DETAILED ACTION
Status of Claims
This is a Final Office Action in response to the arguments and/or amendments filed on 4 May 2026.
Claim(s) 1 is/are amended.
Claim(s) 1-6, 10-13, and 21-23 is/are currently pending and have been examined.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 10-13, and 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims not listed below are rejected based on dependency.
Claim 1 recites the non-original limitation “training, by one or more computers of a machine learning system, a predictive model with evidence-based case literature, wherein the trained predictive model is configured to generate resilience fuzzy membership levels.”
Applicant’s remarks identify Page 11, Lines 16-19; Page 12, Lines 14-17; Page 13, Lines 25-32; Page 15, Lines 28-32; Page 33, Lines 4-8; and Page 49, Lines 8-13 as support for the identified limitations.
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None of these disclosures appear to describe or suggest a trained model that “generate[s] resilience fuzzy membership levels.” For example, the first disclosure says that “Supervise Learning techniques” (which may be understood to reasonably imply a trained model) “offer[s] greater specificity to the weighting of … resilience fuzzy membership levels.” However, a trained model weighting resilience fuzzy membership levels does support a trained model generating those levels. As such, one of ordinary skill in the art would not consider these disclosures as supporting the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims contain a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected under the written description requirement.
Amended claim 1 recites the non-original limitation “generate first fuzzy set membership rules that can specify a resilience level for each of the hospital plurality of acquired infection impact reduction strategies based on regional, environmental, and demographic factors associated with the potential hospital employing a respective one of plurality of specific hospital acquired infection impact reduction strategies.”
Applicant’s remarks identify Page 12, Lines 8-13, Pages 20-21, Lines 31-6, and Page 24, Lines 27-29 as support for the identified limitation.
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The first disclosure does not appear relevant to the identified limitation. The second disclosure states “generate fuzzy set membership rules” and the third disclosure indicates that “regional, environmental, and demographic risk and operational factors” are relevant in HAI factors. These disclosures when considered together do not clearly suggest or support “generate fuzzy set membership rules … based on regional, environment, and demographic factors associated with a potential hospital employing a respective one of the plurality of specific hospital acquired infection impact reduction strategies”, much less “generate first fuzzy set membership rules that can specify a resilience level.” As such, one of ordinary skill in the art would not consider these disclosures as supporting the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims contain a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected under the written description requirement.
Amended claim 1 recites the non-original limitation “generate second fuzzy set membership rules that can specify a risk level for each of the plurality of hospital acquired infection impact reduction strategies based on the regional, environmental, and demographic factors associated with the potential hospital employing a respective one of the plurality of specific hospital acquired infection impact reduction strategies.”
Applicant’s remarks identify Page 11, Lines 13-15, Page 15, Lines 3-5, Pages 20-21, Lines 31-6; and Page 21, Lines 23-33 as support for the identified limitation.
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The first two disclosures do not relate to fuzzy membership set rule generation. The third and fourth disclosures state “generate fuzzy set membership rules” without reference to the remainder of the limitation at issue. None of these disclosure suggest or support generating a fuzzy set membership rules that specify a risk level for a HAI impact reduction strategy based on the claimed factors. As such, one of ordinary skill in the art would not consider these disclosures as supporting the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims contain a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected under the written description requirement.
Claim 1 recites the non-original limitation “inferring, by the one or more computers of the machine learning system, a resilience performance of the specific hospital in hospital infection risk factor prevention of each of the plurality hospital acquired infection impact reduction strategies at the specific hospital using a fuzzy inference system employing the first fuzzy membership set rules.”
Applicant’s remarks identify Pages 20-21, Lines 31-2; Page 21, Lines 23-28, and Page 22, Lines 5-6 as support for the identified limitation.
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All of the preceding disclosures describe inferring a performance, but none of them suggest inferring a resilience performance. Further, the first and second disclosures include a list of elements, and both lists clearly separate assessing resilience and inferring performance. As such, one of ordinary skill in the art would not consider these disclosures as supporting the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims contain a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected under the written description requirement.
Claim 1 recites the non-original limitation “inferring, by the one or more computers of the machine learning system, a risk prevention performance of the specific hospital in hospital infection risk factor prevention of each of the plurality hospital acquired infection impact reduction strategies at the specific hospital using the fuzzy inference system employing the second fuzzy membership set rules.”
Applicant’s remarks identify Page 21, Lines 23-28, Page 22, Lines 1-5, and Original Claim 1 as support for the identified limitation.
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Original Claim 1:
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The first and third disclosures inference of a performance “in hospital acquired infection risk factor prevention”, but none of these disclosures describe or suggest evaluation such risk prevention performance for each of the infection impact reduction strategies. The second disclosures indication that risk factor prevention may include different strategies does not suggest or imply inference across multiple strategies. As such, one of ordinary skill in the art would not consider these disclosures as supporting the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims contain a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected under the written description requirement.
