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 December 26, 2025. Claims 1, 10, 19, 26 and 29 have been amended. Therefore, claims 1, 3-5, 7-10, 12-14, 16-19, and 21-29 and 21-29 are pending and addressed below.
Applicant’s amendments to the claims are not sufficient to overcome the rejections set forth in the previous office action dated June 4, 2025.
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, 3-5, 7-10, 12-14, 16-19, and 21-29 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(s) 1, 10 and 19 are directed to an abstract idea of collecting and analyzing data to predict a medical outcome using mathematical techniques and machine learning. The claims 1, 10 and 19 all recite “accessing (a) is configured based on information associated with instances of a first set of time series measurements of one or more urinary parameters comprising at least urine osmolality for a plurality of individuals; and (b) is configured to implement one or more decision elements and to indicate information corresponding to predictions of occurrence or recurrence of urolithiasis; based on collecting a sequence of urinary measurements for a patient: determining a second set of time series measurements of one or more urinary parameters comprising urine osmolality for the patient; applying patient data, wherein the patient data is associated with the sequence of urinary measurements and further is associated with instances of the second set of time series measurements of the one or more urinary parameters comprising at least urine osmolality for the patient; generating forecast data associated with a predictions regarding occurrence or recurrence of urolithiasis; determining a set of Holder exponents and a recurrence quantification analysis (RQA) recurrence rate based on at least the second set of time series measurements; and utilizing at least the RQA recurrence rate and at least a subset of the set of Holder exponents to estimate a likelihood of urolithiasis over a future time interval for the patient; and treating the patient for the urolithiasis with a therapeutic dose of a xanthine oxidase inhibitor, wherein treating the patient for the urolithiasis comprises administering to the patient a xanthine oxidase inhibitor therapy that (i) is based on the prediction regarding theurolithiasis for the patient and based further on the estimated likelihood of the urolithiasis for the patient and that (ii) includes the therapeutic dose of the xanthine oxidase inhibitor.”
The limitations of “accessing (a) is configured based on information associated with instances of a first set of time series measurements of one or more urinary parameters comprising at least urine osmolality for a plurality of individuals; and (b) is configured to implement one or more decision elements and to indicate information corresponding to predictions of occurrence or recurrence of urolithiasis; based on collecting a sequence of urinary measurements for a patient: determining a second set of time series measurements of one or more urinary parameters comprising urine osmolality for the patient; applying patient data, wherein the patient data is associated with the sequence of urinary measurements and further is associated with instances of the second set of time series measurements of the one or more urinary parameters comprising at least urine osmolality for the patient; generating forecast data associated with a predictions regarding occurrence or recurrence of urolithiasis; determining a set of Holder exponents and a recurrence quantification analysis (RQA) recurrence rate based on at least the second set of time series measurements; and utilizing at least the RQA recurrence rate and at least a subset of the set of Holder exponents to estimate a likelihood of urolithiasis over a future time interval for the patient; and treating the patient for the urolithiasis with a therapeutic dose of a xanthine oxidase inhibitor, wherein treating the patient for the urolithiasis comprises administering to the patient a xanthine oxidase inhibitor therapy that (i) is based on the prediction regarding theurolithiasis for the patient and based further on the estimated likelihood of the urolithiasis for the patient and that (ii) includes the therapeutic dose of the xanthine oxidase inhibitor,” as drafted, is a process that, under its broadest reasonable interpretation, covers the performance of Mental Process which are concepts performed in the human mind (including an observation, evaluation, judgment, opinion) and/or Mathematical Concepts (e.g. Holder exponents and RQA) which are concepts performed that encompasses mathematical relationships, mathematical formulas or equations, and mathematical calculations, but for the recitation of generic computer components. That is, other than reciting “processor; sensor, machine-learning electronic model,” nothing in the claim element precludes the step from practically being performed in the mind and/or being performed by concepts that encompasses mathematical relationships, formulas, equations, and/or calculations. For example, but for the “processor, “determining” in the context of this claim encompasses the user manually defining one or more urinary parameters. Similarly, the inputting patient data, under the broadest reasonable interpretation covers the performance of steps being performed in the mind, but for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers the steps being performed in the mind and/or being performed by concepts that encompasses mathematical relationships, formulas, equations, and/or calculations, but for the recitation of generic computer components, then it falls within the “Mental Process and/or Mathematical Concepts,” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of using a “processor; sensor, machine-learning electronic model” to perform all of the “accessing, determining, applying, generating, utilizing and treating” steps. The “processor; sensor, machine-learning electronic