DETAILED ACTION
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 .
Response to Amendment
No new amendments have been presented. Claims 36-53 remain pending in the application and are examined herein. Claims 1-35 are previously canceled.
Status of Objections and Rejections
All rejections from the previous office action are maintained.
Response to Arguments
Applicant's arguments, see pages 6-10, filed 10/06/2025, with respect to the rejection of claims 36-53 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues (p. 7) that the Office Action fails to comply with the August 4, 2025 USPTO memorandum because it allegedly does not explain how the claim limitations interact when determining whether the judicial exception is integrated into a practical application. Applicant argues that merely identifying an abstract idea and reaching an eligibility conclusion is insufficient, and that a rejection must be supported by a preponderance of the evidence. Applicant further contends that the Office Action provides only conclusory reasoning and therefore does not establish that the claims lack a practical application. Based on this alleged deficiency, Applicant concludes that claims 36-53 are patentable.
The Examiner respectfully disagrees.
Contrary to Applicant’s assertion, the Office Action does consider the interaction of the claim limitations. When the steps are evaluated together, the claims recite: (i) receiving data, (ii) performing a mathematical calculation, (iii) evaluating the result, and (iv) displaying information for a treatment determination. As an ordered combination, these steps still amount to information processing and presentation, and do not result in any technological action beyond the abstract calculation itself. The interaction of the elements does not produce a technical effect, control a physical process, or change the operation of a machine (See the reiterated Alice/Mayo test below).
Secondly, the August 4, 2025 memorandum does not require examiners to accept eligibility absent certainty, nor does it shift the burden of persuasion away from Applicant. The memorandum reiterates that eligibility determinations must be reasoned and supported, not that every rejection must involve uncertainty or speculation. Here, the Office has affirmatively determined, based on the claim language, that the claims do not integrate the abstract idea into a practical application because they end with the presentation of information for human decision-making and do not recite any concrete action based on the calculated result.
Thirdly, Applicant’s reliance on “preponderance of the evidence” is misplaced in the context of 35 U.S.C. 101. The Office is not required to prove ineligibility by evidentiary showings like anticipation or obviousness through 35 U.S.C. 102 and 103, respectively. The Office need only apply the eligibility framework to the claim language, which here clearly recites mathematical processing of Kt/V values to calculate a generation rate and present information. Subject matter eligibility is a question of law, resolved by evaluating the claim language itself against the eligibility framework. The claim language here affirmatively demonstrates that the alleged invention is limited to mathematical evaluation and informational output, which the courts and the USPTO have repeatedly recognized as abstract.
Finally, Applicant has not identified any claim limitation, alone or in combination, that effects a practical application, such as controlling dialysis equipment, modifying treatment parameters, or improving computer functionality. Absent such limitations, the claims remain directed to a judicial exception with no practical application and without significantly more.
Reiterated Alice/Mayo test (Steps 2A/1/2) and Conclusory Reasoning
Regarding Step 2A Prong 1, The Office Action identified the abstract idea recited by the claims: 1) mathematical calculation (calculate a generation rate) and 2) evaluation of information (determine a nutritional status)). The Examiner explained that the additional claim elements, individually and in combination, merely automate that abstract idea using generic computer components. This satisfies the analytical requirements of Step 2A Prong 1 of the USPTO eligibility framework.
Regarding Step 2A Prong 2, when the claim limitations are evaluated as an ordered combination, the claims recite: obtaining Kt/V-related values, calculating a generation rate as a mathematical function of Kt/V, concentration, and time, evaluating the calculated generation rate, and displaying information indicative of a physiological or nutritional status. The August 4, 2025 USPTO memorandum does not require a different outcome merely because multiple variables (such as Kt/V and generation rate) are mathematically related. These limitations interact only to perform a mathematical calculation and evaluation of information. The interaction of Kt/V and generation rate does not cause any technical action, control any dialysis equipment, or alter any dialysis treatment parameters. Instead, the interaction results solely in a numerical output informational display, which courts have found insufficient to integrate an abstract idea into a practical application (See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968). For example, MPEP 2106.04( d)(2) explains that " [ o ]ne way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition". Instead, the instant claims stop at displaying the generation rate derived from Kt/V for determining whether treatment is needed, which constitutes insignificant post-solution activity under the Alice/Mayo test (See MPEP 2106(b)).
