DETAILED ACTION
This office action is based on the claim set filed on 11/05/2025.
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 .
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 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 11/05/2025 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 12-16.
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”, Examiner respectfully disagree. 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).
On page 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 continuous AKI risk prediction, the continuous AKI risk prediction comprising: ... and dynamic patient condition data gathered via the patient monitor, ... 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 ...." 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. 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 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 repecfully disagree. As mentioned in the response to remarks mailed on 08/22/2025, the patient monitor is described as a generic computing component and as a tool for collecting, analyzing and outputting data. For example, the 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 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.
On page 14-15 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”, Examiner respectfully disagree. Examiner bring the Applicant attention that 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 15-16 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, 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
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 extension fee 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 date of this final action.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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