model” is/are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of executing computer-executable instructions for implementing the specified logical function(s) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claim 1 has additional limitations (i.e., processor; sensor, machine-learning electronic model). Claim 10 has additional limitations (i.e., processor; sensor, machine-learning electronic model). Claim 19 has additional limitations (i.e., sensor, machine-learning electronic model). Looking to the specification, these components are described at a high level of generality (¶ 61 and 63; One embodiment of interface 142 takes the form of a graphical user interface and application, which may be embodied as a software application (e.g., decision support application 140) operating on one or more mobile computing devices, tablets, smartphones, front-end terminals in communication with back-end computing systems, laptops, or other computing devices. In an embodiment, the application includes the PowerChart® software manufactured by Cerner Corporation. In an embodiment, interface 142 includes a Web-based application (which may take the form of an applet or app) or set of applications usable to manage user services provided by an embodiment of the technologies described herein.). The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, although the claims add “[storage]” steps, it is only considered as insignificant extrasolution activity. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
It is worth noting that the above analysis already encompasses each of the current dependent claims (i.e., claims 3-5, 7-9, 12-14, 16-18, and 21-29). Particularly, each of the dependent claims also fails to amount to “significantly more’ than the abstract idea since each dependent claim is directed to a further abstract idea, and/or a further conventional computer element/function utilized to facilitate the abstract idea. Accordingly, none of the current claims implements an element—or a combination of elements—directed to an inventive concept (e.g., none of the current claims is reciting an element—or a combination of elements—that provides a technological improvement over the existing/conventional technology). These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Process and/or Mathematical Concepts,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claims 1, 3-5, 7-10, 12-14, 16-19, and 21-29 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Response to Arguments
Applicant’s arguments filed December 26, 2025 have been fully considered but they are not persuasive. In the remarks applicant argues:
Rejections under 35 U.S.C. 101 Claims 1-20 were rejected by the Office under 35 U.S.C. 101 because the claimed invention is ostensibly directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Applicant respectfully traverses this rejection.
the claims do not fall under any of the enumerated categories set forth by the 2019 guidance.
Under prong 1 of step 2A, applicant submits that the claims do not fall under any of the enumerated abstract idea categories as laid out in the 2019 guidance. The enumerated categories or groupings that the claimed elements must fall under is as follows, "
mathematical concepts: mathematical relationships, mathematical formulas or equations, mathematical calculations... certain method of organizing human activity: fundamental economic principles or practices...commercial or legal interactions...legal obligations... advertising, marketing or sales activities...business relations...managing personal behavior or relationships or interactions between people......mental processes: concepts performed in the human mind (including an observation, evaluation, judgment, opinion.1
On page 3 of the Office Action, the Office states that the claims are directed to certain methods of a mental process.
Applicant respectfully submits the independent claims do not recite a mental process. As simplified in the chart below, Examples 37-40 in the 2019 PEG Examples 37 through 42 (Issued January 7, 2019) discuss recitations of a mental process.
Similar to the examples, the present claims recite at least one element that cannot be performed in the mind. Unlike merely determining an amount or comparing data, claim 1, for example, recites, "utilizing the mathematical predictor, generating a forecast of the likelihood of urolithiasis over a future time interval; and based on the generated forecast, automatically initiating an intervening action comprising one or more of modifying treatment, ordering additional diagnostics, scheduling treatment or diagnostics, and issuing a notification to a caregiver." The human mind cannot utilize a mathematical predictor and automatically initiate an intervening action, as recited. Accordingly, Applicant submits that the claims cannot be performed merely in the mind.
ii. the claims are integrated into a practical application. Under prong 2, examiners should evaluate whether the claim as a whole integrates the recited judicial exception into a practical application. A claim integrates a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
Applicant submits that each of the claims as a whole integrate any purported judicial exception into a practical application. For example, the claims are directed to an improvement in computerized-clinical decision support. The Federal Circuit recently stated that claims that "focus on a specific means or method that improves" the technology and "are not directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery" are directed to an improvement and not an abstract idea.2 In Cardionet v. Infobionic, the Court found the claims to be directed to a practical application because the "written description identifies a number of advantages gained by the elements recited in the claimed ... device."3 There the claimed invention more accurately detected the occurrence of atrial fibrillation and atrial flutter through variability determination logic, relevance determination logic, and an event generator.
