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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31 and 43 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 31 and 43 each recite the phrase “selected thick enough to block most thermal neutrons, but thin enough not to absorb too high a fraction of the gamma-rays due to neutron capture”. What qualifies as “most thermal neutrons”? What qualifies as “too high a fraction”? The terms are relative term, are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claim(s) 1, 29, 30, 31, 33, 40, 41, 42, 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by L. VERBURG1.
Regarding claims 1 and 39, VERBURG disclose a radiation dose quantification system and method of using, comprising:
providing one or more detectors with respective sensitive volumes and configured to detect gamma-rays emitted as a result of capture of neutrons by a composition in a subject subjected to an irradiation program (FIG 1; section 2.1 – Detector; page L39),
the composition comprising one or more thermal neutron capture agents, the neutrons having been generated by non-elastic collisions between a primary beam of particles and nuclei in the subject (water phantom is irradiated with a proton beam; abstract; introduction I, page L39),
wherein the particles consist of any one or more of protons, deuterons, tritons and heavy ions (protons; abstract),
the irradiation program comprises at least one period of irradiation with a beam duration that includes beam-on periods and beam-off periods (section 2.2 – Proton Beam; during each cyclotron RF period, a bunch of 230 MeV protons are extracted);
providing an energy gate configured to apply at least one predefined energy window or filter such that the system accepts only detection events in the one or more detectors resulting from gamma-rays with an energy indicative of selected gamma-rays arising from the capture of thermal neutrons by the one or more thermal neutron capture agents, wherein the thermal neutrons are neutrons with energies below approximately 0.4 eV (section 3.5 – Gamma emission along proton beam path; “total prompt gamma-ray emission integrated over the 3.0–7.0 MeV energy window”; FIG 2 shows energy window expanded from 2-8 MeV);
a timing gate configured to receive beam data indicative of start or end of the respective beam-on periods and to generate from the beam data, and apply, a timing window configured such that the system rejects or ignores detection events in the one or more detectors resulting from at least prompt gamma-rays produced in non-neutron capture events (prompt gamma rays integrated over a 2 ns time window, any event within 10 ns of an event in the primary detector considered coincidence; FIG 2; Section 2.4 – Digital pulse analysis); and
an output for outputting data indicative of the accepted detection events and determining the radiation dose of neutron radiation received by the subject during the irradiation program from at least the accepted detection events or determining a dose map of the radiation received by the subject from at least the accepted detection events (L44; section 3.5 – Gamma emission along proton beam path; describes outputting a deposited dose by protons based on prompt gamma detection; FIG 7 shows “integral depth dose” based on counts corresponding to clinically commissioned depth-dose curve).
Regarding claims 29 and 42, VERBURG discloses configuring the timing window to reject the prompt gamma-rays by rejecting gamma-rays that arrive in the respective sensitive volumes from the start of each beam-on period to approximately 11 ns, approximately 12 ns, or from 10 to 12 ns, after the end of the respective beam-on period (Any events in the active shield that were recorded with an estimated time within 10 ns of an event in the primary detector were considered to be coincident; § 2.4).
Regarding claim 30, VERBURG discloses shielding the detectors with thermal neutron absorbing material different from the one or more neutron capture agents (§ 2.1, 2.6, active lead shielding; Figure 1 show lead blocks).
Regarding claims 31 and 43, VERBURG discloses providing a lead shielding of 15 cm thickness (FIG 1; § 2.6).
Regarding claim 33, VERBURG discloses planning a radiation therapy involving generating of thermal neutrons within a patient by beam-target nuclear interactions in and around the treatment site (§ 4; “A determination of these concentrations can help establish the range of the beam and may also provide useful information for tumour characterization and optimization of the treatment plan”).
Regarding claim 40, VERBURG discloses the detector is sensitive to the angle of arrival (scintillator crystals such as BGO are naturally angle dependent based on crystal structure for light collection and detection efficiency; § 2.2).
Regarding claim 41, VERBURG discloses a data logger device configured to determine the radiation dose of the radiation received by the subject during the program from the counted gamma rays (FIG 7 illustrates data logging with representative dose corresponding to counts within the phantom).
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.
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.
Claim(s) 32, 34, 35, 36, 38, 44, 45, 46, 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over L. VERBURG in view of LINDSTROM.2
Regarding claims 32, 34, 38, 44, 45, 49, VERBURG discloses the capture agent as lead (collimator), but does not specify the agent as based on B-10 and/or Gd-157. However, LINDSTROM teaches it is known in the art to provide Boron (BORAL: B4C) in a capture material to reduce stray neutrons and, because of their respective high cross sections for absorbing thermal neutrons. In light of the benefits of the material disclosed by LINDSTROM, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of VERBURG. LINDSTROM further discloses BORAL as a capture agent (which includes B-10). VERBURG discloses the detector comprises BGO crystals and a PMT (§ 2.1; page L39).
Regarding claims 35 and 46, VERBURG discloses beam duration of 9 ns (§ 2.2). Furthermore, Cd, Gd, and Hf are known alternatives to B-10 as slow neutron moderators, and it would have been obvious to one of ordinary skill in the art at the time of the invention to substitute in the shielding of boron as taught by LINDSTROM.
Regarding claim 36, VERBURG discloses BGO as a detector material (§ 2.2). Furthermore, Gd-157 is a known alternative to B-10 as a slow neutron moderator, and it would have been obvious to one of ordinary skill in the art at the time of the invention to substitute in the shielding of boron as taught by LINDSTROM.
Claim(s) 37 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over L. VERBURG in view of KIM et al.3 further in view of HOJO et al.4
Regarding claims 37 and 48, VERBURG discloses a proton beam, but does not specify a carbon or helium beam. In the same field of endeavor, KIM discloses carbon-ion beam radiotherapy as a known alternative for tumor treatment, with the advantage of improved dose distribution compared to proton beams. In light of the teachings of Kim, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of VERBURG. KIM does not disclose a beam duration of 1 ms for carbon-ion therapy. In the same field, HOJO discloses providing carbon ion beam therapy of 1 ms pulse duration is known to be suitable of heavy-ion therapy (abstract). In light of the teachings of HOJO, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of KIM and VERBURG.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY BRYANT whose telephone number is (571)270-7329. The examiner can normally be reached M-F // 7-3P EST.
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CASEY BRYANT
Primary Examiner
Art Unit 2884
/CASEY BRYANT/Primary Examiner, Art Unit 2884
1 L. VERBURG: “Energy- and time-resolved detection of prompt gamma-rays for proton range verification,” Phys. Med. Biol. 58 (2013) L37–L49.
2 R. M. LINDSTROM: J Res Natl Inst Stand Technol. 1993 Jan-Feb;98(1):127–133.
3 Kim J, Park JM, Wu H. Carbon Ion Therapy: A Review of an Advanced Technology. Prog. Med. Phys. 2020;31:71-80.
4 HOJO et al.: Nuclear Instruments and Methods in Physics Research B 240 (2005) 75–78.