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 .
Status of Claims
Claims 1-14 are currently pending in application 18/726,799.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/4/2024, 3/20/2026, and 8/26/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 3-5, 8, 10, and 11 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the expression "quantity representative of the beam delivery sequence". However, neither the claim nor the specification clearly specifies what particular parameter or measurable quantity represents the beam delivery sequence, which renders the claim unclear/ subjective, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 1 further recites "data related to the time-resolved measurement". The nature and type of this data are not clearly defined in the claim, and therefore it is unclear what specific data is being compared with the simulation.
Claim 3 recites obtaining simulated dose information and measured dose information and comparing the dose information including physical dose, RBE weighted dose, and FLASH dose. However, the Examiner is unclear how these dose parameters, particularly the RBE weighted dose and FLASH dose, are determined from the time-resolved simulation and measurement data. The description in the specification merely refers to these dose types without explaining the specific method or model used to calculate them.
Claim 4 states that the time-resolved measurement is obtained "based on a dry-run of the plan". However, the term "dry-run" is not clearly defined in the claim and the technical meaning of this feature remains uncertain.
Claim 5 recites that the time-resolved measurement is obtained "based on delivery of the treatment plan to a patient". However, the claim does not clearly define how the measurement is obtained or the means used to obtain such measurement.
Claim 8 recites obtaining delivered FLASH dose information from the time-resolved measurement and simulated FLASH dose information from the time-resolved simulation and comparing the two. However, the Examiner is unclear how the FLASH dose information is derived from the beam delivery sequence or the system model.
Claim 10 recites that the action includes adjusting the model of the system based on the result of the comparison. However, the Examiner is unclear which parameters of the system model are adjusted or how such adjustment is carried out in practice.
Claim 11 includes the feature "assessing the function of the delivery system". The claim does not specify what particular function of the delivery system is assessed or how such assessment is carried out.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13 and 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 can be infringed by mere possession of the computer program product without performing the steps of the method. Note the recitation of the method steps is part of a functional language recitation describing the capability of the performing of the method, not a recitation of actual execution resulting in active method steps. Since no active steps are recited, claims 1-12 drawn to the method, would not be infringed by the mere possession of the computer program product that would infringe claim 13. As a result, claim 13 is in improper dependent form.
Claim 14 can be infringed by mere possession of the computer system without performing the steps of the method. Note the recitation of the method steps is part of a functional language recitation describing the capability of instructions, not a recitation of actual execution resulting in active method steps. Since no active steps are recited, claims 1-12 drawn to the method, would not be infringed by the mere possession of the computer system that would infringe claim 14. As a result, claim 14 is in improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-14 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to non-statutory subject matter, specifically an abstract idea.
Claims 1-14 are directed to a judicial exception (i.e., abstract idea), without providing a practical application, and without providing significantly more.
Under the 35 U.S.C. §101 subject matter eligibility two-part analysis, Step 1 addresses whether the claim is directed to one of the four statutory categories of invention, i.e., process, machine, manufacture, or composition of matter. See MPEP §2106.03. If the claim does fall within one of the statutory categories, it must then be determined in Step 2A [prong 1] whether the claim is directed to a judicial exception (i.e., law of nature, natural phenomenon, and abstract idea). See MPEP §2106.04. If the claim is directed toward a judicial exception, it must then be determined in Step 2A [prong 2] whether the judicial exception is integrated into a practical application. See MPEP §2106.04(d). Finally, if the judicial exception is not integrated into a practical application, it must additionally be determined in Step 2B whether the claim recites "significantly more" than the abstract idea. See MPEP §2106.05.
Examiner note: The Office’s 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) is currently found in the Ninth Edition, Revision 10.2019 (revised June 2020) of the Manual of Patent Examination Procedure (MPEP), specifically incorporated in MPEP §2106.03 through MPEP §2106.07(c).
Regarding Step 1,
Claims 1-12 are directed toward a process (method). Claim 13 is directed toward a computer program product having computer-readable tangible storage media (article of manufacture). Claim 14 is directed toward an apparatus (system). Thus, all claims fall within one of the four statutory categories as required by Step 1.
Regarding Step 2A [prong 1],
Claims 1-14 are directed toward the judicial exception of an abstract idea. Independent claims 1, 13 and 14 are directed specifically to the abstract idea process management based on data analysis.
