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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
In the submission dated 8/11/2026, no amendments were made.
Claims 1 – 20 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 1 – 20 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.
The claim(s) recite(s) subject matter within a statutory category as a process (claims 15 – 20), machine (claims 1 – 14) which recite steps of
present a plurality of controllable variables for selection, and wherein a selected controllable variable is scheduled to be modified for the patient over a testing period; and
a compliance entry feature configured to receive compliance information related to the patient, wherein the patient enters compliance confirmation entries,
perform an evaluation to determine whether the selected controllable variable is to be included in the overall kidney maintenance plan, the evaluation including:
receiving first evaluation data as a baseline, the first evaluation data including a first score corresponding to a stage of kidney damage that is determined from a chronic kidney disease test of the patient performed during a first time of the testing period, wherein the chronic kidney disease test includes at least one of an albumin-to-creatinine ratio ("ACR") test or a glomerular filtration rate ("GFR") test performed on the patient,
receiving second evaluation data including a second score corresponding to a stage of kidney damage that is determined from the chronic kidney disease test of the patient performed during a subsequent, second time of the testing period,
analyzing the evaluation data by using an algorithm to compare multiple time ranges of evaluation data against limits that are standard for multiple patients, against limits that are based upon patient historical data, and/or combinations thereof,
determining from the first evaluation data and the second evaluation data whether a kidney function worsens by determining if the second score is lower than the first score,
using the compliance information to confirm that the selected controllable variable was modified over the testing period as scheduled, wherein the confirmation is completed by comparing the stored data collected during the testing period with the compliance confirmation entries submitted by the patient during the testing period to evaluate the patient's consistency in performing the selected controllable variable modification,
adding the selected controllable variable to the overall kidney maintenance plan as an approved controllable variable when (i) a worsening of kidney function is not determined between the first evaluation data and the second evaluation data, and (ii) the compliance information provides a confirmation that the selected controllable variable was modified over the testing period, and
omitting the selected controllable variable from the overall kidney maintenance plan when a worsening is determined between the first evaluation data and the second evaluation data,
transmit the overall kidney maintenance plan including at least one approved controllable variable and
wherein an appropriate dialysis treatment is administered to the patient to treat the chronic kidney disease of the patient.
These steps of claims 1 – 20, as drafted, under the broadest reasonable interpretation, includes performance of the limitation in the mind 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 practically being performed in the mind. For example, but for the server language, receiving in the context of this claim encompasses a mental process of the user. Similarly, the limitation of determining, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the automated language, learning in the context of this claim encompasses a mental process of the user. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
These steps of claims 1 – 20, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The Examiner understands the claimed invention in light of the Specification. For example, the Specification states:
[0002] The present disclosure relates generally to medical fluid delivery and more particularly to personalized chronic renal care.
[0010] The present disclosure sets forth systems, apparatuses and methods providing an overall renal failure treatment regime that attempts to (i) identify people whose activities and related clinical and physiological data indicate that they are at-risk for chronic kidney disease ("CKD"), (ii) provide such people with pre-CKD education and prevention efforts, (iii) monitor the health and therapy-adherence of CKD dialysis patients currently undergoing treatment, (iv) slow the progression of end-stage renal disease, and (v) monitor, manage and report on CKD patients in its various stages to enhance the medical standard of care, identify positive or negative therapy trends, and advance new treatment protocols, techniques and methodologies.
The claimed invention describes an abstract idea applied to technology. The claimed invention obtains all the improvements obtained by applying the abstract idea to technology. The invention does not include an improvement to technology or a technological improvement. The result of the invention is data that has a potential application and therefore there is no practical application.
T he claims includes an “automated learning method.” However, the Specification does not describe a particular learning function. Rather the invention learns via trial and error, as described in paragraph 24
[0024] In an embodiment, the learning method determines if the particular control variable needs to undergo one or more additional trial for repeatability. If so, the one or more additional trial for the particular control variable is repeated. If not, or if all trials have been completed, then the results of the subsequent ACR and/or GFR test (or combination of multiple subsequent tests) are compared with the baseline ACR and/or GFR test results to determine if the patient's kidney disease and/or kidney functioning have worsened. If so, then the particular control variable is not added to an overall kidney maintenance plan. But if the patient's kidney disease and/or kidney functioning have stayed the same or improved, the particular control variable is added to the overall kidney maintenance plan.
There is no algorithmic learning but rather an automation of manual learning.
Regarding the word “administering,” the Specification does not include the word. However, the Specification does state that the invention is implemented. For example, with paragraph 22 for context and emphasis added.
