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 .
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 1 – 16 are presented for examination.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3 are rejected under 35 U.S.C. 103 as being unpatentable over Toshiba (JP 2016214760A; pub. Jul. 3, 2019) and in view of Sun et al. (US 2025/0140515 A1; pub. May 1, 2025).
Regarding claim 1, Toshiba discloses: A boron neutron capture therapy (BNCT) system, (para. [0013]) comprising:
a neutron beam irradiation module configured to generate a neutron beam (para. [0013]-[0014]);
a blood boron concentration detecting device configured to detect an actual blood boron concentration of an irradiated body (para. [0046]-[0048]);
an irradiation dose correction module configured to acquire a corrected irradiation dose according to the actual blood boron concentration (para. [0046]-[0048]).
Toshiba is silent about:
a treatment planning module configured to generate a preset treatment plan;
a control module configured to invoke the preset treatment plan from the treatment planning module, and control irradiation time of the neutron beam irradiation module according to the corrected irradiation dose, such that an irradiation dose received by a patient reaches a target dose.
In a similar field of endeavor Sun et al. disclose: a treatment planning module configured to generate a preset treatment plan (para. [0244]);
a control module configured to invoke the preset treatment plan from the treatment planning module (para. [0244]), and control irradiation time of the neutron beam irradiation module according to the irradiation dose, such that an irradiation dose received by a patient reaches a target dose (para. [0244] teaches the preset treatment plan has predefined radiation doses) motivated by the benefits for a fast and optimized treatment.
In light of the benefits for a fast and optimized treatment, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Toshiba with the teachings of Sun et al.
Regarding claim 3, Toshiba and Sun et al. disclose: the irradiation dose correction module is configured to correct a target dose rate according to the actual blood boron concentration to obtain the corrected irradiation dose (the claim is rejected on the same basis as claim 1).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Toshiba (JP 2016214760A; pub. Jul. 3, 2019) and in view of Sun et al. (US 2025/0140515 A1; pub. May 1, 2025) and further in view of Liu (US 2020/0155871 A1; pub. May 21, 2020).
Regarding claim 2, Sun et al. disclose: the treatment planning module is configured to perform calculation according to a preset blood boron concentration to obtain the preset treatment plan (para. [0244]) motivated by the benefits for a fast and optimized treatment.
The combined references are silent about: the treatment planning module is configured to perform simulation according to a preset blood boron concentration to obtain the preset treatment plan.
In a similar field of endeavor Liu discloses: the treatment planning module is configured to perform simulation according to a preset blood boron concentration to obtain the preset treatment plan (para. [0066]) motivated for improved treatment effectiveness and accuracy.
In light of the benefits for improved treatment effectiveness and accuracy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Toshiba and Sun et al. with the teachings of Liu.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Toshiba (JP 2016214760A; pub. Jul. 3, 2019) and in view of Sun et al. (US 2025/0140515 A1; pub. May 1, 2025) and further in view of Tanaka et al. (CN 105938731A; pub. Sep. 14, 2016).
Regarding claim 4, Toshiba and Sun et al. disclose: a neutron dose detecting device configured to detect a neutron count in real time to obtain the irradiation dose (see rejection of claim 1).
The combined references are silent about: a neutron dose detecting device configured to detect a cumulative neutron count.
In a similar field of endeavor Tanaka et al. disclose: a neutron dose detecting device configured to detect a cumulative neutron count in real time (para. [0067], [0070]) motivated by the benefits for preventing patient overexposure.
In light of the benefits for preventing patient overexposure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Toshiba and Sun et al. with the teachings of Tanaka et al. to have; a neutron dose detecting device configured to detect a cumulative neutron count in real time to obtain the irradiation dose.
Claims 9-10, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (CN 105938731A; pub. Sep. 14, 2016) in view of Toshiba (JP 2016214760A; pub. Jul. 3, 2019).
