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 .
This communication is in response to the amendment received on 12/01/2025. Claims 1-15 remain pending in this application.
The objection to claim 2 has been withdrawn in light of the amendment made to this claim.
The 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph rejection of claims 14 and 15 has been withdrawn in light of the amendments made to these claims.
The 35 U.S.C. 101 rejection for claim 14 for claim being directed to a non-statutory subject matter (the computer program product is non-transitory) has been withdrawn in light of the amendment made to this claim.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-13 are drawn to a method which is within the four statutory categories (i.e. process). Claim 14 is drawn to a non-transitory medium which is within the four statutory categories (i.e. manufacture). Claim 15 is drawn to a system which is within the four statutory categories (i.e. machine).
Step 2A, Prong 1:
Claim 1 has been amended to recite “obtaining an optimization problem including an objective function related to the combined therapeutic effect of the mulItimodality treatment and at least one constraint based on a biological or physical model; defining at least a first and a second scenario related to a first uncertainty in a parameter associated with the mulItimodality treatment, wherein the uncertainty comprises inter-modality interplay or spatial displacement of a treatment target;…; and generating a treatment plan comprising machine delivery parameters for delivering one of the treatment modalities to a patient”.
These limitations correspond to an abstract idea of “certain methods of organizing human activity”. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic computer system including a processor and a memory does not take the claim out of the methods of organizing human interactions grouping. Thus, the claim recites an abstract idea.
The limitation of “performing robust optimization of the at least one machine delivery parameter using a simplified machine model for treatment delivery system to optimize the objective function over the set of scenarios” correspond to mathematical relationships, therefore the limitation falls within the “mathematical concept” grouping of abstract ideas.
Claims 2-13 are ultimately dependent from claim 1 and include all the limitations of claim 1. Therefore, claims 2-13 recite the same abstract idea. Claims 2-13 describe a further limitation regarding the basis for defining and performing robust optimization for multimodality treatments. These are all just further describing the abstract idea recited in claim 1, without adding significantly more.
Claims 14 and 15 are rejected for the same reason given for claim 1.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “treatment delivery system”, “a processor” “a memory”, “memory comprising instructions that when executed by the processor cause the method to be performed”, using processor to perform the functions of obtaining, defining, performing and generating , which corresponds to hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the claim steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Von Busch et al. (hereinafter Von Busch) (US 2010/0185133 A1).
Claim 1 has been amended to recite a computer-based method of planning a multimodality treatment including a first treatment plan of a first treatment modality and a second treatment plan of a second treatment modality, comprising:
obtaining an optimization problem including an objective function related to the combined therapeutic effect of the mulItimodality treatment and at least one constraint based on a biological or physical models (Von Busch discloses “…a second or additional treatment modality does not find the object in its original (i.e., in its untreated) state. In some cases, for example, an initial damage or sensitization to a second treatment modality is induced by the first treatment modality. Hence, optimizing each treatment in isolation is likely to produce a Sub-optimal result” in [0005], “A treatment modality filter 108 may be used to filter or otherwise constrain the treatment modalities included in the treatment protocol 110. In one implementation, the filter 108 constrains the treatment modalities initially considered by the treatment modeler to a subset of the treatment space 104, for example so that only a single or other limited number of treatment modalities is considered…” in [0027]);
defining at least a first and a second scenario related to a first uncertainty in a parameter associated with the mulItimodality treatment, wherein the uncertainty comprises inter-modality interplay or spatial displacement of a treatment target (Von Busch discloses “…The method includes modeling a treatment effect of a first treatment modality, a side effect of the first treatment modality, and an interaction between the first treatment modality and a second treatment modality. The method also includes using a result of the modeling to generate a treatment protocol for application to an object.” in [0008] and “In the case of radiation oncology, for example, the treatment effect function 202 may include a TCP, the side effect function 204 may include an NTCP, and the treatment parameter p, may include an applied dose. In other example, the treatment effect function 202 may include a dose applied to a target, the side effect function 204 may include a dose applied to a non-target portion of the object, and the treatment parameter p, may include one or more parameters related to the application of a spatially varying radiation or other applied energy. While only a single treatment parameter p, is depicted in FIG. 2 for clarity of illustration, it will be under stood that additional treatment parameters p, (e.g., dose rate and/or application interval) may also be modeled. Boundary conditions 119 for the treatment parameter p, (e.g., minimum and maximum applied doses) are depicted at 206 and 208, respectively.” in [0032]);
performing robust optimization of the at least one machine delivery parameter using a simplified machine model for a treatment delivery system to optimize the objective function over the set of scenarios (Von Busch discloses “The treatment modeler 102 employs the treatment models 112, in conjunction with a suitable optimization function 126, to seek a treatment protocol 110 that optimally or otherwise satisfies the goal states 106, taking into account an interaction between treatment modalities in the treatment space 104.” in [0024]) and
generating a treatment plan comprising machine delivery parameters for delivering one of the treatment modalities to a patient (Von Busch discloses “An operation of treatment planning system…A treatment effect is modeled at 602, for example by using a suitable mathematical model to predict the effects of a treatment protocol that includes one or more treatment modalities. Where the modeled treatment protocol employs a plurality of treatment modalities, a combined treatment effect of the various treatment modalities may be calculated, taking into account an interaction between two or more of the treatment modalities.” in [0078]-[0079]).