As claimed, the generation rate is derived entirely through mathematical manipulation of known variables. The Federal Circuit has explained that collecting, analyzing, and displaying information is insignificant extra-solution activity (See , Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). Likewise, the Supreme Court has held that “A competent draftsman could attach some form of post-solution activity to almost any mathematical formula” (See Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)). Here, Kt/V values are collected, a generation rate is calculated, and the result is displayed for assessment, precisely the type of activity described as insignificant extra-solution activity and therefore does not amount to significantly more.
Accordingly, the Office Action sufficiently establishes that the claims are not patent-eligible under 35 U.S.C. 101 Step 2A1/2 (See ineligibility under Step 2B in the subsequent arguments). Applicant’s arguments do not overcome the rejection. Claims 36-53 therefore remain rejected.
Applicant (pp. 7-8) relies on Enfish, LLC v. Microsoft Corp., 822 F.3d (Fed. Cir. 2016) to argue that claims 36 and 37 are directed to a “technical improvement” and therefore satisfy Step 2B of the Alice/Mayo test (See MPEP 2106(b)). To support this argument, Applicant states the Federal Circuit explained that "[s]oftware can make non- abstract improvements to computer technology, just as hardware improvements can," and that "the claims are directed to an improvement to computer functionality versus being directed to an abstract idea." Id. at 1336.
The Examiner respectfully disagrees.
Firstly, in evaluating the claims against Step 2B of the Alice/Mayo test (See MPEP 2106(b)), the Examiner finds that the claims are directed to calculating a generation rate using Kt/V, which is a well-known dialysis adequacy parameter. Specifically, the instant publication (US 20220093231 A1) states that “standard Kt/V”, also known as standardized Kt/V or stdKt/V…is an established measure of dialysis adequacy,” and goes on to recite the Gotch equation of stdKt/V (See para. [0041]) which is the same equation used in reference, Bonert (Equation 2, page 8, line 1), for rejecting claims 36-53 in the Office Action. Implementing the equation on a generic computer merely automates a known calculation and does not add significantly more under Step 2B of the Alice/Mayo test.
Secondly, In Enfish, LLC v. Microsoft Corp., 822 F.3d (Fed. Cir. 2016), the Federal Circuit held that the claims “were directed to an improvement in computer capabilities and not directed to an abstract idea” (See MPEP 2106.04(d)(1)). The claims in Enfish recited a new self-referential table structure that changed how data was stored and retrieved, and improved memory usage, flexibility, and processing efficiency of the computer itself. Critically, the improvement was internal to the computer technology, not merely an improvement in the result of a calculation. By contrast, Applicant’s claims do not improve computer memory structures, data storage models, processor operation, or any aspect of how a computer functions. Instead, the instant claims use generic processor and memory to receive Kt/V values and concentration data, mathematically calculate a generation rate, and display the result. This is an alleged improvement to a mathematical or clinical model, not to computer technology. The Federal Circuit has repeatedly clarified that improving speed, accuracy, or efficiency of an abstract calculation does not constitute an improvement to computer functionality (See MPEP 2106.05(b)(II)). The outcome of the Enfish case does not support the proposition that any software-based efficiency gain is patent eligible. Rather, it requires that the claims be directed to a specific technological improvement in the computer itself. In the instant claims, the alleged efficiency arises solely from algebraic rearrangement of the Gotch stdKt/V relationship and reduced data requirements. These are conceptual and mathematical efficiencies, not technological ones.
The facts here align closely with Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) and not Enfish. In SAP America, the Federal circuit explains that “in order for a machine to add significantly more, it must "play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly" (See MPEP 2106.05(b)(II)). The computer of the instant claims performs arithmetic, stores values, and displays results. The computer does not enable the method in a way that was previously impossible, nor does it perform any function beyond generic computation. It merely allegedly makes the calculation faster or more convenient, which SAP America holds is insufficient. The claimed “novelty” (p. 6, last para.), computing generation rate from stdKt/V, exists independently of the machine and could be performed manually. The computer is “merely an object on which the method operates,” exactly the scenario described in MPEP 2106.05(f).
