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 .
Response to Arguments
Rejections under 35 USC 101
Applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive. Claims 1-3, 5-15 and 17-20 do not merely involve a mathematical concept but recite a mathematical concept. All of the limitations of the independent claim are directed to retrieving data and performing calculations using the data to modify a model for a radiation therapy system, which is itself an abstract idea (a model is an abstract idea). There is no practical application that brings the invention of these claims to significantly more than an abstract idea. Linking the use of this mathematical concept to the particular technological environment (such as radiation therapy) and insignificant extra-solution activity (acquiring data) do not qualify as significantly more. Examples of practically applying the calculation to achieve significantly more include claims 21 and 22 of the instant application, which recite (claim 21), “revising, by the processor, one or more settings of the MLC of the radiation therapy system based on the adjusted does determination source model.” These claims elevate the invention to beyond a mere calculation because the calculation is being used to impose an adjustment to the MLC of the radiation therapy system. It is recommended to incorporate the limitations of claims 21/22 into the independent claims to overcome the rejection under 35 USC 101.
Rejections under 35 USC 112(b)
In view of the amendments to claims 2-3 and 12-13, the rejections under 35 USC 112(b) have been withdrawn.
Rejections under 35 USC 112(a)
Applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive. As discussed in the interview 12/18/2025 and further elaborate here, the amendments do not overcome the written description rejection under 35 USC 112(a) because the disclosure is void of an algorithm, flow chart, prose, as to how “determining…a plurality of attenuation lengths…based upon the dose determination source model…” is accomplished. Although the disclosure as indicated in the Remarks points to the specification and figures as giving details as to what the determination is based on, the disclosure does not adequately explain how it is based on these items. There is no written description to explain how one of ordinary skill in the art could take these items that the determination/calculation is based on and use them to obtain the end result (the plurality of attenuation lengths). This is required to meet the written description requirement of 35 USC 112(a).
Rejections under 35 USC 102 and 103
Applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive. Earl modifies Ikonen to teach “responsive to retrieving the photon energy spectrum data and beam angle distribution data, adjusting, by the processor, one or more parameters of the dose determination source model based on the photon energy spectrum data, the beam angle distribution data, and the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation,” as recited in amended claim 1. See the rejection detailed below.
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 therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites
a method comprising: receiving, by a processor, a dose determination source model of a radiation therapy system including three-dimensional (3D) geometry data… determining, by the processor, a plurality of attenuation lengths (based upon the model including the data)…retrieving, by the processor, photon energy spectrum data and beam angle distribution data…and adjusting, by the processor, one or more parameters of the dose determination source model (base on the data and determined attenuation lengths)…
is an abstract idea, particularly a mathematical concept (prong 2A YES, see MPEP 2106 III.). Claims 2-13 which depend on claim 1 only function to further limit the abstract idea (prong 2A YES for each of these claims). This judicial exception is not integrated into a practical application because claims 1-13 do not recite additional elements that amount to significantly more than the judicial exception (prong 2B: NO). The claims are directed to a method that allows for retrieving and determining various data to adjust a model. The claims do not apply this calculation to a practical application and the claims do not amount to anything beyond this calculation. Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) teaches that the inventive concept “cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself” (see MPEP 2106.05 I).
Claim 1 appends the abstract idea with a processor, are mere instructions to implement an abstract idea using a processor (From claim 1, “receiving, by a processor…, determining, by a processor…, retrieving, by the processor…, adjusting, by the processor…”). Doing so does not amount to “significantly more”, as taught by point i. of MPEP 2106.05 I. A., ‘Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception’.
Claims 10 and 11 further limits the abstract idea (Mathematical calculation) by providing further details of the calculation.