Regarding claim 9, Tanaka et al. disclose: An irradiation dose correction method for a boron neutron capture therapy (BNCT) system (para. [0005]), comprising:
generating a preset treatment plan in combination with a preset boron concentration and medical image data of an irradiated body (para. [0060]).
Tanaka et al. are silent about:
acquiring a corrected irradiation dose according to an actual boron concentration; and controlling irradiation time according to the corrected irradiation dose, such that an irradiation dose received by a patient reaches a target dose.
In a similar field of endeavor Toshiba discloses: acquiring a corrected irradiation dose according to an actual boron concentration; and controlling irradiation time according to the corrected irradiation dose, such that an irradiation dose received by a patient reaches a target dose (para. [0013]-[0014], [0046]-0048]) motivated by the benefits for an effective treatment that spares healthy tissues (Toshiba para. [0011]).
In light of the benefits for an effective treatment that spares healthy tissues as taught by Toshiba, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus Tanaka et al. with the teachings of Toshiba.
Regarding claim 10, Tanaka et al. and Toshiba disclose: acquiring the corrected irradiation dose specifically comprises: correcting a preset target dose rate in the preset treatment plan according to the actual blood boron concentration to obtain a corrected target dose rate; and performing calculation according to the corrected target dose rate to obtain the corrected irradiation dose (the claim is rejected on the same basis as claim 9).
Regarding claim 15, Tanaka et al. disclose: controlling, by a control module, a neutron beam irradiation module to stop irradiation when the cumulative neutron count detected by the neutron dose detecting device reaches the corrected cumulative neutron count or when the irradiation dose reaches the target dose (para. [0067]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (CN 105938731A; pub. Sep. 14, 2016) in view of Toshiba (JP 2016214760A; pub. Jul. 3, 2019) and further in view of Kikuchi et al. (WO2014132502 A1; pub. Sep. 4, 2014).
Regarding claim 16, the combined references are silent about: calculating target irradiation time, and controlling, by a control module, a neutron beam irradiation module to stop the irradiation when actual irradiation time reaches the target irradiation time.
In a similar field of endeavor Kikuchi et al. disclose: calculating target irradiation time, and controlling, by a control module, a neutron beam irradiation module to stop the irradiation when actual irradiation time reaches the target irradiation time (end of pg.28 – beginning of pg.29) motivated by the benefits for preventing patient overexposure.
In light of the benefits for preventing patient overexposure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus Tanaka et al. and Toshiba with the teachings of Kikuchi et al.
Allowable Subject Matter
Claims 5-8, 11-14 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.
Regarding claim 5, the prior arts alone or in combination fail to teach, disclose, suggest or render obvious: the irradiation dose correction module is configured to calculate a corrected cumulative neutron count, and determine whether the irradiation dose reaches the target dose based on the cumulative neutron count in real time and the corrected cumulative neutron count.
Claims 6-7 are rejected on the same basis as claim 5 for dependency reasons.
Regarding claim 8, the prior arts alone or in combination fail to teach, disclose, suggest or render obvious: a corrected target dose rate.
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Regarding claim 10, the prior arts alone or in combination fail to teach, disclose, suggest or render obvious: acquiring the corrected irradiation dose specifically comprises: correcting a preset target dose rate in the preset treatment plan according to the actual blood boron concentration to obtain a corrected target dose rate; and performing calculation according to the corrected target dose rate to obtain the corrected irradiation dose.
Regarding claim 11, the prior arts alone or in combination fail to teach, disclose, suggest or render obvious: detecting a cumulative neutron count in real time, calculating a corrected cumulative neutron count, and determining whether the irradiation dose reaches the target dose based on the cumulative neutron count in real time and the corrected cumulative neutron count.
Claims 12-13 are rejected on the same basis as claim 11 for dependency reasons.
Regarding claim 14, the prior arts alone or in combination fail to teach, disclose, suggest or render obvious: a corrected target
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAMADOU FAYE whose telephone number is (571)270-0371. The examiner can normally be reached Mon – Fri 9AM-6PM.
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/MAMADOU FAYE/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