Regarding independent claims 1, 13 and 14, the underlined limitations emphasized below correspond to the abstract ideas of the claimed invention:
A computer-based method for use in a radiotherapy treatment delivery system arranged to deliver ion radiotherapy treatment according to a plan, the method comprising the steps of;
obtaining a time-resolved simulation of a quantity representative of the beam delivery sequence for delivery of the plan according to a model of the system,
obtaining a time-resolved measurement of the quantity representative of a beam delivery sequence for delivery of the plan related to the delivery of the treatment plan,
comparing data related to the time-resolved measurement to the time-resolved simulation, taking action in dependence of the result of the comparison, wherein the action includes determining whether to adapt the model, or the plan.
As the underlined claim limitations above demonstrate, independent claims 1, 13 and 14 are directed to the abstract idea of Mathematical concepts (mathematical relationships, mathematical formulas or equations, mathematical calculations); Mental processes (concepts performed in the human mind (including an observation, evaluation, judgment, or opinion) - The phrases "obtaining a simulation," "obtaining a measurement," "comparing data," and "determining whether to adapt" describe intellectual steps. A person can perform data comparison, evaluation, and decision-making in their mind or using generic pen and paper logic); and Certain methods of organizing human activity (commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations)).
Dependent claims 2-12 provide further details to the abstract idea of claims 1, 13 and 14 regarding the data received, therefore, these claims include mathematical concepts, mental processes, and certain methods of organizing human activities for similar reasons provided above for claims 1, 13 and 14.
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.
Regarding Step 2A [prong 2],
Claims 1-14 fail to integrate the recited judicial exception into any practical application. The claims recite additional limitations which are hardware or software elements or particular technological environment, such as a “computer”, a “system”, a “computer program product”, a “non-transitory storage medium”, a “processor”, and a “computer program product”. However, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these limitations are merely invoked as a tool to perform instruction of an abstract idea in a particular technological environment and/or are generally linking the use of the abstract idea to a particular technological environment or field of use, and merely applying and abstract idea in a particular technological environment and merely limiting use of an abstract idea to a particular field or a technological environment do not provide practical application for an abstract idea (MPEP 2106.05 (f) & (h)). The claims do not amount to "practical application" for the abstract idea because they neither (1) recite any improvements to another technology or technical field; (2) recite any improvements to the functioning of the computer itself; (3) apply the judicial exception with, or by use of, a particular machine; (4) effect a transformation or reduction of a particular article to a different state or thing; (5) provide other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
The relevant question under Step 2A [prong 2] is not whether the claimed invention itself is a practical application, instead, the question is whether the claimed invention includes additional elements beyond the judicial exception that integrate the judicial exception into a practical application by imposing a meaningful limit on the judicial exception. This is not the case with Applicant’s claimed invention. Automating the recited claimed features as a combination of computer instructions implemented by computer hardware and/or software elements as recited above does not qualify an otherwise unpatentable abstract idea as patent eligible. Examples where the Courts have found selecting a particular data source or type of data to be manipulated to be insignificant extra-solution activity include selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016); While the context involves a "beam delivery sequence" and a "treatment plan" (radiation therapy), the actual operations requested (comparing two data sets and deciding to change a model) are treated as generic data manipulation. The claim does not require a specific, unconventional physical transformation or a concrete improvement to the mechanics of the treatment machine itself; therefore, the abstract idea is not integrated into a practical application. Dependent claims 2-12 merely incorporate the additional elements recited above, along with further embellishments of the abstract idea of independent claims respectively, but these features only serve to further limit the abstract idea of independent claims. Therefore, the additional elements recited in the claimed invention individually, and in combination fail to integrate the recited judicial exception into any practical application.
Regarding Step 2B,
Claims 1-14 fail to amount to “significantly more” than an abstract idea. The claims recite additional limitations which are hardware or software elements or particular technological environment, such as a “computer”, a “system”, a “computer program product”, a “non-transitory storage medium”, a “processor”, and a “computer program product”. However, these limitations are not enough to qualify as “significantly more” being recited in the claims along with the abstract idea since these limitations are merely invoked as a tool to perform instruction of Abstract idea in a particular technological environment and/or are generally linking the use of the abstract idea to a particular technological environment or field of use, and merely applying and abstract idea in a particular technological environment and merely limiting use of an abstract idea to a particular field or a technological environment do not provide significantly more to an abstract idea (MPEP 2106.05(f) & (h)). The step of "determining whether to adapt the model" based on a comparison is a standard feedback loop. Without reciting how the measurement is physically captured in a novel way or how the model adaptation specifically modifies the physical operation of the delivery system, the claim does not provide significantly more than the basic abstract concept of comparing numbers. The claims do not amount to "significantly more" than the abstract idea because they neither (1) recite any improvements to another technology or technical field; (2) recite any improvements to the functioning of the computer itself; (3) apply the judicial exception with, or by use of, a particular machine; (4) effect a transformation or reduction of a particular article to a different state or thing; (5) add a specific limitation other than what is well-understood, routine and conventional in the field; (6) add unconventional steps that confine the claim to a particular useful application; nor (7) provide other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Dependent claims 2-12 merely recite further additional embellishments of the abstract idea of independent claims 1, 13 and 14 respectively, but these features only serve to further limit the abstract idea of independent claims 1, 13 and 14; however, none of the dependent claims recite an improvement to a technology or technical field or provide any meaningful limits. The addition of another abstract concept to the limitations of the claims does not render the claim other than abstract. Under the Interim Guidance on Patent Subject Matter Eligibility (PEG 2019), it specifically states that narrowing an abstract idea of claims do not resolve the claims of being "significantly more" than the abstract idea. Thus, the additional elements in the dependent claims only serve to further limit the abstract idea utilizing the computer components as a tool and/or generally link the use of the abstract idea to a particular technological environment.