Claims 2 (further limiting the beam of radiation and the attenuation lengths at leaf), 3 (further limiting the attenuation lengths at leaf) 9 (further limiting the beam of radiation), 12 (further limiting the attenuating material for the beam of radiation), and 13 (further limiting the attenuating material for the beam of radiation) links the use of this mathematical concept to the particular technological environment, however linking the use of a judicial exception to a particular field of use does not qualify as “significantly more”. See point ii. of MPEP 2106.05 I. A., ‘Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception’.
Claims 5 (further limiting the beam spectrum data that is retrieved), 6 (further limiting the beam spectrum data that is retrieved), 7 (further limiting the beam spectrum data that is retrieved), 8 (receiving data) and 9 (further limiting the data that is received, ) are insignificant extra-solution activity (mere data gathering), which does not qualify as “significantly more”. See point iii. of MPEP 2106.05 I. A., ‘Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception’.
Claims 14-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 14 recites
“A system comprising: a server comprising a processor and a non-transitory computer-readable medium containing instructions that when executed by the processor causes the processor to perform operations comprising: receive a dose determination source model of a radiation therapy system including three-dimensional (3D) geometry data…; determine a plurality of attenuation lengths of at least one leaf…based upon the dose determination source model including the 3D geometry data the MLC; retrieve photon energy spectrum data and beam angle distribution data…; and responsive to retrieving…the data…adjust one or more parameters of the dose determination source model….”
is an abstract idea, particularly a mathematical concept (prong 2A YES, see MPEP 2106 III.). Claims 15-20 which depend on claim 14 only function to further limit the abstract idea (prong 2A YES for each of these claims). This judicial exception is not integrated into a practical application because claims 14-20 do not recite additional elements that amount to significantly more than the judicial exception (prong 2B: NO). The claims are directed to a method that allows for retrieving and determining various data to adjust a model. The claims do not apply this calculation to a practical application and the claims do not amount to anything beyond this calculation. Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) teaches that the inventive concept “cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself” (see MPEP 2106.05 I).
Claim 14 appends the abstract idea with a server comprising a processor and a non-transitory computer-readable medium, are mere instructions to implement an abstract idea using a server. Doing so does not amount to “significantly more”, as taught by point i. of MPEP 2106.05 I. A., ‘Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception’.
Claims 20 further limits the abstract idea (Mathematical calculation) by providing further details of the calculation.
Claims 15 (further limiting the beam of radiation and the attenuation lengths at leaf) and 19 (further limiting the beam of radiation) link the use of this mathematical concept to the particular technological environment, however linking the use of a judicial exception to a particular field of use does not qualify as “significantly more”. See point ii. of MPEP 2106.05 I. A., ‘Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception’.
Claims 17 (further limiting the beam spectrum data that is retrieved), 18 (receiving data) and 19 (further limiting the data that is received, ) are insignificant extra-solution activity (mere data gathering), which does not qualify as “significantly more”. See point iii. of MPEP 2106.05 I. A., ‘Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception’.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2161.01 I. recites, “original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.”
Regarding claim 1 and claim 14:
Claim 1 recites “determining, by the processor, a plurality of attenuation lengths of at least one leaf of the MLC in attenuating the beam of radiation based upon the dose determination source model including the 3D geometry data for the MLC.” The disclosure merely recites similar language ([0009]-[0010], [0020], [0046], [0054], [0063], Step 404 of Fig. 4, ) without providing an algorithm as to HOW the plurality of attenuation lengths of at least one leaf of the MLC in attenuating the beam of radiation are determined based upon the dose determination source model including the 3D geometry data for the MLC. There is no algorithm or steps disclosed indicating how this determination is performed based on this information. Consequently, the limitation lacks written description.
Claim 1 recites “adjusting, by the processor, one or more parameters of the dose determination source model based on the photon energy spectrum data, the beam angle distribution data, and the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation.” The disclosure merely recites this similar language (see paragraphs [0005]-[0010], [0046], [0057]-[0058] and step 408 of Fig. 4) without providing an algorithm as to HOW the dose determination source model is adjusted based on the data and attenuation length(s). Consequently, the limitation lacks written description.
