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 1-20 were previously pending and subject to a non-final Office Action having a notification date of June 16, 2025 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on September 16, 2025 (the “Amendment”), amending claims 1-5, 7-10, 12-16, and 18-20 and canceling claims 6 and 17.
The present Final Office Action addresses pending claims 1-5, 7-16, and 18-20 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
On page 9 of the Amendment, Applicant takes the position that claim 1 does not recite "mental processes," "certain methods of organizing human activity," or "mathematical concepts" because it recites several limitations that cannot be performed in the human mind (e.g., iteratively simulating each combination of a subset of training scenarios of the plurality of different training scenarios with a subset of subject subpopulations of the plurality of different subject subpopulations, wherein the estimated clinical success data represents a degree of behavioral change by the subset of subject subpopulations with respect to one or more commonly-unattained skills, wherein the simulation comprises utilizing a Monte Carlo method for random sampling of input variables). The Examiner disagrees.
The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). MPEP 2106.04(a)(2)(III). While claims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind, for instance when the human mind is not equipped to perform the claim limitations (See SRI Int’l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1304 (Fed. Cir. 2019)), the present claims in contrast do contain limitations that can practically be performed in the human mind.
As noted in the rejection below, there are many claim limitations (including the "iterative simulation" step) that amount to thinking that can be performed in the human mind ("mental processes") and relate to managing relations among/between people ("certain methods of organizing human activity"). See detailed example provided in rejection below.
Regarding how the estimated clinical success data generation simulation step is somehow performed "utilizing a Monte Carlo method for random sampling of input variables," this limitation constitutes "mathematical concepts" because it amounts to mathematical calculations. This limitation is similar to performing a resampled statistical analysis to generate a resampled distribution, SAP America, Inc. v. Investpic, LLC (898 F.3d 1161, 1163-65, 127 USPQ2d 1597, 1598-1600 (Fed. Cir. 2018)). MPEP 2106.04(a)(2)(I)(C). Alternatively, the Examiner asserts that such limitations amount to additional limitations that do no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
On pages 10-14 of the Amendment, Applicant takes the position that the present claims recite limitations that that solve technical challenges in the field of neurodevelopmental disorder (ND) treatment including identifying and selecting effective training scenarios for addressing NDs across heterogeneous subject subpopulations. Specifically, Applicant asserts that the limitations directed to generating the efficacy data, generating the estimated clinical success data by performing the iterative simulation, and selecting particular subject subpopulation and training scenario subsets provides a "practical application" of the abstract idea(s) by covering a particular solution to the noted technical challenges rather than reciting only the idea of a solution.
However, the “practical application” analysis is made with respect to the additional limitations rather than with respect solely to the abstract idea itself. MPEP 2106.04(d). In the present case, all of the above limitations asserted by Applicant as providing a "practical application" of the abstract idea cannot do so because they are actually part of the abstract idea itself as discussed in detail in the rejection below.
Furthermore, it is important to keep in mind that an improvement in the abstract idea itself is not an improvement in technology. MPEP §2106.05(a)(II). In the present case, an improved technique for selecting effective training scenarios for NDs is just an improvement in the abstract idea itself (selecting training scenarios for NDs) rather than an improvement in technology.
