DETAILED ACTION
This office action is based on the claim set filed on 04/29/2026.
Claims 1, 11, and 16 have been amended.
Claims 1-12 and 14-21 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/29/2026 has been entered.
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.
Claim(s) 21 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In order to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2161.01(1). However, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed, and even original claims may fail to satisfy the written description requirement when the invention is claimed and described in functional language but the specification does not sufficiently identify how the invention achieves the claimed function, See MPEP 2161.01(1) citing in part Ariad, 598 F.3d at 1349 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries.").
Specifically, with regard to computer-implemented functional claims, the specification must provide a disclosure of the computer and the algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, including how to program the disclosed computer to perform the claimed function. MPEP 2161.01(1).
Claim 21, recites “one or more therapeutic devices to perform automated administration of the at least one of the one or more baseline clinical interventions, and one or more medical management devices to perform automated administration of the at least one of the one or more baseline clinical interventions in response to the order from the patient monitor”, for which the subject matter of the limitation 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, at the time the application was filed, had possession of the claimed invention. As best understood, it appears that there is no support for the underlined recitation in the original disclosure of the present application for this limitation. While as described in applicant’s specification [0082], the description discloses “the AKI decision support application 108 may order an automated administration of at least one of the one or more baseline clinical interventions via one or more of the therapeutic devices 118, and/or order an automated administration of at least one of the one or more baseline clinical interventions via one or more of the medical management devices 116”, the specification, [0036, 0038, 0085, 0087], the description discloses “the therapeutic device 116 may supply and/or monitor the administration...”, “the medical management device 118 may supply and/or monitor the administration of one or more patient medications...”. However, ordering an automatic intervention is providing a request for intervention while performing the administration is an execution step demonstrated by a physical act which is a separate action than ordering. There is not explicit disclosure as filed describing the feature “to perform automated administration” as claimed.
The examiner takes the position that with respect to these limitations or features of the claims, the specification fails to provide an adequate written description of the invention to an extent that would sufficiently show that applicant was in possession of an invention that could operate as claimed. Simply disclosing a vague description, without actually explaining how to perform the function(s) claimed, results in a written description problem under 112(a). The examiner has no idea how applicant actually contemplated doing these steps because nothing is disclosed other than the broad disclosure of the specification as mentioned above.
Therefore, applicant has failed to show the actual subject matter in their possession at the time of the invention in a way sufficient to reasonably convey to one skilled in the relevant art that applicant had possession of the claimed invention at the time the application was filed. Therefore, these limitations of the claims are considered to be new matter. Appropriate correction is required.
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 1-12 and 14-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-10 and 21 are drawn to an apparatus/system, Claims 11-12 and 14-15 are drawn to a method, and Claims 16-20 are drawn to an art of manufacturer, and each of which is within the four statutory categories (i.e. a machine and a process). Claims 1-12 and 14- 21 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for assessment of a disease/injury risk. Evaluating a medical condition (e.g., injury) based on collected patient information is an abstract idea that could have been performed by a human mind but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for steps citing a process of identifying a medical condition risk predication according to baseline to determine the condition stage for which both the instant claims and the abstract idea are defined as metal process that can be performed using human mind with the aid of pencil and paper.
