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 .
Status of Claims
This office action for the 18/030116 application is in response to the communications filed June 26, 2026.
Claim 1 was amended June 26, 2026.
Claims 1-3, 5, 7-9, 12, 14, 16-20, 22, 23, and 25-27 are currently pending and considered below.
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 1-3, 5, 7-9, 12, 14, 16-20, 22, 23, and 25-27 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.
As per claim 1,
Step 1: The claim recites subject matter within a statutory category as a process.
Step 2A is a two-prong inquiry, in which Prong 1 determines whether a claim recites a judicial exception. Prong 2 determines if the additional limitations of the claim integrates the recited judicial exception into a practical application. If the additional elements of the claim fail to integrate the judicial exception into a practical application, claim is directed to the recited judicial exception, see MPEP 2106.04(II)(A).
Step 2A Prong 1: The claim contains subject matter that recites an abstract idea, with the steps of a method of estimating a residual renal function (“RRF”) in a dialysis patient, said method comprising: obtaining first and second concentration values (C1, C2) for a substance in blood of the dialysis patient at a start and an end of a first treatment session of intermittent dialysis therapy, and a third concentration value (C3) for a substance in the blood of the dialysis patient at a start of a second treatment session, which is consecutive to the first treatment session, the substance being selected from the group of urea, creatinine, beta-2-microglobin, β-trace protein, and cystatin C; receiving timing data from the dialysis system indicative of operation of the extracorporeal circuit including time points (t1, t2, t3) for the start and the end of the first treatment session and the start of the second treatment session; and calculating an estimation value (Kr/V) of the RRF as a function of the first, second, and third concentration values (C1, C2, C3), and the time points (t1,t2,t3), wherein the first and second treatment sessions are performed during a therapy time period T, wherein calculating the estimation value (Kt/V) is based on an assumption that the concentration of the substance in the blood of the dialysis patient is substantially equal at a start and an end of the therapy time period (T), and wherein calculating the estimation value (Kt/V) comprises: representing an unknown generation rate (G/V) of the substance in the dialysis patient by a functional dependence on a standard Kt/V for the therapy time period (T), representing the standard Kt/V by a predefined estimation function (f3), which is based on the assumption and operates on the time points (t1,t2,t3), the therapy time period (T), an unknown session Kt/V of the first treatment session, and the RRF to be estimated, representing the unknown session Kt/V of the first treatment session by a first calculation function (f1), which operates on the unknown generation rate (G/V), the first and second concentration values (C1, C2), and the time points (t1, t2) for the start and the end of the first treatment session, and representing the estimation value (Kt/V) by a second calculation function (f2), which operates on the unknown generation rate (G/V), the second and third concentration values (C2, C3), and the time points (t2, t3) for the end of the first treatment session and the start of the second treatment session and prescribing hemodialysis, peritoneal dialysis, and/or other renal interventions to preserve RRF by factoring the estimation value (Kr/V) into the dialysis therapy treatment. These steps, as drafted, under the broadest reasonable interpretation are directed to:
certain methods of organizing human activity (e.g., fundamental economic principles or practices including: hedging; insurance; mitigating risk; etc., commercial or legal interactions including: agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations; etc., managing personal behavior or relationships or interactions between people including: social activities; teaching; following rules or instructions; etc.) but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from being directed to certain methods of organizing human activity. For example, but for the additional element(s) of “computer-implemented” and “displaying the estimation value (Kr/V), evaluating the estimation value (Kr/V) for assessment of a physiological status of the dialysis patient, and displaying an indicator of the physiological status of the dialysis patient”, the identified abstract idea, law of nature, or natural phenomenon identified above, in the context of this claim, encompasses a certain method of organizing human activity, namely managing personal behavior or relationships or interactions between people. This is because each of the limitations of the abstract idea recites a list of rules or instructions that a human person can follow in the course of their personal behavior. If a claim limitation, under its broadest reasonable interpretation, covers at least the recited methods of organizing human activity above, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. See MPEP 2106.04(a).
