DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed December 9, 2025 has been entered. Claims 29, 32, 33, 36, 71-78, and 81-85 are pending, all previous and intervening claims cancelled.
Applicant’s amendments have removed terms previously interpreted under 35 U.S.C. 112(f).
Applicant’s amendments have overcome rejections to the claims under 35 U.S.C. 112(a) and 112(b). Particularly, since the training steps entailing what defines a “trained model” recited in the independent claims are present in the independent claims, the claims are no longer directed a broad genus of trained models. Such amendments also eliminate antecedent basis issues and indefiniteness issues for terms recited in dependent claims.
The rejection of claims under 35 U.S.C. 101 has been re-written to consider limitations of cancelled dependent claims 30, 31, 34, and 35 now included in independent claims 29 and 36. Particularly, the term “trained model” is no longer treated as an additional element, but merely embodiment of evaluation steps on a processor.
The rejection of claims under 35 U.S.C. 103 has been obviated due to Applicant’s inclusion of claims 30, 31, 34, and 35 (which have no prior art rejections) into the independent claims. Such claims recite a particular series of evaluation steps which are not identified or suggested as obvious in the prior art.
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 29, 32, 33, 36, and 71-78, and 81-85 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of the claims recites steps or instructions for ascertaining and processing data to measure a blood pressure of a mammal subject, which is grouped as a mental process. Accordingly, each of the claims recites an abstract idea.
Independent claim 29 recites:
receiving a plurality of sub-epidermal moisture (SEM) delta values associated with the patient (data gathering, additional element);
automatically inputting, via a processor, the plurality of SEM delta values into a trained model configured to calculate a probability value of the patient developing DTI, wherein the trained model is trained by performing the steps comprising:
receiving a set of training data comprising:
a plurality of SEM delta values associated with a set of patients, wherein each patient in the set of patients has a known DTI status, and a threshold value, wherein the threshold value is a number between 0 and 1;
automatically inputting the training data into an optimization algorithm to receive a plurality of optimal weight values; and automatically updating the trained model with the plurality of optimal weight values, wherein the optimization algorithm is configured to:
(a) generate a plurality of ascending random numbers between 0 and 2 as a plurality of weight values;
(b) input the training data and the plurality of weight values into the trained model to receive a set of predicted DTI statuses associated with the set of patients;
(c) compare the predicted DTI statuses with the known DTI statuses associated with the set of patients;
(d) calculate a true positive rate (TPR) and a false positive rate (FPR) based on the comparison, wherein the TPR is calculated as percentage of patients in the set of patients whose predicted DTI status matches their known DTI status, and the FPR is calculated as percentage of patients in the set of patients whose predicted DTI status does not match their known DTI status;
repeat steps (a) to (d) for a predetermined number of iterations to obtain a plurality of TPRs and FPRs;
identify an optimal TPR and FPR from the iterations; and output the optimal plurality of weight values associated with the optimal TPR and FPR; (data gathering or extra-solution activity, additional element and/or evaluation and/or mathematical concept),
outputting a prediction of the likelihood of the patient developing DTI based on the probability value (extra-solution activity).
Independent claim 36 recites analogous limitations in a broader method claim; thus, the analysis of claim 29 applies mutatis mutandis to claim 36.
As indicated above, the independent claim recites at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting a generic computer components, can be grouped as a mental process (see italicized portions above), and is addressed as follows:
Thus, the limitation of the trained model is configured to… [perform claimed evaluation steps] encompasses an individual performing evaluation on gathered input data (SEM delta values) to arrive at an output (a probability value/likelihood), whereby such action is performable mentally or by pen-and-paper practice. The trained model being trained merely entails performing evaluations of the model on a gathered data set to arrive at a model with adjusted parameters. No limitations are provided that would force the complexity of any of the identified evaluation steps to be precluded from being performed by at least pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) (i.e., evaluation and training of a model) to derive a conclusion based on input of medical data, which corresponds to concepts identified as abstract ideas by the courts, such as in Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989). The concept of the recited steps above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
The dependent claims merely include limitations that either further define the abstract idea (e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process) or details of the data gathered. Thus, each dependent claim amounts to no more than generally linking the use of the abstract idea (a trained model) to a particular technological environment or field of use (deep tissue injury analysis) because they are merely extra-solution activity or incidental or token additions to the claims that do not alter or affect how the process steps are performed.
More specifically:
Claims 32, 33, 71-78, and 83-85 further describe details of gathered data and further evaluation steps required by an optimization algorithm, only serving to further define the abstract idea of the mental process and/or mathematical concept identified in the independent claims.
Claims 81-82 describe selection of an intervention and the specifics of such intervention based on the results of the evaluation steps in the independent claims. Such limitations define an additional mental process step of judgement or evaluation based on observation of results of previous steps.
Thus, the claims are each directed to an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
More specifically:
Independent claim 29 recites the additional elements of:
a processor;
Independent claim 36 does not recite an input device or processor.
Even should an input device be understood to possess a particular structure (e.g., an SEM measurement device), its use in the mental process as presently claimed would amount to mere extra-solution activity. See MPEP 2106.05(b).III:
“Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted)”
The processor is recited at a high-level of generality (i.e., as a generic processors and memory performing a generic computer function of performing calculations and storing data, respectively) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
The evaluations of a trained model are carried out via a processor; thus, the trained model may also be regarded as evaluation steps or mathematical concepts carried out via a generically-recited computer component.
Thus, such additional elements do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified generically recited elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea is not integrated into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application under because the claimed invention merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer (e.g., processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s Specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract ideas identified above in the independent claims (and their respective dependent claims) are not integrated into a practical application.