[0022] The systems of the present disclosure in various embodiments employ learning methods to help the patient and to build databases to streamline the methods. One learning method operated at the system of the present disclosure is configured to help people who have properly functioning kidneys but show one or more risk factors for developing kidney disease, people who have properly functioning kidneys but show early signs of kidney disease, or for patients who have mild loss of kidney function. One goal for any of these situations is to stem further development of kidney disease or loss of kidney function. As explained in detail below, a glomerular filtration rate ("GFR") test is a blood test used to evaluate a patient's kidney function, while an albumin-to-creatinine ratio ("ACR") test is used to evaluate whether the patient has kidney disease. Either one or both of the GFR test and the ACR test is used with the learning method to determine if modifying a control variable produces positive results for the patient. The control variable may be (i) nutrition based, e.g., reduce phosphorous or sodium, (ii) lifestyle based, e.g., exercise more frequently or get more rest, or (iii) medicinally based, e.g., take blood pressure reducing medicine.
[0023] In initial steps, the patient performs a baseline ACR and/or GFR test and a list of the different control variables to test is determined. Then a first one of the control variables is selected for implementation. The selected control variable is then implemented over a suitable period of time, e.g., a few weeks to a month. During implementation, the patient enters into his or her smartphone or personal computer information indicating that the patient is complying with the control variable modification. The compliance entries may be satisfied or augmented via data from relevant sensors, such as cameras, weight scales, blood pressure monitors, etc. When control variable modification is completed, a determination is made whether the level of patient compliance has been sufficient. If not, the selected control variable is tested again. If so, then the patient undergoes a subsequent ACR and/or GFR test.
This patient manual action is further emphasized within the detailed description
[00148] At diamond 134, when there is no additional control variable to analyze, method 110 at block 136 combines all control variables from block 132 determined to be part of the patient's overall kidney maintenance plan to form the plan. Smartphone 40 or computer 50 thereafter implements, monitors and controls the overall kidney maintenance plan. For each control variable of the overall kidney maintenance plan, smartphone 40 or computer 50 prompts patient 12 to enter compliance information and/or receives compliance information or data from one or more sensor 20.
[00153] In an embodiment, method 150 is a patient-implemented, caregiver assisted method, which is again carried out primarily at the patient's smartphone 40 or computer 50 in combination with one or more sensor 20. At oval 152, method 150 begins. At block 154, patient 12 enters into the patient's smartphone 40 or computer 50 a co-morbidity goal, such as to (i) regulate patient volume, (ii) regulate blood pressure, or (iii) regulate blood sugar.
[00154] At block 156 (which may be performed before or after block 154) patient 12, e.g., in cooperation with a doctor or clinician, develops a list of controllable variables selected to determine their effect, if any, on the selected goal entered at block 154. For example, controllable variables for patient volume include (i) limit the weight of food consumed per day to a certain amount, (ii) limit the weight of liquid consumed per day to a certain amount, (iii) limit the weight of food and liquid consumed per day to a certain amount, (iv) regulate the amount of food and/or liquid consumed after treatment, so that a greater percentage of food and/or liquid is consumed, e.g., closer to (or farther from) the next dialysis treatment, or if dialysis treatment is daily to ingest food on a daily basis closer to (or farther from) the next treatment.
[00155] Controllable variables for patient blood pressure include (i) limit sodium intake, (ii) limit sodium level of dialysis fluid used during treatment, (iii) limit fatty foods, and (iv) limit alcohol intake. Controllable variables for patient blood sugar include (i) limiting sugar intake and (ii) limiting dextrose or glucose levels in peritoneal dialysis fluids.
In general, the Specification discloses treatment guidelines.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 14 and 16 – 20, reciting particular aspects of how creating a maintenance plan may be performed in the mind but for recitation of generic computer components).
This judicial exception is not integrated 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 (such as recitation of on the server amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of receiving … evaluation data amounts to mere data gathering, recitation of confirm the selected … amounts to selecting a particular data source or type of data to be manipulated, recitation of transmit the overall kidney maintenance plan… amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 14 and 16 – 20, additional limitations which amount to invoking computers as a tool to perform the abstract idea). Looking at the limitations 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 provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/do not include additional elements that are sufficient to 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 generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, 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 claims 1 – 20; server receiving, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); adding…, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii))
Additional elements
software – paragraph 102, 103
server – paragraph 17
network – paragraph 104, 116
patient device – paragraph 66
sensor – paragraph 24 such as cameras, weight scales, blood pressure monitors, etc.
data receiving device – paragraph 16 The data receiving device may for example be the patient's smartphone or computer that runs a program or application.
data output device – paragraph 16 a data output device (which may or may not be the same as the data receiving and/or data analytics device).
data analytics device - paragraph 16 a data analytics device (which may or may not be the same as the data receiving device),
Currently claimed in the dependent claims, the invention uses “sensors.” As stated in paragraph 11, (emphasis added)
[0011] Each of (i) to (v) above involves the use of sensors, the collection of data from such sensors, the analysis of collected data to look for specified parameters, and the communication of the outcome of the analysis to the patient and/or caregiver. In one example, existing CKD patients are provided with at least one of a leg sensor and a wristband sensor. The leg sensor may for example identify nocturnal leg movement. The leg sensor or the wrist sensor may also detect autonomic variables, such as heart rate and blood pressure. The wrist sensor may also monitor the patient's sleep patterns, including sleep timings and sleep cycles. Data collected from the sensors is transmitted to one or more software algorithm that analyzes the data to look for certain results. For example, leg sensor nocturnal movement data may be used to determine if a patient has restless leg syndrome. If so, the patient and/or a health care provider ("HCP") may be notified automatically. The HCP may then order a ferritin level blood test and possibly prescribe a treatment, such as an iron therapy.
