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
Applicant’s arguments, see Amendment/Remarks, filed 7/31/2026, with respect to the rejection of claims 1-3,6,7,10,11,15-16, and 19-20 under 35 USC 102 have been fully considered and are persuasive.
Claims 2-4,7-8,11-12,16-17 have been canceled. Therefore, the rejection of claims of 1,6,10,15, and 19-20 under 35 USC 102 has been withdrawn.
Claims 1, 5-6, 9-10, 13-15, and 18-20 remain pending.
Applicant's arguments filed 7/31/2026 with respect to the rejection of claims 1, 5-6, 9-10, 13-15, and 18-20 under 35 USC 101 have been fully considered but they are not persuasive.
Applicant argues on page 9 of the Remarks, “As described in paragraphs [0006]-[0008] of the instant application publication, for example, generating an optimal treatment plan is a time consuming, tedious, difficult, and complex process, especially in the field of intensity modulated radiation therapy where complex matrix manipulations are required for calculating and optimizing treatment plans. Generally, optimization is an iterative process during which the dose distribution within a patient is evaluated at each iteration until a satisfactory dose distribution is obtained. The evaluation of the dose distribution at each iteration is, however, a very slow process mainly due to the extent of the volume in which the dose distribution is being evaluated. And, although the volume has been reduced from the full patient volume to the treatment volume, the computation time is still very slow since the treatment volume can be much larger than the extent of the plan dose distribution volume.” And further argues that the instant invention solves this problem “by reducing the size of the volume for which dose calculation/evaluation is done to its minimum. As described in paragraphs [0001], and [0070]-[0075]..”.
The examiner respectfully disagrees this renders the currently amended claims statutory. The claims as amended still merely set forth a step of obtaining data and then a series of steps for performing calculations on the data and the added limitations serve to only further limit the abstract idea itself. Reducing the treatment volume by applying a bounding box to crop the treatment volume serves to merely limit the data set on which the abstract idea is performed. The computer and algorithm are still performing as expected and are not operating differently but are merely operating on a smaller set of data due to the established reduced volume. The abstract idea as claimed does not change the functioning or operation of the computer itself but only serve to arrive at an optimized does distribution by reducing the data set on which the computer and corresponding algorithm operates.
Applicant argues on page 10 of the Remarks, “ ..the combination of elements recited in the claims are not well-understood, routine, conventional activities in the field, as the steps of applying a corresponding field bounding box to crop the treatment volume, the cropping including defining the corresponding field bounding box to enclose the target volume and cropping the treatment volume at the intersection of the field bounding box with the body structure, is novel.”
The examiner respectfully disagrees this renders the currently amended claims statutory.
With respect to claims 1, 6 and 19, 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 or positively controlling the radiation therapy system to provide the radiation treatment to the patient based on the optimized treatment plan as set forth.
With respect to claims 10 and 15, the system merely sets forth additional elements including a processor and memory in claim 19 and a user interface and treatment planning module in claim 15 . These additional elements are all recited at an extremely high level of generality and
may be interpreted as generic computing devices used to implement the abstract idea. Per MPEP
2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract
idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in
the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As
such, these additional elements do not integrate the abstract idea into a practical application of utilizing any system components or positively controlling the radiation therapy system to provide the radiation treatment to the patient based on the optimized treatment plan as set forth.
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, 5-6, 9-10, 13-15, and 18-20 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, 6, 10,15, and 19, the claims recite the following limitation(s):
Claim 1: method for optimizing a treatment plan for delivering a radiation dose to a treatment volume within a patient from one or more radiation fields, comprising:
for each radiation field,
obtaining a reduced volume for which dose distribution is calculated;
calculating a dose distribution for each reduced dose calculation volume; and
calculating a dose distribution for the treatment plan by summing the
calculated dose distributions for each individual radiation field.
wherein obtaining a reduced volume for a radiation field includes applying a corresponding field bounding box to crop the treatment volume,
wherein the treatment volume is a body structure containing at least a target volume and an organ at risk, and
wherein the cropping includes defining the corresponding field bounding box to enclose the target volume and cropping the treatment volume at the intersection of the field bounding box with the body structure.
