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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 1-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to an abstract idea without significantly more.
With Respect to claims 1, 14, 26, and 28 the claims recite the following limitation(s):
Claim 1: A method for protecting healthy tissue in particle therapy, the method comprising:
defining a particle arc range for a radiotherapy treatment of a patient;
generating a spot selection for an arc sequence over the particle arc range, including a trajectory for delivering the radiotherapy treatment, based on a temporal dose heterogeneity parameter or a spatial dose heterogeneity parameter;
optimizing fluence of the arc sequence for the radiotherapy treatment;
and outputting the fluence optimized arc sequence for use in the radiotherapy treatment.
Claim 14: A method for protecting healthy tissue in particle therapy, the method comprising:
defining a particle arc range for a radiotherapy treatment of a patient;
generating an arc sequence for the particle arc range, including a trajectory for delivering the radiotherapy treatment;
optimizing fluence of the arc sequence for the radiotherapy treatment,
based on an applied temporal dose heterogeneity specific cost function or an 29
applied spatial dose heterogeneity specific cost function modifying the arc sequence; and
outputting the fluence optimized arc sequence for use in the radiotherapy treatment.
Claim 26: A method for protecting healthy tissue in particle therapy, the method comprising:
defining a particle arc range for a radiotherapy treatment of a patient;
generating a spot selection for an arc sequence for the particle arc range,
including a trajectory for delivering the radiotherapy treatment, based on a temporal dose heterogeneity parameter and a spatial dose heterogeneity parameter;
optimizing fluence of the arc sequence for the radiotherapy treatment,
based on an applied temporal dose heterogeneity specific cost function and an applied spatial dose heterogeneity specific cost function;
outputting the fluence optimized arc sequence for use in the radiotherapy treatment.
Claim 28: A method for protecting healthy tissue in particle therapy, the method comprising:
defining a particle arc range for a radiotherapy treatment of a patient;
generating a spot selection for an arc sequence, including a trajectory for delivering a radiotherapy treatment, based on a temporal dose heterogeneity parameter or a spatial dose heterogeneity parameter;
optimizing fluence of the arc sequence for the radiotherapy treatment; and
outputting the fluence optimized arc sequence for use in the radiotherapy treatment.
Step 1- claims 1, 14, 26, and 28 are directed to a method for protecting healthy tissue in particle therapy respectively.
Step 2a Prong 1 – The claimed invention is directed to non-statutory subject matter. The above limitations, under their broadest reasonable interpretation, fall within the “Certain
Mathematical concepts and mental processes grouping of abstract ideas, enumerated in MPEP
2106.04(a)(2)(I and III), in that they recite a series of mathematical calculations and mental steps which
produce a radiotherapy treatment plan. When given their BRI, the limitations are considered an abstract idea of being certain mathematical concepts and mental processes.
With respect to claim 1, The method sets forth, defining a particle arc range for a radiotherapy treatment, generating a spot selection for an arc sequence over the particle arc range, optimizing fluence of the arc sequence for the radiotherapy treatment, and outputting the fluence optimized arc sequence for use in the radiotherapy treatment. The steps appear merely directed to the mental processes and mathematical concepts of an abstract idea for implementing a radiotherapy treatment plan capable of being implanted on a generic computer and are not incorporated into a practical application.
With respect to claim 14, The method sets forth, defining a particle arc range for a radiotherapy treatment, generating a spot selection for an arc sequence over the particle arc range, optimizing fluence of the arc sequence for the radiotherapy treatment, and outputting the fluence optimized arc sequence for use in the radiotherapy treatment. The steps appear merely directed to the mental processes and mathematical concepts of an abstract idea for implementing a radiotherapy treatment plan capable of being implanted on a generic computer and are not incorporated into a practical application.
With respect to claim 26, The method sets forth, defining a particle arc range for a radiotherapy treatment, generating a spot selection for an arc sequence over the particle arc range, including a trajectory for delivering the radiotherapy treatment, optimizing fluence of the arc sequence for the radiotherapy treatment, and outputting the fluence optimized arc sequence for use in the radiotherapy treatment. The steps appear merely directed to the mental processes and mathematical concepts of an abstract idea for implementing a radiotherapy treatment plan capable of being implanted on a generic computer and are not incorporated into a practical application.