Step 2A Prong 2: The claim does not recite additional elements that integrate the judicial exception into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception, see MPEP 2106.05(f), such as:
“performed by a dialysis system including a blood treatment device having an extracorporeal circuit” and “via a blood sampling device and a blood analysis apparatus coupled to the dialysis system” which corresponds to merely reciting the words “apply it” (or an equivalent) with the judicial exception. As written, these limitations merely assign the functions of the method in general and the obtaining step in particular to a medical device. This medical device is otherwise inconsequential to the invention aside from creating the setting or environment in which these functions exist. Accordingly, these limitations amount to nothing more than applying the abstract idea to these hardware components of the medical device.
“computer-implemented”, “at least one processor for” and “by the at least one processor” which corresponds to merely using a computer as a tool to perform an abstract idea. Page 13 Lines 3-18 describe the system that implements the method at a level consistent with a generic computer. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or 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 of intermediated settlement on a generic computer.
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“displaying the estimation value (Kr/V), evaluating the estimation value (Kr/V) for assessment of a physiological status of the dialysis patient, and displaying an indicator of the physiological status of the dialysis patient” which corresponds to mere data gathering and/or output.
Accordingly, this claim is directed to an abstract idea.
Step 2B: The claim does not recite additional elements that amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, see MPEP 2106.05(d)(II), such as:
“displaying the estimation value (Kr/V), evaluating the estimation value (Kr/V) for assessment of a physiological status of the dialysis patient, and displaying an indicator of the physiological status of the dialysis patient” which corresponds to receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 2,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the estimation value (Kt/V) of the RRF is calculated independently of data representing urine collected from the dialysis patient.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 3,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the first, seconds and third concentration values (C1, C2, C3) represent equilibrated concentrations of the substance in the blood of the dialysis patient.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 5,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the therapy time period (T) comprises a week.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 7,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein said functional dependence comprises multiplying the standard Kt/V, and an estimated concentration value (Cs), which is representative of an average pre-dialysis concentration of the substance in the blood of the dialysis patient during the therapy time period (T), and the reciprocal of the therapy time period (T).” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 8,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein said calculating the estimation value (Kr/V) comprises: generating a plurality of data points, each of the data points comprising a unique combination of candidate values of the session Kt/V and the RRF; calculating, for a respective data point, an associated value of the generation rate (G/V) by use of the predefined estimation function (f3) populated by the time points (t1, t2, t3); determining a matching data point among the plurality of data points; and setting the estimation value (Kr/V) to the candidate value of the RRF in the matching data point, wherein the candidate values of the matching data point match an apparent session Kt/V for the first treatment session and an apparent RRF, wherein the apparent session Kt/V is a function of the first and second concentration values (C1, C2), the time points (t1, t2) for the start and the end of the first treatment session, and the associated value of the generation rate (G/V) for the matching data point, and wherein the apparent RRF is a function of the second and third concentration values (C2, C3), the time points (t2, t3) for the end of the first treatment session and the start of the second treatment session, the associated value of the generation rate (G/V) for the matching data point.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 9,
Claim 2 depends from claim 8 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein determining the matching data point among the plurality of data points comprises: operating intermediate functions (f4, f5, f6, f7) on the respective data point and the associated value of the generation rate (G/V), to calculate first, second, third, and fourth intermediate values (~C1, ~C2, ~`C2, ~`C3); operating scaling functions (f8, f9) on the respective data point to calculate first and second scale factors (M, N); and determining the estimation value (Kr/V) as a function of the plurality of data points, the first, second, third, and fourth intermediate values (~C1, ~C2, ~`C2, ~`C3) generated for the respective data point, and the first and second scale factors (M, N) generated for the respective data point.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 12,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein determining the estimation value (Kr/V) comprises finding, among the plurality of data points, a fitting data point for which the second intermediate value (~C2) substantially equals the first intermediate value (~C1) multiplied by the first scaling factor (M), and for which the fourth intermediate value ~`C3) substantially equals the third intermediate value (~`C2) multiplied by the second scale factor (N), wherein the matching data point is determined based on the fitting data point.