Applicant argues (pp. 9-10) that reference Bonert relies on measured variables, whereas Applicant’s approach permits assumptions or estimations, for example, estimating concentration values from a single treatment session even when the equalization period includes additional sessions. Applicant contends that neither Akonur nor Bonert discloses or suggests making such assumptions, and that the ability to substitute assumptions for measurements renders Applicant’s calculation faster, simpler, and more efficient. Applicant therefore asserts that merely rearranging Bonert’s equation would not achieve the same result, and concludes that instant claims 36-37 recite a novel and nonobvious approach that is patentable over Akonur alone or in combination with Bonert.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., assumptions or estimations, for example, estimating concentration values from a single treatments session even when the equalization period includes additional sessions) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s distinction relies on features that are not required by the claims. Independent claims 36 and 37 broadly recite calculating a generation rate as a function of standard Kt/V, a concentration value, and a predefined time period. The claims do not require that the concentration value or standard Kt/V be obtained via assumptions, estimations, or reduced measurements, nor do they exclude the use of measured values. As such, any reliance on assumption-based computation describe in the specification cannot distinguish the claims from the prior art. Limitations not recited in the claims cannot confer patentability.
Applicant’s assertion that Bonert “relies on measured variables” and is silent as to assumptions is not persuasive. Bonert discloses a mathematical relationship between standard Kt/V, concentration, time, and generation rate. That relationship is independent of how the input values are obtained. One of ordinary skill in the art would have understood that clinical parameters such as concentration, volume, and clearance are routinely estimated, averaged, or inferred in dialysis modeling, particularly when complete data is unavailable. The use of assumptions or estimations in applying Bonert’s equation therefore represents routine clinical and mathematical practice, not a technical departure from Bonert.
Applicant’s argument that its approach is faster or simpler because it avoids certain measurements does not establish nonobviousness. Using assumptions, approximations, or reduced datasets to simplify computation is a form of routine optimization that would have been well within the skill of a person of ordinary skill in the art (See MPEP 2144).
The Office Action correctly explains that Applicant’s calculation can be obtained by algebraically rearranging Bonert’s disclosed relationship to solve for generation rate. The fact that Applicant may apply assumptions to populate the variables does not change the mathematical equivalence of the equation. Rearranging a known equation to solve for a different variable, and populating it with estimated or measured values, would have been obvious to one of ordinary skill in the art with a reasonable expectation of success as a predictable variation (See MPEP 2143.01(III)).
Applicant further asserts that the claimed calculation more easily allows a system to determine malnutrition. However, this alleged benefit flows directly from having a calculated generation rate, which Bonert already teaches. An intended use or clinical advantage does not distinguish the claimed method where the underlying calculation and inputs are taught or suggest by the prior art.
In conclusion, Applicant’s attempt to distinguish over Akonur and Bonert based on the use of assumptions is unsupported by the claim language and reflects, at most, routine optimization in applying a known mathematical relationship. Bonert teaches the relevant generation rate calculation, and it would have been obvious to rearrange and apply that equation using measured or estimated values as needed. Accordingly, Akonur in view of Bonert renders Claims 36 and 37 obvious, and the rejection is maintained.
Applicant’s arguments do not overcome the rejection. Claims 36-53 therefore remain rejected.
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 36-53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (Step 2A/1)(i.e., a law of nature, a natural phenomenon, or an abstract idea) without practical application (Step 2A/2) or significantly more (Step 2B) (See MPEP 2106). Although the instant claims encompass a manufacture (Step 1), they are directed to the following abstract ideas through mental processes and mathematical calculations, and natural phenomena (Step 2, Prong 1):
Claims 36 and 37 recite:
- (1) “receive a first concentration value for a substance in the blood of a dialysis patient at a start of a treatment session of an intermittent dialysis therapy”.
- (2) “receive a standard Kt /V value for the substance over a predefined time period that includes the treatment session; calculate a generation rate of the substance in the dialysis patient as a function of the standard Kt/V value, multiplied by the first concentration value and divided by the predefined time period, the generation rate being relative to a distribution volume V of the substance in the blood of the dialysis patient”.
Recitations (1) and (2) are directed to the abstract idea of collecting and processing information which is a mental process. The claim recites a processor configured to receive data, but this processor is a generic computer component performing well-understood, routine, and conventional functions. The human brain is capable of receiving the same concentration values and Kt/V values through the human ear or eyes.
- (3) “calculate a generation rate of the substance in the dialysis patient as a function of the standard Kt/V value, multiplied by the first concentration value and divided by the predefined time period, the generation rate being relative to a distribution volume V”.