With respect to claim 28, The method sets forth, defining a particle arc range for a radiotherapy treatment, generating a spot selection for an arc sequence over the particle arc range, optimizing fluence of the arc sequence for the radiotherapy treatment, and outputting the fluence optimized arc sequence for use in the radiotherapy treatment. The steps appear merely directed to the mental processes and mathematical concepts of an abstract idea for implementing a radiotherapy treatment plan capable of being implanted on a generic computer and are not incorporated into a practical application.
Step 2a Prong 2 - The recitation of the additional elements of a user device merely invokes such additional element(s) as a tool to perform the abstract idea. MPEP 2106.05(f). Further, the recitation of these additional element(s) in the claim generally links the use of the abstract idea to a particular technological environment or field of use, i.e., a computerized environment. MPEP 2106.05(h).
As such, under Prong 2 of Step 2A, when considered both individually and as a whole, the limitations of claims 1, 14, 26, and 28 are not indicative of integration into a practical application (Prong 2, Step 2A: NO). MPEP 2106.04(d)
With respect to claims 1, 14 ,26, and 28, There do not appear to be any additional elements provided and the abstract idea is not integrated into a practical application of utilizing any system components and performing the radiotherapy treatment plan in accordance with the optimized fluence arc sequence using the algorithm set forth. Merely outputting the optimized arc sequence for use in radiotherapy treatment does not incorporate the abstract idea into a practical application.
As such, these additional elements do not integrate the abstract idea into a practical application and therefore the claim is directed to the judicial exception.
Step 2B - The lack of recitation of additional elements is acknowledged, as identified above with respect to Prong 2 of Step 2A. Merely outputting the optimized arc sequence for use in radiotherapy treatment does not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Even when considered as an ordered combination, outputting a sequence in claims 1, 14, 26, and 28 do not add anything that is not already present when they are considered individually. Therefore, under Step 2B, there are no meaningful limitations in claims 1, 14, 26, and 28 that transform the judicial exception into a patent eligible application such that the claim amounts to significantly more than the judicial exception itself (Step 2B: NO). MPEP 2106.05.
Accordingly, under the Subject Matter Eligibility test, claims 1, 14, 26, and 28 are ineligible.
Furthermore, the dependent claims, 2-13, 15-25, and 27 do not add significantly more to the
abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Regarding claims 2 and 15, The method of claim 1, wherein the spot selection is generated based on both of the temporal dose heterogeneity parameter and the spatial dose heterogeneity parameter. The limitation appears to merely further limit the abstract idea.
Regarding claims 3, 16 and 27, The method of claim 1, further comprising, optimizing a final spot trajectory of the fluence optimized arc sequence based on an improvement to delivery speed. The limitation appears to merely further limit the abstract idea. The limitation appears to merely further limit the abstract idea.
Regarding claims 4 and 17, The method of claim 1, wherein selection of the temporal dose heterogeneity parameter minimizes a number of shots within non-targeted tissue. The limitation appears to merely further limit the abstract idea.
Regarding claims 5 and 18, The method of claim 4, wherein the number of shots represent a number of paints from different scanning layers or spot groups delivered within a specified time period on the non-targeted tissue. The limitation appears to merely further limit the abstract idea.
Regarding claims 6 , The method of claim 5, wherein the number of paints delivered to the non-targeted tissue is minimized to zero or one. The limitation appears to merely further limit the abstract idea.
Regarding claims 7 ,20, and 21, The method of claim 5, wherein the spot groups include one or more of single spots, multiple spots within a single energy layer, single spots within multiple energy layers, or multiple spots within multiple energy layers. The limitation appears to merely further limit the abstract idea.
Regarding claim 8, The method of claim 7, wherein the number of shots represent a number of paints from different scanning layers or spot groups delivered within a specified time period on the non-targeted tissue. The limitation appears to merely further limit the abstract idea.
Regarding claim 9, The method of claim 8, wherein the number of paints on the non-targeted tissue is limited to zero or one. The limitation appears to merely further limit the abstract idea.