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 14,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein calculating the estimation value (Kr/V) comprises: setting a first candidate value of the RRF and a second candidate value of the session Kt/V; calculating a reference value of the generation rate (G/V) by use of the predefined estimation function (f3) populated by the time points (t1, t2, t3), the therapy time period (T), and the first and second candidate values; calculating a comparison score indicative of the first candidate value in relation to an apparent RRF given as a function of the reference value, the second and third values (C2, C3), and the time points (t2, t3) for the end of the first treatment session and the start of the second treatment session; iteratively modifying the first candidate value while calculating the reference value and the comparison score until the comparison score fulfils a convergence criterion; and setting the estimation value (Kr/V) to the candidate value for which the comparison score fulfils the convergence criterion.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 16,
Claim 2 depends from claim 14 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein calculating the reference value comprises: calculating the standard Kt/V by operating the predefined estimation function (f3) on the time points (t1, t2, t3), the therapy time period (T), and the first and second candidate values; calculating an estimated generation rate (G/V) based on the standard Kt/V; and determining the reference value based on the estimated generation rate (G/V).” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 17,
Claim 2 depends from claim 16 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein calculating the reference value further comprises: updating the second candidate value by operating a refinement function (f1) on the estimated generation rate (G/V), the first and second concentration values (C1, C2), and the time points (t1, t2) for the start and end of the first treatment session; and repeatedly calculating the standard Kt/V, calculating the estimated generation rate (G/V), and updating the second candidate value, until a second convergence criterion is fulfilled, wherein determining the reference value based on the estimated generation rate sets the reference value to the estimated generation rate (G/V) for which the second convergence criterion is fulfilled.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 18,
Claim 2 depends from claim 14 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein calculating the comparison score comprises: operating the intermediate functions (f6, f7) on the reference value and the first candidate value to calculate the first and second intermediate values (~C1, ~C2); and operating a scaling function (f9) on the first candidate value to calculate a scale factor (N), wherein the comparison score defines a relation between the second intermediate value (~C2) to the product of the first intermediate value (~C1) and the scale factor (N).” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 19,
Claim 2 depends from claim 18 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the intermediate functions (f6, f7) are populated by the second and third concentration values (C2, C3) and the time points (t2, t3) for the end of the first treatment session and the start of the second treatment session, and wherein the scaling function (f9) is populated by the time points (t2, t3) for the end of the first treatment session and the start of the second treatment session.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 20,
Claim 2 depends from claim 14 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the comparison score is calculated to be further indicative of the second candidate value in relation to an apparent session Kt/V given as a function of the reference value, the first and second values (C1, C2), and the time points (t1, t2) for the start and the end of the first treatment session, and wherein the first and second candidate values are iteratively modified until the comparison score fulfils the convergence criterion.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 22,
Claim 2 depends from claim 7 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: calculating the estimated concentration value (Cs) as a function of at least one of the first and third concentration values (C1, C3).” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 23,
The method of claim 22.
“further comprising: calculating the estimated concentration value (Cs) as a weighted average of at least the first and third concentration values (C1, C3).” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 25,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising obtaining a volume value (UFV) representative of total fluid volume removed from the blood during the first treatment session, wherein the estimation value (Kr/V) of the RRF is further calculated as a function of volume value (UFV).” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 26,
Claim 26 is substantially similar to claim 1. Accordingly, claim 26 is rejected for the same reasons as claim 1.
Claim 26 further introduces additional elements that are insufficient to provide a practical application or something significantly more:
“A computer-readable medium comprising program instructions which, when executed by a processor, cause the processor to” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 27,
Claim 27 is substantially similar to claim 1. Accordingly, claim 27 is rejected for the same reasons as claim 1.
