DETAILED ACTION
Status of Claims
This action is in reply to the application filed on 6 March, 2026.
Claims 1,2, 5 and 6 have been amended.
Claims 1 – 12 and 14 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.
The following rejection is formatted in accordance with MPEP 2106.
Claim 1 is representative. Claim 1 recites:
A computer implemented dose calculation method for brachytherapy treatment, in which radiation is provided by one or more radiation sources from at least a first and a second dwell position within a patient, the radiation provided in each dwell position resulting in a dose contribution from that dwell position, the method comprising:
independently for each dwell position automatically selecting, using a computing device, a first dose calculation algorithm to be used to calculate the dose contribution from the first dwell position and a second dose calculation algorithm to be used to calculate the dose contribution for the second dwell position, the second dose calculation algorithm being different from the first dose calculation algorithm,
wherein the selecting comprises
evaluating, for each dwell position, tissue material properties in a voxel-based surrounding of the dwell position to determine an index value indicative of heterogeneity and
selecting the dose calculation algorithm based on the index value;
calculating, by the computing device, the dose contribution from the first dwell position according to the first dose calculation algorithm;
calculating, by the computing device, the dose contribution from the second dwell position according to the second dose calculation algorithm; and
calculating, by the computing device, a total dose as the sum of the dose contributions from the at least first and second dwell positions.
Claim 12 recites medium with program code executed by a computing device that executes the steps of the method recited in Claim 1, and Claim 14 recites a computer that executes the program code recited in Claim 12.
Claim 11 recites a method for optimizing dwell times for a corresponding set of dwell positions that includes calculating the total dose using the method of Claim 1.
Claims 1 – 12 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept – i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
STEP 1
The claims are directed to a device, a method and non-transitory computer readable medium which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the mathematical formula or relationship grouping; the limitations including:
A dose calculation method for brachytherapy treatment, in which radiation is provided by one or more radiation sources from at least a first and a second dwell position within a patient, the radiation provided in each dwell position resulting in a dose contribution from that dwell position, the method comprising:
calculating the dose contribution from the first dwell position according to the first dose calculation algorithm;
calculating the dose contribution from the second dwell position according to the second dose calculation algorithm; and
calculating a total dose as the sum of the dose contributions from the at least first and second dwell positions.
The claims recite a method comprising calculating a total dose (of radiation) as the sum of the dose contributions from a first and second dwell position. This is a simple mathematical addition of two numeric values. The claims further recite calculating the dose contribution from each of the first and second dwell positions using a selected dose calculation algorithm. An algorithm for calculating the dose contribution at a particular dwell position is a mathematical formula or relationship. Further, the broadest reasonable interpretation of the recited algorithms for calculating dose contributions at a dwell position, include known mathematical algorithms, as disclosed in the specification.
The specification discloses that dose calculations for brachytherapy “use known algorithms for such calculations”, that use either a calculation based on “simplified assumptions” (i.e. the tissue is water equivalent and homogeneous); or based on “dose engine calculations” – i.e. a Monte Carlo dose engine that calculates dose for heterogeneous tissue. Here, Examiner asserts that a well-known radiation does calculation algorithms represent mathematical relationships.
The claims, as amended, further recite:
evaluating, for each dwell position, tissue material properties in a voxel-based surrounding of the dwell position to determine an index value indicative of heterogeneity.
The specification discloses two methods for evaluating tissue material properties to determine/calculate an index value indicative of heterogeneity – ray tracing and sub-volumes. The claims expressly recite: “tissue material properties in a voxel-based surrounding of the dwell position” which limits the “evaluating” to the sub-volume method where “a sub-volume is defined around a dwell position. The relevant tissue property or properties are determined for all voxels within the sub-volume and the index value is calculated by accumulating the tissue property values for these values.” (@ 031) “Relevant tissue properties include density, effective electron density, photo-electric effect, and Compton scattering”. (@ 026) Tissue properties are accumulated (i.e. added together in a weighted summation) according to Equation (3). Notably, the claims require evaluating tissue material properties, but not determining the properties themselves. This is in keeping with the specification, which is silent with respect to any technical details as to how these “relevant tissue properties” may be determined. In any event evaluating tissue properties involves summing their contribution to the total index value according to Equation (3); and is a mathematical formula or relationship. As such, the claims recite an abstract idea within the mathematical formula or relationship grouping.
Further, the Claims as represented by Claim 1 recites limitations that encompass as abstract idea within the “mental processes” grouping – concepts performed in the human mind including observation, evaluation, judgment and opinion.
The claims recite:
calculating the dose contribution from the first dwell position according to the first dose calculation algorithm;
calculating the dose contribution from the second dwell position according to the second dose calculation algorithm; and
calculating a total dose as the sum of the dose contributions from the at least first and second dwell positions.