Claim 1 recites the non-original limitation “outputting, by the one or more computers of the machine learning system, a ranking of performance safety outcomes for the plurality of hospital acquired infection impact reduction strategies employed by the specific hospital based on their inferred resilience performances and inferred risk prevention performances.”
Applicant’s remarks identify Page 18, Lines 6-8, Page 20, Lines 3-5, Page 27, Lines 4-5, and Table 18 as support for the identified limitation.
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Table 18:
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The first and second disclosures contemplate rankings but not “a ranking of performance safety outcomes.” Table 18 includes a “Associated Risk Prevention Ranking Input”, but the table does not appear to rank according to “Performance Safety Inference Output.” Further the table does not appear to indicate that the ranking is “based on their inferred resilience performances and inferred risk prevention performances.” As such, one of ordinary skill in the art would not consider these disclosures as supporting the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims contain a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected under the written description requirement.
Claim 21 recites the non-original limitation “altering a hospital strategy for managing a risk of hospital acquired infections based on the inferred resilience performances and inferred risk prevention performances.”
Applicant’s remarks identify Page 21, Lines 6-9, Page 22, Lines -78, Page 22, Lines 9-10, Page 22, Lines 24-28, and Page 22, Lines 32-34 as support for the identified limitation.
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The first, third, fourth, and fifth disclosures do not appear to be relevant to the identified limitation. The second limitation describes “altering a hospital strategy for managing risk of hospital acquired infections based on the inferred performance.” However, that performance is described in Lines 5-6 as with “[t]he performance of the hospital may be inferred based on the fuzzy membership set rules and contextual infection data.” Thus that performance is not described as either a resilience performance of a risk prevention performance. As such, one of ordinary skill in the art would not consider these disclosures as supporting the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims contain a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected under the written description requirement.
Claim 22 recites the non-original limitation “adaptively modifying the first fuzzy set membership rules in dependence on inferred performance of the resilience performance of the specific hospital in hospital infection risk factor prevention.”
Applicant’s remarks identify Page 21, Lines 3-4 as support for the identified limitation.
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While the identified disclosure does state the function of adaptive modification of membership rules, it does not specify the particular set of fuzzy membership rules and only indicates that the modifying is “in dependence on the inferred performance” in contrast to an “inferred performance of the resilience performance.” The current claims describe two separate types of performance: “resilience performance” and “risk prevention performance.” As there are difference types of performances, and the disclosure only describes adaptive modification based on a generic performance, one of ordinary skill in the art would not consider this disclosure as supporting the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims contain a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected under the written description requirement.
Claim 23 recites the non-original limitation “adaptively modifying the second fuzzy set membership rules in dependence on inferred performance of the risk prevention performance rules in dependence on inferred performance of the risk prevention performance of the specific hospital in hospital infection risk factor prevention.”
Applicant’s remarks identify Page 21, Lines 3-4 as support for the identified limitation.
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While the identified disclosure does state the function of adaptive modification of membership rules, it does not specify any particular set of fuzzy membership rules and only indicates that the modifying is “in dependence on the inferred performance” in contrast to an “inferred performance of the risk prevention performance rules.” The current claims describe two separate types of performance: “resilience performance” and “risk prevention performance.” As there are difference types of performances, and the disclosure only describes adaptive modification based on a generic performance, one of ordinary skill in the art would not consider this disclosure as supporting the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims contain a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected under the written description requirement.
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.
Claim(s) 1-6, 10-13, and 21-23 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites: a method for assessing hospital acquired infection reduction strategies to prevent risks of hospital acquired infections, comprising:
[creating], a predictive model with evidence-based case literature, wherein the
using,
using,
for each of the plurality of hospital acquired infection impact reduction strategies, assessing,
for each of the plurality of hospital acquired infection reduction strategies, assessing,
inferring,
inferring,
outputting,
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of using fuzzy analyses to evaluate a hospital acquired infection performance. This concept describes a mental process that a healthcare data analyst should follow to evaluate hospital acquired infection performance similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such the claims are determined to set forth a method of organizing human activity. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claim 1 recites the additional element of one or more computers of a machine learning system. This additional element is recited at an extremely high level of generality, and is interpreted as a generic computing device used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not integrate the abstract idea into a practical application.
Claim 1 further recites the additional element of training a model. This additional element amounts to instructions to implement the abstract idea with a computing device. As such, this additional element does not integrate the abstract idea into a practical application. There are no further additional elements. When considered as a combination, the additional elements only amount to instructions to implement the abstract idea with a computing device. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite additional elements which may be interpreted as generic computing devices used to implement the abstract idea or instructions to implement the abstract idea with a generic computing device. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements does not amount to significantly more. Further, as the combination of additional elements only amount to instructions to implement the abstract idea with a computing device, the combination of additional elements similarly does not amount to significantly more. There are no further additional elements. Therefore, when considered individually and as a combination, the additional elements of the independent claim do not amount to significantly more than the abstract idea. Thus the independent claim is not patent eligible.
