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
The following Office action in response to communications received June 24, 2026. Claims 1, 6, 8 and 15 have been amended. Claims 2-5 have been canceled. Claims 21-24 have been added. Therefore, claims 1 and 6–24 are pending and addressed below.
Applicants’ amendments to the claims are sufficient to overcome the 35 USC § 103 rejections set forth in the previous office action dated March 26, 2026.
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 and 6–24 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. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 1 recites a computer-implemented method and is directed to a process. Claim 8 recites one or more non-transitory media having computer-readable instructions and is directed to a manufacture. Claim 15 recites a system having one or more hardware processors and is directed to a machine. Accordingly, claims 1, 8, and 15 fall within a statutory category.
Independent claims 1, 8, and 15 are directed to an abstract idea consisting of processing “physiological sensor measurements” to generate “a forecast of a likelihood of urolithiasis over a future time interval.”
Claim 1 recites, in relevant part:
determining a time series of measurements; detecting a set of constant values in measurement data; inputting … the time series of measurements to a forecasting model; receiving from the forecasting model a set of Hölder exponent values and an RQA recurrence rate value; and generating a forecast of a likelihood of urolithiasis over a future time interval.
Claims 8 and 15 recite substantially the same operations in non-transitory-media and system form.
The claims recite mathematical concepts because they expressly require “a time series of measurements, a forecasting model, a set of Hölder exponent values, an RQA recurrence rate value,” and a forecast of a likelihood of urolithiasis over a future time interval.” These limitations recite mathematical processing of time-series data and use of resulting values in a model to generate a forecast.
The claims also recite mental processes because they encompass observing “physiological sensor measurements,” evaluating whether measurement data include “a set of constant values,” evaluating time-series and model-related values, and generating the judgment represented by “a forecast of a likelihood of urolithiasis over a future time interval.” The claims do not require administering treatment, controlling a medical device, changing a physical state, or improving a specified computer, sensor, or medical-records-system operation.
But for generic computer components, the claims recite receiving patient information, evaluating measurement data and calculated values, generating a forecast, and generating information for a potential clinical response.
The claims additionally recite “one or more hardware processors, at least one processor, an electronic digital memory, a medical records computer system, one or more non-transitory media having computer-readable instructions, physiological sensor measurements, data collection, data storage, data retrieval, generation … of instructions to modify a treatment program, and initiating … an intervening action.”
These elements are recited at a high level of generality. They are used to receive, collect, store, retrieve, process, and generate information. The claims do not recite a particular processor architecture, memory architecture, electronic-health-record architecture, sensor configuration, sensor-calibration procedure, signal-processing improvement, model-architecture improvement, or medical-device-control operation.
The specification describes the computing environment in generic terms. For example, computer system 120 may be implemented as one or more servers, a desktop computer, laptop, tablet, cloud-computing device, distributed computing architecture, or mobile phone.
The recited “physiological sensor measurements, first set of patient data, and second set of patient data” are input information used in the recited mathematical analysis. The recited “generation … of instructions to modify a treatment program” generates information; it does not require that treatment actually be modified. Likewise, “initiating … an intervening action” is recited alternatively with instruction generation and does not require an actual physical treatment, diagnostic-device operation, or change in a patient’s physical state.
Claims 6, 9, 12, 13, 16, 19, and 20 identify such actions as “modifying treatment, ordering an additional diagnostic, scheduling a diagnostic, scheduling treatment, and issuing a notification to a caregiver.” These limitations identify possible outputs, recommendations, notifications, or workflow activities based on the forecast. They do not require administration of treatment, performance of a diagnostic test, or control of a medical apparatus.
Claims 7, 10, 11, 14, 17, 18, and 20 identify timing, input sources, or informational content. Claims 21–24 further identify storage, retrieval, re-acquisition, re-evaluation, conditions for processing, and urine-osmolality information. These limitations do not recite an improvement in computer technology, medical-records technology, sensor technology, or treatment technology. Accordingly, the additional elements do not integrate the judicial exception into a practical application.
The ordered combination does not add significantly more than the judicial exception. The claimed processors, memory, medical-records computer system, non-transitory media, and forecasting model perform generic functions of receiving data, collecting data, storing data, retrieving data, processing data, generating a forecast, generating instructions, and communicating information.