Claim 27 further introduces additional elements that are insufficient to provide a practical application or something significantly more:
“A computer system for estimating a residual renal function (“RRF”) in a dialysis patient, said computer system being configured to” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
Subject Matter Free of Prior Art
Claims 1-3, 5, 7-9, 12, 14, 16-20, 22, 23, and 25-27 contain subject matter that is free of prior art. The Examiner has conducted a thorough search of the prior art and could not find a single reference, or combination of references with suitable rationale to combine, to teach the limitation of “representing the standard Kt/V by a predefined estimation function (f3), which is based on the assumption and operates on the time points (t1,t2,t3), the therapy time period (T), an unknown session Kt/V of the first treatment session, and the RRF to be estimated, representing the unknown session Kt/V of the first treatment session by a first calculation function (f1), which operates on the unknown generation rate (G/V), the first and second concentration values (C1, C2), and the time points (t1, t2) for the start and the end of the first treatment session, and representing the estimation value (Kt/V) by a second calculation function (f2), which operates on the unknown generation rate (G/V), the second and third concentration values (C2, C3), and the time points (t2, t3) for the end of the first treatment session and the start of the second treatment session” as taught by claim 1. Claims 26 and 27 recite similar limitations. The closest prior art that the Examiner was able to find was:
Chamney et al. (US 2018/0080947; herein referred to as Chamney): which teaches obtaining a plurality of concentration values for a substance in blood in a dialysis patient at different times and estimating a residual renal function value based on these concentration values. However, Chamney is deficient in collecting the concentration values at the claimed times as well as how the residual renal function is specifically calculated.
Sternby (Sternby, J. (2018). Mathematical Representation of Standard Kt/V Including Ultrafiltration and Residual Renal Function. In ASAIO Journal (Vol. 64, Issue 5, pp. e88–e93). Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.1097/mat.0000000000000764): which teaches a calculation method for mathematically representing a standard Kt/V for a patient using a plurality of time points. The standard Kt/V is based upon an unknown average generation rate an a mean predialysis urea concentration modified by a time factor T. However, Sternby is deficient in teaching time points t1, t2, and t3 where these variables correspond to a start of a first treatment session, the end of the first treatment session and the start of the second treatment session, respectively. Further, Sternby is deficient in teaching a representation of the unknown session Kt/V and estimation value (Kr/V)
Neither of these references disclose the limitations of claim 1. Even if it could be established that Chamney and Sternby could teach the limitations of claim 1, it is understood that such a combination could have only resulted from impermissible hindsight reasoning from use of the instant disclosure to arrive at such a combination. Accordingly, claims 1-3, 5, 7-9, 12, 14, 16-20, 22, 23, and 25-27 contain subject matter that is free of prior art.
Response to Arguments
Applicant's arguments filed June 26, 2026 have been fully considered.
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 101 are not persuasive.
The Applicant argues that the cited features of claim 1 go well beyond mere organization of human activity by providing a specific technical improvement in the manner in which dialysis treatment systems acquire physiological data, model patient-specific solute dynamics and estimate residual renal function. Specifically, there is a problem with the error prone and inaccurate process of conventional RRF estimations via urine collection. The pending claims provide an improvement to conventional RRF estimate techniques that are based on blood concentration levels.
The Examiner respectfully disagrees. The identified problem that is attempted to be solved is that “Conventional techniques for estimating GFR rely on 24 hour collection of urine, which is quite cumbersome and error prone, for example caused by errors in collection and incomplete bladder emptying” (Page 1 Lines 19-22 of the as-filed specification). This problem is not a problem with technology per se. This problem of 24 hour urine collection lies with the subjects providing the sample, and the user collecting and/or handling the sample. This has nothing to do with technology. Rather, the claimed invention merely changes what sample is being analyzed as opposed to changing how the same sample is being analyzed differently. Accordingly, there is no basis to conclude that technology is being improved.
The Applicant further argues that the claimed method leverages technical components to automatically obtain and process patient-specific data during and between treatment sessions thereby rooting a novel approach to RRF estimation that is rooted in the technical operations of a dialysis machine.
