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 25-44 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Claims filed on 03/26/2025.
Claim Objections
Claim 25 is objected to because of the following informalities: Claim 25, line 5 recites “determining, on a selected type”. However, Examiner asserts this should read “determining, based on a selected type”. Appropriate correction is required.
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 25-44 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 25-42 fall within the statutory category of a process. Claim 43 falls within the statutory category of an apparatus or system. Claim 44 falls within the statutory category of an article of manufacture as a computer-readable medium.
Step 2A, Prong One
As per Claim 25, the limitations selecting type of management and a corresponding guideline comprising a plurality of procedures; determining, on a selected type of management and corresponding guideline comprising a plurality of procedures, for each of the procedures in the guideline, a procedure compliance score, based on level of execution of the procedure and/or on temporal pattern of execution of the procedure; calculating an adherence score of the guideline, based on the plurality of the procedure compliance scores; and assessing quality of management, based on the guideline adherence score, under its broadest reasonable interpretation, covers performance of the limitation in the mind. The steps of selecting type of management and corresponding guideline, determining a procedure compliance score, calculating an adherence score of the guideline, and assessing quality of management 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. Claim 25 describes that the method is computerized for executing the abstract idea of assessing quality of long-term management of patients at a health care facility. The computer is not recited in the claim, but the use of a computer to apply the abstract idea amounts to mere instructions to apply the exception, as per MPEP 2106.05(f)(2). Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
Claim 25 does 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 only additional element includes the computerized method including the abstract idea which amounts to no more than mere instructions to apply the exception using a generic computing component. 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 26-44 add further limitations which are also directed to an abstract idea. Claims 26-28, 30-36, and 41 further specify or limit the elements of the independent claim and are therefore directed to the same abstract idea. Claim 29 includes applying temporal fuzzy logic algorithms to the abstract idea of obtaining procedure compliance scores and/or guideline adherence score. As per MPEP 2106.05(f), applying a mathematical algorithm to the abstract idea amounts to mere instructions to apply the exception which does not integrate the abstract idea into a practical application or provide significantly more than the abstract idea. Claims 37 and 38 include displaying quality assessment related parameters to a user which amounts to mere data outputting. This amounts to insignificant extra-solution activity as mere data outputting which is well-understood, routine, and conventional similar to presenting offers, as per MPEP 2106.05(d)(II). Claims 39 and 40 include allowing a user to select presenting information to a user which is an interaction between people and therefore falls into the abstract grouping of certain methods of organizing human activity. Claim 42 includes providing a recommendation to a health care provider which is activity routinely performed in the care of a patient by a healthcare provider and therefore this is managing personal behavior which amounts to certain methods of organizing human activity. Claim 43 includes a system comprising a processor which executes the abstract idea of the invention. The processor is recited at a high-level of generality as a general purpose computer which executes the abstract idea, such that it amounts to mere instructions to apply the exception. Claim 44 includes a non-transitory computer-readable medium storing processor executable instructions on a computing device which execute the abstract idea of the invention. The computer-readable medium is recited at a high-level of generality as a general purpose computer component which executes the abstract idea, such that it amounts 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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 25-28, 31, 33, 35, and 37-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gaines et al. (US 2013/0275149 A1), hereinafter Gaines.
As per Claim 25, Gaines discloses a computerized method for assessing quality of long-term management of patients at a health care facility (Abstract evaluate quality of care of patients), the method comprising:
selecting type of management and a corresponding guideline comprising a plurality of procedures (see Fig. 3 where protocols are displayed for the selected sepsis management, where sepsis comprises plurality of events, [0018] protocols include treatment guidelines for various conditions, [0023-0024] map a protocol for sepsis (selected condition) which includes plurality of steps, [0030] process map for a protocol is selected);
determining, on a selected type of management and corresponding guideline comprising a plurality of procedures, for each of the procedures in the guideline, a procedure compliance score, based on level of execution of the procedure and/or on temporal pattern of execution of the procedure ([0010] evaluate the patient data for compliance with the protocol based on the mapping, i.e. plurality of procedures, [0015] determine protocol compliance metrics based on plurality of steps of the protocol, [0023] compliance measures evaluate compliance with the protocol);
calculating an adherence score of the guideline, based on the plurality of the procedure compliance scores ([0036] generate a score for variance in compliance based on plurality of compliance scores); and
assessing quality of management, based on the guideline adherence score (Abstract/[0011] metrics are determined to evaluate quality of care and compliance with the protocols for treating conditions, [0023] monitor quality of care provided to patients for a protocol for treating a medical condition, [0034] where the metric is a compliance rate which indicates the adherence to compliance with the protocol).