Calculating the dose contribution at a first dwell position, assuming a water equivalent, is a calculation that one of ordinary skill can perform mentally, or with the aid of pen and paper. The broadest reasonable interpretation of an algorithm being “different” may simply involve applying an adjustment or weighting factor as part of the second algorithm to the results of a first algorithm, such as a water equivalent calculation – i.e. dose in non-water equivalent tissue = dose in a water equivalent tissue x index value. This multiplication can be readily performed mentally, or with the aid of pen and paper. Similarly, adding the two numerical values from the first and second dwell positions can be performed mentally.
The claims further recite:
independently for each dwell position selecting a first dose calculation algorithm to be used to calculate the dose contribution from the first dwell position and a second dose calculation algorithm to be used to calculate the dose contribution for the second dwell position, the second dose calculation algorithm being different from the first dose calculation algorithm, and selecting the dose calculation algorithm based on the index value.
The claims recite selecting an algorithm based on a calculated index value indicative of heterogeneity. The specification discloses that the index value may be compared to a threshold in order to select from one of two algorithms. In Electric Power Group the Court found that selecting information, by content or source, for collection, analysis and display is an ordinary mental process, whose implicit exclusion from U.S.C. 101 undergirds the information-based category of abstract ideas. As such, comparing an index value to a threshold to judge which algorithm to apply, is an ordinary mental process. As such, the claims recite an abstract idea within the mental process grouping.
The claims, as illustrated by Claim 1, also recite limitations that encompass an abstract idea within the “certain methods of organizing human activity” grouping –
managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions; the limitations including:
A dose calculation method for brachytherapy treatment, in which radiation is provided by one or more radiation sources from at least a first and a second dwell position within a patient, the radiation provided in each dwell position resulting in a dose contribution from that dwell position, the method comprising:
independently for each dwell position selecting a first dose calculation algorithm to be used to calculate the dose contribution from the first dwell position and a second dose calculation algorithm to be used to calculate the dose contribution for the second dwell position, the second dose calculation algorithm being different from the first dose calculation algorithm,
wherein selecting comprises evaluating, for each dwell position, tissue material properties in a voxel-based surrounding of the dwell position to determine an index value indicative of heterogeneity and selecting the dose calculation algorithm based on the index value;
calculating the dose contribution from the first dwell position according to the first dose calculation algorithm;
calculating the dose contribution from the second dwell position according to the second dose calculation algorithm; and
calculating a total dose as the sum of the dose contributions from the at least first and second dwell positions.
The claims recite calculating a total radiation dose by selecting a dose calculation algorithm for a first dwell position, and a different calculation algorithm for a second dwell position based on an calculated index value indicative of heterogeneity, and summing the results. The specification discloses that an algorithm may be selected based on “any suitable criteria” including geometry of the treatment site or radiation source; an index value indicative of material properties such as “density . . . or the variation in material properties in the tissue”; a heterogeneity index; etc. This feature is construed as “filtering content” – i.e. filtering dose calculation algorithms, which is a method of organizing human activity. (See MPEP 2106.04(a)(2) II C).
Further, calculating a total dose for brachytherapy procedures is typical in medicine, where a doctor calculates the contribution from dwell positions as part of routine brachytherapy treatment planning, and is a process that merely organizes this human activity. (See MPEP 2016.04 (a)(2) II C finding that “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions” is a method of organizing human activity, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). As such, the claims recite an abstract idea within the certain methods of organizing human activity grouping.
STEP 2A PRONG TWO
The claims recite limitations that include additional elements beyond those that encompass the abstract idea above including:
computer implemented method;
automatically selecting, using a computing device;
calculating by the computing device
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with the MPEP. (see MPEP 2106.05)
The computer is recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using a generic computer component. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment. Nothing in the claim recites specific limitations directed to an improved technology or technological process. Similarly, the specification is silent with respect to these kinds of improvements; purporting to “provide time-efficient calculations”. A general purpose computer that applies a judicial exception by use of conventional computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a generic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claim do not integrate the abstract dose calculation process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract dose calculation process. The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure, which are disclosed in the specification as being purely conventional and/or known in the industry. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting well-understood, routine and conventional computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently well-known that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination the limitations recited in the claims add nothing that is not already present when the steps are considered individually. As such, the additional elements recited in the claim do not provide significantly more than the abstract dose calculation process, or an inventive concept.
