DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/9/2026 has been entered.
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 amendment dated 3/9/2026, the following has occurred: Claims 1 and 15 have been amended.
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 therefor, 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 up on 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.
The 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 factor 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 3/9/2026 have been fully considered but they are not persuasive.
35 U.S. C § 101 Rejection
The Applicant states, “Similar to BASCOM and Desjardins, independent Claims 1 and 15 recite a technology-based solution that, when the claim elements are combined, provides ongoing updates for a health care provider ("HCP") regarding whether a patient requires immediate medical attention or a modification to their treatment plan.” However, both BASCOM and Desjardins are significantly different from the instant invention because they were both technological improvements. These technological improvements were present in the claimed invention, understood at a whole, in light of the specification.
Further arguments that related to technological improvements are similarly moot. The Applicant cannot show where the invention, understood as a whole, in light of the Specification is a technological improvement. The invention provides benefits of technology. That is, the invention applies technology to the abstract idea to obtain all the benefits of applying that technology to the abstract idea.
The Applicant states, “Known systems are impractical due to their limitations around incorporating and removing specific individual variables from kidney maintenance plans in real time based on analysis of data gathered by the system.” The Examiner does not see references to the Applicant’s opinion within the Specification. Regardless, applying existing technology to an abstract idea often produces better results.
The Applicant further states, “Patients can enter compliance information, but HCPs cannot confirm that the patient slept when they said they slept, ate what they said they ate, or otherwise accurately entered the controllable variable data into the system.” The Examiner notes that this is an example of why the invention is directed towards methods of organizing human activity.
The Applicant states, “Specifically, the smartphone or computer acting as the data receiving device and/or the data output device is performing a function it has never performed before - monitoring and optimizing a renal maintenance treatment plan.” The smartphone or computer are acting as smartphones or computers with applications applied to them. Their respective functions have not changed.
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.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626
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