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 .
DETAILED ACTION
Status of the Application
Claims 1-15 and 19-23 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendment to the Claims and Remarks filed on 06/05/2026.
Claims 1-2, 6, 8-9, 12, 14-15, and 19-20 are currently amended.
Claims 16-18 are canceled and not considered at this time.
Claims 21-23 are newly added.
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 1-15 and 19-23 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-7 fall within the statutory category of an apparatus or system. Claims 8-13 and 21-23 fall within the statutory category of an article of manufacture as a computer-readable medium. Claims 14-15 and 19-20 fall within the statutory category of a process.
Step 2A, Prong One
As per Claims 1, 8, and 14, the claims recite:
monitoring a first set of electronic health records associated with one or more network-based storage devices to determine a first change in condition for a first set of patients;
monitoring a second set of electronic health records associated with the one or more network- based storage devices to determine a second change in condition associated with at least one of a set of decision epochs associated with a second set of patients that shares a set of clinical concepts with the first set of patients;
determining caregiver behavior-pattern information for a set of caregivers that corresponds to the first set of patients;
based at least in part on the caregiver behavior-pattern information, the second set of patients, and the set of decision epochs: determining (i) a cluster distance between record data of a target patient and one or more other patients and (ii) that a decision epoch of the set of decision epochs applies to the target patient having the set of clinical concepts; and
initiating, in response to the determining that the at least one decision epoch applies to the target patient, execution of a set of machine-readable code associated with information corresponding to a recommendation based on the at least one decision epoch, wherein:
the set of machine-readable code includes instructions stored at a data structure and is associated with the one or more network-based storage devices,
the set of machine-readable code is further associated with one or both of an algorithm agent and a solver agent configured to execute at least one of an algorithmic instruction or a logic instruction, and
the initiating of the execution of the set of machine-readable code corresponds at least partially to the algorithm agent or the solver agent updating one or more parameters, used by the machine-readable code, based at least partially on data associated with the monitoring, wherein updating the one or more parameters comprises operating a plurality of agents in parallel, each agent of the plurality of agents operating with a different value of at least one of the one or more parameters to evaluate a likelihood of a condition for at least one patient of the second set of patients, comparing accuracy of the evaluations across the plurality of agents, and weighting a parameter value associated with a more accurate evaluation for future use by the set of machine-readable code in evaluating a target patient for risk of the condition.
The underlined elements above including monitoring a first set of health records associated with one or more network-based storage devices to determine a first change in condition for a first set of patients; monitoring a second set of health records associated with the one or more network- based storage devices to determine a second change in condition associated with at least one of a set of decision epochs associated with a second set of patients that shares a set of clinical concepts with the first set of patients; determining caregiver behavior-pattern information for a set of caregivers that corresponds to the first set of patients; based at least in part on the caregiver behavior-pattern information, the second set of patients, and the set of decision epochs: determining a cluster-distance between record data of a target patient and other patients, and that a decision epoch of the set of decision epochs applies to the target patient having the set of clinical concepts; and in response to the determining that the at least one decision epoch applies to the target patient, updating one or more parameters based at least partially on data associated with the monitoring which comprises evaluating a likelihood of a condition for at least one patient of the second set of patients, comparing accuracy of the evaluations of the plurality of agents, and weighting a parameter value associated with a more accurate evaluation for future use in evaluating a target patient for risk of the condition, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The steps of monitoring health records to determine a change in condition, determining caregiver behavior-pattern information for caregivers that corresponds to a set of patients, determining a decision epoch applies to a target patient having the set of clinical concepts, and updating parameters based on the determination that a decision epoch applies to the target patient are concepts performed including observation, evaluation, judgement and opinion in the human mind. If a claim limitation, under its broadest reasonable interpretation, covers the 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. The step of determining a cluster-distance between record data of a target patient and one or more other patients can also fall into the abstract grouping of mathematical concepts because determining a cluster-distance is a mathematical equation or relationship. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claims recite the additional elements – hardware processors (Claim 1) and non-transitory media having instructions executed by hardware processors (Claim 8). The hardware processor and non-transitory media in these steps is recited at a high-level of generality, such that it amounts to 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 claims also recites the additional elements of electronic health records associated with one or more network-based storage devices, where the network-based storage devices are recited at a high-level of generality such that it amounts to mere instructions to apply the exception. The storage of electronic health records on the storage devices is the use of general purpose computing devices in their ordinary capacity for tasks such as storing data amounts to mere instructions to apply the exception, as per MPEP 2106.05(f). The claims also recite the additional elements of initiating execution of a set of machine-readable code, wherein: the set of machine-readable code includes instructions stored at a data structure and is associated with the one or more network-based storage devices, the set of machine-readable code is further associated with one or both of an algorithm agent and a solver agent configured to execute at least one of an algorithmic instruction or a logic instruction, and the initiating of the execution of the set of machine-readable code corresponds at least partially to the algorithm agent or the solver agent used by the machine- readable code which amounts to mere instructions to apply the exception. The use of machine-readable code which includes instructions stored at a data structure and associated with network-based storage devices describes storing instructions in memory, which amount to mere instructions to apply the exception because the use of general purpose computing devices in their ordinary capacity for tasks such as storing data amounts to mere instructions to apply the exception, as per MPEP 2106.05(f). The use of machine-readable code associated with one or both of an algorithm agent and a solver agent configured to execute at least one of an algorithmic instruction or a logic instruction describes invoking computers or machinery to apply a mathematical algorithm which amounts to mere instructions to apply the exception, as per MPEP 2106.05(f). The claims also recite the additional element of operating a plurality of agents in parallel, each agent of the plurality of agents operating with a different value of at least one of the one or more parameters, which amounts to insignificant extra-solution activity, as per MPEP 2106.05(g)(1). The use of a plurality of agents in parallel is a well-known analysis technique similar to Bilski v. Kappos, 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (2010). Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional elements of a hardware processors and non-transitory media having instructions executed by hardware processors to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The hardware processors are not specified and are thus general purpose computers. The non-transitory media having instructions executed by hardware processors are recited at a high-level of generality and are recited as generic computer components by reciting storage devices such as RAM, ROM, flash memory, etc. (Specification, [0022]), which do not add meaningful limitations to the abstract idea beyond mere instructions to apply an exception. The claims also include the additional elements of storage of electronic health records on the storage devices and initiating execution of a set of machine-readable code, wherein: the set of machine-readable code includes instructions stored at a data structure and is associated with the one or more network-based storage devices, the set of machine-readable code is further associated with one or both of an algorithm agent and a solver agent configured to execute at least one of an algorithmic instruction or a logic instruction, and the initiating of the execution of the set of machine-readable code corresponds at least partially to the algorithm agent or the solver agent used by the machine-readable code which have been found to be mere instructions to apply the exception. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. The claims also recite the additional element of operating a plurality of agents in parallel, each agent of the plurality of agents operating with a different value of at least one of the one or more parameters which is insignificant extra-solution activity. A showing can be made that an additional element is well-understood, routine, and conventional, and, therefore, does not amount to significantly more than the recited abstract idea, by citing a prior publication that teaches or discloses the limitation (MPEP § 2106.07(a)(III)). In light of Uyen and Chung (N. T. V. Uyen and T. C. Chung, "A New Framework for Distributed Boosting Algorithm," Future Generation Communication and Networking (FGCN 2007), Jeju, Korea (South), 2007, pp. 420-423), hereinafter Uyen, which teaches the operation of a plurality of models in parallel (Page 1, Abstract each site uses its own data, i.e. different data sets, to run a plurality of models; Page 5 3.4 Performance evaluation utilize the parallelism inherent in distributed environments when each site processes its local data simultaneously); and Wang (US 2006/0112039 A1), hereinafter Wang, which teaches strategies for ensemble modeling which include using different data points for each classifier/model and operating parallel processing approach ([0013]). Therefore, the There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims
Dependent Claims 2-7, 9-13, 15, and 19-23 add further limitations which are also directed to an abstract idea. Claims 2, 9, and 15 include generating a decision support recommendation which can be performed in the human mind which falls into the abstract grouping of a mental process, but also is activity performed by a physician in the care of a patient which falls into the abstract grouping of certain methods of organizing human activity. The claim recites the use of machine-readable code as the algorithm agent or solver agent which is mere instructions to apply the exception. Claims 3 and 10 include displaying the recommendation which is mere data outputting that amounts to insignificant extra-solution activity that is well-understood, routine, and conventional similar to presenting offers, as per MPEP 2106.05(d)(II). Claim 4 includes facilitate a determination of a patient risk which falls into the abstract groupings of a mental process and also certain methods of organizing human activity for the same reasons as Claim 2. Claims 5 and 11 include determining a clinical concept that is associated with each of the target patient and a role of a caregiver which falls into the abstract groupings of a mental process and also certain methods of organizing human activity for the same reasons as Claim 2. The claims also include storing the concept which amounts to mere instructions to apply the exception, similar to the well-known computer function of storing data as per MPEP 2106.05(f)(2). Claims 7, 12-13, and 19-20 further limit or specify the elements of the independent claims and are therefore directed to the same abstract idea. Claim 20 also includes determining a clinical concept associated with each of the target patient and role of a caregiver which falls into the abstract groupings of a mental process and also certain methods of organizing human activity as in the independent claims. Claim 21 includes detecting that a number of patients in the second set of patients is below a threshold and weighting more recent patient information higher than older patient information which can be performed using human mental observation, evaluation, judgment, or opinion and therefore falls into the abstract grouping of a mental process. Claim 22 further specifies or limits Claim 8 including using a natural language processing service to execute the abstract idea which amounts to mere instructions to apply the exception. Claim 23 includes the use of a trajectory-mining solver agent to execute the abstract idea which amounts to mere instructions to apply the exception. As per MPEP 2106.05(f)(2), the use of a mathematical algorithm applied on a general purpose computer has been found by the courts to do no more than invoke computers as a tool and amount to mere instructions to apply the exception. Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
Subject Matter Free of the Prior Art
The following is an examiner’s statement of subject matter free of the prior art: The
limitations in Claims 1, 8, and 14 stating: determining that at least one decision epoch of
the set of decision epochs applies to a target patient having the set of clinical concepts, based
at least in part on the caregiver behavior-pattern information, the second set of patients, and
the set of decision epochs, is free of the prior art. The broadest reasonable interpretation of the
claim language requires the use of all three of caregiver behavior-pattern information, second
set of patients, and set of decision epochs to be used in determining when a first decision epoch applies to a target patient.
Response to Arguments
Applicant’s arguments, see Pages 10-15, “Rejections under 35 U.S.C. §101”, filed 06/05/2026 with respect to claims 1-20 have been fully considered but they are not persuasive.
Applicant argues that the claims are not directed to a mental process because Claim 1 (as representative) includes updating the parameters which comprises operating a plurality of agents in parallel, each agent operating with a different value of at least one of the parameters to evaluate a likelihood of a condition for at least one patient of the second set of patients, comparing accuracy of the evaluations across the plurality of agents, and weighting a parameter value associated with a more accurate evaluation for future use by the machine-readable code in evaluating a target patient for risk of the condition, which Applicant argues cannot be performed by human mental processing. Appellant specifically argues that a plurality of agents executing concurrently is a multi-agent, parallel experimentation-and-selection pipeline operating over EHR data cannot be performed by a human. Examiner notes that a human can perform multiple calculations with different data values in the mind or with aid of pen and paper. A person can update parameters by executing algorithms with different values of the parameters to evaluate a likelihood of a condition for at least one patient, compare accuracy of the evaluations, and weight a parameter value for future use by human mental processing. Carrying out the processing of the algorithms using different parameter values by operating a plurality of agents in parallel is an additional element that amounts to insignificant extra-solution activity, as per MPEP 2106.05(g)(1), because the use of a plurality of agents in parallel is a well-known analysis technique similar to Bilski v. Kappos, 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (2010). The well-known analysis technique is evidenced by Uyen and Wang which both teach operation of a plurality of models in parallel, as per the rejection above. Therefore, the claim recites an abstract idea.