The recitation is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind via mathematical calculations, but for the recitation of generic computer components. That is, other than reciting “by a processor,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “by a processor” language, “calculating” in the context of this claim encompasses the user manually calculating this generation rate after receiving a first concentration and Kt/V value which can be achieved by hand and/or in the mind using the known stdKt/v equation first presented by Gotch (instant specification, page 8, lines 20-23). This limitation is therefore an abstract idea.
- (4) “determine a nutritional status of the dialysis patient using the generation rate of the substance in the dialysis patient”
- (5) “determining whether a treatment is needed for changing the nutritional status of the dialysis patient”
Recitations (4)-(5) are processes that, under its broadest reasonable interpretation, cover performance of the limitation in the mind and are therefore abstract ideas. Other than reciting “by a processor,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “by a processor” language, “determining” in the context of this claim encompasses the user mentally analyzing a value to draw a conclusion. This can be performed in the mind by making a decision using no particular criteria and is therefore a mental process, an abstract idea.
Step 2A/2: This judicial exceptions are not integrated into a practical application.
Claims 36-37: The claims only recite the additional functionalities of the processor: receiving a first concentration value, receiving a Kt/V value, and displaying the nutritional status information based upon the mental determination step. Receiving data is merely data gathering (pre-solution activity, see MPEP 2106.05 (g)) only for the purpose of executing the abstract idea of the determination step. Simply outputting the result of a mental process by displaying the results of the determination step for nutritional status is considered post-solution activity (MPEP 2106.05 (g)). Additionally, displaying the results is only used to implement yet another abstract idea of determining the appropriate treatment. The processor in all three steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of inputting data into a mathematic equation, drawing conclusions, displaying results, and drawing more conclusions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. The processor does not carry out these steps using novel functionality, for example by use of artificial intelligence that trains an algorithm for deep learning, but rather automates a manual task of mathematical calculations and decision making (See MPEP 2106.05 (a)(I). The display of information does not provide a practical application. 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 ideas. The claims are directed to an abstract idea with no practical application.
Step 2B: The claims do not include additional elements that are sufficient to
amount to significantly more than the judicial exception
Claims 35-36: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As mentioned in Step 2A/2, the previous process steps of the claims are abstract ideas, mere data gathering, and are routine and conventional in the art. These steps therefore, cannot provide an inventive concept (See the U.S.C 103 rejection below in view of Akonur and Bonert). The claims are not patent eligible.
Claims 37-53 are rejected upon dependency of rejected claims 35-36.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 36-53 are rejected under 35 U.S.C. 103 as being unpatentable over Akonur et. al (US 20110257891 A1) and Clark incorporated by reference in Akonur (Quantifying the Effect of Changes in the Hemodialysis Prescription on Effective Solute Removal with a Mathematical Model, 1999) in view of Bonert et al. (“A Non-Dimensional Analysis of Hemodialysis”; 2010).
Regarding claim 36, Akonur teaches a non-transitory, computer-readable medium (the output of the doctor's computer can be stored on a portable memory device such as a universal serial bus ("USB") drive that is taken and inserted into the renal failure therapy machine; [0010]) storing instructions (a memory device that stores a plurality of instructions; [0019]), which when executed by a processor (a device having a processor programed to receiving data and performing calculations based on that data; [0171]), cause the processor to:
receive a first concentration value for a substance in the blood of the dialysis patient at the start of a treatment session (Fig. 3 shows at t = 0 minutes the urea, B2-M, and phosphate concentrations in mg/L wherein “FIGS. 2 to 8B…can be implemented on the processing and memory of one or more computer”; [0097]) of an intermittent dialysis therapy (Home therapy or HHD,” wherein “the patient can choose a therapy frequency, or number of therapies per week, that is most convenient and/or most effective,” such as six therapies a week at 2.5 hours per therapy or five therapies a week at three hours per therapy”; [0007]);
receive a standard Kt/V value for the substance over a predefined time period that includes the treatment session (“the graphs can be used to determine one or more clinically acceptable parameters, such as standard Kt/V of urea,” wherein “graphs illustrating the output of the prediction component” can be stored on the USB to be received by the processor; [0014]; Fig. 24 shows the relationships between urea stdKt/v, 32-M MPC and therapy duration); and
calculate the generation rate (the concentration or clearance results are then fed into a series of models or algorithms for the estimation component to determine a set of estimated patient parameters for (i) the particular patient, (ii) the particular molecule and (iii) its corresponding algorithm. For example, one of the parameters is G, which is the generation rate for the particular solute; [0013]; Equation (P) of [0147]-[0148]) and a “Kt/V value (the target (i.e., input) urea stdKt/v”; [0090]), the generation rate being relative to a distribution volume V of the substance in the blood of the dialysis patient (“V…is the distribution volume”; [0013]);
determine a nutritional status (nutritional status; [0065]) of the dialysis patient using the generation rate of the substance in the dialysis patient (“estimated patient parameters 32 are tailored to the patient's physiologic make-up”, wherein “one of the parameters is G, which is the generation rate” [0065][0013]);
display information indicative of the nutritional status of the dialysis patient (The information/data obtained for the hemodialysis patient can be displayed/printed out; [0141) for determining whether a treatment is needed for changing the nutritional status of the dialysis patient (Optimal prescription/regimen/nutritional therapies; [0150]).