Claim 6: A method for optimizing a treatment plan for delivering a prescribed radiation dose to a predefined treatment volume within a patient using a radiation beam delivery system, the method comprising:
receiving information related to the prescribed radiation dose, the predefined
treatment volume, and a plurality of parameters associated with the radiation beam delivery system, the plurality of parameters including information regarding radiation beam fields; and
applying a treatment plan optimization algorithm to calculate dose distribution within the treatment volume based on the received information by:
reducing a dose calculation volume at each radiation field;
calculating a dose distribution for each reduced dose calculation volume; and
adding the dose distributions obtained for each of the reduced dose calculation volumes to obtain the dose distribution for the treatment plan,
wherein the treatment volume is a body structure containing at least a target volume, and
wherein the reducing of the dose calculation volume at each radiation field includes defining a field bounding box for each radiation field and cropping the treatment volume at an intersection of the bounding box with the body structure.
Claim 10: A system for developing a treatment plan for the delivery of a prescribed radiation dose to a treatment volume within a patient, comprising:
a processor; and
a memory coupled to the processor, the memory including instructions that
when executed by the processor cause the processor to:
receive information related to the prescribed radiation dose, the treatment volume, and a plurality of parameters associated with the radiation beam delivery system, the plurality of parameters including information regarding radiation beam fields;
develop a treatment plan optimization model based on the received information, the treatment plan optimization model being configured to find an optimal dose distribution within the treatment volume for each radiation beam field; and
generate an optimal treatment plan based on the treatment plan optimization model,
wherein the developing of the treatment plan optimization model includes restricting the treatment volume for which the dose distribution is determined at each iteration of the optimization algorithm,
wherein the restricting of the treatment volume includes cropping, for each radiation field, the treatment volume for which radiation dose is calculated, and
wherein the cropping includes defininq a bounding box for the treatment volume for each radiation field and cropping the treatment volume at an intersection of the respective bounding box with the treatment volume.
Claim 15: A treatment planning system, comprising:
a user interface; and
a treatment planning module configured to generate a treatment plan for delivering a prescribed radiation dose to a treatment volume within a patient from one or more radiation fields based on prescribed clinical goals received via the user
interface, wherein the treatment planning module optimizes the treatment plan by:
calculating dose distribution within the treatment volume at each iteration of the optimization process;
determining whether the calculated dose distribution is within an
acceptable threshold of the desired dose distribution;
modifying one or more treatment parameters and repeating the optimization process until a predetermined endpoint is reached, wherein the calculating of the dose distribution includes:
determining dose distribution individually for each field; and summing the dose distributions obtained for each individual field, and wherein the determining dose distribution individually for each field includes:
cropping the treatment volume to a minimum volume; and
calculating the dose distribution for the corresponding minimum volume,
wherein the cropping of the treatment volume includes applying a corresponding field bounding box, and
wherein the cropping includes cropping the treatment volume at an intersection of the field bounding box with the treatment volume.
Claim 19: A non-transitory computer-readable storage medium having treatment planning software stored thereon, the treatment planning software including software for optimizing a treatment plan for irradiating a treatment volume using a radiation therapy system, the treatment planning software comprising:
instructions for causing the radiation system to define a field bounding box for
each dose field of the treatment plan;
instructions for causing the radiation system to reduce a dose calculation volume associated with each individual dose field using the correspondingly defined field bounding box;
instructions for causing the radiation system to calculate dose distributions for each of the reduced calculation volumes; and
instructions for causing the radiation system to sum the individual dose distributions to obtain the dose distribution for the treatment plan,
wherein the reducing of the dose calculation volume includes cropping the treatment volume at an intersection of the field bounding box with the treatment volume for each individual dose field.