The following portion of the claim limitations are insignificant extra-solution activity: receiving … a first set of patient data; collecting … a second set of patient data; storing the first set of patient data; retrieving the first plurality of physiological sensor measurements; storing the second set of patient data; inputting … the time series of measurements to a forecasting model; receiving from the forecasting model a set of Hölder exponent values and an RQA recurrence rate value; generation … of instructions to modify a treatment program; and issuing a notification to a caregiver.”
These limitations gather, store, retrieve, provide, receive, generate, or communicate information associated with the recited mathematical concepts and mental processes. The claims do not recite a non-conventional arrangement of components or a technological improvement produced by that arrangement.
Accordingly, claims 1, 6–24 are directed to an abstract idea without significantly more and therefore are not patent eligible under 35 U.S.C. §101.
“Subject Matter Free of Prior Art”
The following section identifies claim subject matter for which the presently reviewed publications did not provide an adequate basis for a §103 rejection. It is not a statement that the identified subject matter is allowable, patentable, novel, or nonobvious. It is also not binding in later prosecution. It reflects only that the available search record did not identify sufficient pre–May 15, 2025 prior art for the identified limitations and combinations.
The reviewed Oleynik publication teaches electronic medical records, patient monitoring, comparison of patient data, assessment of future disease or condition, and treatment-related recommendations. The reviewed Monga publication teaches kidney-stone analysis, feature extraction, classifiers, and predictive models. The reviewed references do not adequately teach the following claimed combination:
-- inputting, via the at least one processor, the time series of measurements to a forecasting model;
-- in response to inputting the time series of measurements, receiving from the forecasting model a set of Hölder exponent values and an RQA recurrence rate value associated with the time series of measurements; and
-- based on the first set of patient data, the measurement data, the second set of patient data, the second plurality of physiological sensor measurements, the time series of measurements, the set of Hölder exponent values, and the RQA recurrence rate value, generating a forecast of a likelihood of urolithiasis over a future time interval.
Response to Arguments
Applicants’ arguments, filed on June 24, 2026, with respect to arguments in the remarks, have been considered but are moot in view of the new ground(s) of rejection necessitated by the new Claims 21-24 and new limitations added to Claims 1, 6, 8 and 15.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pub. No.: US 20140358585 A1; The present invention relates to an apparatus and method for implementing a medical critical results communication, including: receiving an identification and a classification of a finding of criticality on a patient; creating and transmitting a critical results communication to a recipient by electronic methods; receiving and storing an acknowledgement from the recipient that the critical results communication was received; receiving and storing feedback and/or the initiation of clinical intervention and a follow-up action from the recipient, and transmitting same to the health care provider sender; receiving and storing diagnostic confirmation from the recipient and/or the healthcare provider sender; performing an analysis of critical results data, and performing a compliance analysis with stored established medical standards; and providing the critical results data analysis and the compliance analysis to at least the health care provider sender.
Pub. No.: US 20080125666 A1; Biological data, such as human heart rate data, is acquired and processed in a non-linear manner to facilitate an assessment of the physiological state of the subject, and/or to assist in predicting incipient disorders or instability. Determinism, laminarity and recurrence measures are derived for a rolling sample of a time series of said data. The recurrence measure can be the Euclidean threshold (.epsilon..sub.thresh) at a given recurrence rate. A representation, such a colour coded matrix or multi-dimensional vector, is formed from a combination of the derived determinism, laminarity and recurrence measures. The representation can then be analysed to detect indicators of physiological instability, such as arrhythmia, or to discriminate between arrhythmias. The analysis may be performed visually, or in an automated manner in real time, such as in an ambulatory or implanted device, or post hoc by a bedside monitor.
Pub. No.: US 20090098553 A1; This invention relates to methods for determining the presence of cancer in a subject based on the analysis of the expression levels of an under-expressed tumour marker (TM) and at least one other TM. Specifically, this invention relates to the determination of a cancer, particularly bladder cancer, by performing ratio, regression or classification analysis of the expression levels of at least one under-expressed TM, particularly an under-expressed bladder TM (BTM), and at least one over-expressed TM, particularly an over-expressed BTM. In various aspects, the invention relates to kits and devices for carrying out these methods.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD B WINSTON III whose telephone number is (571)270-7780. The examiner can normally be reached M-F 1030 to 1830.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.B.W/ Examiner, Art Unit 3683
/ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683