While utilizing a Monte Carlo method might go beyond what a human can practically perform in their mind, this limitation constitutes "mathematical concepts" because it amounts to mathematical calculations. This limitation is similar to performing a resampled statistical analysis to generate a resampled distribution, SAP America, Inc. v. Investpic, LLC (898 F.3d 1161, 1163-65, 127 USPQ2d 1597, 1598-1600 (Fed. Cir. 2018)). MPEP 2106.04(a)(2)(I)(C). Alternatively, the Examiner asserts that such limitation amounts to an additional limitation that does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
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 1-5, 7-16, and 18-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 1-5 and 7-11 are directed to a method (i.e., a process), claims 12-16 and 18 are directed to a device (i.e., a machine), and claims 19 and 20 are directed to one or more non-transitory computer-readable media (i.e., a manufacture). Accordingly, claims 1-20 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 12 includes limitations that recite at least one abstract idea. Specifically, independent claim 12 recites:
A computing device comprising:
one or more processors; and
memory storing instructions that, when executed by the one or more processors, cause the computing device to:
receive population data that indicates a plurality of different subject subpopulations;
receive skill data that indicates a plurality of different skills associated with one or more behaviors exhibited by individuals with one or more neurodevelopmental disorders;
identify, based on the population data and the skill data, behavioral goals for each subject subpopulation of the plurality of different subject subpopulations, wherein the behavioral goals correspond to one or more commonly-unattained skills for each subject subpopulation of the plurality of different subject subpopulations;
generate scenario data which indicates a plurality of different training scenarios for training one or more skills of the plurality of different skills;
generate efficacy data by estimating, for each training scenario of the plurality of different training scenarios, a probability that each skill of the plurality of different skills can be trained by the training scenario;
generate estimated clinical success data by iteratively simulating each combination of a subset of training scenarios of the plurality of different training scenarios with a subset of subject subpopulations of the plurality of different subject subpopulations, wherein the estimated clinical success data represents a degree of behavioral change by the subset of subject subpopulations with respect to one or more commonly-unattained skills, wherein the simulation comprises utilizing a Monte Carlo method for random sampling of input variables; and
select, based on the behavioral goals, the efficacy data, and the estimated clinical success data, a particular combination of a particular subset of subject subpopulations of the plurality of different subject subpopulations and a particular subset of training scenarios of the plurality of different training scenarios, wherein the particular training scenarios of the plurality of different training scenarios is associated with training two or more of the plurality of different skills.
The Examiner submits that the foregoing underlined limitations constitute "mental processes" because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper).
As an example, a medical professional could practically in their mind with pen and paper:
-receive/review "population data" (e.g., demographic data, test scores, medical data) corresponding to a plurality of different subject subpopulations (e.g., different age groups, different levels of affluence, different types of neurodevelopmental disorders, etc.);
-receive/review "skill data" that indicates a plurality of different skills associated with one or more behaviors exhibited by individuals with one or more neurodevelopmental disorders (e.g., meets with friends regularly, uses personal credit card, keeps secrets as requested, etc.);
-identify, based on the population data and the skill data, behavioral goals for each of the subject subpopulations corresponding to one or more commonly-unattained skills (e.g., verbal communication with new people; following multi-step directions, better penmanship, etc.);
-generate scenario data indicating different training scenarios for training one or more of the skills (e.g., purchasing one item from a convenience store and returning another item to the convenience store; writing five sentences so that others can understand what is written, etc.);
-generate efficacy data by estimating, for each of the training scenarios, a probability that each of the skills can be trained by the training scenario (e.g., high likelihood that verbal communication with new people can be trained by the visiting a convenience store scenario; low likelihood that improved penmanship can be trained by the visiting a convenience store scenario; etc.). In the case where there are for instance three training scenarios (e.g., (1) writing five sentences so that others can understand what is written, (2) engaging in a conversation about a non-preferred topic for two minutes, and (3) purchasing one item from a convenience store and returning another item to the convenience store) and three subject subpopulations (e.g., (1) child ages 8-12, (2) child ages 13-17, and (3) adults ages 18-22), a medical professional could estimate a degree of behavioral change regarding the commonly-unattained skills for each combination of a subset of the training scenarios and subset of the subject subpopulations. For example, the medical professional could first analyze training scenarios 1 and 2 (a subset of training scenarios) with subject subpopulations 1 and 2 (a subset of subject subpopulations). During this analysis, the medical professional could ascertain based on their experience that there is a low likelihood that writing five sentences and engaging in a non-preferred topic conversation for two minutes will elicit a behavioral change with respect to improved penmanship and verbal communication skills (commonly unattained skills) with respect to subpopulation 1 (low "clinical success") but a greater likelihood of such behavioral change elicitation with respect to subpopulation 2 (higher "clinical success"). The medical professional could iteratively/repeatedly perform such analysis for each subset of training scenarios for each subset of subject subpopulations; and
select, based on the behavioral goals, the efficacy data, and the estimated clinical success data, a particular combination of a particular subset of the subject subpopulations and a particular subset of the training scenarios associated with training two or more of the skills. For instance, the medical professional could select the second and third subject subpopulations (a "particular subset" of the subject subpopulations) and second and third training scenarios (a "particular subset" of the training scenarios) in the above example which is associated with improving verbal communication with new people and following multi-step directions (two or more of the different skills).