Applicant argues that, as per Claim 1, computation of a cluster-distance between record data of a patient and one or more other patients cannot be performed mentally because the computation is performed over data structures stored on network-storage devices and is therefore a computer-implemented statistical operation. Examiner respectfully disagrees. The use of data which is stored on a computer network storage device is merely applying the abstract idea of determining a cluster-distance to a computer. The storing of data on a computer, merely uses the computer in its ordinary capacity for storing data, as per MPEP 2106.05(f)(2), and therefore the use of the computer amounts to mere instructions to apply the exception. A person can perform the computation of a cluster-distance between data of a target patient and data of other patients and therefore, this is directed to a mental process.
Applicant argues that the claims integrates the abstract idea into a practical application by providing technological improvements to the operation of clinical support computer systems. Applicant further argues that operating a plurality of agents in parallel provides specific, computer-rooted improvements including empirically validating parameter choices, supplying adaptive accuracy improvement over time, solving a concrete, computer-rooted technical problem of data-dependent parameter optimality, producing quantifiable statistical certainty, exploit computational concurrency, and drive downstream reduction in clinical resource burden. Examiner respectfully disagrees. Examiner respectfully disagrees. Improvements which result from validating parameter choices by evaluating candidate values in parallel and selecting the better performing variables is an improvement that results from updating the parameters comprising executing algorithms in parallel with different values to evaluate a likelihood of a condition which is part of the abstract idea. Improvements in adaptive accuracy by determining the more accurate parameter is also an improvement which results from the abstract idea itself. Improvements of data-dependent parameter optimality result from observing the accuracy of a model and comparing to other accuracy values which is part of the abstract idea. Improvements which result from comparing results of the models such as statistical certainty are based on the comparing step of the abstract idea. Improvements to the reduction of clinical resource burden is based on the information which is provided to a health care provider which is not a technical improvement, but rather just improved information that is output from the abstract idea. These are improvements that are attributable to the abstract idea itself and not a technical improvement to a technical problem. No matter how much of an advance in the field the claims recite, the advance lies entirely in the realm of abstract ideas, with no plausibly alleged innovation in the nonabstract application realm. An advance of that nature is ineligible for patenting. The concept of computation concurrency is an additional element which is found to be well-understood, routine, and conventional as evidenced by Uyen and Wang in the rejection above and is therefore not a technical improvement to a technical field.
Applicant argues that determining a cluster-distance between record data of the target patient and other patients provides a particular algorithmic technique which improves the underlying clinical decision support system. Examiner respectfully disagrees. Determining a cluster-distance can be performed in the human mind by using stored values and human mental evaluation to determine the result. This can also fall into the abstract category of a mathematical concept and therefore is not an additional element and does not integrate the abstract idea into a practical application. This computation does not provide an improvement in computer capability.
Applicant argues that the claims recite significantly more than the abstract idea. Applicant further argues that the parallel-agent technique is not well-understood, routine, and conventional and therefore provides significantly more than the abstract idea. Examiner respectfully disagrees. As per the rejection above, operating a plurality of agents in parallel is shown to be well-understood, routine, and conventional as evidenced by Uyen and Wang.
Applicant argues that cluster-distance computation step is not a generic computer function. Examiner respectfully disagrees. The step of determining a cluster-distance between target patient data and other patient data is part of the abstract idea itself. The use of a computer to carry out the limitation is mere instructions to apply the exception, but the determination is part of the abstract idea and therefore cannot provide significantly more than the abstract idea itself.
Applicant’s arguments, see Page 15, “Double Patenting”, filed 06/05/2026 with respect to claims 1-4, 6-10, 12-17, and 19-20 have been fully considered. Examiner notes that Applicant alleges that a terminal disclaimer was submitted concurrently with the Remarks. However, there is no terminal disclaimer filed as of the time of this office action. Examiner also notes that due to the amendments to the claims of the present application and the amendments to the claims of the 18/492,202 application, the double patenting rejection has been withdrawn.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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