DETAILED ACTION
Status of Claims
This is a Final Office Action in response to the arguments and/or amendments filed on 25 March 2026.
Claim(s) 21 and 22 is/are canceled. Claim(s) 1, 3, 11, 13, and 20 is/are amended.
Claim(s) 1, 3-11, and 13-20 is/are currently pending and have been examined.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-11, and 13-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1, which is representative of claims 11 and 20, recites: a method for determining and applying an optimized radiation treatment plan, comprising:
optimizing,
computing,
determining, based on an approximation of a Jacobian generated based on a weighted sum of a first approximation of the Jacobian and a second approximation of the Jacobian;
determining,
optimizing,
providing,
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract ideas to more clearly demonstrate the limitations setting forth the abstract ideas. The underlined portions of the claim are interpreted as setting forth a separate second abstract idea, addressed later. The remaining limitations describe a concept of designing, evaluating, and updating a radiotherapy treatment plan. This concept describes a mental process that radiotherapy planner should follow to create an appropriate radiotherapy plan similar to “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such, these limitation set forth a method of organizing human activity. Therefore the claims are determined to recite an abstract idea.
The claims also recite based on an approximation of a Jacobian generated based on a weighted sum of a first approximation of the Jacobian and a second approximation of the Jacobian. This limitation describes a concept of performing mathematical calculations. This limitation describes sufficiently specific mathematical concepts (a weighted sum of two approximations of Jacobians, where the Jacobian should be understood to refer to a specific vector calculus operation) that it “recites” rather than merely “involves” a mathematical concept. As such, the claims are determined to recite a mathematical concept.
While the above limitations set forth concepts that fall within different groupings of abstract ideas, they all set forth abstract ideas. As such, per MPEP 2106.04(II)(B), these concepts are considered together as a single abstract idea for further analysis. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claim 1 recites the additional element of one or more processors. Claim 11 recites the additional element of a system comprising one or more processors and a memory. Claim 20 recites a computer-readable medium. 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.
The claims further recite the additional element of providing the treatment plan to a radiation machine; revising, based on the updated treatment parameters, one or more radiation control parameters of a radiating component of the radiation machine; and providing, via the radiation machine, a radiation dose to the anatomical region using one or more radiation beams having at least one of beam angles, intensities, or shapes defined by the one or more radiation control parameters. The “radiation machine” of these limitations is recited at a high level of generality and as such is not interpreted as any particular machine. The revision of control parameters is also recited at a high level of generality and is not interpreted as a transformation of an article to another state. Further, any plausible improvement of the claim appears to be entirely based on the abstract idea rather than the combination of the abstract idea with one or more additional elements, meaning that the claims do not provide a technical improvement indicating that the claims integrate the abstract idea into a practical application. The purpose of a radiation treatment plan is to guide radiation treatment by a radiation machine. As such, the provision of a radiation treatment plan to, and use by, a radiation machine is only an insignificant application (i.e., insignificant extra-solution activity) of the abstract idea. Per MPEP 2106.04(d), such additional elements do not integrate an abstract idea into a practical application.
There are no further additional elements. When considered as a combination, the additional elements do not constitute an improvement technology, do not apply the abstract idea with a particular treatment, do not implement the abstract idea with a particular machine that is integral to the claim, and do not apply the abstract idea in some other meaningful way. Instead, the combination of additional elements only generally link the use of the abstract idea to a technological environment of radiation therapy. As such, the combination of additional elements does not integrate the abstract idea into a practical application. As the additional elements do not integrate the abstract idea into a practical application, the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite additional elements which may be interpreted as generic computing devices used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing does not add significantly more in Step 2B, 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 amount to significantly more.
As previously noted, the claims recite an additional element of providing the treatment plan to a radiation machine; revising, based on the updated treatment parameters, one or more radiation control parameters of a radiating component of the radiation machine; and providing, via the radiation machine, a radiation dose to the anatomical region using one or more radiation beams having at least one of beam angles, intensities, or shapes defined by the one or more radiation control parameters. Maurer, Jr et al (US 2008/0013687 A1) demonstrates that such processing and use of a radiation treatment plan to a radiation machine for delivering a radiation dose was conventional long before the priority date of the claimed invention (“With conventional IMRT (Intensity Modulated Radiation Therapy) systems having an MLC, treatment planning is performed by, first, determining an optimal dose distribution at each node of the treatment system, i.e. each desired angle. After the dose distribution has been determined, field shapes are generated using a leaf sequencing algorithm, taking into account constraints of the MLC. That is, a set of instructions is generated to move the leaves in a given pattern, in order to achieve as closely as possible the optimum dose distribution. After the predicted dose distribution is calculated from the generated leaf sequencing algorithm, the radiation treatment of the target volume of interest ("VOI") occurs.” [0010]). As noted above under Prong Two, this additional element was considered insignificant extra-solution activity. When considered at Step 2B, the demonstrated conventionality of this additional element reinforces the conclusion that this additional element is insignificant extra-solution activity. As such, this additional element does not amount to significantly more.
There are no further additional elements. When considered as a combination, the additional elements continue to only generally link the use of the abstract idea to a technological environment of radiation therapy. As such, the combination of additional elements does not amount to significantly more than the abstract idea. Therefore, when considered individually and as an ordered combination, the additional elements of the independent claims do not amount to significantly more than the judicial exception. Thus the independent claims are not patent eligible.