Akonur is silent to explicitly teaching generation rate of the substance in the dialysis patient as a function of the standard Kt/V value multiplied by the first concentration value and divided by the predefined time period.
Akonur does teach the relationship between the stdKt/v as a function of time with a starting concentration in the graph of Fig. 24. Additionally, equation (P) ([0147]) for a generation rate is an expanded form of the definition of stdKt/v as derived by Gotch who is credited as the first presenter of the stdKt/v term (instant specification, page 8, lines 20-23). This expansion is also justified in the article “Standard Kt/Vurea: a method of calculation that includes effects of fluid removal and residual kidney clearance” by Daugirdas et al (See PTO-892).
Bonert teaches the generation rate of the substance in the dialysis patient as a function of the standard Kt/V value multiplied by the first concentration value and divided by the predefined time period (Equation (2); page 139, column 2), the generation rate being relative to a distribution volume V of the substance in the blood of the dialysis patient (V=volume of distribution (m3); page 139, column 2).
Although the equation of Bonert would need slight rearrangement to mirror equation (2) of the instant specification (page 8, line 1), merely rearranging a known mathematical relationship from a known reference only involves routine algebra and is not a new non-obvious concept. It would have been obvious to try to rearrange the equation from the finite variables to yield predictable solutions with a reasonable expectation of success. Minimizing or maximizing the parameters of the algorithm taught by Akonur is routine optimization (Akonur, Title; [0014][0090])(See MPEP 2143).
Bonert is considered to be analogous to the claimed invention because it is in the same field of endeavor for estimating generation rate of substance in dialysis patients. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Akonur to incorporate the teachings of Bonert by simplifying and rearranging the stdKt/V definition equation in order to improve computation speed as a known and expected benefit of optimizing a mathematical operation through algebraic manipulation.
Regarding claim 37, Modified Akonur teaches a system for calculating a generation rate of a substance in a dialysis patient (determine a set of estimated patient parameters… one of the parameters is G, which is the generation rate for the particular solute; [0013]) comprising:
a dialysis machine (computing device 202 to communicate with a suitable dialysis machine; [00176]; Fig 10) including:
a memory (memory device 208; [0172]; Fig. 10); and
a processor in communication with the memory (computing device 202 preferably includes one or more processors 204 electrically coupled by an address/data bus 206 to one or more memory devices 208; [0172]; Fig. 10), the processor configured to:
receive a first concentration value for a substance in the blood of the dialysis patient at a start of a treatment session (Fig. 3 shows at t = 0 minutes the urea, B2-M, and phosphate concentrations in mg/L wherein “FIGS. 2 to 8B…can be implemented on the processing and memory of one or more computer”; [0097]) of an intermittent dialysis therapy (Home therapy or HHD,” wherein “the patient can choose a therapy frequency, or number of therapies per week, that is most convenient and/or most effective,” such as six therapies a week at 2.5 hours per therapy or five therapies a week at three hours per therapy”; [0007]);
receive a standard Kt/V value for the substance over a predefined time period that includes the treatment session (“the graphs can be used to determine one or more clinically acceptable parameters, such as standard Kt/V of urea,” wherein “graphs illustrating the output of the prediction component” can be stored on the USB to be received by the processor; [0014]; Fig. 24 shows the relationships between urea stdKt/v, 32-M MPC and therapy duration); and
calculate the generation rate (the concentration or clearance results are then fed into a series of models or algorithms for the estimation component to determine a set of estimated patient parameters for (i) the particular patient, (ii) the particular molecule and (iii) its corresponding algorithm. For example, one of the parameters is G, which is the generation rate for the particular solute; [0013]; Equation (P) of [0147]-[0148]) and a Kt/V value (the target (i.e., input) urea stdKt/v; [0090]), the generation rate being relative to a distribution volume V of the substance in the blood of the dialysis patient (“V…is the distribution volume”; [0013]);
determine a nutritional status (nutritional status; [0065]) of the dialysis patient using the generation rate of the substance in the dialysis patient (“estimated patient parameters 32 are tailored to the patient's physiologic make-up”, wherein “one of the parameters is G, which is the generation rate” [0065][0013]);
display information indicative of the nutritional status of the dialysis patient (The information/data obtained for the hemodialysis patient can be displayed/printed out; [0141) for determining whether a treatment is needed for changing the nutritional status of the dialysis patient (Optimal prescription/regimen/nutritional therapies; [0150]).