Therefore, since there are no limitations in the claims 1-14 that transform the exception into a patent eligible application such that the claims amount to significantly more than the exception itself, and looking at the limitations as a combination and as an ordered combination adds nothing that is not already present when looking at the elements taken individually, claims 1-14 are rejected under 35 USC § 101 as being directed to non-statutory subject matter under 35 U.S.C. § 101.
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 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Owens et al. (US 2019/0054320 A1).
As per independent Claims 1, 13, and 14, Owens discloses a computer-based method (a computer program product comprising a non-transitory storage medium containing computer program code which, when run in a computer, will cause the computer to perform the method; a computer system comprising a processor- and a program memory wherein the program memory comprises a computer program product) for use in a radiotherapy treatment delivery system arranged to deliver ion radiotherapy treatment according to a plan (See at least Fig. 10A-10B; Para 0005, Para 0007, Para 0031-0032, and Para 0037), the method comprising:
obtaining a time-resolved simulation of a quantity representative of the beam delivery sequence [obtaining a simulation dose] for delivery of the plan according to a model of the system (See at least Para 0006, calculating expected or planned radiation delivery metrics at pre-determined time points; the "planned radiation delivery metric" mentioned in claim 1 of Owens corresponds to the simulation in terms of claim 1 of the present application),
obtaining a time-resolved measurement of the quantity representative of a beam delivery sequence for delivery of the plan related to the delivery of the treatment plan [obtaining an actual dose] (See at least Fig. 10A-10B; Para 0006, calculating the actual or current radiation delivery metrics at those pre-determined time points),
comparing data related to the time-resolved measurement to the time-resolved simulation (See at least Para 0006-0007), taking action in dependence of the result of the comparison, wherein the action includes at least one of determining whether to adapt the model, or the plan, or diagnosing the function of the delivery system (See at least Para 0033, “adjust certain parameters to help radiation delivery conform more closely to the planned fluence and/or dose profile").
As per Claim 2, Owens discloses wherein comparing data includes comparing the time-resolved measurement to the time-resolved simulation (See at least Fig. 10A-10B; Para 0006-0007, Claim 2).
As per Claim 3, Owens discloses the steps of: obtaining simulated dose information based on the time-resolved simulation (See at least Para 0050, the value of the dose-volume delivery metrics may be calculated at each pre-determined time point), obtaining measured dose information based on the time-resolved measurement (See at least Para 0053), wherein the step of comparing includes comparing the simulated dose information to the measured dose information, the dose information including information regarding at least one of physical dose, RBE weighted dose, and FLASH dose resulting from the plan (See at least Para 0053).
As per Claim 4, Owens discloses wherein the time-resolved measurement is obtained based on a dry- run of the plan (See at least Para 0006, a mentioned QA session is considered as a dry-run of the plan).
As per Claim 5, Owens discloses wherein the plan is a treatment plan and the time-resolved measurement is obtained based on delivery of the treatment plan to a patient (See at least Para 0005-0007, Para 0037, and Para 0042).
As per Claim 6 (5), Owens discloses wherein the treatment plan is designed to be delivered to the patient in two or more fractions, wherein the time-resolved simulation is obtained for one or more of these fractions (See at least Para 0050-0054).
As per Claim 7 (6), Owens discloses wherein the time-resolved measurement is obtained during delivery of the same one or more of the fractions as the time-resolved simulation, wherein the step of taking action includes adapting delivery of one or more subsequent fractions (See at least Para 0050-0054).