These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III). Claims “directed to collection of information, comprehending the meaning of that collected information, and indication of the results, all on a generic computer network operating in its normal, expected manner,” fail step one of the Alice framework. In re Killian, 45 F.4th 1373, 1380 (Fed. Cir. 2022). Claims directed to “collecting, analyzing, manipulating, and displaying data’’ are abstract. Univ. of Fla. Research Found., Inc. v. General Elec. Co., 916 F.3d 1363, 1368 (Fed. Cir. 2019).
Furthermore, many of the foregoing underlined limitations constitute "certain
methods of organizing human activity" because they relate to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). The limitations are similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
Still further, that the estimated clinical success data generation simulation step is somehow performed "utilizing a Monte Carlo method for random sampling of input variables" constitutes "mathematical concepts" because it amounts to mathematical calculations. This limitation is similar to performing a resampled statistical analysis to generate a resampled distribution, SAP America, Inc. v. Investpic, LLC (898 F.3d 1161, 1163-65, 127 USPQ2d 1597, 1598-1600 (Fed. Cir. 2018)). MPEP 2106.04(a)(2)(I)(C).
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 3-5, 7, 9-11, 14-16, and 18 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claims 3 and 14 call for recite how selecting the particular combination includes identifying that at least one of the different subject subpopulations has not performed a training scenario associated with the two or more of the plurality of different skills which a person could practically ascertain in their mind such as via watching ("mental processes") and relates to managing relations between people ("certain methods of organizing human activity").
-Claims 4 and 15 recite how generating the estimated clinical success data includes using one or more of a Vineland Adaptive Behavior Scale (VABS) or a Goal Attainment Scale (GAS) which a person could practically performing in their mind with pen and paper ("mental processes") and relates to managing relations between people ("certain methods of organizing human activity").
-Claims 5 and 16 recite how selecting the particular combination is based on a trainability value assigned to the two or more of the plurality of different skills which just further defines the " mental processes" and "certain methods of organizing human activity" discussed previously.
-Claims 7 and 18 recite how each subset of the subject subpopulations includes at least two of the plurality of different subject subpopulations which again just further defines the " mental processes" and "certain methods of organizing human activity" discussed previously.
-Claim 9 recites how the estimated clinical success data indicates one or more of an absolute effect size of a performance level of each subject subpopulation of the subset or a standardized effect size of the performance level of each subject subpopulation of the subset which again just further defines the " mental processes" and "certain methods of organizing human activity" discussed previously.
-Claim 10 recites how simulating the degree of behavioral change includes weighting the performance level by applying a function to the performance level that is based on a rarity of each of the subject subpopulations which again just further defines the " mental processes" and "certain methods of organizing human activity" discussed previously.