Step 1- Claims 1, 6, 10,15, and 19 are directed to a method, a system, and software for optimizing a treatment plan for delivering a radiation dose to a treatment volume within a patient.
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)(III), in that they recite a series of mathematical calculations and mental steps which
produce an optimized radiation dose 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 merely sets forth a step of obtaining data and then a series of steps for performing calculations on the data and subsequently reducing the data set or target volume:
(represents insignificant data gathering)
calculating a dose distribution for each reduced dose calculation volume; and
calculating a dose distribution for the treatment plan by summing the
calculated dose distributions,
wherein obtaining a reduced volume for a radiation field includes applying a corresponding field bounding box to crop the treatment volume,
wherein the treatment volume is a body structure containing at least a target volume and an organ at risk, and
wherein the cropping includes defining the corresponding field bounding box to enclose the target volume and cropping the treatment volume at the intersection of the field bounding box with the body structure.
With respect to claim 6, the method merely sets forth a step of receiving data and then a series of steps for applying an algorithm and performing calculations on the data:
(represents insignificant data gathering)
applying a treatment plan optimization algorithm to calculate dose distribution within the treatment volume based on the received information by:
reducing a dose calculation volume at each radiation field;
calculating a dose distribution for each reduced dose calculation volume; and
adding the dose distributions obtained for each of the reduced dose calculation volumes to obtain the dose distribution for the treatment plan.
wherein the treatment volume is a body structure containing at least a target volume, and
wherein the reducing of the dose calculation volume at each radiation field includes defining a field bounding box for each radiation field and cropping the treatment volume at an intersection of the bounding box with the body structure.
With respect to claim 10, the system claim merely adds a processor and memory for which the Mathematical concepts and mental processes of optimizing a treatment plan for delivering a radiation dose to a reduced treatment volume within a patient are implemented.
( generic computing elements to implement the abstract idea)
( generic computing elements to implement the abstract idea)
when executed by the processor cause the processor to:
receive information related to the prescribed radiation dose, the treatment volume, and a plurality of parameters associated;
develop a treatment plan optimization model based on the received information; and
generate an optimal treatment plan based on the treatment plan optimization model,
wherein the developing of the treatment plan optimization model includes restricting the treatment volume for which the dose distribution is determined at each iteration of the optimization algorithm,
wherein the restricting of the treatment volume includes cropping, for each radiation field, the treatment volume for which radiation dose is calculated, and
wherein the cropping includes defining a bounding box for the treatment volume for each radiation field and cropping the treatment volume at an intersection of the respective bounding box with the treatment volume.
With respect to claim 15, the system claim merely adds a user interface and a treatment module/processor for which the Mathematical concepts and mental processes of optimizing a treatment plan for delivering a radiation dose to a reduced treatment volume within a patient are implemented.
( generic computing elements to implement the abstract idea)
- (generic computing elements to implement the abstract idea)
wherein the treatment planning module optimizes the treatment plan by:
calculating dose distribution within the treatment volume at each iteration of the optimization process;
determining whether the calculated dose distribution is within an acceptable threshold of the desired dose distribution;
modifying one or more treatment parameters and repeating the optimization process
wherein the calculating of the dose distribution includes:
determining dose distribution individually for each field; and
summing the dose distributions obtained for each individual field, and wherein the determining dose distribution individually for each field includes:
cropping the treatment volume to a minimum volume; and
calculating the dose distribution for the corresponding minimum volume,
wherein the cropping of the treatment volume includes applying a corresponding field bounding box, and
wherein the cropping includes cropping the treatment volume at an intersection of the field bounding box with the treatment volume.