Regarding claim 10, The method of claim 1, wherein selection of the spatial dose heterogeneity parameter maximizes a dose difference within a non-targeted tissue neighborhood. The limitation appears to merely further limit the abstract idea.
Regarding claim 11, The method of claim 10, wherein the maximized dose difference is measured in a number of paints by different spot groups having a minimum spatial distance of high dose regions within the non-targeted tissue neighborhood. The limitation appears to merely further limit the abstract idea.
Regarding claim 12, The method of claim 11, wherein the number of paints delivered to the non-targeted tissue neighborhood is minimized to zero or one. The limitation appears to merely further limit the abstract idea.
Regarding claims 13 and 25, The method of claim 1, wherein the fluence optimized arc sequence is used in particle delivery via intensity modulated proton therapy (IMPT), a proton arc, or a proton arc with one-dimensional (1D)-only lateral scanning. The limitation appears to merely further limit the abstract idea.
Regarding claims 19 and 22-24, The method of claim 18, wherein minimizing the number of shots includes using a penalizing function, an additional objective, or a constraint. The limitation appears to merely further limit the abstract idea.
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) 1-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over TRANEUS et al.( US 20210038914) hereinafter TRANEUS et al. in view of L. De Marzi et al., Exploiting the full potential of proton therapy: An update on the specifics and innovations towards spatial or temporal optimization of dose delivery, Cancer/Radiothérapie 24 (2020) 691–698 hereinafter L. De Marzi et al.
TRANEUS et al. teaches a method of radiotherapy treatment planning for creating a plan for delivery of radiation to a patient in at least one particle-based arc is proposed. The delivery time for the plan is reduced by including a penalty in the objective function, designed to limit the number of energy layers and/or the number of energy layer changes. The lateral position of the Bragg peak can be controlled using electromagnets to deflect the focused beam. This allows for the delivery of highly localized doses at well-controlled positions in the patient. The dose delivered from a certain combination of kinetic energy, and lateral deflection of the beam is referred to as a spot. The number of particles delivered to a spot is commonly referred to as the spot weight. By providing spots in many different locations in a three-dimensional space, the target volume can be fully covered with the desired dose distribution. This procedure is called active scanning ion beam therapy, also known as pencil beam scanning. [0006] Proton arc therapy involves radiation in a sequence of a large number of beams from different angles, for example 10 or more, 50 or more, or 100 or more angles, each having a number of energy layers, for example up to 20 energy layers. The adjustment between each energy layer, and between each angle, takes time. The arc can be delivered either as multiple separate beams or through a continuous moving arc. In the latter case, the beams will serve as control points as we know it from photon arc therapy. Hereinafter, the terms beam, beam direction or beam angle could equally well be substituted by the term control point, if the arc is continuous. There is always a desire to reduce delivery time, while still maintaining a high quality plan which will ensure effective treatment of the patient. [0011] The invention relates to a method of radiotherapy treatment planning for creating a plan for delivery of at least one particle-based arc to a patient using an apparatus arranged to deliver radiation in the form of charged particles from a number of different directions comprising the steps of [0012] a. determining at least one arc trajectory including a set of beam angles [0013] b. determining a set of energy layers for each beam angle [0014] c. optimizing the plan using an optimization problem formulation designed to produce a suitable dose distribution, in such a way that the plan will use only subsets of beam angles and energy layers from the set of beam angles and the set of energy layers, respectively, wherein the optimization is subject to a penalty designed to limit the number of energy layers.