-Claim 11 recites how identifying the behavioral goals is based on one or more of: a range of subject ages; a range of Full-Scale Intelligence Quotient (FSIQ) values; or a range of Social Responsiveness Scale - Version 2 ("SRS Total") t-scores which just further defines the " mental processes" and "certain methods of organizing human activity" discussed previously.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A computing device comprising:
one or more processors; and
memory storing instructions that, when executed by the one or more processors, cause the computing device to:
receive population data that indicates a plurality of different subject subpopulations;
receive skill data that indicates a plurality of different skills associated with one or more behaviors exhibited by individuals with one or more neurodevelopmental disorders;
identify, based on the population data and the skill data, behavioral goals for each subject subpopulation of the plurality of different subject subpopulations, wherein the behavioral goals correspond to one or more commonly-unattained skills for each subject subpopulation of the plurality of different subject subpopulations;
generate scenario data which indicates a plurality of different training scenarios for training one or more skills of the plurality of different skills;
generate efficacy data by estimating, for each training scenario of the plurality of different training scenarios, a probability that each skill of the plurality of different skills can be trained by the training scenario;
generate estimated clinical success data by iteratively simulating each combination of a subset of training scenarios of the plurality of different training scenarios with a subset of subject subpopulations of the plurality of different subject subpopulations, wherein the estimated clinical success data represents a degree of behavioral change by the subset of subject subpopulations with respect to one or more commonly-unattained skills, wherein the simulation comprises utilizing a Monte Carlo method for random sampling of input variables; and
select, based on the behavioral goals, the efficacy data, and the estimated clinical success data, a particular combination of a particular subset of subject subpopulations of the plurality of different subject subpopulations and a particular subset of training scenarios of the plurality of different training scenarios, wherein the particular training scenarios of the plurality of different training scenarios is associated with training two or more of the plurality of different skills.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the computing device includes processor and memory with instructions, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
As an alternative to the limitations reciting how the simulation is performed using a Monte Carlo method for random sampling of input variables constituting "mathematical concepts," the Examiner asserts that such limitations amount to additional limitations that do no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 12 and analogous independent claims 1 and 19 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 12 and analogous independent claims 1 and 19 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claims 2, 13, and 20 call for causing an extended reality device to provide, to a user associated with the particular subset of subject subpopulations, an extended reality environment based on particular subset of training scenarios. These additional limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Specifically, the additional limitations provide only a result-oriented solution and lack details as to how the extended reality device provides such extended reality environment based on the first training scenario. Claims drafted using largely (if not entirely) result-focused functional language, containing no specificity about how the purported invention achieves those results, are almost always found to be ineligible for patenting under Section 101.” Beteiro, LLC v. DraftKings Inc., 104 F.4th 1350, 1356 (Fed. Cir. 2024).
-Claim 8 calls for transmitting, by the computing platform and to a user computing device, an indication of the particular combination which causes the user computing device to display the indication of the particular combination. These limitations represent insignificant extra-solution activity (transmitting data) (see MPEP § 2106.05(g)) and using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 12 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the computing device includes processor and memory with instructions, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
As an alternative to the limitations reciting how the simulation is performed using a Monte Carlo method for random sampling of input variables constituting "mathematical concepts," the Examiner asserts that such limitations amount to additional limitations that do no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claims 2, 13, and 20 call for causing an extended reality device to provide, to a user associated with the particular subset of subject subpopulations, an extended reality environment based on particular subset of training scenarios. These additional limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Specifically, the additional limitations provide only a result-oriented solution and lack details as to how the extended reality device provides such extended reality environment based on the first training scenario. Claims drafted using largely (if not entirely) result-focused functional language, containing no specificity about how the purported invention achieves those results, are almost always found to be ineligible for patenting under Section 101.” Beteiro, LLC v. DraftKings Inc., 104 F.4th 1350, 1356 (Fed. Cir. 2024).
-Claim 8 calls for transmitting, by the computing platform and to a user computing device, an indication of the particular combination which causes the user computing device to display the indication of the particular combination. These limitations represent insignificant extra-solution activity (transmitting data) (see MPEP § 2106.05(g)) and using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Therefore, claims 1-5, 7-16, and 18-20 are ineligible under 35 USC §101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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