With respect to claim 19, merely sets forth software to implement the Mathematical concepts and mental processes of optimizing a treatment plan for delivering a radiation dose to a treatment volume within a patient are implemented including:
instructions for causing the radiation system to define a field bounding box for
each dose field of the treatment plan;
instructions for causing the radiation system to reduce a dose calculation volume associated with each individual dose field using the correspondingly defined field bounding box;
instructions for causing the radiation system to calculate dose distributions for each of the reduced calculation volumes; and
instructions for causing the radiation system to sum the individual dose distributions to obtain the dose distribution for the treatment plan,
wherein the reducing of the dose calculation volume includes cropping the treatment volume at an intersection of the field bounding box with the treatment volume for each individual dose field.
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, 6, 10,15, and 19 are not indicative of integration into a practical application (Prong 2, Step 2A: NO). MPEP 2106.04(d)
With respect to claims 1, 6 and 19, 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 or positively controlling the radiation therapy system to provide the radiation treatment to the patient based on the optimized treatment plan as set forth.
With respect to claims 10 and 15, the system merely sets forth additional elements including a processor and memory in claim 19 and a user interface and treatment planning module in claim 15 . These additional elements are all recited at an extremely high level of generality and
may be interpreted as generic computing devices used to implement the abstract idea. Per MPEP
2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract
idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in
the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As
such, these additional elements do not integrate the abstract idea into a practical application of utilizing any system components or positively controlling the radiation therapy system to provide the radiation treatment to the patient based on the optimized treatment plan as set forth.
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 recitation of the additional elements is acknowledged, as identified above with respect to Prong 2 of Step 2A. These additional elements do 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, the additional elements of claims 1, 6, 10,15, and 19 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, 6, 10,15, and 19 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, 6, 10,15, and 19 are ineligible.
Regarding claims 5, 9,13, and 18 the claims merely set forth further calculations for determining the absorbed dose of radiation and do not add significantly more to the abstract idea.
Regarding claim 14 the claim merely sets forth calculating dose distribution for the treatment volume by summing dose distributions obtained for each of the cropped treatment volumes and does not add significantly more to the abstract idea.
Regarding claim 20 the claim merely sets optimizing by iteratively performing the steps until a predetermined endpoint is reached and does not add significantly more to the abstract idea.
Thus, the dependent claims 5,9,13,14,18, and 20 do not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
SJÖLUND et al.( US 20180311509) teaches methods for treatment planning for a radiation therapy system. The method includes setting a number of objectives reflecting clinical criteria are set for the regions of interest and generating radiation dose profiles to be delivered to these regions of interest. A convex optimization function for optimizing the delivered radiation based on the objectives is provided and dose profiles for specific treatment configurations including beam shape settings for the radiation dose profiles are calculated using the convex optimization function. Treatment plans including determining the radiation dose profiles to be delivered during treatment based on the treatment configurations are created and an optimal treatment plan that satisfies the clinical criteria is selected.
NAZARETH(WO 2022032209) teaches volumetric modulated arc therapy (VMAT) treatment plan may be optimized by obtaining a VMAT treatment plan and calculating a radiation dose matrix corresponding to each a plurality of beamlets, wherein each beamlet represents a change in field when an MLC leaf is moved a predetermined unit distance. The method includes defining an enhanced objective function (EOF) for achieving one or more clinical objectives and minimizing the EOF for proposed leaf positions iterating through each leaf of at least a subset of the leaves of the VMAT treatment plan (wherein the proposed leaf positions move each leaf into the field or out of the field by the predetermined unit distance and correspond to the addition or subtraction of the corresponding radiation dose matrix). The set of leaf positions of the VMAT treatment plan is updated according to the proposed leaf positions of the minimized EOF.
SIOCHI(EP 904805) teaches specifying a prescription dose volume histogram. A fixed number of fields are defined on the body. An initial setting of a multi-leaf collimator and a radiation field intensity for each field are selected. The dose volume histogram corresponding to the openings is calculated, the histograms are compared and radiation is delivered if the calculated and prescription dose volume histograms are sufficiently close.
THIS ACTION IS MADE FINAL. 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.
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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