Independent claims 1, 11, 16 recite the steps of:
“a user interface; and a patient monitor communicatively coupled to the user interface, the patient monitor to:
determine whether a baseline AKI risk prediction is above a baseline threshold based on patient demographic data and patient medical history data;
perform a framework that combines a plurality of types of AKI assessments from a plurality of machine-learning based prediction models to determine a continuous AKI risk prediction, the continuous AKI risk prediction comprising:
determine whether an any risk of AKI prediction is above an any AKI threshold based on dynamic intervention data and dynamic patient condition data gathered via the patient monitor, wherein the any AKI threshold determines a risk of developing any AKI within a specified warning time period;
determine an AKI stage prediction in response to a determination that the any risk of AKI prediction is above the any AKI threshold based on the dynamic intervention data and the dynamic patient condition data gathered via the patient monitor
determine one or more baseline clinical interventions in response to a determination that the baseline AKI risk prediction is above the baseline threshold;
transmit a signal indicating a need for administration of at least one of the one or more baseline clinical interventions, the one or more baseline clinical interventions comprising administration of dialysis treatments via one or more therapeutic devices, or administration of at least one of the one or more baseline clinical interventions the one or more baseline clinical interventions comprising administration of one or more of blood pressure medications, diuretic medications, anti-anemia medications, cholesterol lowering medications, and vitamin supplements via one or more medical management devices
iterate the performing the continuous AKI risk prediction in response to a determination that the any risk of AKI prediction is below the any AKI threshold to adjust power consumption by adapting data collection frequency and data transmission frequency in response to continuous AKI risk prediction”.
The limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations by a human mind with aid of pen and paper, thus, an abstract idea, but for the recitation of generic computer components. The claimed concept encompasses to performance of the limitations of a mental process that encompasses the user manually the ability to obtain a known patient data/information, analyze the information according to identified baseline information to perform risk predication, and determine a medical condition/injury stage, which are steps reciting mental process that could have been performed by a human mind with aid of pen and paper but other than the mere nominal recitation of "computing device, patient monitor, user interface", to implement the abstract idea for performing the steps of observing, evaluating, judgment and opinion which are citing a process for which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the Mental Process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “computing device, user interface, patient monitor, computer readable medium, medical management devices, therapeutic devices” that is/are recited at a high - level of generality to perform the steps of the claim(s), e.g., “transmit a signal indicating a need for...”, and performing generic computer functions for generating a predicted results associated with medical condition/injury, such that it amounts no more than adding the words "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), adding insignificant extra-solution activity to the judicial exception, (e.g. “to adjust power consumption...,”) which is/are analyzed as a nominal or tangential addition to the abstract idea and does not affect the generation of the data object and as such amounts to insignificant post/extra-solution activity to apply the exception using generic computer component to perform the function and such as mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.05(d)(g). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] 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, looking at the claim as a whole, individually and 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.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f), adding insignificant, extra solution activity that has been found to not amount to significantly more than an abstract idea and mere data gathering that does not add a meaningful limitation to the above abstract idea, for example, the function for adjusting limits have been recognized as well-understood, routine, and conventional activity of a general-purpose computer, see MPEP 2106.05(d)-(g), and see Bancorp Services v. Sun Life. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an 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."). The claims are not patent eligible.
Dependent Claims 2-10, 12, 14-15, and 17-20 include all of the limitations of claim(s) 1, 11, and 16, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 2-3, 5-6, 9-10, 14, and 18-19 the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible.
As for claims 4, 7-8, 12, 15, 17, and 20-21, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “user interface, therapeutic devices, medical management devices, sensors” that implement the identified abstract idea. These hardware components are recited at a high level of generality (i.e., general purpose computers/components implementing generic computer functions; applicant's specification makes no mention of any specific hardware) to perform the steps, e.g., “transfer a notification...,” that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Response to Amendment
Applicant's arguments filed 04/29/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 11-17.
On page 12-13 of the remarks, Applicant argues “Regarding prong two of Step 2A, the Applicant respectfully submits that claim 1 should be found to be patent eligible at least at Prong Two by reciting additional elements to integrate the exception into a practical application... Applicant respectfully submits that such operations recite additional elements to integrate the exception into a practical application ... at least due to the additional elements effect a particular treatment or prophylaxis for a disease or medical condition, as the claims recite "automated administration."”, Examiner respectfully disagree. As described in the Final OA mailed 12/30/2025, the claims under BRI recites an abstract idea for monitoring patient and determine an AKI risk predication and transmitting a signal indicating a need for administration of an intervention without a clear recitation of administrating the treatment and using devices to monitor the administration and gathering data. As mentioned, that the step for transmitting a signal indicating a need for administrating a treatment is not similar to the performance of the treatment administration. In addition, the claim does not affirmatively recite any steps or functions that effect a particular treatment or prophylaxis for a disease or medical condition or how or would it effect the condition other than just transmitting a signal indicating a need for a treatment, then it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “effect a particular treatment or prophylaxis”. This is similar to in Mayo steps of performing administration of a treatment and gather data that is directed to a diagnostic focus, see MPEP 2106.04(d)(2).