Regarding claims 1, 2, 10-14, and 25 - 28, TRANEUS et al. teaches defining a particle arc range for a radiotherapy treatment of a patient, generating a spot selection for an arc sequence over the particle arc range, including a trajectory for delivering the radiotherapy treatment, optimizing fluence of the arc sequence for the radiotherapy treatment and outputting the fluence optimized arc sequence for use in the radiotherapy treatment. Note paragraphs [0006] and [0011] discuss defining an arc or an arc portion as a subset of an angle of the arc. Paragraphs [0042] – [0048] set forth generating spot selections for the arc trajectory ([0036]-[0041], and optimizing the fluence is set forth in paragraph [0048]. It is noted that the terms "temporal/spatial dose heterogeneity parameters" are very broad, a standard provision of different doses to different tissue voxels implying spatial heterogeneity; fractionation or application of a pulsed beam implying temporal heterogeneity. TRANEUS et al. certainly, implies taking into consideration temporal dose heterogeneity parameter and a spatial dose heterogeneity parameter. [0068] To reduce the damage to surrounding tissue further, the described optimization method could be combined with an approach where the plan is set up of similar arcs delivered on different treatment fractions delivered on different days. The different arcs include different beam angles, so that the target is covered in the same way, but the way through the patient to the tumor is different for different fractions. [0047] If the arc comprises a large number of angles, this could be exploited in the setup of the initial spot pattern in each energy layer to increase the spot spacing, thus reducing the total number of spots, which will result in a lower surface dose. [0054] The objective functions and constraints in the optimization problem should be able to optimize on different quantities, most importantly dose and LET-related quantities, such as LET and dose-weighted LET, (The LET (Linear Energy Transfer) could more efficiently be focused inside the target using proton arcs than in normal IMPT, if considered in the optimization.)
TRANEUS et al. does not explicitly teach generating a spot selection for an arc sequence over the particle arc range, including a trajectory for delivering the radiotherapy treatment, based on a temporal dose heterogeneity parameter or a spatial dose heterogeneity parameter.
L. De Marzi et al. teaches spatiotemporal optimisation (based on flash, proton minibeam radiation therapy or hypofrac-tionated delivery methods) has been gaining some attention in proton therapy as a mean of improving(biological and physical) dose distribution. Note section 1, the introduction discusses spatial and temporal optimization and section 3, discuses Innovations in the temporal optimization of the dose. Hypofractionation and ultrahypofractionation (stereotacticbody radiation therapy) regimens allow for escalation of the bio-logically effective dose of radiation therapy and have successfully improved local control and overall survival in various tumors. Section 4 further discusses the spatial optimization of the dose.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to include in the system of TRANEUS et al. generating a spot selection for an arc sequence over the particle arc range, including a trajectory for delivering the radiotherapy treatment, based on a temporal dose heterogeneity parameter or a spatial dose heterogeneity parameter as is known to do and taught by L. De Marzi et al. as a means of improving (biological and physical) dose distribution, tumor coverage while sparing organs at risk.
Regarding claims 3, TRANEUS et al. teaches optimizing a final spot trajectory of the fluence optimized arc sequence based on an improvement to delivery speed. Note paragraph [0055].
Regarding claims 4, TRANEUS et al. teaches wherein selection of the temporal dose heterogeneity parameter minimizes a number of shots within non-targeted tissue. [0047] If the arc comprises a large number of angles, this could be exploited in the setup of the initial spot pattern in each energy layer to increase the spot spacing, thus reducing the total number of spots, which will result in a lower surface dose.
Regarding claims 5-9, TRANEUS et al. teaches wherein the number of shots represent a number of paints from different scanning layers or spot groups delivered within a specified time period on the non-targeted tissue. Note paragraphs [0006], [0011], [0040]-[0048].
Regarding claims 15-24 TRANEUS et al. teaches optimizing the fluence is based on both the applied temporal dose heterogeneity specific cost function and the applied spatial dose heterogeneity specific cost function and optimizing final spot trajectory of the fluence optimized arc sequence based on an improvement to delivery efficiency, wherein the applied temporal dose heterogeneity specific cost function minimizes a number of shots within non- targeted tissue, wherein the number of shots represent a high dose overlap from different scanning layers or spot groups delivered within a specified time period on the healthy tissue, wherein minimizing the number of shots includes using a penalizing function, an additional objective, or a constraint, and wherein the number of shots represent a high dose overlap from different scanning layers or spot groups delivered within a specified time period on the non-targeted tissue. Note paragraphs [0006], [0011], [0040]-[0048], [0017] The penalty may be expressed in terms of the number of energy layers. Minimizing the number of energy layers used reduces the plan delivery time because changing between different energy layers is time consuming. Alternatively, the penalty may be expressed in terms of the number of energy layer changes between adjacent angles. This will enable, for example, keeping the energy layer when changing beam angles, thus saving time. It is also possible to express the penalty in terms of both the number of energy layers and the number of energy layer changes. [0018] The penalty may be defined to act on the entire arc or on one or more sub-sets of the arc, each sub-set comprising one or more beams.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bzdusek(US 8663084) teaches treatment planner (102) generates fluence maps (140) indicative of a desired fluence distribution at various locations (304, 312) along a treatment arc (302). A converter (142) converts the fluence distributions (140) to treatment device settings (144). The settings (144) may include multiple segments. A segment distributor (146) distributes the settings to locations in the vicinity of their original positions.
