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 .
DETAILED ACTION
This action is in reference to the communication filed on 5 AUG 2025.
Amendments to claims 1, 2, 5-7, 9, 13, 14, 17, 18, 20, 25, 26 are entered and considered as is the cancellation of claims 8, 10-12, 21-24, 27, 28. No new claims added.
Claims 1-7, 9, 13-20, 25, 26, pending and examined.
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 1-7, 9, 13-20, 25, 26 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-7, 9, 13-20, 25, 26 the independent claim(s) 1, 13, 25, 26 recite(s) a system, method, a computer program product, and a non-tangible computer readable medium, each of which is a process, machine, or article of manufacture, i.e. a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-7, 9, 13-20, 25, 26 the independent claim(s) (claims 1, 13, 25, 26) is/are directed, in part, to, as shown in exemplary claim 1:
A
select ICD codes related to oropharyngeal dysphagia;
select variables with a higher capacity of predicting oropharyngeal dysphagia as a function of the selected ICD codes; and
train an expert module as a function of the selected variables;
wherein the expert module is trained by executing a random forests model and a high information
density disperse Bayesian network (RBDADJ) model having a higher information density than a Bayesian network model, the RBDADI model resulting from limiting arcs of a directed acyclic graph of a Bayesian network model according to Shannon’s mutual information index for each arc; and
the at least one prediction
determine the risk of suffering from oropharyngeal dysphagia of at least one patient using the
inputting the data of the at least one patient to the random forests model of the expert module; inputting the data of the at least one patient as input to the RBDADI model of the expert module; and
for each of the at least one patient: determining a positive risk of suffering from oropharyngeal dysphagia when results of the random forest model and the RBDADI model are both above 50%;
determining that there is no risk of suffering from oropharyngeal dysphagia when the results of the random forest model and the RBDADI model are both equal to or below 50%; and
repeating execution of both the random forest model and the RBDADI model by applying a risk parameter A between 0 and 1 when the results of the random forest model and the RBDADI model include a result above 50% and a result equal to or below 50%.
The limitations of requesting/receiving patent data, selecting the databases, selecting variables, training the expert as a function, and determining a risk of suffering from oropharyngeal dysphagia as a function of modeling, require concepts performed in the human mind such as observation, evaluation, judgement, and opinion.
The limitations regarding the functioning of the training of the expert, and of the random forest/RBDADI training and modeling are found to recite mathematical concepts such as mathematical relationships, formulas, equations, and/or calculations.
If a claim limitation, under its broadest reasonable interpretation, covers concepts performed in the mind including observation, evaluation, judgment, and opinion, then it falls within the “mental processes” grouping of abstract ideas. Further, if a claim limitation under its broadest reasonable interpretation, covers mathematical relationships, formulas, equations and/or calculations, then it falls within the mathematical concepts grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional elements: each of the claims recites a “digital” system comprising multiple servers and a query terminal to receive a request, as well as a training server. In the interest of compact prosecution Examiner notes that patient data is requested and “received” via the digital system. Claims 1, 13 do not include any further additional elements. Claim 25 recites “a computer program comprising instructions which once executed on a processor…,” while claim 26 recites “a non-tangible computer readable means comprising instructions which once executed on a processor…”.
Examiner finds the “digital” aspects of the claims including the server(s), as well as the query terminal, to be at best adding “apply it (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)), or particularly with regard to the term “digital” generally linking the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). With regard to the nominal sending/receiving of data, Examiner notes this is generally considered insignificant extra solution activity (see MPEP 2106.05g) (In the interest of compact prosecution Examiner leaves reference to the previously omitted database in the rejection: if the database were to be claimed with any functionality, the storing of data on a database would generally be considered in the same manner). With regard to the computer program and non-tangible computer readable means as claimed in 25, 26, Examiner finds similarly – this is at best mere instructions to implement the abstract idea on a computer or merely using a computer as a tool (see MPEP 2106.05f). Examiner finds improvement to the functioning of the computer, or to any other technology or a technical field of use (see MPEP 2106.05a). Nothing about these additional elements suggests a finding of applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception (see MPEP 2106.05(e)).
Accordingly, this/these additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as:
Each of the claims recites a “digital” system comprising multiple servers and a query terminal to receive a request. The “means” of selecting/predicting are “digital,” and in the interest of compact prosecution Examiner notes that patient data is requested and “received” via the digital system. Claims 1, 13 do not include any further additional elements. Claim 25 recites “a computer program comprising instructions which once executed on a processor…,” while claim 26 recites “a non-tangible computer readable means comprising instructions which once executed on a processor…”.