Moreover, Applicant argues claim(s) feature that is recited in the claim(s) and specification "order an automated administration of ...clinical interventions..." as it is understood that the claim limitation is for ordering an automated administration while no administration is or has been performed rather than sending a request to device(s) to perform an intervention such as the medical and/or therapeutic devices described is configured to supply (perform) and monitor an administration but no performing automatic administration nor a physical administration has been performed via therapeutic and/or medical management devices, see at least claims 8, 15, 20, 21 and specification (PGPub [0082], [0084-0087]).
On page 12-13 of the remarks, Applicant argues that “the Applicant respectfully submits that claim 1 should be found to be patent eligible at least at Prong Two by reciting additional elements to integrate the exception into a practical application. More specifically, claim 1 recites operations to "the patient monitor to: ... perform a framework that combines a plurality of types of AKI assessments from a plurality of machine-learning based prediction models to determine a continuous AKI risk prediction ... dynamic patient condition data gathered via the patient monitor, ... iterate the performing the continuous AKI risk prediction ...." Applicant respectfully submits that such operations recite additional elements to integrate the exception into a practical application at least due to the additional elements being applied with a particular machine and providing an improvement to other technology or technical field”, Examiner respectfully disagree. As mentioned above and as described in the 101 rejection, the claim, under BRI, recite steps that can be performed by human. The claims additional elements such as patient monitor is recited at a high level of generality and as a tool to perform the claim function using computing components. For example, the patient monitor is described as a generic computing component and as a tool for collecting, analyzing and outputting data, see Applicant PG-Pub specifications [0032-0033] describes “the patient monitor 110 may comprise a bedside-type monitor, a transport-type monitor, a central station-type monitor, the like, and/or combinations thereof”, which clearly is not describing a specific type of monitor designed to perform a unique manufacturing process that would be considered to involve a "particular machine" rather a mere description of generic hardware “any monitor” used as a tool to perform the functions. Therefore, the additional elements do not use the exception to affect a particular treatment or prophylaxis for a disease, do not apply the exception using particular machines, and do not effect a transformation or reduction of a particular article to a different state or thing, rather the computer elements are generally stated as to their structure and function and are only used to evaluate kidney disease instead of treating patients.
Moreover, the instant claim(s) and specifications do not recite an improvement to technology but rather addressing a health facility and patient administrative problem, to the performance of an abstract idea such as analyzing patient data for predicting AKI risk while using well-known computer system and components. In addition, by relying on computing devices to perform routine tasks more quickly or more accurately is insufficient to render a claim patent eligible (See Alice, 134 S. Ct. at 2359 "use of a computer to create electronic records, track multiple transactions, and issue simultaneous instructions" is not an inventive concept). Accordingly, looking at the claim as a whole, individually and 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.
On page 13 of the remarks, Applicant argues that “This framework of amended claim I improves the technical field by addressing problems associated with individual assessment of AKI risk factors using AKI predictive models...”, Examiner respectfully disagree. The Applicant amended claims is adapting performance of framework to determine AKI risk prediction which organizes rules, concepts, etc., to analyze data and predict AKI risk which is adding step(s) to the performance of the identified abstract idea. For example, the Applicant specification [0053]-[0063] describes rules for predicting AKI risk such that splitting the continuous AKI risk prediction into two associated prediction tasks with two decision thresholds and clinical protocols linked together. As such, nowhere in the specification describes how such framework is providing a specific technical improvement to the computer function of machine-learning models, see PGPub [0064] “Such procedures provide a framework to link machine learning based algorithm predictions to actions (e.g., interventions)”.