The rejections under 35 USC 112(a) and the evidence supporting the rejection recited above applies mutatis mutandis to claim 14, which teaches a similar limitation.
Regarding claim 10:
Claim 10 recites “wherein the adjusting step further comprises adjusting the dose determination source model based on the plurality of attenuation lengths of at least one leaf of the MLC and based on the data representing the input spectrum and the beam angle distribution for each respective beam segment of the beam of radiation.” The disclosure merely recites similar language (see paragraphs [0062], [0064], [0067], and step 504 of Fig. 5) without providing an algorithm as to HOW the dose determination source model is adjusted based on the beam spectrum data and based on the plurality of attenuation lengths. Consequently, the limitation lacks written description.
Claims 2-3, 5-13, and 21 are rejected by virtue of their dependence on claim 1.
Claims 15, 17-20, and 22 are rejected by virtue of their dependence on claim 14.
Claim 11 is rejected by virtue of its dependence on claim 10.
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.
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, 5, 7-10, 12-15, 18-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ikonen, et. al. (US 20200298018 A1), hereinafter Ikonen, in view of Earl, et. al. (US 20040071261 A1), hereinafter Earl.
Regarding claim 1, Ikonen teaches a method comprising:
receiving, by a processor (processor, [0009], [0026]), a dose determination source model of a radiation therapy system (treatment plan, [0026], [0040]) including three-dimensional (3D) geometry data for a multi-leaf collimator (MLC) ([0040] 3D geometry of the multileaf collimator is defined, Fig. 6 block 604), wherein leaves of the MLC are comprised of an attenuating material for a beam of radiation (beam-blocking leaves, [0040], [0041]);
determining, by the processor ([0009], [0026]), a plurality of attenuation lengths of at least one leaf of the MLC in attenuating the beam of radiation based upon the dose determination source model including the 3D geometry data for the MLC (dosimetric projection of the collimator involves calculating the dosimetric opacity/dosimetric thickness (attenuation length) along the beamline at the MLC leaf and is based on the 3D geometry [0041]-[0042], Fig. 6 block 606);
retrieving, by the processor ([0009], [0026]), photon energy spectrum data and beam angle distribution data for the beam of radiation (Fig. 6, block 606-608, Fig. 8, block 808-810, [0041]-[0042], and [0047]-[0048], [0050], particularly [0048] teaches that radiation source characteristics such as the primary particle type, energy spectrum, and radiation transport physics can be considered in obtaining the opacity) corresponding to the attenuating material for the beam of radiation ([0041] teaches the value of dosimetric opacity depends on the material the collimator is made of, the ‘thickness’ of the material along which the radiation passes, and the position of the collimator in relation to the beam center line, so therefore this information must be retrieved by the processor in order to complete steps 606-608); and
Ikonen does not teach responsive to retrieving the photon energy spectrum data and beam angle distribution data, adjusting, by the processor, one or more parameters of the dose determination source model based on the photon energy spectrum data, the beam angle distribution data, and the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation.
Earl teaches responsive to retrieving the photon energy spectrum data and beam angle distribution data ([0018]), adjusting (optimization method, Abstract, Fig. 1, [0040]-[0043]), by the processor ([0005]), one or more parameters of the dose determination source model (optimization variables of the radiation treatment plan including the positions of the MLC leaves used to shape each aperture, [0005], [0041]) based on the photon energy spectrum data, the beam angle distribution data, ([0018] number of beams, beam energies, and beam angles) and the MLC leaves in attenuating the beam of radiation ([0027], [0029] teaches MLC made of tungsten alloy where the position of the leaves of the MLC defines the aperture shape for a treatment, [0035], and [0040]-[0043] teaches optimizing the position of the MLC leaves to optimize the aperture shapes based on the treatment goals (desired dose).).
