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 July 29, 2026. Claims 1, 3-8, 10-15 and 17-20 have been amended. Claims 2, 9 and 16 have been canceled. Claims 21-23 have been added. Therefore, claims 1, 3-8, 10-15 and 17-23 are pending and addressed below.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC § 103, rejections set forth in the previous office action dated April 1, 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, 3-8, 10-15 and 17-23 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:
Independent Claim 1 recites, in part:
Receiving, at a medical records computer system, a plurality of physiological measurements corresponding to one or more urinalysis variable values of a target patient; determining a time series of physiological measurements; based on the time series, determining wavelet transform information including at least one wavelet set of data associated with a frequency representation of a first portion of the time series and two or more time-scale representations associated with the frequency representation and/or a second portion of the time series; utilizing analysis information corresponding at least partially to the time series of physiological measurements, the wavelet transform information, an algorithmic predictor, or any combination thereof to generate a forecast of a likelihood of urolithiasis for the target patient over a future time interval; and, based at least partially on the generated forecast and the likelihood of urolithiasis for the target patient over the future time interval, initiating an intervening action to administer a particular treatment procedure to the target patient in association with treating a particular condition associated with the generated forecast.
Independent Claim 8 recites the same or similar limitations in method form, and Independent Claim 15 recites the same or similar limitations in non-transitory computer-readable-medium form.
The limitations of Claims 1, 8, and 15, as drafted, under their broadest reasonable interpretation, cover the performance of:
Mental processes, including collecting or observing patient measurements, evaluating temporal patterns, determining a likelihood of future recurrence, and deciding whether a patient should receive intervention based on the prediction.
Certain methods of organizing human activity, including clinical decision support, management of patient monitoring, treatment planning, scheduling interventions, communicating recommendations or alerts, and coordinating healthcare delivery based on predicted risk.
Mathematical concepts, including wavelet transformation, frequency-domain or time-scale representation of data, wavelet-based analysis of a time series, recurrence-based or exponent-based characterization of physiological signals, predictive modeling, and comparison of a computed forecast against a threshold or control criterion.
But all for the recitation of generic computer components and a generic clinical environment, the claim steps are simply receiving patient urinalysis-related measurements, mathematically analyzing the resulting time series, generating a recurrence-risk forecast, and using that forecast to determine whether an intervention should occur.
The claims recite, at a high level of generality, one or more hardware processors, at least one processor associated with an electronic digital memory, a medical records computer system, a measurement device, electronic health record systems, network communications, a decision-support application, an algorithmic predictor, model data and model storage, generic user or clinician interfaces, storage and record-management components, and non-transitory computer-readable media. These elements merely use generic computer and information-management components to perform generic computer functions such as receiving data, storing data, retrieving data, executing mathematical routines, generating outputs, and communicating results. Looking to the specification, these components are described as conventional computing infrastructure, including servers, desktops, laptops, tablets, smartphones, memory, processors, networks, EHR systems, graphical user interfaces, and standard software packages for statistical and time-series processing (see paragraph [0061]).
The additional elements do not integrate the abstract idea into a practical application. The claims do not recite an improvement to the functioning of the claimed computer, medical-record platform, network, sensor, wavelet-processing architecture, or recurrence-analysis architecture. Instead, the recited processors, memories, records systems, interfaces, and model components are used as tools to gather patient data, execute mathematical analysis, and present or act upon the result in a conventional computing environment. The recited limitation that an intervening action is initiated to administer “a particular treatment procedure” does not meaningfully limit the claim because the claim does not identify any actual treatment, drug, therapeutic composition, dose, route of administration, treatment regimen, operative therapeutic device setting, or specific medical procedure. Under the broadest reasonable interpretation, that language encompasses merely selecting or generically initiating any suitable treatment after a risk score is generated. The present claims are analogous to the ineligible example because they do not require any concretely defined therapeutic intervention.