As per Claim 26, Gaines discloses the method of Claim 25. Gaines also teaches the procedure compliance score is calculated based on type and/or characteristic of the procedure ([0018]/[0041] protocols are treatment guidelines for a particular medical condition, [0036] generate scores to determine compliance with the protocol).
As per Claim 27, Gaines discloses the method of Claim 26. Gaines also teaches the characteristics of a procedure comprise: binary constraint, cyclical (periodic) constraint, time constraint, entry- condition constraint, order constraint, multiple constraints, or any combinations thereof ([0026] steps of the protocol include attributes which include event time such as how often an event is required to occur, such as every four hours, can also include an event type such as a physician order, also can include a time attribute/constraint, [0052] procedure includes events such as a binary constraint including checking for respiratory distress, or a cyclical constraint including performing a lactic acid test every four hours, and time constraints based on what time particular events occur in the workflow of the guideline/protocol).
As per Claim 28, Gaines discloses the method of Claim 25. Gaines also teaches the procedure compliance score is calculated based on: binary calculation, proportional calculation, temporal fuzzy logic calculation, or any combinations thereof ([0034] compliance metric is calculated as a percentage, i.e. proportional calculation, Examiner notes that only one of the above options is required by the claim).
As per Claim 31, Gaines discloses the method of Claim 25. Gaines also teaches at least some of the procedures are comprised of one or more discrete components/actions ([0041-0042] protocol specifies guidelines for a medical condition and includes a workflow with a series of events/steps).
As per Claim 33, Gaines discloses the method of Claim 25. Gaines also teaches the guidelines are comprised of stages, each stage comprises one or more procedures ([0041-0042] protocol specifies guidelines for a medical condition and includes a workflow with a series of events/steps and each of these steps includes attributes associated with each event/step).
As per Claim 35, Gaines discloses the method of Claim 25. Gaines also teaches the guideline(s) are predetermined, based on the type of management ([0041] protocols which specify the treatment guidelines for the condition are received form a data source such as a health organization, i.e. predetermined).
As per Claim 37, Gaines discloses the method of Claim 25. Gaines also teaches displaying to a user one or more quality assessment related parameters (see Fig. 8 which displays compliance metrics, [0036-0037] determining compliance with protocol and provide analytic views, where the analytic views are displayed such that they can be selected to identify problems).
As per Claim 38, Gaines discloses the method of Claim 37. Gaines also teaches displaying to a user one or more quality assessment related parameters of all patients, a selected group of one or more patients, one or more quality assessment related parameters over a selected time period, one or more quality assessment related parameters of selected health care providers, one or more quality assessment related parameters of selected wards of the health care facility, or any combinations thereof ([0036] the analytic views which provide the scores and reports are provided by caregivers, particular departments, particular shifts (time periods), [0037] analytic views are provided as a display with drill down capabilities to display metrics by department, shift, individuals, etc.).
As per Claim 39, Gaines discloses the method of Claim 25. Gaines also teaches allowing a user to select presenting to a user one or more of: guideline adherence score of all patients, guideline adherence score of a selected group of one or more patients, guideline adherence score over selected time frames, guideline adherence score of selected health care providers, guideline adherence score of selected wards of the health care facility, or any combination thereof ([0036] the analytic views which provide the scores and reports are provided by caregivers, particular departments, particular shifts (time periods), [0037] analytic views are provided as a display with drill down capabilities to display metrics by department, shift, individuals, etc. where the user selects the metrics to view by clicking on an event on the display).
As per Claim 40, Gaines discloses the method of Claim 25. Gaines also teaches allowing a user to select presenting to a user one or more of: one or more procedure compliance score(s) of all patients, one or more procedure compliance score(s) of a selected group of one or more patients, one or more procedure compliance score(s) over selected time frame(s), one or more procedure compliance score(s) of selected health care providers, one or more procedure compliance score(s) of selected wards of the health care facility, or any combination thereof ([0036] the analytic views which provide the scores and reports are provided by caregivers, particular departments, particular shifts (time periods), [0037] analytic views are provided as a display with drill down capabilities to display metrics by department, shift, individuals, etc. where the user selects the metrics to view by clicking on an event on the display).
As per Claim 41, Gaines discloses the method of Claim 25. Gaines also teaches the quality assessment is retrospective ([0027] EMR data is used to determine metrics and the EMR data is collected over a period of time, i.e. not real-time data, [0053-0054] population EMR data is used to map to the process map and determine metrics).