Earl does not explicitly teach adjusting based on the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation, however in order for the dose to be calculated in the optimization process, as in [0040], the effect of the MLC and its attenuation of the beam must inherently be taken into account. Additionally, this limitation would be considered obvious when combined with Ikonen. Ikonen teaches using the plurality of attenuation lengths at leaf of the MLC leaves in attenuating the beam of radiation (dosimetric projection of the collimator involves calculating the dosimetric opacity/dosimetric thickness (attenuation length) along the beamline at the MLC leaf and is based on the 3D geometry [0041]-[0042], Fig. 6 block 606) to calculate the dose that would result from such a geometry (see Fig. 6). The method shown in Fig. 6 of Ikonen could be utilized by the optimization process of Earl, particularly in the dose determination portion of step 66 in Fig. 1, to achieve the claimed method of “adjusting the dose determination source model based on… on the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation.”
Earl modifies Ikonen by suggesting an optimization method such that the dose determination model is adjusted based on data of the beam and based on the interaction of the beam with the MLC.
Since Earl and Ikonen are both directed to radiation therapy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl adjusting the parameters of the treatment plan allows for determining the optimal radiation treatment plan for a patient using specified clinical objectives, (Earl, [0005]).
Regarding claim 2, Ikonen teaches wherein each of the plurality of attenuation lengths of at least one leaf of the MLC in attenuating the beam of radiation is based on distance that the beam travels in leaf ([0041]).
Although Ikonen implies beam segments/beamlets (Figs. 1 and 1A show the beam split into multiple beam segments, as depicted by the arrows projecting from the electron beam 104) Ikonen does not explicitly teach wherein the beam of radiation includes a plurality of beam segments/beamlets.
Earl teaches wherein the beam of radiation includes a plurality of beam segments/beamlets ([0019]).
Earl modifies Ikonen by suggesting that the beam includes a plurality of beam segments. As a result, there would be a plurality of attenuation lengths (dosimetric thicknesses) of the at least one leaf of the MLC the beamlets based on the distance the beamlet travels in the leaf along the respective beam segment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl because dividing the beam into a grid of small beamlets allows calculation of dose distribution for each beamlet, (Earl, [0019]).
Regarding claim 3, Ikonen teaches wherein each of the plurality of attenuation lengths of at least one leaf of the MLC in attenuating the beam of radiation is based on distance that a beam travels in leaf ([0041]).
Although Ikonen implies beam segments/beamlets (Figs. 1 and 1A show the beam split into multiple beam segments, as depicted by the arrows projecting from the electron beam 104) Ikonen does not explicitly teach beam segments/beamlets.
Earl teaches beam segments/beamlets ([0019]).
Earl modifies Ikonen by suggesting that the beam includes a plurality of beam segments. As a result, there would be a plurality of attenuation lengths (dosimetric thicknesses) of at least one leaf of the MLC for the beamlets based on the distance the beamlet travels in the leaf along the respective beam segment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl because dividing the beam into a grid of small beamlets allows calculation of dose distribution for each beamlet, (Earl, [0019]).
Regarding claim 5, Ikonen teaches wherein the photon energy spectrum data comprise a look-ups data set for a plurality of attenuation length intervals of the attenuating material (pre-calculated look-up table, [0047]-[0048]).
Regarding claim 7, Ikonen teaches wherein the photon energy spectrum data comprise Monte Carlo simulated spectra ([0039]).
Regarding claim 8, Ikonen teaches further comprising receiving, by the processor ([0009], [0026]), data representing an input spectrum of the beam of radiation (characteristics of the radiation source can be provided as an initial spatial photon spectrum describing the fluence, energy, and directions in a beam reference plane, [0039], [0048]).
Regarding claim 9, Ikonen teaches wherein the data representing the input spectrum and the beam angle distribution of the beam of radiation includes data representing the input spectrum and beam angle distribution ([0039], [0048] teaches radiation source characteristics including fluence, energy, and directions).