Dependent claims 2-6, 10-13, and 21-23 further describe and narrow the method of organizing human activity, but these claims continue to set forth a method of organizing human activity and recite an abstract idea. Dependent claims 2-6, 10-13, and 21-23 recite no further additional elements. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract idea into a practical application for the same reasons as indicated above. As such, these claims continue to be directed to an abstract idea. Further, the previously identified additional elements, individually and as a combination, do not amount to significantly more than the narrowed abstract idea for the same reasons as indicated above. Thus as the dependent claims remain directed to an abstract idea, and as the additional elements of the dependent claims do not amount to significantly more, the dependent claims are not patent eligible.
Response to Arguments
Applicant’s Argument Regarding 112(a) Rejections of claims 1-6, 10-13, and 21-23: Applicant has demonstrated possession of each above-recited features of a claimed invention such that one skilled in the art can reasonably conclude that the inventor has possession of the claimed invention.
Examiner’s Response: Applicant's arguments filed 4 May 2026 have been fully considered but they are not persuasive. Applicant’s newly provided support has been considered in the updated rejections above.
Applicant’s Argument Regarding 101 Rejections of claims 1-6, 10-13, and 21-23:
The specification presents the technical solution of “evaluating system performance safety” with “supervised learning techniques such as OLS [which] offer greater specificity to the weighting of different system risk and resilience fuzzy membership levels. An approach is provided for using Resilience Inference Fuzzy Membership Categories based on Fuzzy Risk Capacity, Resilience Capability, and Performance Safety outcomes as a basis for Fuzzy Inference System decision rules. The methodology establishes a process for inputting fuzzy HAI Risk and HAI Resilience membership function parameters into a Fuzzy Inference System that could estimate specific HAI Performance Safety outcomes.”
In rejecting the claim, the Office Action improperly parses individual method steps into irregular overly broad phrases. …the Office Action considers “training” to be a sole additional element on its own that is to be considered separate from “a predictive model with evidence-based case study literature…” … Applicant respectfully submits that this is an oversimplification of the claim element.
In Example 39, the Office found that the limitation “training the neural network in a first stage using the first training set” does not recite a judicial exception. … In doing so, it is noted that the Office in Example 39 did not split out that particular claim limitation into multiple parts and instead treated the limitation in its entirety and found the limitation to be not capable of being practically performed as a mental operation.
Applicant submits that “training, by one or more computers of a machine learning system, a predictive model with evidence-based case study literature, wherein the trained predictive model is configured to generate resilience fuzzy membership levels that define performance qualities of a plurality of hospital acquired infection impact reduction strategies for preventing a hospital acquired infection” is not capable of being performed as a mental operation. For at least this reason, claim 1 is patent eligible.
Applicant submits that the combination of limitations … when evaluated as a whole with the other recited features in the claims is a technical improvement over prior art systems.
Examiner’s Response: Applicant's arguments filed 4 May 2026 have been fully considered but they are not persuasive.
The improvement asserted by Applicant does not appear to be reflected by the current claims which do not recite weighting of difference system risk and resilience fuzzy membership levels, fuzzy inference categories based on reference fuzzy risk capacity, resilience capability or performance safety outcomes, fuzzy decision rules, or inputting fuzzy HAI risk and HAI resilience membership function parameters.
Examiner notes Example 48, Claim 2 which recited a limitation of “using a deep neural network (DNN) to determine embedding vectors V using the formula V=fƟ(X) is a global function of the mixed speech signal x.” The guidance specifically considers the “determine embedding vectors V…” portion of the limitation to be part of the abstract idea and the “using a deep neural network (DNN)” as an additional element. As such, Applicant’s argument that such parsing is oversimplification appears directly contrary to subject matter eligibility guidance.
Example 39 is inapposite to the present claims. The limitation at issue in the example (“training the neural network in a first stage using the first training set”) purely recites training. That limitation is not analogous to the current claimed training step. Further, the guidance makes it clear that Example 39 does not recite any abstract idea. Thus definitionally the training step of the example cannot be subdivided.
The rejection does not rely on “training, by one or more computers of a machine learning system…” being a mental process. As such, Applicant’s assertion that “training, by one or more computers of a machine learning system…” cannot be performed at as a mental operation does not address the eligibility rejection.
Per MPEP 2106.05(a), “If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification.” The disclosure does not include technical details of implementing the referenced features, and as such the asserted improvement is not considered a technical improvement.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 of the prior office actions dated 15 August 2024, 10 April 2025, and 4 February 2026.
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 Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Bion A Shelden/Primary Examiner, Art Unit 3685 2026-07-02
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