Further, the specification primarily describes downstream actions such as modifying a care program, automatically scheduling interventions or consultations, generating notifications, issuing recommendations, or otherwise intervening in patient care at a high level, rather than actual implementation of a defined treatment procedure (see paragraph [0005]). Accordingly, the additional elements merely apply the abstract idea in a clinical field of use and in a conventional computer environment and do not impose a meaningful limit on the judicial exception.
The ordered combination of claim elements adds nothing significantly more than the abstract idea itself. The claims merely combine conventional data acquisition, conventional medical-record storage and retrieval, conventional processor-based execution of mathematical operations, conventional predictive-model implementation, and conventional output or intervention management. The claimed use of wavelet-based analysis, predictor models, and threshold evaluation may make the abstract idea more detailed, but it does not supply an inventive concept because the claims still recite the use of mathematical tools on generic computer infrastructure for the purpose of clinical prediction and decision support. Any receiving, storing, displaying, transmitting, scheduling, recommendation-generating, or reporting steps constitute insignificant extra-solution activity or well-understood, routine, and conventional computer implementation.
Accordingly, claims 1, 3-8, 10-15 and 17-23 are directed to an abstract idea without significantly more and therefore are not patent eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-8, 10-15 and 17-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amended limitation requiring “initiating an intervening action to administer a particular treatment procedure to the target patient” lacks adequate written description support in the application as filed. The specification describes actions that may be carried out automatically or recommended, such as intervening in the patient’s care, modifying a care program, automatically scheduling interventions or consultations with specialist caregivers, generating notifications, recommendations, information, alerts, or alarms, and receiving orders or providing instructions through a clinician interface. However, the specification does not clearly describe possession of a system or method that actually administers a particular treatment procedure to the patient. The disclosure does not identify a specific treatment procedure that is administered by the claimed system, nor does it describe the operational steps, treatment-apparatus control, medication delivery, procedure execution, or other implementation details by which such administration occurs. Instead, the disclosure supports decision support, recommendations, scheduling, communication, and care-management actions at a high level of generality.
Appropriate clarification and correction are required.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-8, 10-15 and 17-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In particular, the phrase “initiating an intervening action to administer a particular treatment procedure” renders independent Claims 1, 8, and 15 indefinite because it is unclear what constitutes the recited “particular treatment procedure,” what concrete acts amount to “administering” that procedure, and what boundary separates the claimed treatment administration from merely recommending treatment, scheduling treatment, ordering treatment, modifying a care plan, generating an alert, or notifying a clinician. The specification actions broadly as recommendations, care-program modification, automatic scheduling of interventions or consultations, notifications, alerts, decision support, etc., but does not provide a clear boundary for what “administering a particular treatment procedure” encompasses in the claims. The phrase is functional and result-oriented because it defines the limitation by what it is intended to accomplish rather than by reciting sufficiently definite structure or treatment action. As written, one of ordinary skill in the art would not reasonably know whether the limitation covers issuing an order or physically delivering a therapy or automatically controlling a treatment device.
Appropriate clarification and correction are required.
"Subject Matter Free of Prior Art"
Examiner notates below the reasons why the claims overcome the prior art. The limitations most likely to distinguish over the cited combination of AMLAND et al., Vairavan et al. and KONNO. Upon determination of the subject matter eligibility issues under 35 U.S.C. 101 and 35 U.S.C. 112, the presently applied prior art of record does not appear to teach or suggest certain limitations directed to wavelet-transform-based, multi-scale urinalysis time-series analysis and the use of RQA recurrence-rate and Hölder-exponent features in forecasting recurrent symptomatic urolithiasis.
Response to Arguments
Applicants’ arguments, filed on July 29, 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 limitations added to Claims 1, 3-8, 10-15 and 17-23.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 analyzed 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.
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 tumor marker (TM) and at least one other TM. Specifically, this invention relates to the determination of 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.
Applicants’ 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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/E.B.W/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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