Although Ikonen implies beam segments/beamlets (Figs. 1 and 1A show the beam split into multiple beam segments, as depicted by the arrows projecting from the electron beam 104) Ikonen does not explicitly teach wherein the beam of radiation includes a plurality of beam segments/beamlets.
Earl teaches wherein the beam of radiation includes a plurality of beam segments/beamlets ([0019]).
Earl modifies Ikonen by suggesting that the beam includes a plurality of beam segments. As a result, the data representing the input spectrum and beam angle distribution of the beam of radiation would include data representing the input spectrum and beam angle distribution for each respective beam segment of the beam of radiation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl because dividing the beam into a grid of small beamlets allows calculation of dose distribution for each beamlet, (Earl, [0019]).
Regarding claim 10, Ikonen teaches the plurality of attenuation lengths of at least one leaf of the MLC (dosimetric projection of the collimator involves calculating the dosimetric opacity/dosimetric thickness (attenuation length) along the beamline at the MLC leaf and is based on the 3D geometry [0041]-[0042], Fig. 6 block 606) and data representing the input spectrum and the beam angle distribution of the beam of radiation ([0039], [0048] teaches radiation source characteristics including fluence, energy, and directions).
Ikonen does not teach wherein the adjusting step further comprises adjusting the dose determination source model based on the plurality of attenuation lengths of at least one leaf of the MLC and based on the data representing the input spectrum and the beam angle distribution for each respective beam segment of the beam of radiation.
Earl teaches wherein the adjusting step further comprises adjusting (optimization method, Abstract, Fig. 1, [0040]-[0043]) the dose determination source model (optimization variables of the radiation treatment plan including the positions of the MLC leaves used to shape each aperture, [0005], [0041]) based on the MLC ([0027], [0029] teaches MLC made of tungsten alloy where the position of the leaves of the MLC defines the aperture shape for a treatment, [0035], and [0040]-[0043] teaches optimizing the position of the MLC leaves to optimize the aperture shapes based on the treatment goals (desired dose)) and based on the data representing the input spectrum and beam angle distribution ([0018] number of beams, beam energies, and beam angles) for each respective beam segment of the beam of radiation ([0019]).
Earl does not explicitly teach adjusting based on the plurality of attenuation lengths at leaf of the MLC, however in order for the dose to be calculated in the optimization process, as in [0040], the effect of the MLC and its attenuation of the beam must inherently be taken into account. Additionally, this limitation would be considered obvious when combined with Ikonen. Ikonen teaches using the plurality of attenutation lengths at leaf of the MLC (dosimetric projection of the collimator involves calculating the dosimetric opacity/dosimetric thickness (attenuation length) along the beamline at the MLC leaf and is based on the 3D geometry [0041]-[0042], Fig. 6 block 606) to calculate the dose that would result from such a geometry (see Fig. 6). The method shown in Fig. 6 of Ikonen could be utilized by the optimization process of Earl, particularly in the dose calculation portion of step 66 in Fig. 1, to achieve the claimed method of “adjusting the dose determination source model based on… the plurality of attenuation lengths of at least one leaf of the MLC.”
Earl modifies Ikonen by suggesting an optimization method such that the dose determination model is adjusted based on details of the beam and based on the interaction of the beam with the MLC for each beam segment of the beam of radiation.
Since Earl and Ikonen are both directed to radiation therapy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl because adjusting the parameters of the treatment plan allows for determining the optimal radiation treatment plan for a patient using specified clinical objectives, (Earl, [0005]) and because dividing the beam into a grid of small beamlets allows calculation of dose distribution for each beamlet, (Earl, [0019]).
Regarding claim 12, Ikonen teaches an attenuating material for the beam of radiation (beam-blocking leaves, [0027], dosimetric opacity depends on material of collimator, [0041]).
Ikonen does not explicitly teach wherein the attenuating material for the beam of radiation comprises an alloy material.