The sensors are used to collect data. The sensors act as input to the instant invention which then analyzes the received data. Therefore, the sensors are additional elements that provide extra-solution activity.
The Specification discusses “algorithms” as mentioned in paragraph 11 and further disclosed within other Specification paragraphs. However, the Specification never discloses the actual algorithms used. The Examiner cautions the use of a not disclosed algorithm to the functions of things that are known.
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 14 and 16 – 20, additional limitations which amount to electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)). Looking at the limitations 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 provide conventional computer implementation.
Response to Arguments
Applicant's arguments filed 8/11/2026 have been fully considered but they are not persuasive.
35 U.S. C § 101 Rejection
I. CLAIM I IS REPRESENTATIVE
II. THE OFFICE ACTION OVERSIMPLIFIES THE CLAIMED ABSTRACT IDEA BY DISREGARDING THE SENSOR-VERIFIED COMPLIANCE CROSS-CHECK AND DUALCONDITIONAL GATING LOGIC
A. Governing Standard
B. The Office Action s Characterization Ignores Specific Claim Limitations
The Applicant states, “Applicants respectfully submit that this characterization strips away, and fails to account for, at least the following limitations that a human mind, even an unusually diligent one cannot practically perform. First, Claim 1 recites that patient compliance be verified not by self-report alone, but by "comparing the sensor data collected during the testing period with the compliance confirmation entries submitted by the patient during the testing period to evaluate the patient's consistency in performing the selected controllable variable modification."” The claim compares “sensor data.” The sensor is therefore extra-solution to the instant invention.
The fact that the sensor provides the data into the server is noted. However, if the claimed invention had removed the sensor with a database of data, labeled “sensor data,” then the invention would produce the same results. The invention compares data stored in a database. A mental activity.
Further arguments directed towards the sensor are considered moot.
The Applicant states, “This is a specific, multi-source comparative methodology that includes testing the patient's data against population norms and/or the patient's own longitudinal history.” The Applicant’s point is that the invention uses an algorithm to compare data. Humans can follow specific methods and use pencil and paper.
The Applicant states, “This conjunctive, two-factor decisional architecture is a specific control structure, not an undifferentiated instruction to determine and add.” The Applicant is describing mathematical steps. There is no architecture or structure claimed.
The Applicant further states, “However, the Step 2A, Prong One analysis in the Office Action does not explain why a verification step requiring two independently sourced, machine-collected data streams, or a dual-conjunctive gating decision, reduces to an unaided mental process.” The Applicant is at best arguing at best that the “generic computer components” suddenly are not generic computer components. However, the Specification disagrees.
The invention is a series of steps that compare data using an algorithm. These are procedures that a human can perform mentally, with the aid of pencil and paper. As claimed, the invention uses generic computer components, applied to the abstract idea, to achieve all the benefits of applying those components to the abstract idea.
C. The Correct Level of Abstraction Supports Eligibility or, at Minimum, Requires Withdrawal of the Current Rejection
The Applicant states, “Applicants further note that the Office Action's simultaneous invocation of both the "Mental Processes" grouping (Office Action ¶9) and "certain methods of organizing human activity" (Office Action ¶10), without identifying which specific claim limitations fall within which grouping or which of the enumerated sub-groupings of organizing human activity applies compounds the oversimplification problem and leaves Applicant without the notice required to formulate an effective response.” The Examiner notes that the argument is without basis. The Applicant’s previous responses show the lack of confusion.
III. THE CLAIMS INTEGRATE ANY JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION BECAUSE THEY RECITE A PARTICULAR TREATMENT OF CHRONIC KIDNEY DISEASE ANALOGOUS TO VANDA
A. Governing Standard
B. Claim I Recites a Particular Treatment, not a Generic Field of Use
The Applicant states, “This is directly analogous to the administration step in Vanda, where the claim used the results of a genotyping assay to determine a dosing regimen that was then administered to more safely treat the patient. 887 F.3d at 1135. As in Vanda, the administration step here is not performed merely to gather data for further diagnostic analysis. The analysis has instead already occurred by the time the dialysis treatment is administered such that the outcome of that analysis is used to determine and deliver the patient's actual treatment.” However, unlike Vanda, the instant invention ends with a generic apply it vs a particular treatment.