On page 13-14 of the remarks, Applicant argues that “the patient monitor 110 is specifically described as a particular machine (such as a bedside-type monitor, a transport-type monitor, or a central station-type monitor) adapted to determine measured patient data (e.g., via one of more of the sensors 112), and not merely a generic computer”, Examiner respectfully disagree. As described in the specification [0032-0033] “patient monitor 110 may comprise a bedside-type monitor, a transport-type monitor, a central station-type monitor, the like, and/or combinations thereof”, where the specification is describing such monitors as a generic device without detailing the features, specific data collection or processing, as such describing a generic hardware but not a particular machine.
On page 14 of the remarks, Applicant argues that “Here, the claim is directed to operation of a single device (e.g., a patient monitor), where the single device is adapted to both gather dynamic patient condition data and perform a continuous AKI risk prediction, and not a generic computer. Accordingly, Applicant respectfully submits that the claims are directed to an application via a particular machine as set forth in MPEP 2106.0S(b)”, Examiner respectfully disagree. As mentioned in the response to remarks mailed on 08/22/2025 and 12/30/2025, the patient monitor is described as a generic component and as a tool for collecting, analyzing and outputting data. As discussed above, the PG-Pub specifications [0032-0033], clearly does not describe a specific type of monitor designed to perform a unique manufacturing process that would be considered to involve a "particular machine" rather a mere description of generic hardware “any monitor” used as a tool to perform the functions. Therefore, the additional elements do not use the exception to affect a particular treatment or prophylaxis for a disease, do not apply the exception using particular machines, and do not effect a transformation or reduction of a particular article to a different state or thing, rather the additional elements are generally stated as to their structure and function and are only used to evaluate kidney disease instead of treating patients.
On page 15-16 of the remarks, Applicant discussed the improvement considered to existing technology in Enfish and argues “The present specification sets out operations that improve system operation efficiency in any other technology or technical field by enabling the patient monitors themselves to directly control patient monitoring frequency depending on the particular patients AKI condition ... such operations advantageously improve system operations by allowing for controlling power consumption by controlling patient monitoring frequency... The present claims contain limitations directed to these improvements in system operation efficiency in any other technology or technical field by reducing power consumption.”, Examiner respectfully disagree. In Enfish, the claim(s) provided an improvement to a computer function and/or technical field (self-pointing database) reciting a self-referential table for a computer database providing a particular improvement in the computer's functionality that improves the way a computer stores and retrieves data in memory whereas the instant claim(s) and specifications do not recite an improvement to technology, as in Enfish, but to performance of an abstract idea such as analyzing patient data for predicting AKI risk while using well-known computer system and components and the step for adjusting the power consumption based on data collection and transmission is a known computer function and is analyzed as a nominal or tangential addition to the abstract idea and does not affect the generation of the data object to predict the AKI risk and as such amounts to insignificant post/extra-solution activity to apply the exception using generic computer component to perform the function.
On page 16 of the remarks, Applicant argues “Furthermore, the claims do not pre-empt AKI risk prediction, except in conjunction with all the other recited features. See, Diamond v. Diehr ... Thus, the claims are not directed to an abstract idea since the claims do not preempt every possible way of AKI risk prediction”, Examiner respectfully disagree. As discussed above and in the final OA mailed 12/30/2025, the claims, under BRI, recite steps for predicting an AKI risk while the transmitting of signal for need of an intervention is not describing preventing an AKI risk. Furthermore, in Diehr, a "[process] for molding raw, uncured synthetic rubber into cured precision products while using Arrhenius equation for curing synthetic rubber decision which held that controlling the execution of a physical process, by running a computer program. In contrast claim 1 is/are reciting a performing AKI risk using patient collected data and compare to a baseline to determine if the risk is above or below threshold and indicate a need for administrating an intervention. Therefore, the present claim(s) is/are nor analogues to Diehr.
Therefore, the Applicant argument is found to be unpersuasive and Examiner remains the 101 rejections of claims which have been updated to address Applicant's argument.
Conclusion
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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