Earl teaches wherein the attenuating material for the beam of radiation comprises an alloy material ([0027] teaches tungsten alloy or other heavy materials.).
Earl modifies Ikonen by suggesting that the attenuating material comprises an alloy material such as tungsten alloy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl because the tungsten alloy ([0027]) of Earl is able to shape the beam, ([0025]).
Regarding claim 13, Ikonen does not teach wherein the alloy material comprises a tungsten alloy.
Earl teaches wherein the alloy material comprises a tungsten alloy.
Earl modifies Ikonen by suggesting that the alloy material is tungsten alloy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl because the tungsten alloy ([0027]) of Earl is able to shape the beam, ([0025]).
Regarding claim 14, Ikonen teaches a system comprising:
a server comprising a processor and a non-transitory computer-readable medium containing instructions that when executed by the processor causes the processor to perform operations ([0009], [0026], [0054]) comprising:
receive a dose determination source model of a radiation therapy system (treatment plan, [0026], [0040]) including three-dimensional (3D) geometry data for a multi-leaf collimator (MLC) ([0009], [0040] 3D geometry of the multileaf collimator is defined, Fig. 6 block 604), wherein leaves of the MLC are comprised of an attenuating material for a beam of radiation (beam-blocking leaves, [0040], [0041]);
determine a plurality of attenuation lengths of at least one leaf of the MLC in attenuating the beam of radiation based upon the dose determination source model including the 3D geometry data the MLC (dosimetric projection of the collimator involves calculating the dosimetric opacity/dosimetric thickness (attenuation length) along the beamline at the MLC leaf and is based on the 3D geometry [0041]-[0042], Fig. 6 block 606);
retrieve, photon energy spectrum data and beam angle distribution data for the beam of radiation (Fig. 6, block 606-608, Fig. 8, block 808-810, [0041]-[0042] ray-tracing, and [0047]-[0048], [0050], particularly [0048] teaches that radiation source characteristics such as the primary particle type, energy spectrum, and radiation transport physics can be considered in obtaining the opacity) corresponding to the attenuating material for the beam of radiation ([0041] teaches the value of dosimetric opacity depends on the material the collimator is made of, the ‘thickness’ of the material along which the radiation passes, and the position of the collimator in relation to the beam center line, so therefore this information must be retrieved by the processor in order to complete steps 606-608); and
Ikonen does not teach responsive to retrieving the photon energy spectrum data and beam angle distribution data, adjust one or more parameters of the dose determination source model based on the photon energy spectrum data, the beam angle distribution data, and the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation.
Earl teaches responsive to retrieving the photon energy spectrum data and beam angle distribution data ([0018]), adjust (optimization method, Abstract, Fig. 1, [0040]-[0043]) one or more parameters of the dose determination source model (optimization variables of the radiation treatment plan including the positions of the MLC leaves used to shape each aperture, [0005], [0041]) based on the photon energy spectrum data, the beam angle distribution data, ([0018] number of beams, beam energies, and beam angles) and the MLC leaves in attenuating the beam of radiation ([0027], [0029] teaches MLC made of tungsten alloy where the position of the leaves of the MLC defines the aperture shape for a treatment, [0035], and [0040]-[0043] teaches optimizing the position of the MLC leaves to optimize the aperture shapes based on the treatment goals (desired dose).).
Earl does not explicitly teach adjusting based on the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation, however in order for the dose to be calculated in the optimization process, as in [0040], the effect of the MLC and its attenuation of the beam must inherently be taken into account. Additionally, this limitation would be considered obvious when combined with Ikonen. Ikonen teaches using the plurality of attenuation lengths at leaf of the MLC leaves in attenuating the beam of radiation (dosimetric projection of the collimator involves calculating the dosimetric opacity/dosimetric thickness (attenuation length) along the beamline at the MLC leaf and is based on the 3D geometry [0041]-[0042], Fig. 6 block 606) to calculate the dose that would result from such a geometry (see Fig. 6). The method shown in Fig. 6 of Ikonen could be utilized by the optimization process of Earl, particularly in the dose calculation portion of step 66 in Fig. 1, to achieve the claimed method of “adjusting the dose determination source model based on… on the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation.”