Claim 2 has been amended to recite the method of claim 1, wherein the multimodality treatment includes treatment plans for two or more of the following treatment modalities:- radiotherapy - chemotherapy - surgery - hyperthermia - immunotherapy - cryotherapy - hormonotherapy (Von Busch discloses “…treatment modalities have included Surgery, chemo therapy, external radiotherapy (ERT), internal radiotherapy (IRT) such as brachytherapy, and radioimmunotherapy (RIT)…” in [0002] and “The treatment modeler models an interaction between first and second treatment modalities of the treatment space.” in [0007]).
Claim 3 recites the method of claim 1, wherein the at least one parameter includes a parameter related to the predicted combined effect of the first and the second treatment plan (Von Busch discloses “…the modeler uses a result of the modeling to generate a treatment protocol 110 that includes one or more modality treatment plans 128. The treatment plans 128 describe the treatment parameters 130 of the treatment modality or modalities to be applied…” in [0025]).
Claim 4 recites the method of claim 1, wherein parameters includes one or more of the following:- the spatial position of the treatment volume during the treatment, - change of the spatial position of the treatment volume between the treatment modalities, - the delivered quantities over the course of the treatment, - any parameter affecting the treatment (e.g. heat transfer uncertainty of the hyperthermia treatment due to blood perfusion, tissue thermal and dielectric properties, the delivered specific absorption rate (SAR) distribution), - the combined effect of the different modalities, - density of treated tissue, - interplay effects of the various modalities, - range uncertainty, - organ movement and/or biological model parameter values (Von Busch; [0032], [0039], [0063]-[0070]).
Claim 5 recites the method of claim 1, wherein the first treatment plan has already been determined and the robust optimization involves optimizing the optimization function value for the second treatment plan accounting for the pre-existing first plan (Von Busch; [0021], [0031]).
Claim 6 recites the method of claim 1, wherein the robust optimization includes co-optimizing the first and the second plan by calculating the optimization function value accounting for the combined effect of the first and the second plan (Von Busch; [0021], [0031]).
Claim 7 recites the method of claim 1, wherein the first treatment plan is a chemotherapy treatment plan, a surgery treatment plan or a hyperthermia treatment plan and the second treatment plan is a radiotherapy treatment plan (Von Busch; [0002], [0005]).
Claim 8 recites the method of claim 1, wherein the first treatment plan is a radiotherapy treatment plan and the second treatment plan is a surgery treatment plan, a chemotherapy treatment plan or a hyperthermia treatment plan (Von Busch; [0002], [0005]).
Claim 9 recites the method of claim 1, wherein the multimodality treatment plan further includes one or more additional treatment plans (Von Busch; [0002], [0005]).
Claim 10 recites the method of claim 1, wherein the optimization problem comprises constraints which define parameters that are maintained during optimization (Von Busch; [0027]).
Claim 11 recites the method of claim 1, wherein the optimization problem comprises a biological or a physical objective (Von Busch; [0022]).
Claim 12 recites the method of claim 1, wherein the optimization problem is defined to optimize machine parameters of at least one delivery system arranged to deliver one of the treatment plans (Von Busch; [0024]).
Claim 13 recites the method of claim 1, wherein the optimization problem includes a simplified machine model for the delivery system (Von Busch; [0024]).
