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 1-20 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Preliminary Amendment to the Claims filed on 03/14/2025.
Claim 1 is currently amended.
Claims 2-20 are newly added.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-4, 6-10, 12-17, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-11, and 16 of copending Application No. 18/492,202 (the ‘202 application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4, 6-10, 12-17, and 19-20 of the current application are essentially the same as claims 1, 9-11, and 16 of the ‘202 application as shown below.
Current (19/028,080) application
18/492,202 Application
Claims 1 and 14
a. system including having one or more hardware processors configured to facilitate a plurality of operations, the operations comprising:
b. 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;
c. 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;
d. determining caregiver behavior-pattern information for a set of caregivers that corresponds to the first set of patients;
e. based at least in part on the caregiver behavior-pattern information, the second set of patients, and the set of decision epochs: determining that at least one decision epoch of the set of decision epochs applies to a target patient having the set of clinical concepts; and
f. 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,
g. 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,
h. 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
i. 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
Claim 8: One or more non-transitory media having instructions that, when executed by one or more hardware processors, cause the one or more hardware processors to facilitate a plurality of operations
Claim 1
a. system including one or more hardware processors configured to perform a plurality of operations, the operations comprising:
invoking one or more agents coupled to a logic data store and operable on data in a first clinical nomenclature at the logic data store, wherein the logic data store includes logic to determine based on information in the first clinical nomenclature a patient risk for developing a particular disease or condition;
b. determining a change in condition for a first set of patients based at least on monitoring a first set of electronic health records from one or more network-based storage devices;
c. determining a change in condition associated with at least one of a set of decision epochs based at least on monitoring a second set of electronic health records corresponding to a second set of patients from the one or more network-based storage devices, wherein the first set of patients and the second set of patients share a set of clinical concepts;
receiving caregiver data comprising a second clinical nomenclature and associated with clinical caregiver behavior patterns;
performing a first data-conversion operation, on the caregiver data comprising the second clinical nomenclature, to create a set of transformed caregiver data in the first clinical nomenclature;
d. utilizing the set of transformed caregiver data in the first clinical nomenclature to determine, via the one or more agents, caregiver behavior-pattern information for a first set of caregivers that correspond to the first set of patients;
e. determining that at least a first 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;
f. based on the determining that the first decision epoch applies to the target patient, executing the logic based on information associated with the target patient in the first clinical nomenclature to generate a decision support recommendation, wherein (h,i) the one or more agents comprise at least an algorithm agent coupled to the logic data store, and wherein the algorithm agent updates parameters used by the logic based on results of patient monitoring; and
updating a clinician graphical user interface of a clinician device to present a version of the decision support recommendation converted to the second clinical nomenclature.
Claim 11: One or more non-transitory media having instructions that, when used executed by one or more hardware processors, cause the one or more hardware processors to facilitate a plurality of operations
Claims 2, 9, and 15
executing the machine-readable code, via the one or both of the algorithm agent and the solver agent, corresponds at least in part to generating a decision support recommendation.
From Claim 1
… executing the logic based on information associated with the target patient in the first clinical nomenclature to generate a decision support recommendation
Claims 3, 10, and 16
the operations further comprise updating a clinician interface of a clinician device to display the decision support recommendation.
From Claim 1
… updating a clinician graphical user interface of a clinician device to present a version of the decision support recommendation
Claims 4 and 17
the data structure includes logic configured to facilitate a determination of a patient risk for developing a particular disease or condition.
From Claim 1
…invoking one or more agents coupled to a logic data store and operable on data in a first clinical nomenclature at the logic data store, wherein the logic data store includes logic to determine based on information in the first clinical nomenclature a patient risk for developing a particular disease or condition
Claims 6, 12, and 19
the at least one decision epoch is determined to apply to the target patient based further on a first comparison associated with patients in the second set of patients and a second comparison associated with the set of decision epochs.
Claim 9
the operations further comprise: determining, based at least in part on the caregiver behavior-pattern information, a comparison for each patient in the second set of patients and a comparison of the set of decision epochs, that at least the first decision epoch applies to the target patient.
Claims 7, 13, and 20
the data structure further includes one or more parameters, and wherein the operations further comprise determining a definition of the set of decision epochs based at least on the one or more parameters.
Claim 10
the logic data store further includes one or more parameters, and wherein the operations further comprise: determining a definition of the set of decision epochs based at least on the one or more parameters.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 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 fall within the statutory category of an article of manufacture as a computer-readable medium. Claims 14-20 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 that at least one decision epoch of the set of decision epochs applies to a 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.
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 that at least one decision epoch of the set of decision epochs applies to a 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, 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. 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). 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. 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, and 15-20 add further limitations which are also directed to an abstract idea. For example, Claims 2, 9, and 15 include generating a decision support recommendation which can be performed mentally which falls into the abstract grouping of a mental process, but this is also activity which is performed routinely by a physician in the care of a patient which falls into the abstract grouping of certain methods of organizing human activity. Claims 3, 10, and 15 include displaying the decision support recommendation which amounts to mere data outputting which is insignificant extra-solution activity. The data is output to a clinician interface of a clinician device which is a general purpose computer component and therefore amounts to mere instructions to apply the exception. Claims 4 and 17 includes determining patient risk for developing a particular disease or condition which can be performed using human mental evaluation, opinion, observation, or judgment and falls into the abstract grouping of a mental process. Claims 5, 11, and 18 include determining a clinical concept, in a coded clinical format, that is associated with each of the target patient and a particular role of a caregiver which falls into the abstract grouping of a mental process. The claims also include storing the clinical concept in a collection of clinical information for the set of clinical concepts which, as per MPEP 2106.05(f) is mere instructions to apply the exception because it is using computers for functions such as storing data. Claims 6, 12, and 19 include determining a decision epoch to apply to the target patient based on a first comparison associated with patients in the second set of patients and a second comparison associated with the set of decision epochs which can be performed using human mental evaluation, opinion, observation, or judgment and falls into the abstract grouping of a mental process. Claims 7, 13, and 20 include determining a definition of the set of decision epochs based at least on the parameters which can be performed using human mental evaluation, opinion, observation, or judgment and falls into the abstract grouping of a mental process. 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ennett et al. (US 2010/0324938 A1) teaches analyzing patient data and determining events which precede an intervention for a condition, which is a set of decision epochs causing a change in patient condition. Ennett teaches making associations between events, outcomes, and interventions for a patient condition.
Trost et al. (US 2005/0119534 A1) teaches determining change in medical condition based on patient data including treatment information, patient condition. The use of predictive modeling and statistical analysis analyze relationships between data to predict risk of medical condition.
Soto et al. (US 2005/0203773 A1) teaches statistical models to predict health outcome based on data from questionnaire responses.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682