As per Claim 42, Gaines discloses the method of Claim 25. Gaines also teaches providing a recommendation to a health care provider, based on one or more procedure compliance score(s) and/or the guideline adherence score ([0037] remedies are determined such as additional training or new internal shift change procedures, based on the compliance and variance from protocol).
As per Claim 43, Gaines discloses a system for assessing quality of long-term management of patients at a health care facility, the system comprising a processor ([0057-0058] CQA system which executes the invention is a computer platform including processors) configured to execute the method of claim 25 (taught by Gaines as described above).
As per Claim 44, Gaines discloses a non-transitory computer-readable medium storing processor executable instructions on a computing device, when executed by a processor, the processor executable instructions causing the processor ([0057-0058] CQA system which executes the invention includes a computer readable medium which provides instructions to the processors) to perform the method of claim 25 (taught by Gaines as described above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Gaines (US 2013/0275149 A1), in view of Sazonov (US 2015/0351981 A1), hereinafter Sazonov.
As per Claim 29, Gaines discloses the method of Claim 25. Gaines also teaches applying temporal fuzzy logic algorithm(s) to obtain one or more of the procedure compliance score(s) and/or the guideline adherence score ([0047] use of fuzzy logic rules to determine compliance with clinical guidelines such as number or duration of events performed).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present application to combine the known concept of the use of fuzzy logic to determine compliance scores for clinical guidelines from Sazonov with the known treatment protocol guidelines from Gaines in order to ensure that patient care events meet the guidelines such as proper pressure relief actions being undertaken to provide care for the patient (Sazonov [0049]).
Claims 30, 32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Gaines (US 2013/0275149 A1), in view of Bettencourt-Silva et al. (US 2021/0118577 A1), hereinafter Bettencourt-Silva.
As per Claim 30, Gaines discloses the method of Claim 25. Gaines also teaches at least some of the procedures are assigned a different weight for calculating the guideline adherence score ([0091-0092] scoring module which calculates a score for each clinical practice guideline (CPG) and the score is used to rank or weight the guideline).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present application to combine the known concept of assigning weights in the calculation of compliance metrics from Bettencourt-Silva with the known treatment protocol guidelines from Gaines in order to provide insight into the estimation of compliance with the guidelines (Bettencourt-Silva [0027]).
As per Claim 32, Gaines discloses the method of Claim 31. Gaines also teaches at least some of the components of a procedure are given a different weight for the calculation of the compliance score of the procedure ([0091-0092] scoring module which calculates a score for each clinical practice guideline (CPG) and the score is used to rank or weight the sections of a guideline).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present application to combine the known concept of assigning weights in the calculation of compliance metrics from Bettencourt-Silva with the known treatment protocol guidelines from Gaines in order to provide insight into the estimation of compliance with the guidelines (Bettencourt-Silva [0027]).
As per Claim 34, Gaines discloses the method of Claim 33. Gaines also teaches at least one of the stages is assigned a different weight for the calculation of the guideline adherence score ([0091-0092] scoring module which calculates a score for each clinical practice guideline (CPG) and the score is used to rank or weight the guideline).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present application to combine the known concept of assigning weights in the calculation of compliance metrics from Bettencourt-Silva with the known treatment protocol guidelines from Gaines in order to provide insight into the estimation of compliance with the guidelines (Bettencourt-Silva [0027]).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Gaines (US 2013/0275149 A1), in view of Bloch (US 2022/0270761 A1), hereinafter Bloch.
As per Claim 36, Gaines discloses the method of Claim 25. Gaines may not disclose the following which is taught by Bloch: the guideline(s) comprise computerized structured guideline ([0032-0033] curated guideline database includes health screening guidelines, [0039] curated guideline database connected to the processor which is matched to personal data, [0050] determining events to be performed based on the curated guidelines database, see also [0073]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present application to combine the known concept of computerized structured guidelines from Bloch with the known treatment protocol guidelines from Gaines in order to provide care providers with practical strategies and tools for applying guidelines to patients in an objective matter which encourages compliance with suggested actions (Bloch [0026-0027]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mok et al. (US 2013/0226617 A1) teaches a system which generates guidelines for patient treatment plan related to a medical condition and determines a score for patient compliance with the guidelines.
Monier et al. (US 2016/0063212 A1) teaches generation of medical guidelines, ranking interventions and determine weight of interventions and use scores to determine recommendations.
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