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
Claim 2 is objected to because of the following informalities: lines 2-3, “deliver radiation at dose rate” should be -- deliver radiation at a dose rate-- . Appropriate correction is required.
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 7-10 are 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.
Regarding claim 7, line 3, “the position of the at least one radiation source” lacks antecedent basis.
Regarding claim 8,
Line 3, “of the target of a target “ is unclear.
Line 4, “using a monoenergetic proton ultra-high does rate beam” is unclear in that “at least one monoenergetic proton ultra-high does rate beam” is already set forth in claim 1 and it is unclear if this is in addition to the monoenergetic beam set forth in claim 1 or intended to refer to the monoenergetic beam in claim 1.
Regarding claim 9, line 3, “a range of energies” is already set forth in claim 1 and it is unclear if this is intended to refer to the range of energies set forth in claim 1 or add a new “range of energies”.
Regarding claim 10, line 3, “and/or” is indefinite. The examiner notes the use of “and/or” is not indefinite by itself but the use of multiple instances such as set forth in claim 1 and claim 10 creates multiple alternative scenarios making the intended scope of the claim unclear.
Claim Rejections - 35 USC § 102
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 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, 2, 9,10, 12 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by TRANEUS et al.( WO 2021185797) hereinafter TRANEUS et al.
TRANEUS et al. teaches radiotherapy treatment planning method for achieving a FLASH radiotherapy treatment plan involves optimizing the plan using an optimization problem that has been designed to maximize the part of the irradiation that will be delivered under FLASH conditions, in particular to an organ at risk, to minimize the damage to the organ at risk.
Regarding claims 1 , 12 and 13, TRANEUS et al. teaches at least one radiation source comprising a proton accelerator, the at least one radiation source adapted to provide proton radiotherapy; a control unit for configuring the at least one radiation source in: a first configuration, wherein the at least one radiation source is configured to irradiate one or more sub-volumes and/or adjacent volumes of a target using at least one monoenergetic proton ultra-high dose rate beam; and a second configuration, wherein the at least one radiation source is configured to irradiate a remaining volume of the target, wherein the radiation is delivered using a range of energies. Note paragraph [008] As will explained below, when delivering FLASH therapy to a patient, because of the nature of the dose delivery, a portion of the irradiation dose will be delivered to each voxel at a lower non-FLASH dose rate. The Total Effective Dose (TED) is defined as the sum of the iso-effective doses from the FLASH portion and the non-FLASH portion. As explained above, FLASH dose involves a much higher dose rate than conventional therapy, for example, 40 Gy/s or 50 Gy/s or even up to more than 500 Gy/s. This means that a typical dose to a patient can be delivered much faster than with conventional therapy. Because irradiation delivered under FLASH conditions causes less damage to the tissue than conventional, non-FLASH irradiation, for the same dose, the invention aims at maximizing the portion of the irradiation that is delivered under FLASH conditions, to at least one organ at risk. [0023] The dose may be delivered as one beam or as a number of beams. The optimization problem includes an objective function designed to maximize the FFASH component in at least one organ at risk. As will be understood, this may also be formulated as minimizing the non- FFASH component in the at least one organ at risk. As is common in the art, this objective may be achieved by in different ways, including optimizing one or more of the following: the spot scan order, and/or the spot placement and/or the spot weights and/or the beam arrangement, with respect to the energy, directions and/or number of beams and the spot shape.
Regarding claim 2, TRANEUS et al. teaches a dose rate greater than 40 Gy/s (FLASH) in the first configuration. Note paragraph [008].
Regarding claim 9, TRANEUS et al. teaches wherein, in the second configuration, the control unit controls the proton accelerator to deliver a range of energies and to deposit the energies in the target. [0023] The dose may be delivered as one beam or as a number of beams. To achieve this, the optimization problem includes an objective function designed to maximize the FFASH component in at least one organ at risk. As will be understood, this may also be formulated as minimizing the non- FFASH component in the at least one organ at risk. As is common in the art, this objective may be achieved by in different ways, including optimizing one or more of the following: the spot scan order, and/or the spot placement and/or the spot weights and/or the beam arrangement, with respect to the energy, directions and/or number of beams and the spot shape.