Akonur is silent to explicitly teaching generation rate of the substance in the dialysis patient as a function of the standard Kt/V value multiplied by the first concentration value and divided by the predefined time period.
Akonur does teach the relationship between the stdKt/v as a function of time with a starting concentration in the graph of Fig. 24. Additionally, equation (P) ([0147]) for a generation rate is an expanded form of the definition of stdKt/v as derived by Gotch who is credited as the first presenter of the stdKt/v term (instant specification, page 8, lines 20-23). This expansion is also justified in the article “Standard Kt/Vurea: a method of calculation that includes effects of fluid removal and residual kidney clearance” by Daugirdas et al (See PTO-892).
Bonert teaches the generation rate of the substance in the dialysis patient as a function of the standard Kt/V value multiplied by the first concentration value and divided by the predefined time period (Equation (2); page 139, column 2), the generation rate being relative to a distribution volume V of the substance in the blood of the dialysis patient (V=volume of distribution (m3); page 139, column 2).
Although the equation of Bonert would need slight rearrangement to mirror the equation (2) of the instant specification (page 8, line 1), merely rearranging a known mathematical relationship from a known reference only involves routine algebra and is not a new non-obvious concept. It would have been obvious to try to rearrange the equation from the finite variables to yield predictable solutions with a reasonable expectation of success. Minimizing or maximizing the parameters of algorithm taught by Akonur is routine optimization (Akonur, Title; [0014][0090])(See MPEP 2143).
Bonert is considered to be analogous to the claimed invention because it is in the same field of endeavor for estimating generation rate of substance in dialysis patients. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Akonur to incorporate the teachings of Bonert by simplifying and rearranging the stdKt/V definition equation in order to improve computation speed as a known and expected benefit of optimizing a mathematical operation through algebraic manipulation.
Regarding claim 38, Modified Akonur teaches the system of claim 37, wherein the processor is further configured to:
receive a session Kt/V value for the treatment session (“the graphs can be used to determine one or more clinically acceptable parameters, such as standard Kt/V of urea,” wherein “graphs illustrating the output of the prediction component” can be stored on the USB to be received by the processor; [0014]; Fig. 24 shows the relationships between urea stdKt/v, 32-M MPC and therapy duration)(See Fig. 24 with sessions 1-4 and respective Kt/V values) or a second concentration value for the substance in the blood of the dialysis patient at an end of the treatment session (“T is a time after an end of the hemodialysis treatment session,” therefore the processor has the functional capability of receiving a session Kt/V at an end of the treatment session based on the times chosen to input into the formulas described by Akonur; [0130])) (The limitation of “receive a session Kt/V value for the treatment session” has been satisfied by Akonur and therefore the satisfying the alternative limitation of “a second concentration value” is not needed.)
receive a volume value representative of total fluid volume removed from the blood during the predefined time period (output of the optimization component is…overall volume of ultrafiltrate removed during therapy; [0011])(the processor has the functional capability of meeting this limitation); and
receive a duration of the treatment session (t.sub.tx is a total duration of the hemodialysis treatment session; [0162]), wherein receiving the standard Kt/V value comprises electronically computing the standard Kt/V value as a function of the volume value, the duration, and one of the session Kt/V value or the first and second concentration values (the processor is programmed to compute the standard Kt/V using mathematical formulas and availability of the volumes, times, and session Kt/V values; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 39, Modified Akonur teaches the system of claim 37, wherein the substance is urea (urea concentration; [0012]).
Regarding claim 40, Modified Akonur teaches the system of claim 37, wherein the substance is creatinine (solute generation rates for urea, creatinine, and β2M; Clark (incorporated by reference of Akonur, page 602, column 2, lines 5-6).