Claims 32, 33, 71-78, and 83-85 further describe details of gathered data and further evaluation steps required by an optimization algorithm, and thus do not contain additional elements which integrate the abstract ideas into a practical application.
Claims 81-82 describe selection of an intervention and the specifics of such intervention based on the results of the evaluation steps in the independent claims. The act of selection is a mental process step and not an additional element, and further is not a particular treatment or prophylaxis which would integrate the abstract idea into a practical application.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
Independent claim 29 recites the additional elements of:
a processor;
Independent claim 36 does not recite an input device or processor and is treated as encompassed by the analysis below.
The processor is described within a system which “can comprise any suitable type of microprocessor-based device, such as a personal computer, workstation, server or handheld computing device (portable electronic device) such as a phone or tablet (Paragraph 0098).
Similarly, the trained model is interpreted as embodying process steps carried out via a generic computer. The term “neural network” is defined at Paragraph 0050 in an elementary sense such that the skilled artisan would recognize that Applicant is referring to conventionally-known neural network algorithms. Thus, the term “neural network” and its accompanying training details are what provides the closest support for the claim term “trained model” (notwithstanding the rejection under 35 U.S.C. 112(a)). While details regarding how a neural network is trained are provided throughout the specification, the most detail regarding the special programming of the neural network itself is not provided in the specification. At best, Paragraphs 0061 and 0071 state minor details regarding basic architecture of a neural network:
“In an aspect, the neural network is a single-layer neural network. In an aspect, the neural network is a multi-layer neural network. In an aspect, the neural network comprises at least one hidden layer, at least two hidden layers, at least three hidden layers, at least four hidden layers, or at least five hidden layers. In an aspect, the neural network uses a supervised learning algorithm. In an aspect, the neural network uses an unsupervised learning algorithm.”
This is a generalized description of known elements of a neural network, and does not constitute special programming or algorithms.
Accordingly, in light of Applicant’s specification, the processor and the trained model are reasonably construed as a generic computing device and known algorithms embodied thereon. Generic computer-based components do not integrate an abstract idea into a practical application. See DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014) (“[A]fter Alice, there can remain no doubt: recitation of generic computer limitations does not make an otherwise ineligible claim patent eligible.”); see also MPEP § 2106.05(f). Accordingly, the claim 1 limitation of “the trained model is configured to calculate a probability value corresponding to the likelihood of the patient developing DTI” amounts to “[s]tating an abstract idea while adding the words ‘apply it with a computer,”’ which does not confer patent eligibility to the abstract idea. Alice, 573 U.S. at 223; Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437, slip op. at 18 (Fed. Cir. Apr. 18, 2025) (“[P]atents that do no more than claim the application of generic machine learning to new data environments, without disclosing improvements to the machine learning models to be applied, are patent ineligible under § 101.”).
Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear from the claims themselves and the specification that these limitations require no improved computer resources and merely utilize already available computers with their already available basic functions to use as tools in executing the claimed process (intake of specific data to evaluate via a trained model, and further evaluations involving training the model).
Each other dependent claim merely recites steps which further define the abstract idea and data/data-processing steps as previously stated in prior analysis steps. Examiner notes that the dependent claims recite limitations which are extra-solution or part of the abstract idea itself do not constitute significantly more.
Examiner further notes that an improvement to a technology cannot come from elements determined to be part of the abstract idea, and must instead come from identified additional elements to the abstract idea.
See MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
The recitation of the above-identified additional limitations in the claims amount to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
For at least the above reasons, the claims are directed to applying an abstract idea on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (processing received data using a trained model). That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself, or (ii) provide a technical solution to a problem in a technical field.
Therefore, none of the claims amounts to significantly more than the abstract idea itself.
Accordingly, the claims are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
Response to Argument
Applicant's arguments filed December 9, 2025 with respect to the rejection of the claims under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The portions of Applicant’s Remarks directed to the rejection of the claims under 35 U.S.C. 101 are addressed as follows:
Page 5 summarizes Examiner’s position, followed by Applicant’s statement of disagreement.
Pages 6-7 summarizes how the two-part "Alice Mayo test" is performed.
Pages 7-8 repeat verbatim claim language of the independent claims.
On Pages 8-9 alleges that “respectfully submits that when considered as a whole, the claims are not directed to an abstract idea, for at least the reason that the claims do not end by solely claiming a mathematical concept, certain methods of organizing human activity, or mental processes..” This statement is not followed by substantive argument and is viewed as bare allegation. The claims as a whole are analyzed. See rejection under 35 U.S.C. 101 above.
Pages 9-10 alleges that the present claims are found to be eligible akin to Example 47 of the "July 2024 Subject Matter Eligibility Examples" issued by the USPTO on July 17, 2024. Applicant’s claims 29 and 36 are more analogous to claim 2 of Example 47, which is found to be ineligible. Claim 1 of Example 47 is eligible because it recites specific structural features of computer memory required to form an application specific integrated circuit, and thus is not considered an abstract idea. Claim 3 of Example 47 is found to be eligible because it is directed to an improvement to computer technology because the disclosed invention detects network intrusions and takes real-time remedial actions, including dropping suspicious packets and blocking traffic from suspicious source addresses. Claim 2, most akin to Applicant’s invention, receives data and performs a series of evaluation steps implemented by a computer to process data and output it. Applicant’s present claims use evaluations (a model trained in a specific manner) as a tool to analyze medical data in order to arrive at a conclusion. As per the updated rejection of the claims under 35 U.S.C. 101, the claimed “trained model” is no longer considered an additional element in light of Applicant’s amendments, but a series of evaluation steps embodied on a generic computer processor.
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 JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791