Regarding claim 10, TRANEUS et al. teaches where the sub-volumes or adjacent volumes of the target overlap [005] Published US patent application No. 2019/0022411 also relates to FLASH therapy, which is said to give reduced side effects for the same dose. Dose rates of 40 Gy/s or more, up to more than 500 Gy/s are mentioned, allowing a dose fraction to be delivered in a fraction of a second. The radiation may be delivered by a number of beams from different angles. The problem of overlapping beams near the target, resulting in a higher dose than desired to the regions in which there is overlap is discussed. The planning method is focused on minimizing the overlap between beams outside of the target by considering the geometry of the patient and target and the beam angles.
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.
Claim(s) 3, 5-6, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over TRANEUS et al.( WO 2021185797) hereinafter TRANEUS et al. in view of LABARBE et al.( US 20210402214) hereinafter LABARBE et al.
Regarding claims 3 and 5-6, TRANEUS et al. teaches the claimed invention as set forth above including the optimization problem includes an objective function designed to maximize the FFASH component in at least one organ at risk. As will be understood, this may also be formulated as minimizing the non- FFASH component in the at least one organ at risk. As is common in the art, this objective may be achieved by in different ways, including optimizing one or more of the following: the spot scan order, and/or the spot placement and/or the spot weights and/or the beam arrangement, with respect to the energy, directions and/or number of beams and the spot shape.
TRANEUS et al. does not specifically teach moving the source sequentially to irradiate a number of spots in the one or more sub-volumes or adjacent volumes of the target in the first configuration.
LABARBE et al. teaches in paragraph [0030] each specific volume may be comprised within a specific peripheral surface and the sequence optimization for each specific volume may be determined by steps to define a specific volume outline (V0) formed by a projection parallel to the beam direction of the specific peripheral surface of the specific volume onto the surface plane (P0), define a sub-set of the spot position pattern (x, y) comprising the spots intersecting or included within the specific volume outline, define a scarf sequence unit cell with the following steps, define an initial spot for being irradiated first by a first beamlet, define successive second, third, to w.sup.th spots, each sequentially adjacent to one another and all aligned along a width direction, define a (w+1).sup.th spot as being adjacent to the w.sup.th spot along a length direction, different from, and in some embodiments normal to the width direction, define (w+.sub.2).sup.nd to 2w.sup.th spots each sequentially adjacent to one another and all aligned along the width direction, define a (2w+1).sup.th spot as being adjacent to the 2w.sup.th spot along the length direction. Note also paragraphs [0094]-[095] teach Ultra-high dose rate (HDR) irradiation and sequentially scanning overlapping volumes. Paragraph [0116] teaches continuous scanning.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of TRANEUS et al. moving the source sequentially to irradiate a number of spots in the one or more sub-volumes or adjacent volumes of the target and irradiating a continuous beam as taught by LABARBE et al. to ensure that a target treated is effectively irradiated at high Dose rates where required taking account of any overlapping dose deposition distribution of all beamlets leaking over a given spot to be treated.
Regarding claim 11, TRANEUS et al. in view of LABARBE et al. does teach it is common in the art, optimizing one or more of the following: the spot scan order, and/or the spot placement and/or the spot weights and/or the beam arrangement, with respect to the energy, directions and/or number of beams and the spot shape.
TRANEUS et al. does not specifically teach the specific size of the spots or irradiation volumes or subvolumes.
It is noted that there are a limited number of choices available to a person of ordinary skill in the art to select specific irradiation volume sizes to ensure the target is covered. Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to vary the volume sizes and try different spot sizes or volume sizes as one of a finite number of methods ensuring the target volume is covered, with a reasonable expectation of successfully irradiating the target while minimizing the damage to healthy tissue. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claim(s) 4, 7, 8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over TRANEUS et al.( WO 2021185797) hereinafter TRANEUS et al. in view of SHI et al.( CN 113082551) hereinafter SHI et al.
TRANEUS et al. teaches the claimed invention as set forth above but does not teach a specific delivery time of FLASH or ultra-high radiotherapy of less than 1s to less than 200ms.