The Applicant states, “Applying the particularity, non-nominal-relationship, and non-extra-solution-activity factors of MPEP § 2106.04(d)(2): the treatment (dialysis) is a specifically identified, particular modality, not a generic instruction to "treat the patient".” As the Applicant is aware, dialysis includes several different treatment options plus other variables. The Applicant’s arguments disagree with the family of dialysis treatments.
C. The Office Action's Mere-Instructions and Extra-Solution-Activity Findings are Independently Unsupported
1. The Claims do not Recite Mere Instructions to Apply an Exception
The Applicant states, “Unlike the claim in Electric Power Group, which merely recited that data be "received," "detected," and "displayed" without specifying how… This is a description of how the result is achieved, not merely a claim to the result itself.” The invention, like Electric Power Group, receives data, processes the received data, and outputs the results of received and processed data. (As stated in MPEP 2106.05(h)(vi) “Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis”)
The Applicant states, “The Office Action does not explain, and Applicants respectfully submit it cannot explain, why a server executing this specific verification and gating architecture is the functional equivalent of a server that merely receives, stores, or transmits data in its ordinary capacity.” The Applicant’s opinion on “specific” differs from the broad claim language. Further, unlike TLI and Thales, the instant invention is not described as a technical or technological improvement.
2. The Claims do not Recite Insignificant Extra-Solution Activity
The Applicant states, “This is not an unconstrained instruction to gather data by any means.” As noted above, the claim language differs from the Applicant’s opinion.
The Applicant states, “Nor is the sensor-verified compliance cross-check, or the dual-conditional gating logic that depends on it, nominal or tangential to the invention.” The Examiner is not arguing that the abstract idea is less than the abstract idea. The Examiner disagrees regarding what components are extra-solution, such as the sensor, and are generic, such as the computer and algorithms. Further, the “sensor-verified cross-check” is not claimed but rather the Applicant’s opinion.
D. The Practical-Application Argument was Not Addressed by the Office Action
The Applicant states, “It does not address the particular treatment or prophylaxis consideration under MPEP § 2106.04(d)(2) at all, notwithstanding that Claim 1 expressly recites administration of dialysis treatment to treat chronic kidney disease.” The Applicant’s opinion that a particular treatment occurs is noted. However, this is the Applicant’s opinion, but the Specification and the Examiner disagree.
IV THE STEP 2B WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL FINDING AND THE ORDERED-COMBINATION FINDING ARE UNSUPPORTED CONCLUSORY ASSERTIONS UNDER BERKHEIMER
A. Governing Standard
B. The Office Action's W URC Finding Lacks the Evidentiary Support Berkheimer Requires
The Applicant states, “The Office Action cites no specification admission, no additional case decision addressing this specific combination, no prior-art publication, and does not invoke official notice (which would in any event be subject to challenge).” The Applicant is mistaken. Please see #15 above which has also appeared in previous Office Actions.
The Applicant states, “An examiner cannot simultaneously maintain that a specific algorithmic and verification architecture is unknown in its particulars and that its application is nonetheless well-understood and routine.” This is interesting in that it is in these remarks that the Applicant is arguing specifics. However, the Examiner notes the generic nature of the invention as explained by the Specification.
The Examiner’s position is consistent in that the Specification shows generic technology. The Examiner believes that generic technology is known. If the Applicant wishes to include specific technology that is also not disclosed then the Applicant may have a written description problem. Please see MPEP 2163 regarding written description.
C. The Ordered-Combination Finding is Independently Conclusory
The Applicant states, “This statement does not identify what specific arrangement was considered, nor does it explain why the arrangement of a sensor independently verifying patient-entered compliance data, cross-referenced against a two-timepoint, multi-source algorithmic comparison of CKD severity, gating inclusion in a plan that is then transmitted to drive administered dialysis treatment, is the routine or predictable result of simply combining generic sensor, server, and network components.” The Examiner first lays out the abstract idea. Then the Examiner states which areas the abstract idea falls under. Lastly, the Examiner explains how these are understood. The Applicant’s attempt to include language not found within the claims to argue the Examiner’s style is not persuasive.
The Applicant states, “The Office Action's ordered-combination analysis does not engage with this inquiry at all.” The Examiner notes that an “ordered-combination analysis” relates to technical or technological improvements. These improvements are not disclosed or claimed. Therefore, the Applicant’s arguments are moot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Soykan Pub. No.: US 2015/0149096 A device, system and related methods for monitoring a mammal with heart failure, kidney disease or both, to make predictions about the likelihood of a life threatening ventricular arrhythmia.
Awadalla Pub. No.: US 2016/0001000 A system and method of determining the estimated glomerular filtration rate of the kidneys of a patient.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626
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