The dependent claims add additional features including:
those that merely serve to further narrow the abstract idea above such as:
further limiting the first and second algorithms to a particular type; (Claim 2, 3);
further limiting the selection criteria for selecting the algorithm; (Claim 4 - 9);
and those that recite additional abstract ideas such as:
performing a third calculation and using in the sum; (Claim 10);
optimizing brachytherapy dwell times using an optimization procedure; (Claim 11)
calculating a total does; (Claim 11).
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. As such, the additional element do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention.
The apparatus claims are no different from the method claims in substance. “The equivalence of the method, system and media claims is readily apparent.” “The only difference between the claims is the form in which they were drafted.” (Bancorp). The method claims recite the abstract idea implemented on a generic computer, while the apparatus claims recite generic computer components configured to implement the same idea. Specifically, Claims 12 and 14 merely add the generic hardware noted above that nearly every computer will include. The apparatus claim’s requirement that the same method be performed with a programmed computer does not alter the method’s patentability under U.S.C. 101 (In re Grams). Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
The Prior Art
The claims recite features that are known in the art including calculating a total dose of radiation for a patient by summing the dose contribution from a number of dwell positions for brachytherapy treatment. The prior art further discloses using different dose calculation algorithms for tissue having different heterogeneity; and determining heterogeneity using a voxel-based analysis. However, the claims recite features that are non-obvious over the prior art; in particular, the claims recite selecting a different dose calculation algorithm independently for each dwell position based on evaluating tissue material properties in a voxel-based surrounding of the dwell position, to determine a heterogeneity index value, and selecting the dose calculation algorithm based on the index value. The prior art does not teach or suggest determining a heterogeneity index value for each dwell position and selecting a dose calculation algorithm for each dwell position based on the index value.
Response to Arguments
Applicant's amendment overcomes the rejections under U.S.C. §112.
Applicant's arguments filed 6 March, 2026, with respect to the U.S.C. §101 rejection have been fully considered but they are not persuasive.
The U.S.C. §101 Rejection
Applicant asserts that the claims are not directed to a mathematical formula, mental processes, and organizing human activity.
With respect to mental processes, Applicant asserts that “a claim is not a mental process if the steps cannot practicably be performed in the human mind” citing the Desjardins Memo. In particular, Applicant asserts that “evaluating” tissue material properties and “generating” a heterogeneity index “is not of a nature susceptible to mental performance.” However, Evaluating and determining” do not require “processing volumetric imaging”. Nothing indicates that summing together the numerical values representing a voxel’s tissue property over a number of voxels, as represented by Equation 3, cannot be performed mentally, or with the aid of pen and paper. Nothing indicates how the tissue property values are determined in the first place – physical tissue characteristics are not “extracted from voxel data”, or “represented in a voxel grid”. Nonetheless; irrespective of how these tissue property values are determined, one of ordinary skill could reasonably add them together.
Applicant further asserts that the recitation of a computing device for each selection and calculation step “precludes any interpretation that it could be performed mentally.” Nonetheless, as Applicant surely is aware, merely executing an abstract idea on a generic computer, as the claims do here, does not transform the claim into patent eligible subject matter.
Applicant asserts that the claims require “executing distinct dose-calculation engines”; including engines such as “Monte Carlo, deterministic solvers, or ray tracing algorithms”. The claims are not so limited. Even if these specific algorithms were positively recited, the distinction would only apply to the second algorithm. These algorithms are still mathematical relations.
Applicant asserts that the claims “address a technical performance problem” – i.e. “the tradeoff between speed and accuracy”. In particular, Applicant contends that selecting an algorithm based on heterogeneity index “reduces computation time in homogeneous regions”. However, Applicant’s arguments are not commensurate with the scope of the claims. Nothing in Claim 1 limits the tissue material properties of either of the first or second dwell position, or that indicate that one of the dwell positions is homogeneous, allowing the selection of a faster algorithm.
Applicant asserts a practical application that “ties the algorithm selection to physical tissue characteristics”, or are “grounded in physical properties”. This effects filtering of the algorithms, which is part of the abstract idea, and not an additional limitation.
Similarly, whether the index computation is conventional is irrelevant to the analysis, since the feature relied on is part of the abstract idea, and not an additional limitation. (see Berkheimer).
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Leksell et al.: (US 5,528,651 A) discloses a voxel-based dose calculation system and method.
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 extension fee 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 date of this final action.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
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Alternatively, official replies to this Office action may still be submitted by any one of fax, mail, or hand delivery. Faxed replies should be directed to the central fax at (571) 273-8300. Mailed replies should be addressed to “Commissioner for Patents, PO Box 1450, Alexandria, VA 22313-1450.” Hand delivered replies should be delivered to the “Customer Service Window, Randolph Building, 401 Dulany Street, Alexandria, VA 22314.”
/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date:20 April, 2026
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