Similar to the Court's decision in Cardionet, the as filed specification describes a number of advantages gained by the elements recited in the claims over conventional computerized-clinical decision support systems. For example, the claims offer an improvement to decision support technology by utilizing the mathematical predictor to generate a forecast of the likelihood of urolithiasis over a future time interval and based on the generated forecast, automatically initiating an intervening action comprising one or more of modifying treatment, ordering additional diagnostics, scheduling treatment or diagnostics, and issuing a notification to a caregiver. Thus the claimed invention provides an improvement to conventional computerized- clinical decision support systems. For instance, claim 1 recites, in part:
receiving a plurality of measurements of one or more urinary parameters;
determining a time series of measurements from the received plurality of measurements;
based on the time series of measurements, determining a set of Holder exponents and an RQA recurrence rate;
utilizing the RQA recurrence rate and at least a subset of the set of Holder
exponents in a mathematical predictor;
utilizing the mathematical predictor, generating a forecast of the likelihood of urolithiasis over a future time interval; and
based on the generated forecast, automatically initiating an intervening action comprising one or more of modifying treatment, ordering additional diagnostics, scheduling treatment or diagnostics, and issuing a notification to a caregiver.
These claims, like those in Cardionet, provide a clear improvement to
computerized-decision support technology and not simply steps that can be practically performed in the mind. Applicant therefore submits that even if, ad arguendo, the claims recite a judicial exception, each of the claims, as a whole, integrates the judicial exception into a practical application that solves an existing problem of conventional computerized-decision support systems. Withdrawal of the 35 U.S.C. § 101 rejection and allowance of the claims is respectfully requested.
In response to argument (1), Examiner respectfully disagrees. Applicant's arguments appear to rely on features which had not been entered as of the present communication. Other arguments merely rehash issues addressed in the Non-Final Rejection mailed 9/26/2025, and incorporated herein. Thus, the rejection of the previous Office Action is maintained.
Applicant argues the independent claims do not recite a mental process. The applying patient data, generating forecast data, determining a set of Holder exponents, utilizing data to estimate a likelihood over a future time interval are all Mental processes in independent claim.
In Recentive Analytics, Inc. v. Fox Corp. (Fed. Cir. 2025), the claims recited conventional machine learning models without specific improvements to the technology itself. The court noted that "iterative training," a claimed feature, was inherent to all machine learning models and thus did not confer eligibility. Additionally, applying machine learning to event scheduling, an activity predating computer, did not transform the abstract idea into a patent-eligible invention. Simply applying generic machine learning techniques to new data domains without improving the underlying technology is insufficient for patent eligibility.
To conclude, the amendment made wherein, “treating the patient for the urolithiasis with a therapeutic dose of a xanthine oxidase inhibitor, wherein treating the patient for the urolithiasis comprises administering to the patient a xanthine oxidase inhibitor therapy that (i) is based on the prediction regarding theurolithiasis for the patient and based further on the estimated likelihood of the urolithiasis for the patient and that (ii) includes the therapeutic dose of the xanthine oxidase inhibitor,” does not appear to be taught in specification or in original claims. Generic mentions such as modifying a care program for treating the patient, determining adherence to or efficacy of treatment or preventive interventions and technologies described herein improve upon conventional decision support tools for treating patients with urolithiasis. However, the Examiner does not see any teaching in the specification specific to treating the patient for the urolithiasis with a therapeutic dose of a xanthine oxidase inhibitor.
Lastly, the amendment made wherein, “treating the patient for the urolithiasis with a therapeutic dose of a xanthine oxidase inhibitor, wherein treating the patient for the urolithiasis comprises administering to the patient a xanthine oxidase inhibitor therapy that (i) is based on the prediction regarding theurolithiasis for the patient and based further on the estimated likelihood of the urolithiasis for the patient and that (ii) includes the therapeutic dose of the xanthine oxidase inhibitor,” in addition to previously named, would fall within the group of Certain Methods Of Organizing Human Activity which are concepts performed by managing personal behavior, relationships or interactions between people (including fundamental economic principles, commercial or legal interactions, social activities, teaching, and following rules or instructions).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pub. No.: US 20090098553 A1 to Guilford; 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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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