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
Response to Amendment
In the amendment dated 11/12/2025, the following occurred: Claims 1, 7, 9, 11 and 15 were amended. Claims 17-20 were canceled.
Claims 1-16 are currently pending.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method, system and device for caregiver guidance system.
Regarding claims 1 and 11, the limitation of (claim 1 being representative) train on historical caregiver actions data and historical patient data to establish correlation patterns; receive caregiver actions data associated with an experienced caregiver and patient data associated with a patient; analyze the caregiver actions data to identify at least one action performed by the experienced caregiver in response to a patient event detected from the patient data; correlate the at least one action performed by the experienced caregiver to the patient event; determine a clinical recommendation and a confidence rating based on correlation between the at least one action and the patient event, wherein the confidence rating quantifies a strength of the correlation and a quantity of similar caregiver actions in the historical caregiver action data; determine when the patient event occurs while an inexperienced caregiver is managing the patient event; present, when the confidence rating exceeds a threshold, the clinical recommendation to the inexperienced caregiver; monitor outcomes of clinical interventions performed in response to presenting the clinical recommendation; and retrain based on the outcomes to improve accuracy of future clinical recommendations, including to update the correlation patterns based on newly established correlations between the outcomes and corresponding caregiver actions as drafted, is a process that, under the broadest reasonable interpretation, covers a method organizing human activity but for the recitation of generic computer components. That is other than reciting (in claim 1) a caregiver guidance system, at least one processing device and a memory device and (in claim 11) a method, the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, but for the caregiver guidance system, at least one processing device and the memory device, the claims encompass a person following a set of rules or instructions to train to establish correlation patterns, receive caregiver actions data and patient data, analyze the caregiver actions data, correlate the at least one action performed by the experienced caregiver to the patient event, determine a clinical recommendation, determine when the patient event occurs while an inexperienced caregiver is managing the patient event, present the clinical recommendation and retrain based on the outcomes to improve accuracy of future clinical recommendation in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a caregiver guidance system, at least one processing device and a memory device. Claim 11 is not tied to any particular technological environment that implements the identified abstract idea. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic server or generic computer components for enabling access to medical information or for performing generic computer functions. See Specification at para. [0042]-[0044]) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1 and 11 further recite the additional elements of an artificial intelligence model. This additional element is interpreted as “apply it” to the abstract idea (See Specification at para. [0054], [0057], [0060] and [0087]). MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the caregiver guidance system, at least one processing device and the memory device to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional element of an artificial intelligence model was determined to be the application of artificial intelligence technology to the identified abstract idea. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(1)(A) indicates that merely saying “apply it’ or equivalent to the abstract idea cannot provide an inventive concept (“significantly more’). As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 2-10 and 12-16 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 and 12 further merely describe(s) receiving the data from a camera-based observation system. Claim(s) 2 and 12 also include the additional element of “a camera-based observation system” which is interpreted as an additional element and does not provide practical application or significantly more. Claim(s) 3 and 12 further merely describe(s) receiving the data from a real time location system. Claim(s) 3 and 12 also include the additional elements of “a real time location system” which is interpreted as an additional element and does not provide practical application or significantly more. Claim(s) 4 and 12 further merely describe(s) receiving the data. Claim(s) 4 and 12 also include the additional element of “an electronic medical record system” and “a patient vital sign detector” which are interpreted as additional elements and do not provide practical application or significantly more. Claim(s) 5 and 13 further merely describe(s) identifying a situation to present the recommendation. Claim(s) 6 and 14 further merely describe(s) analyzing the caregiver action and determining and providing the most common action. Claim(s) 7 and 15 further merely describe(s) determining a strength of caregiver action, generating a confidence rating and issuing an alert. Claim(s) 8 and 16 further merely describe(s) requesting validation. Claim(s) 9 further merely describe(s) monitoring actions and issuing an alert. Claim(s) 10 further merely describe(s) requesting validation. As can be see, all dependent claims further define the abstract idea.
Claim Rejections - 35 USC § 112
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 1-16 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.
Claims 1 and 11 recite functional steps for which the Applicant has not adequately described the steps in sufficient detail for one of the ordinary skill in the art to conclude that the Applicant has possession of the invention at the time of filling.
Specifically, the claims recite (Claim 1 being representative) “and retrain the artificial intelligence model based on the outcomes to improve accuracy of future clinical recommendations, including to update the correlation patterns based on newly established correlations between the outcomes and corresponding caregiver actions.” The Applicant has provided no disclosure on retraining the artificial intelligence model based on outcomes and has provided no disclosure on how to update the correlation patterns based on newly established correlations between the outcomes and corresponding caregiver actions. Moreover, the disclosure is void of any language on how correlation patterns are established.