Claims 3-10 and 13-19 further narrow the abstract idea, but the claims continue to recite abstract ideas, albeit narrowed ones. Claims 3-10 and 13-19 recite no further additional elements. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract ideas into a practical application for the reasons given above in conjunction with the independent claims. Therefore these claims continue to be directed to abstract ideas. At Step 2B, the previously identified additional elements, individually and as a combination, do not amount to significantly more than the narrowed abstract ideas for the reasons given above in conjunction with the independent claims. Thus as the dependent claims remain directed to an abstract idea, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
Response to Arguments
Applicant’s Argument Regarding 101 Rejections of claims 1, 3-11, and 13-22:
The treatment recited in the claims is “particular” within the meaning of MPEP 2106.04(d)(2)(a). The treatment recited in the claims is a specific, recognized therapeutic modality, comparable to the genotype tailored drug dosing found eligible in Vanda Pharmaceuticals.
The relationship between the mathematical calculations and the treatment is far more than “nominal or significant,” thereby satisfying MPEP 2106.04(d)(2)(b). The very purpose of the optimization, quality-scoring, and Jacobian-based adjustment steps is to generate beam angles, fluence patterns, and other control settings that enhance the safety and efficacy of the administered dose.
Amended claim 1 recites “providing … a radiation dose,” thereby reciting a particular therapeutic modality administered to the patient, analogous to the administration of a specific therapeutic agent in Vanda. Amended claim 1 also recites “revising … radiation control parameters of a radiating component of the radiation machine,” thereby reciting a mode of administration. Additionally, amended claim 1 recites constraints on the radiation treatment plan based on which the dose is given, including “an objective function … defined in terms of … optimization objectives” and evaluating when to “determine adjustments to the function parameters” based on “a quality score … associated with one or more clinical objectives” thereby defining constraints to the dose. Thus, as in Vanda Pharmaceuticals, the claims do not merely identify or recommend an optimized treatment.
The treatment steps are not mere extra-solution activity or a field-of-use limitation, thereby satisfying MPEP 2106.04(d)(2)(c). Implementing the radiation treatment plan is not ancillary to the claimed calculations, but is the very objective for which the plan is generated. The optimized treatment parameters exist to be applied to the radiation machine to control beam geometry, intensity, and shape during dose delivery to the patient.
Example 25 makes clear that when mathematical calculations are used to control the operation of a machine to achieve a physical result, the claims are not directed to an abstract idea.
The Office Action does not explain how such machine-control steps differ in kind from the equipment control deemed eligible in Example 25.
The haircut example in MPEP 2106.05(g) involves a purely abstract determination followed by a routine human action that merely carries out the decision. In contrast, the claimed treatment steps include a tightly integrated technical process in which calculated treatment parameters directly control real-time operation of a radiation therapy machine to deliver a patient-specific therapeutic dose.
The technical improvement reflect in the claims is not provided by the alleged abstract idea … but by the integration into a concrete machine-implemented treatment process.
Examiner’s Response: Applicant's arguments filed 25 March 2026 have been fully considered but they are not persuasive.
Examiner notes that Vanda Pharmaceuticals specifically involved the administration of iloperidone, a specific chemical compound. Applicant’s assertion that the claimed administration of a dose of radiation is comparable to the administration of a specific chemical compound is unpersuasive. On their face these are not analogously “particular” treatments.
Examiner agrees with applicant that there does appear to be more than a nominal relationship between the abstract idea and the treatment limitations. As previously noted, MPEP 2106.04(d)(2) does not describe any of the three factors as dispositive. Further, Examiner notes that Applicant’s assertion that the “very purpose of the optimization, quality-scoring, and Jacobian-based adjustment steps is to generate beam angles, fluence patterns, and other control settings” is relevant to the MPEP 2106.04(d)(2)(a) consideration, which states that the “treatment or prophylaxis limitation must be “particular,” i.e., specifically identified so that it does not encompass all applications of the judicial exception(s).” As the very purpose of the judicial exception is to generate and apply radiation control therapies, it appears that the additional element encompasses all applications of the judicial exception.
Examiner disagrees with applicant’s argued analogy to Vanda. “[P]roviding … a radiation dose” is not analogous to “administering iloperidone to the patient.” It is analogous to “administering a chemical compound”, which is not particular. “Revising … radiation control parameters of a radiating component of the radiation machine” is not analogous to Vanda’s requirement that it’s specific chemical compound is internally administered. Using constraints that are determined by an analysis are not analogous to the predetermined dosages in Vanda (i.e., “in an amount of 12 mg/day or less”).
Examiner agrees with applicant’s assertion that the “optimized treatment parameters exist to be applied to the radiation machine to control beam geometry, intensity, and shape during dose delivery to the patient.” This actually supports, rather than refutes, a determination of extra-solution activity. MPEP 2106.05(g) notes that whether “all uses of the recited judicial exception require such data gathering or data output” is a consideration for whether an additional element is extra-solution activity. As these parameters are simply being used they way that they exist to be used, it indicates that the application of the parameters by a radiation machine is insignificant extra-solution activity.
Examiner notes that Applicant’s characterization of Example 25 as providing a rule regarding eligibility of claims that involve machine operation does not appear to be supported by the text of the example. Examiner is unaware of any guidance stating that claims involving machine operation are per se eligible.
When the content of the claims are compared, the present claims do not include features analogous to the constant determination of the temperature of the mold, the repetitive calculations and comparisons, and the opening of the press based on the calculations. As such, the example is not considered analogous.
Contrary to applicant’s argument, the revising of the control parameters and their use with a radiation machine appear to be “routine [] action that merely carries out the decision.” The presence of a machine does not render the claim eligible.
Per MPEP 2106.05(a), “If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification.” Here, there is no apparent technical explanation of how to revise control parameters based on treatment parameters or how to provide a radiation dose. As such, there does not appear to be any technical improvement in the application of the abstract idea by a machine.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 Notice of References Cited with the current office action and the prior office actions dated 28 August 2024, 27 December 2024, and 23 December 2025.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2026-06-09
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