As per Claim 8 (7), Owens discloses obtaining delivered FLASH dose information from the time- resolved measurement and simulated FLASH dose information from the time- resolved simulation and the step of comparing includes comparing the delivered FLASH dose information to the simulated FLASH dose information (See at least Para 0035, Para 0037-0038, and Para 0050-0054).
As per Claim 9 (6), Owens discloses wherein the step of comparing includes comparing accumulated dose information from a number of fractions (See at least Para 0050-0054).
As per Claim 10, Owens discloses wherein taking action includes adjusting the model of the system based on the result of the comparison (See at least Para 0033, Para 0039, and Para 0041, Intervention of the operator in such cases - if parameters are out of tolerance range).
As per Claim 11 (3), Owens discloses wherein the step of taking action includes assessing the function of the delivery system based on the result of the comparison (See at least Para 0067, Assessing the function of the delivery system (status PASSED/ FAILED) based on the result of the comparison).
As per Claim 12, Owens discloses wherein the model of the system includes parameters based on nominal data provided for the delivery system or the model of the system includes parameters obtained by an experimental characterization of the system (See at least Para 0033, Para 0043-0044).
Furthermore, as per Claim 13 and the limitations of the functions of the computer program product (apparatus) or what the computer program product (apparatus) does, i.e. “obtaining a time-resolved simulation of a quantity representative of the beam delivery sequence for delivery of the plan according to a model of the system, obtaining a time-resolved measurement of the quantity representative of a beam delivery sequence for delivery of the plan related to the delivery of the treatment plan, comparing data related to the time-resolved measurement to the time-resolved simulation, taking action in dependence of the result of the comparison, wherein the action includes at least one of determining whether to adapt the model, or the plan, or diagnosing the function of the delivery system”, these carry no patentable weight in an apparatus claim. Apparatus claims should cover what a device is or structures or structural elements, not what a device does. See Hewlett-Packard Co. vs. Bausch & Lomb Inc., 909 F 2.d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As shown above Owens discloses the currently claimed apparatus structure and structural elements.
Claims 1, 2, 13, and 14 are also rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tilly et al. (US 2020/0360731 A1).
As per independent Claims 1, 13, and 14, Tilly discloses a computer-based method (a computer program product comprising a non-transitory storage medium containing computer program code which, when run in a computer, will cause the computer to perform the method; a computer system comprising a processor- and a program memory wherein the program memory comprises a computer program product) for use in a radiotherapy treatment delivery system arranged to deliver ion radiotherapy treatment according to a plan (See at least Fig.1, Para 0027-0034, Para 0039, and Para 0053), the method comprising:
obtaining a time-resolved simulation of a quantity representative of the beam delivery sequence [obtaining a simulation dose] for delivery of the plan according to a model of the system (See at least Fig.1, Para 0008-0009, Para 0071),
obtaining a time-resolved measurement of the quantity representative of a beam delivery sequence for delivery of the plan related to the delivery of the treatment plan [obtaining an actual dose] (See at least Fig.1, Para 0008-0009, Para 0046, and Para 0053; See also Para 0011-0012),
comparing data related to the time-resolved measurement to the time-resolved simulation, taking action in dependence of the result of the comparison, wherein the action includes at least one of determining whether to adapt the model, or the plan, or diagnosing the function of the delivery system (See at least Fig.1; Para 0039; Para 0053, “Intra-fraction radiotherapy treatment workflow 130 communicates with the treatment data source 160 and/or the image data source 150 to determine a need to modify treatment device parameters in real time within a given fraction. In an embodiment, the intra-fraction radiotherapy treatment workflow 130 compares, at a particular time within the fraction, a current patient anatomy and/or a current amount of dose delivered to a target with an expected anatomy and/or dose specified in a treatment plan in accordance with a comparison function ƒ. Based on a deviation between the current anatomy and/or amount and the expected anatomy and/or amount, the intra-fraction radiotherapy treatment workflow 130 modifies parameters of the radiotherapy device according to a function. The function may be any linear, quadratic function or other suitable mathematical expression that may indicate whether to increase, decrease, or make no adjustments to the radiotherapy device parameters based on the deviation.”; See also Para 0058).
As per Claim 2, Tilly discloses wherein comparing data includes comparing the time-resolved measurement to the time-resolved simulation (See at least Fig.1, Para 0053).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found in the PTO-892 Notice of References Cited. The Examiner suggests the applicant review all of these documents before submitting any amendments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN P OUELLETTE whose telephone number is (571)272-6807. The examiner can normally be reached on M-F 8am-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lynda C Jasmin, can be reached at telephone number (571) 272-6782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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August 31, 2026
/JONATHAN P OUELLETTE/Primary Examiner, Art Unit 3629
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