ABEL et al.( US 20210101023) teaches information that describes a target inside a patient to be treated with radiation is accessed from computer system memory. An arrangement of spots inside the target is determined. Each the spots corresponds to a location inside the target where a respective beam of radiation is to be directed during radiation treatment of the patient. A dose rate for each of the beams is determined. The dose rate for each beam is a dose delivered in less than one second to a spot corresponding to that beam. For example, each beam can deliver at least four grays (GY) in less than one second, and may deliver as much as 20 Gy to 50 Gy or 100 Gy or more in less than one second. A radiation treatment plan, that includes the arrangement of the spots and the dose rate for each of the beams, is stored in computer system memory.
NORD et al.( CN 106039576) teaches system, apparatus, and method for selectively evaluate measured point for dosimetry verification of radiation therapy treatment. for the system, method and computer program product for dosimetry verification evaluation measurement point using different evaluation standard to provide radiation therapy treatment. Delivery prediction accuracy of the radiation dose during radiation therapy to successfully or not passed plays an important role to the target based on a predetermined treatment plan. inaccurate dosage delivery may cause radiation sufficient to cure or to nearby healthy tissue and organ at risk with risk organ (OAR) of excessive radiation. over-high radiation dose may cause serious damage tumor surrounding healthy tissue and adjacent organs, and the dose is too low may endanger the possibility of cure. Therefore, the delivered radiation dose to a relatively small error will seriously harm the patient. Therefore, the quality assurance tool and protocol are to be verified without compromising with the risk organs and healthy tissue under the condition that the predetermined radiation dose delivered to the target.
Lu et al.( US 11065476) teaches Systems, methods, and computer-readable storage media providing techniques for probing in-vivo beam ranges directly using therapeutic beams for particle therapy treatment are disclosed. In an embodiment, a configuration is determined for one or more probing spots, each spot corresponding to a planned location within an interior region of a tumor volume where a dose of radiation is to be delivered. At least one therapeutic beam is provided to the tumor volume, and one or more images may be captured to provide an indication of the range/depth of the probing spots. Providing the probing spots to the interior of the tumor volume reduces the risk that the dose is provided to sensitive tissue (e.g., because even if the dose is delivered to a location other than the planned location, the dose is likely to remain contained within the tumor volume).
ENGWALL et al.( EP 3421085) teaches a method for determining a treatment plan comprising a distribution of spots for use with ion beam therapy for providing the spots in a target volume. The method comprises the steps of: selecting energy layers to be used in the treatment plan; determining a number of spot sizes to use; generating, for each energy layer, one copy for each spot size to use and populating each copy with spots of the spot size for that copy; optimizing spots of all copies of all energy layers, by repeatedly varying a weight of at least a subset of the spots and calculating an effect on a performance measurement, wherein the performance measurement is calculated by combining a plurality of evaluation criteria, comprising a first criterion related to total treatment time and a second criterion related to a desired dose distribution.
Ding et al.( US 11623107) teaches a method of optimizing delivery of a particle beam at a target is disclosed. The particle beam is delivered from an output device at a plurality of control points. In implementations, the method comprises delivering a substantially continuous particle beam about the plurality of control points, iteratively adjusting a delivery time of the substantially continuous particle beam about the plurality of control points, and processing to undertake at least one of (i) pre-defining energy layers based on one or both of the control points and a control point sampling frequency, or (ii) sorting the energy layers.
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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