamber (second irradiation room 101C, see paragraph [0060]; deflection electromagnet for deflecting the charged particle beam P, see paragraph [0061]) by:
controlling, by the beam control module, the beam direction switching component to switch the neutron beam from the first irradiation chamber to the second irradiation chamber (deflection electromagnet for deflecting the charged particle beam P, see paragraphs [0060-0061]).
Regarding claim 22, Liu discloses a beam collecting apparatus (beam dump, not shown), wherein the radiotherapy system is configured to control, by the beam control module, the beam direction switching component to switch the neutron beam away from the first irradiation chamber (deflection electromagnet for deflecting the charged particle beam P, see paragraphs [0060-0061]) comprises:
controlling, by the beam control module, the beam direction switching component to switch the neutron beam from the first irradiation chamber to the beam collecting apparatus (deflection electromagnet for deflecting the charged particle beam P to a beam dump, see paragraphs [0060-0061]).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Hollebeek and in further view of Natori et al. (US PGPub 2006/0022152, hereinafter Natori).
Regarding claim 5, Liu discloses the charged particle beam generating portion comprises an accelerator (accelerator 10) and an accelerator auxiliary device (beam transmitting device 20) (see paragraph [0057]), operation data of the charged particle beam generating portion comprises operation data of the accelerator (see paragraph [0060]).
A difference between Liu and the claimed invention is the charged particle beam generating portion includes an ion source. While Liu is silent on the source of the charged particles, Natori discloses a particle beam therapy system with multiple treatment rooms and utilization of a charged particle beam (see abstract). Natori discloses the charged particle beam generator comprises an ion source and a plurality of accelerators (see paragraph [0063]). Natori teaches that the various accelerators (e.g. pre-stage and main accelerator) energizes the ion beam to a preset level of energy (e.g. 100-200 MeV) through the use of the various accelerators (see paragraph [0063]). In view of such teaching, it would have been obvious to the ordinary artisan before the effective filing date to modify Liu by using a known source for charged particles and energize the beam to a desired level for use (e.g. particle therapy or neutron beam formation) as taught by Natori.
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 HANWAY CHANG whose telephone number is (571)270-5766. The examiner can normally be reached Monday - Friday 7:30 AM - 4:00 PM EST.
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Hanway Chang
/HC/ Examiner, Art Unit 2881 /MICHAEL J LOGIE/ Primary Examiner, Art Unit 2881
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