As per amended claim 14, it is an article of manufacture claim which repeats the same limitations of claim 1, the corresponding method claim, as a collection of executable instructions stored on machine readable media as opposed to a series of process steps. Since the teachings of Von Busch disclose the underlying process steps that constitute the method of claim 1, it is respectfully submitted that they likewise disclose the executable instructions that perform the steps as well. As such, the limitations of claim 14, are rejected for the same reasons given above for claim 1.
As per amended claim 15, it is a system claim which repeats the same limitations of claim 1, the corresponding method claim, as a collection of elements as opposed to a series of process steps. Since the teachings of Von Busch disclose the underlying process steps that constitute the method of claim 1, it is respectfully submitted that they provide the underlying structural elements that perform the steps as well. As such, the limitations of claim 15 are rejected for the same reasons given above for claim 1.
Response to Arguments
Applicant's arguments filed 12/01/2025 have been fully considered. Applicant’s arguments will be addressed below in the order in which they appear.
Arguments about 35 USC 101 rejection:
Argument 1: Applicant argues that claim limitations integrate the abstract idea into a practical application, since claim 1 recites robust optimization of machine delivery parameters, which corresponds to treatment equipment and generated machine parameters for treatment delivery.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., delivering medical treatment) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Examiner submits that claim limitation recites “generating a treatment plan comprising machine delivery parameters for delivering one of the treatment modalities to a patient”, which does not recite delivering treatment to the patient, but generating a plan comprising delivery parameters. Also, the recitation of “delivering treatment modalities” correspond to insignificant application (see MPEP§ 2106.05(g)), since the treatment modalities are recited in the claims are: two or more of radiotherapy, chemotherapy, surgery, hyperthermia, immunotherapy, cryotherapy, hormonotherapy.
Argument 2: Applicant argues that the claimed robust optimization with biological/physical constraints to generate actual treatment parameters improves the accuracy, safety, and efficiency of therapy delivery systems.
In response, Examiner submits that determining optimal treatment parameters may improve the outcome of generating treatment plans, however, determining optimal treatment parameters would no improve the technology. More particularly, the claims do not recite: (i) an improvement to the functionality of a computer or other technology or technical field (see MPEP § 2106.05(a)); (ii) a “particular machine” to apply or use the judicial exception (see MPEP § 2106.05(b)); (iii) a particular transformation of an article to a different thing or state (see MPEP § 2106.05(c)); or (iv) any other meaningful limitation (see MPEP § 2106.05(e)).
Arguments about 35 USC 102 rejection:
Applicant argues that Von Busch does not teach performing optimization over a set of defined scenarios representing treatment uncertainties, scenario based modeling of uncertainty and its use within the optimization process, machine-specific parameters using a delivery system model, and generating a treatment plan comprising machine delivery parameters.
In response, Examiner submits that Von Busch teaches “…The method includes modeling a treatment effect of a first treatment modality, a side effect of the first treatment modality, and an interaction between the first treatment modality and a second treatment modality. The method also includes using a result of the modeling to generate a treatment protocol for application to an object.” in [0008] and “In the case of radiation oncology, for example, the treatment effect function 202 may include a TCP, the side effect function 204 may include an NTCP, and the treatment parameter p, may include an applied dose. In other example, the treatment effect function 202 may include a dose applied to a target, the side effect function 204 may include a dose applied to a non-target portion of the object, and the treatment parameter p, may include one or more parameters related to the application of a spatially varying radiation or other applied energy. While only a single treatment parameter p, is depicted in FIG. 2 for clarity of illustration, it will be under stood that additional treatment parameters p, (e.g., dose rate and/or application interval) may also be modeled. Boundary conditions 119 for the treatment parameter p, (e.g., minimum and maximum applied doses) are depicted at 206 and 208, respectively.” in [0032]). Von Busch also discloses “An operation of treatment planning system…A treatment effect is modeled at 602, for example by using a suitable mathematical model to predict the effects of a treatment protocol that includes one or more treatment modalities. Where the modeled treatment protocol employs a plurality of treatment modalities, a combined treatment effect of the various treatment modalities may be calculated, taking into account an interaction between two or more of the treatment modalities.” in [0078]-[0079].
Therefore, the arguments are not persuasive.
Conclusion
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 DILEK B COBANOGLU whose telephone number is (571)272-8295. The examiner can normally be reached 8:30-5:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Obeid Mamon can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687