DETAILED ACTION
Status of Claims
This is a non-final office action on the merits in response to the arguments and/or amendments filed on 12 August 2026 and the request for continued examination filed on 21 August 2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 August 2026 has been entered.
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, terms of one or more optimization objectives related to treatment parameters of the radiotherapy treatment plan;
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, by the one or more processors based on the updated treatment parameters, one or more radiation control parameters of a radiating component of the radiation machine; and instructing, by the one or more processors, the radiation machine to radiate 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. Additionally, per Applicant’s remarks (12 August 2026) “radiation delivery cannot occur without applying the calculated beam angles, intensities, and shapes to the radiating component of the machine”, which indicates that all uses of the abstract idea would require such data output. 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 to 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 amount to instructions to implement the abstract idea with a computing device through insignificant extra-solution application. 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, by the one or more processors based on the updated treatment parameters, one or more radiation control parameters of a radiating component of the radiation machine; and instructing, by the one or more processors, the radiation machine to radiate 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 still do not constitute an improvement to technology, still do not apply the abstract idea with a particular treatment, still do not implement the abstract idea with a particular machine that is integral to the claim, and still do not apply the abstract idea in some other meaningful way. Rather, the combination of additional elements only amount to instructions to implement the abstract idea with a computing device through insignificant extra-solution application. 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 13-20:
The claims do not recite a mental process … Because the claimed limitations cannot practically be performed in the human mind, the claims do not recite a mental process, and the Examiner’s classification under the mental process grouping is inconsistent with the guidance in the Memorandum.
The claims reference a “Jacobian” and a “weighted sum” as general mathematical tools used within the broader optimization process. They do not set forth the specific mathematical formulas, equations, or symbolic expressions that define a Jacobian matrix or the weighting coefficients. Just as “training a neural network” involves mathematical concepts without reciting them because no specific algorithm is named, referencing “an approximation of a Jacobian” involves a mathematical concept without setting forth the specific mathematical relationship being computed.
While the Final Office Action alleges at page 9 that “[t]he treatment of the claim is not at all analogous to the particular treatment in Vanda Pharmaceuticals which recited treatments which specified 1) a particular compound, 2) a mode of administration, and 3) a dosage range” the Applicant respectfully disagrees. Amended claim 1 recites instructing the radiation machine to radiate the anatomical region, 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.
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.
Controlling operational parameters of a tangible electronic device to improve a technology has been recognized as patent-eligible subject matter. .. Example 25 … makes clear that a claim that utilizes a mathematical relationship is nevertheless eligible when the abstract idea is integrated into a process that actively controls and modifies the operation of hardware.
The Office Action at page 10 states that “the present claims do not include features analogous to the constant determination of the temperature of the mold, the repetitive calculations and comparison, and the opening of the press based on the calculations. The Applicant respectfully disagrees. … The quality score computation in the amended claims is analogous to the “constant determination of the temperature of the mold in Example 25.” Just as Example 25 involves repeatedly measuring the temperature of the mold to determine whether the cure is complete, the amended claims recite computing a quality score to determine whether the radiotherapy treatment plan satisfies the clinical objectives.
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 patient-specific therapeutic dose. … Treating such machine-implemented control of a medical device as analogous to cutting hair improperly conflates conventional human activity with the type of physical process control recognized as patent-eligible in Diamond v. Diehr and USPTO example 25.
Unlike cutting hair, radiation delivery cannot occur without applying the calculated beam angles, intensities, and shapes to the radiating component of the machine.
Examiner’s Response: Applicant's arguments filed 12 August 2026 have been fully considered but they are not persuasive.
The current and prior rejection both clearly state that the limitations “set forth a method of organizing human activity.” The rejection indicates that the claim is similar to a concept involving a mental process described in MPEP 2106.04(a)(2)(II)(C), but this section of the MPEP addresses the managing personal behavior or relationships or interactions between people subgrouping of the certain methods of organizing human activity grouping.
MPEP 2106.04(a)(2)(I) states “It is important to note that a mathematical concept need not be expressed in mathematical symbols.“ Examiner notes that Example 47, claim 1 was determined to recite a mathematical calculation based on the incorporation of the limitations “a backpropagation algorithm” and “a gradient decent algorithm.” These terms do not actually reference specific algorithms, but reference classes of algorithms. For example, one of ordinary skill in the art would recognize that “a gradient decent algorithm” encompasses numerous algorithms. The claimed “approximation of a Jacobian” is much closer to “a gradient decent algorithm” than “training” as it’s clearly a reference to a mathematical calculation rather than a nebulous result or operation. Further, Examiner notes that applicant does not provide any substantive explanation for why “weighted sum” is not a mathematical calculation.
Applicant’s 3 arguments regarding the analogy to the particular treatment in Vanda are each unpersuasive and are addressed in turn. A) “Instructing the radiation machine to radiate the anatomical region” is not remotely comparable in specificity to a particular compound. The claim does not even specify a type of radiation, much less specify any limitation analogous to the chemical compound of iloperidone. Note MPEP 2106.04(d)(2)(a) which describes a step of “administering a suitable medication to a patient” as insufficiently particular. The claimed invention is far more analogous to this hypothetical than the claim in Vanda. B) Applicant’s asserted “mode of administration” is again not analogous to that of Vanda. Vanda required that the claims be “internally administered.” While broad, this mode of administration is limiting and would exclude topical administration. Applicant’s referenced “revising… radiation control parameters of a radiating component of the radiation machine” simply describes using the machine, without any further limitation. C) Vanda’s claims included particular, numerically defined, dosage ranges, i.e., “an amount that is greater than 12 mg/day, up to 24 mg/day.” The referenced features provide how a dosage is determined. They are not remotely similar.
Subject matter eligibility guidance does not state that “the very objective” of a claim cannot be extra-solution activity. In fact, it unambiguously indicates the opposite. MPEP 2106.05(g) specifically describes “cutting hair after first determining the hair style” to be an insignificant application. The point of the claims in In re Brown was to cut hair. The claim recited details regarding determining a hair pattern. And the additional element of “using scissors to cut hair according to said assigned hair pattern” was insignificant extra-solution activity. This fact pattern closely parallels the current claims.
Example 25 does not appear state a rule that “a process that actively controls and modifies the operation of hardware” is per se eligible.
Applicant’s argument stretches any similarities beyond their breaking point. A set of calculations (quality score computation) is not analogous to using sensors to monitor a physical environment. A onetime set of calculations (Jacobian-based adjustment and optimization steps) is not analogous to repeated calculations that monitor a process. The application of a machine in its normal way (instructing … the radiation a machine to radiate) is not analogous to using a machine in a meaningfully different way (Note that Example 25 states: “At the time of applicant’s invention, the usual way of operating rubber‐molding presses is for the operator to load and close the press manually”).
Applicant’s efforts to distinguish the claims from those in In re Brown appear to boil down to the application of the analysis with a machine. However, there does not appear to be any subject matter eligibility guidelines that application by a machine is per se eligible where application by a human is not. Additionally, Examiner notes that Diamond v. Diehr does not provide a per se rule that “process control” is patent eligible.
Examiner notes that Applicant’s statement that “radiation delivery cannot occur without applying the calculated beam angles, intensities, and shapes to the radiating component of the machine” provides evidence that “revising … one or more radiation control parameters of a radiating component of the radiation machine” is insignificant extra-solution activity. As “radiation delivery cannot occur” without these steps, all uses of the recited judicial exception require such data output. See MPEP 2106.05(g)(3).
Conclusion
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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/Bion A Shelden/Primary Examiner, Art Unit 3685 2026-08-27
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