SHI et al. teaches Flash therapy is a new non-invasive radiation therapy technology, which is to give a single irradiation dose in a very short time in a non-invasive manner, so as to obtain a very high irradiation dose rate (usually in the 50ms is administered an average dose rate exceeds the irradiation of the 100Gy/s This extremely high irradiation dose rate is applied to a biological cell or tissue method called Flash therapy (flash radiation therapy). compared with conventional dose rate (1-7cGy/s) radiotherapy, Flash treatment in very short time (<0.1s) delivering high irradiation dose. The invention can adopt unique heavy ion treatment device, namely the heavy ion Flash treatment device, but not limited to the heavy ion device, as long as the synchronous accelerator as the main accelerator particle therapy device, such as proton, helium ion, or carbon, oxygen, neon and other heavy ion is still suitable. The beam modulation device 12 is installed between the double scatterer device 11 and the equal center. The beam current after expansion is adjusted and broadening to reach the transverse conformal of the target body. The beam modulation device 12 comprises a range shifter, a ridge filter and a multi-blade grating. a range shifter, configured to adjust the beam energy; the range shifter is a passive energy reducing device, mainly responsible for passive treatment mode (2D and 2 DLS treatment mode) reducing beam energy; reducing the range of carbon ion beam in the patient body; matching with the compensator to realize conformal irradiation of the tumor target back edge.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include a delivery time of FLASH or ultra-high radiotherapy of less than 1s to less than 200ms and to use a ridge filter or range shifter, and the use of heavy ions such as carbon, helium, or neon as taught by SHI et al. to allow for higher doses over shorter periods of time with a controlled beam
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schulte et al.( US 8644571) teaches therapeutic treatment of a patient using intensity-modulated proton therapy is described. In one example, a method of creating a proton treatment plan is presented that divides volumes of interest into sub-volumes, applies dose constraints to the sub-volumes, finds one or more feasible configurations of a proton therapy system, and selects a proton beam configuration that improves or optimizes one or more aspects of proton therapy. In some implementations, the method of dividing volumes into sub-volumes includes creating fractional sub-volumes based at least in part on proximity to a target volume boundary. In some implementations, the method of finding an improved or optimal proton beam configuration from a set of feasible configurations includes finding a minimum of a cost function that utilizes weighting factors associated with treatment sites.
Vanderstraeten et al.( US 11673003) teaches Radiation treatment planning includes accessing values of parameters such as a number of beams to be directed into sub-volumes in a target, beam directions, and beam energies. Information that specifies limits for the radiation treatment plan are accessed. The limits include a limit on irradiation time for each sub-volume outside the target. Other limits can include a limit on irradiation time for each sub-volume in the target, a limit on dose rate for each sub-volume in the target, and a limit on dose rate for each sub-volume outside the target. The values of the parameters are adjusted until the irradiation time for each sub-volume outside the target satisfies the maximum limit on irradiation time. (12) In embodiments according to the invention, instead of the conventional approach of specifying a maximum dose rate and a minimum treatment time in the treatment plan, limits are specified for a maximum irradiation time for each sub-volume in the target, a maximum irradiation time for each sub-volume outside the target, a minimum dose rate for each sub-volume in the target, and a minimum dose rate for each sub-volume outside the target. As noted above, FLASH RT entails delivering a relatively high radiation dose to a target within a short period of time. For example, each beam can deliver at least four grays (Gy) in less than one second, and may deliver as much as 20 Gy or 50 Gy or more in less than one second. In embodiments, the dose threshold is dependent on tissue type.
LABARBE et al.( CN 113856064) teaches a treatment planning system (TPS), the treatment planning system is used for generating a charged particle beam applied to target tissue (3t) containing tumor cells surrounding the peripheral surface by pen-shaped beam scanning (PBS), preferably proton beam treatment plan by radiation, wherein the TPS comprises: a dose defining stage defining a dose-beam defining step to be deposited in the outer peripheral surface, defining the position and size of the fine beam of the PBS during the at least one high rate weight period; the beam defining stage comprises a dose rate defining stage, which comprises at least one high rate quantity j, wherein the ultra-high dose deposition rate (HDR) irradiation comprises healthy cells of the specific region (Vs), wherein HDR=Dj/t is not less than 1Gy/s, j, and a narrow beam scanning sequence stage, which defines the scanning sequence of the irradiation of the fine beam. The fine beam scan sequence phase is intended to optimize the time sequence of the fine beam transmission.
Zwart et al.( US 9962560) teaches particle therapy system comprises a particle accelerator to output a particle beam; and a scanning system for the particle accelerator to scan the particle beam across at least part of an irradiation target. The scanning system is configured to scan the particle beam in two dimensions that are at an angle relative to a direction of the particle beam. A structure defines an edge. (8) The scanning system may be configured to scan the particle beam more quickly in interior sections of the irradiation target than at edges of the irradiation target.
Reindl et al., pMB FLASH – Status and Perspectives of Combining Proton Minibeam with FLASH Radiotherapy, J Cancer Immunol. 2019 Volume 1, Issue 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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