The Examiner respectfully disagrees. While the operations of collecting and analyzing the blood sample involve technical functions of a dialysis machine, the technical components of, for example, a blood sampling device, a blood analysis apparatus, and an extracorporeal circuit, are generic to dialysis machines in general. They amount to nothing more than applying the data collection to this particular field without changing the actual technology involved. The argued technical improvement of improved RRF calculation is simply mathematical functions that a human can otherwise perform. The intervening technology of the dialysis machine is merely the means by which the input data is being collected, or in other words, the technology merely applies the claimed obtaining step to the generic dialysis machine.
The Applicant further argues that the pending claims do not merely calculate a numerical value. Rather, the claimed invention relies on real-world measurement data that produces an RRF value that was previously unattainable without invasive and error-prone procedures.
The Examiner respectfully disagrees. As was stated above, changing what is being analyzed as opposed to how the same thing is being analyzed is not the same as a technical improvement. Relying on urine collection as an error prone process and supplying invasive blood collection as an alternative does not improve the urine analysis technology. It merely redefines what RRF values can be based on. If there is an improvement to RRF values, the improvement would exclusively be based in the abstract as RRF values are inherently abstract. We know that RRF values are inherently abstract because RRF values are nothing more than data and data is inherently abstract.
The Applicant further argues that the pending claims provide a technical improvement in the field of dialysis treatment as it enables accurate RRF estimation using routinely available blood measurements and eliminates the need for urine collection.
The Examiner respectfully disagrees. If it is the case that the claimed RRF estimation is based on routinely available blood measurements, what improvement to technology exists? This argument suggests that the obtaining step is not even inventive, and that merely the calculations of the RRF is inventive. This further undermines the Applicant’s argument that there is an improvement to technology as data is not technology. Data is merely information. If the information has routinely been collected, but has not been analyzed in the claimed manner until now, on what basis can the Applicant possibly conclude that technology is being improved? In this argument, absolutely nothing is changing with the technology itself, as the data being collected is “routinely available”. If technology does not change, it is not possible to say that technology is being improved.
The Applicant further argues that the pending claims do not recite a method of organizing human activity. Specifically the claimed operations rely on automatically acquiring blood concentrations and involve components and analyses that are not able to be performed by a human. They require specialized medical devices.
The Examiner respectfully disagrees. The presence of specialized medical devices does not preclude an abstract idea from being recited by the claims. It merely presents an additional element to the abstract idea. The calculation steps recited by the pending claims are more than capable of being performed by a human.
The Applicant further argues that the pending claims are used to diagnose and treat a physiological condition using a medical device.
The Examiner respectfully disagrees. A device that diagnoses a medical condition does not inherently provide patent eligibility. Diagnosis of a medical condition is a personal behavior of a physician or medical professional. Treating a medical condition could be considered as an eligible concept vis a vis providing a particular treatment or prophylaxis, however, there is nothing in the pending claims that actually effect a treatment. The claim recites prescribing hemodialysis or other renal interventions to a subject, however this does not effect the treatment to the subject. There is nothing causing treatment in the pending claims. The treatment is merely prescribed or otherwise recommended. There is nothing in the pending claims ensuring that treatment is actually administered.
The Applicant further argues that the pending claims do not merely recite generic computer implementations. The arrangement is not well-understood, routine or conventional. The Office Action previously issued indicated that the subject matter in question is novel. This represents that the claimed invention is non-conventional and non-generic.
The Examiner respectfully disagrees. The Applicant cannot confuse novelty with eligibility. A novel abstract idea, as is the case with the pending claims, is still abstract save for the additional elements to the abstract idea. The question of what is well-known, routine and conventional only applies to these additional elements. Otherwise novelty would necessitate patent eligibility. The additional elements to the abstract idea are well-known, routine and conventional for the reasons indicated in the rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAD A NEWTON whose telephone number is (313)446-6604. The examiner can normally be reached M-F 8:00AM-4:00PM (EST).
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/CHAD A NEWTON/Primary Examiner, Art Unit 3681
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