Earl modifies Ikonen by suggesting an optimization method such that the dose determination model is adjusted based on details of the beam and based on the interaction of the beam with the MLC.
Since Earl and Ikonen are both directed to radiation therapy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl adjusting the parameters of the treatment plan allows for determining the optimal radiation treatment plan for a patient using specified clinical objectives, (Earl, [0005]).
Regarding claim 15, Ikonen teaches wherein each of the plurality of attenuation lengths of at least one leaf of the MLC in attenuating the beam of radiation is based on distance that the beam travels in leaf ([0041]).
Although Ikonen implies beam segments/beamlets (Figs. 1 and 1A show the beam split into multiple beam segments, as depicted by the arrows projecting from the electron beam 104) Ikonen does not explicitly teach wherein the beam of radiation includes a plurality of beam segments/beamlets.
Earl teaches wherein the beam of radiation includes a plurality of beam segments/beamlets ([0019]).
Earl modifies Ikonen by suggesting that the beam includes a plurality of beam segments. As a result, there would be a plurality of attenuation lengths (dosimetric thicknesses) at the leaf of the MLC for each beamlet based on the distance the beamlet travels in the leaf along the respective beam segment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl because dividing the beam into a grid of small beamlets allows calculation of dose distribution for each beamlet, (Earl, [0019]).
Regarding claim 18, Ikonan teaches wherein the instructions executed by the processor further cause the processor ([0009], [0026], [0054]) to receive data representing an input spectrum of the beam of radiation (characteristics of the radiation source can be provided as an initial spatial photon spectrum describing the fluence, energy, and directions in a beam reference plane, [0039], [0048]).
Regarding claim 19, Ikonen teaches wherein the data representing the input spectrum and the beam angle distribution data of the beam of radiation includes data representing the input spectrum and beam angle distribution ([0039], [0048] teaches radiation source characteristics including fluence, energy, and directions).
Although Ikonen implies beam segments/beamlets (Figs. 1 and 1A show the beam split into multiple beam segments, as depicted by the arrows projecting from the electron beam 104) Ikonen does not explicitly teach wherein the beam of radiation includes a plurality of beam segments/beamlets.
Earl teaches wherein the beam of radiation includes a plurality of beam segments/beamlets ([0019]).
Earl modifies Ikonen by suggesting that the beam includes a plurality of beam segments. As a result, the data representing the input spectrum and beam angle distribution of the beam of radiation would include data representing the input spectrum and beam angle distribution for each respective beam segment of the beam of radiation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl because dividing the beam into a grid of small beamlets allows calculation of dose distribution for each beamlet, (Earl, [0019]).
Regarding claim 21, Ikonen does not teach further comprising revising, by the processor, one or more settings of the MLC of the radiation therapy system based on the adjusted dose determination source model.
Earl teaches revising, by the processor, one or more settings of the MLC of the radiation therapy system based on the adjusted dose determination source model (optimization process, Fig. 1, steps 71-72, [0047]-[0048], [0005]).
Earl modifies Ikonen by suggesting revising the settings of the MLC based on the optimized dose model.
Since Earl and Ikonen are both directed to radiation therapy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl adjusting the parameters of the treatment plan allows for determining the optimal radiation treatment plan for a patient using specified clinical objectives, (Earl, [0005]).
Regarding claim 22, Ikonen does not teach wherein the instructions executed by the processor further cause the processor to revise one or more settings of the MLC of the radiation therapy system based on the adjusted dose determination source model.
Earl teaches wherein the instructions executed by the processor further cause the processor to revise one or more settings of the MLC of the radiation therapy system based on the adjusted dose determination source model (optimization process, Fig. 1, steps 71-72, [0047]-[0048], [0005]).