As can be see, there is no specific description as to how the artificial intelligence model is retrained, how correlation patterns are established and updating correlation patterns. As such the claimed invention lacks adequate written description.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-16, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Amended claim 1 recites specific limitations directed to training and retraining an artificial intelligence model that integrate any recited judicial exception into a practical application by providing an improvement to the technology of caregiver guidance systems. The claim as a whole reflects a particular technical solution to the technical problem of providing accurate clinical recommendations by leveraging patterns established from experienced caregiver actions and continuously improving the model through outcome monitoring and retraining. The artificial intelligence model limitations now recited in amended claim 1 provide meaningful technical details that move beyond mere generic computer implementation. Claim 1 now requires training an artificial intelligence model on historical caregiver actions data and historical patient data to establish correlation patterns. Specification at [0045]-[0052]... These artificial intelligence model limitations reflect improvements described in the specification that would be apparent to one of ordinary skill in the art. The specification explains that existing caregiver guidance systems fail to leverage the collective knowledge and experience of expert caregivers in providing clinical recommendations to less experienced caregivers. Specification at [0012]-[0018]. The specification further explains that the disclosed system addresses this technical problem by training an artificial intelligence model to identify patterns in how experienced caregivers respond to patient events, thereby capturing expert knowledge that can be used to guide inexperienced caregivers in real time… The retraining limitations added in view of the interview further demonstrate integration into a practical application…
Regarding 1, The Examiner respectfully disagrees. The additional elements of an artificial intelligence model is interpreted as “apply it” to the abstract idea (See Specification at para. [0054] that states “The artificial intelligence models 404 can be applied to process the data” also see para. [0057], [0060] and [0087]). MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(1)(A) indicates that merely saying “apply it’ or equivalent to the abstract idea cannot provide an inventive concept (“significantly more’). As such the claim is not patent eligible. Moreover, the specification does not claim a technical solution to a technical problem and focuses on improvements to patient condition (para. [0028], [0064] and [0087]), patient outcome (para. [0075]), the efficiency and safety of caregivers (para. [0083]) and oxygenation and respiratory mechanics (para. [0090] and [0092]). None of these improvements are related to the technology of artificial intelligence. The claim is ineligible.
Amended claim 1 is directly analogous. Like claim 3 of Example 47, amended claim 1 recites training an artificial intelligence model and using that trained model to provide technical improvements in a specific technical field, here caregiver guidance systems. The claim reflects the improvement by reciting how the model establishes and uses correlation patterns to determine clinical recommendations with quantified confidence ratings, and how the system monitors outcomes and retrains the model to continuously improve accuracy. These limitations provide for improved clinical decision support by proactively providing reliable recommendations to inexperienced caregivers based on patterns learned from experienced caregivers, and by continuously improving those recommendations through outcome monitoring and model retraining. This is not a generic application of an abstract idea using generic computers. Rather, the claim recites a particular technical solution involving specific artificial intelligence training, analysis, and retraining steps that improve the technology of caregiver guidance systems.
Regarding 2, The Examiner respectfully disagrees. Applicants claims are unlike that of Example 47, claim 3. The additional elements in Example 47, claim 3 integrated the abstract idea into a practical application because they provided improvement in the technical field of network intrusion detection. Applicants claims do not provide any technical improvement nor improvements to the functioning of a computer.
Rejection under 35 U.S.C. § 103
Regarding the rejection of claims 1-16, the Examiner has considered the Applicant’s arguments, and finds them persuasive. The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within the independent claim. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: train an artificial intelligence model on historical caregiver actions data and historical patient data to establish correlation patterns; receive caregiver actions data associated with an experienced caregiver and patient data associated with a patient; analyze, by the artificial intelligence model, the caregiver actions data to identify at least one action performed by the experienced caregiver in response to a patient event detected from the patient data; correlate, by the artificial intelligence model using the correlation patterns, the at least one action performed by the experienced caregiver to the patient event; determine, by the artificial intelligence model, a clinical recommendation and a confidence rating based on correlation between the at least one action and the patient event, wherein the confidence rating quantifies a strength of the correlation and a quantity of similar caregiver actions in the historical caregiver actions data; determine when the patient event occurs while an inexperienced caregiver is managing the patient event; present, when the confidence rating exceeds a threshold, the clinical recommendation to the inexperienced caregiver; monitor outcomes of clinical interventions performed in response to presenting the clinical recommendation; and retrain the artificial intelligence model based on the outcomes to improve accuracy of future clinical recommendations, including to update the correlation patterns based on newly established correlations between the outcomes and corresponding caregiver actions.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. 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.
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Mazar (US 2015/0302538) teaches patient care and health information management systems and methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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