When considered individually, the “digital” claim elements including the servers, as well as the query terminal and the computer program comprising instructions/non-tangible computer readable means…” only contribute generic recitations of technical elements to the claims. Examiner finds no improvement to these elements or to the realm of any other technology/field (see MPEP 2106.05e). Instead, these elements are more aligned with generally linking the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05e), and/or adding the words “apply it” with the judicial exception or mere instructions to implement the abstract idea on a computer/using the computer as a tool (see MPEP 2106.05f).
Examiner looks to Applicant’s specification in
[0038] The existence of an application programming interface API which connects the users with the prediction servers, and the use of standards, such as JSON, to transmit and receive information, permits the different users of the system the integration in their own patient management programs, either as a tag, or as a notification when visualizing the clinical record, or any other preferred means. There is complete flexibility on how to integrate the prediction information with the computer systems and compatible with all the existing systems, be it UNIX, Windows or any other.
0039] For example, in one aspect, the communication is direct between the training server 210 and the query terminal 230. This configuration is useful if it is not possible to install an OD server 220 in the population in question. Whilst, in one aspect, the corresponding prediction server 220 responds the queries from the query terminals, after requesting and obtaining the response from the training server 210, in another aspect, it is the prediction server which updates by means of downloading the most recent expert module, and responding the received queries directly. Like this, a server of a computing cluster, can be in charge of training the system continuously. The resulting training models are stored in binary files which are used by the server which performs the predictions. This is connected by means of internal networks, or via internet, and permits clients to perform queries.
[0085]… A cluster or server with a high computation capacity focused only in training the system which serves the training results to the rest of the prediction servers, enabling minimizing the time necessary for training and minimizing the time necessary for performing prediction for the user. 2. Separate the training server from the prediction server enabling having diverse prediction servers located in geographical zones close to the users. For example, there can be one or more prediction servers in Japan giving coverage to Asia, one or many in the United States giving coverage to North America and one or many in Europe giving coverage to the European continent, the system thereby being scalable and permitting adapting very rapidly to user demand. 3. The separation between the training and the prediction servers improves security and adds security to the sensitive data, which would be held only in the training server.
[0087] Furthermore, it is to be understood that the embodiments, realizations, and aspects described herein may be implemented by various means in hardware, software, firmware, middleware, microcode, or any combination thereof. Various aspects or features described herein may be implemented, on one hand, as a method or process or function, and on the other hand as an apparatus, a device, a system, or computer program accessible from any computer-readable device, carrier, or media. The methods or algorithms described may be embodied directly in hardware, in a software module executed by a processor, or a combination of the two.
[0090] The various means may comprise computer-readable media including, but not limited to, magnetic storage devices (for example, hard disk, floppy disk, magnetic strips, etc.), optical disks (for example, compact disk (CD), digital versatile disk (DVD), etc.), smart cards, and flash memory devices (for example, EPROM, card, stick, key drive, etc.). Additionally, various storage media described herein can represent one or more devices and/or other machine-readable media for storing information. The term “machine-readable medium” can include, without being limited to, various media capable of storing, containing, and/or carrying instruction(s) and/or data. Additionally, a computer program product may include a computer readable medium having one or more instructions or codes operable to cause a computer to perform the functions described herein.
Examiner notes no additional description of the “digital” elements, nor any structure whatsoever identifying the query terminal.
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 2-12, 14-24, 27, 28:
Dependent claims 2-12, 14-24, 27, 28 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as types of records/data collected from patients, addition description of the mathematic modeling used, and the mathematical conclusions reached regarding the oropharyngeal dysphagia. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Response to Arguments
Applicant’s remarks as filed on 5 AUG 2025 are fully considered.
Applicant’ s amendments to claim 2 have negated the rejection under 35 USC 112d, and as such it is withdrawn.
Applicants amendments have negated the interpretation under 112f, and as such the corresponding 112a, b, rejections are withdrawn.
Applicant’s remarks regarding the 101 rejection begin on page 13 of the remarks. Examiner notes the amended elements have been added above. Applicant argues on page 13 that the RBDADI model itself improves the functioning of the computer. Examiner respectfully disagrees – as the RBDADI modeling would be analyzed as part of the abstract idea as identified, and as such not a part of the improvement. These mathematical functions are being executed using the computing elements, rather than providing a meaningful improvement therein. The claims as written do not recite an improvement to the processing speed. Examiner suggests further incorporation of the specifics of the RBDADI modeling into the claim itself, as RBDADI is not clearly defined in the claim nor lexicographically in the specification, and it is therefore not clear what if any the improvement provided by it is.
Applicant’s remarks/amendments to claim 26 are found persuasive with regard to the non-transitory computer readable medium, and the rejection is withdrawn.
Conclusion
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 KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687