Earl modifies Ikonen by suggesting revising the settings of the MLC based on the optimized dose model.
Since Earl and Ikonen are both directed to radiation therapy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Earl adjusting the parameters of the treatment plan allows for determining the optimal radiation treatment plan for a patient using specified clinical objectives, (Earl, [0005]).
Claims 6, 11, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ikonen (US 20200298018 A1) in view of Earl (US 20040071261 A1), further in view of Fowler (Fowler, R., et. al. (2018). Beam Hardening Correction (CarouselFit). “Beamhardening.rst”. GitHub. https://github.com/vais-ral/CIL-Docs/blob/master/docs/beamhardening.rst#id5).
Regarding claim 6, Ikonen teaches photon energy spectrum data ([0039], [0041]-[0042], [0047]-[0048]).
Ikonen does not teach wherein the photon energy spectrum data exhibit beam hardening characteristics corresponding to the attenuating material for the beam of radiation.
Fowler teaches wherein the photon energy spectrum data exhibit beam hardening characteristics corresponding to the attenuating material for the beam of radiation (Abstract and Introduction, third paragraph).
Fowler modifies Ikonen by suggesting that the photon energy spectrum data includes a corrected attenutation that exhibits beam hardening characteristics corresponding to the material that the beam of radiation goes through.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Fowler because using a model to convert attenuation values into attenuation values that reflect beam hardening characteristics of the material allows one to remove beam hardening artifacts (Fowler, Introduction, paragraph 3).
Regarding claim 11, Ikonen teaches adjusting the dose determination source model (dose calculation for treatment plan [0051], Fig. 6 block 610).
Ikonen does not teach taking into account hardening of the input spectrum of the beam of radiation in interactions with the attenuating material.
Fowler teaches taking into account hardening of the input spectrum of the beam of radiation in interactions with the attenuating material (Abstract and Introduction, third paragraph).
Fowler modifies the combination by suggesting taking into account the hardening of the beam as it interacts with the attenuating material.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Fowler because using a model to convert attenuation values into attenuation values that reflect beam hardening characteristics of the material allows one to remove beam hardening artifacts (Fowler, Introduction, paragraph 3).
Regarding claim 17, Ikonen teaches wherein the photon energy spectrum data comprise a look-ups data set for a plurality of attenuation length intervals of the attenuating material (pre-calculated look-up table, [0047]-[0048]).
Ikonen does not teach wherein the photon energy spectrum data exhibit beam hardening characteristics corresponding to the attenuating material for the beam of radiation.
Fowler teaches wherein the photon energy spectrum data exhibit beam hardening characteristics corresponding to the attenuating material for the beam of radiation (Abstract and Introduction, third paragraph).
Fowler modifies the combination by suggesting that the pre-calculated photon energy spectrum data include a corrected attenuation that exhibits beam hardening characteristics corresponding to the material that the beam of radiation goes through.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Fowler because using a model to convert attenuation values into attenuation values that reflect beam hardening characteristics of the material allows one to remove beam hardening artifacts (Fowler, Introduction, paragraph 3).
Regarding claim 20, Ikonen in view of Earl teaches adjusting the dose determination source model (see rejection of claim 14 above).
Ikonen does not teach taking into account hardening of the input spectrum of the beam of radiation in interactions with the attenuating material.
Fowler teaches taking into account hardening of the input spectrum of the beam of radiation in interactions with the attenuating material (Abstract and Introduction, third paragraph).
Fowler modifies Ikonen by suggesting taking into account the hardening of the beam as it interacts with the attenuating material.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Fowler because using a model to convert attenuation values into attenuation values that reflect beam hardening characteristics of the material allows one to remove beam hardening artifacts (Fowler, Introduction, paragraph 3).
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.
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LAURA E TANDY
Examiner
Art Unit 2881
/DAVID E SMITH/Examiner, Art Unit 2881