Regarding claim 41, Modified Akonur teaches the system of claim 37, wherein the substance is beta-2-microglobulin (beta 2-microglobulin; [0012]).
Regarding claim 42, Modified Akonur teaches the system of claim 37, wherein calculating the generation rate comprises multiplying the standard Kt/V value, a reciprocal of the predefined time period, and an estimated concentration value, which is representative of an average predialysis concentration of the substance in the blood of the dialysis patient during the predefined time period (the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 43, Modified Akonur teaches the system of claim 42, wherein the processor is further configured to determine the estimated concentration value as a function of the first concentration value (the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 44, Modified Akonur teaches the system of claim 42, wherein the processor is further configured to set the estimated concentration value in relation to the first concentration value (the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 45, Modified Akonur teaches the system of claim 42, wherein the processor is further configured to compute the estimated concentration value as an average of the first concentration value and one or more further concentration values for the substance in the blood of the dialysis patient at the start of one or more further treatment sessions of intermittent dialysis therapy during the predefined time period (the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 46, Modified Akonur teaches the system of claim 37, wherein the predefined time period is selected so that a concentration of the substance in the blood of the dialysis patient is substantially equal at the start and end of the predefined time period (FIG. 17 is a conceptual model used to describe steady state phosphorus mass balance over a time-averaged period; [0051])(the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 47, Modified Akonur teaches the system of claim 37, wherein the predefined time period is a week. (The graphs allow the doctor to view how the concentration 52 of a certain solute varies over the course of, e.g., a week; [0085])(the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 48, Modified Akonur teaches the system of claim 37, wherein the predefined time period includes one or more further treatment sessions, and wherein the standard Kt/V value is estimated to include the one or more further treatment sessions (See Fig. 24 with sessions 1-4 and respective Kt/V values)(the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 49, Modified Akonur teaches the system of claim 48, wherein the standard Kt/V value is estimated in absence of concentration values for the substance in the blood of the dialysis patient during the one or more further treatment sessions and in absence of a Kt/V value for the one or more further treatment sessions (System 10 also contemplates the estimating parameters 32 instead using empirical data, e.g., typical parameter values for the patient based on for example age, weight, sex, blood type, typical blood pressure, height, therapy duration, nutritional status, and disease information related to the kinetics of the solute(s) of interest. It is believed that this data can be developed over time using system 10)(The estimation parameters would be obtained using the concentration values for the substance in the blood, but instead are calculated based on the information stated)(the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 50, Modified Akonur teaches the system of claim 49, wherein the first concentration value of the treatment session is closest to an average predialysis concentration of the substance in the blood of the dialysis patient during the predefined time period, compared to an expected concentration value for the substance in the blood of the dialysis patient at the start of the respective further treatment session (Since the first concentration value can be chosen using the optimization component, the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 51, Modified Akonur teaches the system of claim 37, wherein the processor is further configured to display the generation rate, evaluate the generation rate for assessment of a physiological status of the dialysis patient, or display a parameter value representing the physiological status of the dialysis patient (“a sample estimated patient parameters 32 display screen. Estimated patient parameters 32 can include, for example, generation rate G; [0101])(the processor is programmed to perform this limitation using mathematical formulas; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 52, Modified Akonur teaches the system of claim 37, wherein the processor is configured to calculate the generation rate of the substance in the dialysis patient subsequent to the treatment session (by using the empirical data mentioned in claim 49, the processor to perform this limitation by executing mathematical calculations through given parameters of the substance; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Regarding claim 53, Modified Akonur teaches the system of claim 37, wherein the processor is configured to generate an indicator indicative of a physiological status of the patient based on the calculated generation rate (the processor is programmed to perform this limitation using mathematical formulas by setting thresholds and correlating the parameters to known data of related physiological statuses; See formulas A-Z, AA-FF and [120-121] as demonstrated through Examples in paragraphs [0177]-[0219] and Applications thereof [0220]-[0233]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Janik et al., 2018, (See attached PTO-892), teaches "determining the Kt/V value during dialysis therapy. It takes neither the generation of urea in the patient during therapy nor the so-called rebound effect into account” ([0045])
Daugirdas et al., 2010 (instant PTO-892) teaches expansion of manipulation of stdKt/v equation.
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/V.S./Examiner, Art Unit 1758
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758