DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/05/2026 has been entered.
Response to Amendment
This action is in response to the amendments filed on 06/05/2026. Claims 1, 9, 12, 13, and 16 have been amended, and claim 20 has been canceled. Claims 1-19 are examined below.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claim 1 recites (additional limitations crossed out):
A system for improving healthcare, the system comprising:
receive real-time location data from the plurality of antennas over the network;
receive data from the at least one monitoring device, wherein the data includes a plurality of actions performed by the one or more caregivers, wherein the real-time location data from the plurality of antennas positioned throughout the clinical care environment is obtained from detection of the wireless signals from the tags carried by the one or more caregivers, and wherein the plurality of actions are correlated to locations of the one or more caregivers within the clinical care environment using the real-time location data;
calculate at least one composite healthcare score by analyzing the plurality of actions performed by the one or more caregivers and the locations for the plurality of actions;
identify at least one of the plurality of actions that negatively impacted the at least one composite healthcare score;
generate at least one recommendation for improving the at least one composite healthcare score based on the at least one of the plurality of actions that negatively impacted the at least one composite healthcare score;
present a control
monitor alarms transmitted from the multiple monitoring devices on the network;
classify,
calculate a notification score that identifies problematic notification associated with the alarms from the multiple monitoring devices, wherein the notification score is a component of the at least one composite healthcare score, and wherein the problematic notifications comprise the false alarms classified by the artificial intelligence; and
The above limitations, as drafted, are processes that, under their broadest reasonable interpretation, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people, as well as performance of limitations by the human mind or with pen and paper. That is, other than reciting the claims as being performed by a “multiple monitoring devices”, a “plurality of antennas”, a “processing device”, a “memory device”, a “graphical user interface”, and “artificial intelligence”, nothing in the claims precludes the steps as being described as managing personal behavior or relationships or interactions between people, or performance of limitations by the human mind or with pen and paper. The claims, as written describe receiving location data and data regarding actions of a caregiver, calculating a composite healthcare score based on the actions, identifying actions that negatively affected the composite healthcare score, generating a recommendation to improve the composite healthcare score, presenting a “control” to allow the caregiver to view the score and implement the recommendation (i.e., presenting the score and recommendation), monitoring alarms of monitoring devices, classifying the alarms as true or false alarms, calculating a notification fatigue score, and adjusting an event detection threshold of the monitoring devices based on the notification fatigue score. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes steps that may be performed mentally or with pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of “multiple monitoring devices”, a “plurality of antennas”, a “processing device”, a “memory device, and a “graphical user interface” to perform the steps. These additional elements are recited at a high level of generality (See at least paras. [0036] and [0041] regarding the “antennas” and “monitoring device”. The Examiner notes that there does not appear to be any language describing the “processing device” and “memory device”. Therefore, they shall be interpreted as being generic computer components) such that they amount to no more than mere instructions to apply the exception using generic computing components. In regards to the “artificial intelligence”, it is considered to be generic computer function and/or field-of-use/”general link” implementations and does not meaningfully limit the claim (See Accenture, 728 F.3d 1336, 108 U.S.P.Q.2d 1173 (Fed. Cir. 2013), citing Cf. Diamond v. Diehr, 450 U.S. 175, 191-192 (1981) ("[I]nsignificant post-solution activity will not transform an unpatentable principle in to a patentable process.”). Moreover, the functionality intended to be performed by the artificial intelligence appears to be based on very rudimentary constraints (e.g., data from monitoring devices). Without some prohibition in the claims regarding scalability, computation load, etc., this artificial intelligence could reasonably be considered an additional abstract idea in the “mental process” category, but for which is simply automated (i.e., “apply it”). The claims also recite “automatically” adjusting the multiple monitoring devices Automatically adjusting monitoring devices is mere automation of a manual process which is not sufficient to show an improvement in computer-functionality (See MPEP 2106.05(a).I). The claim further recites “a plurality of antennas positioned throughout a clinical care environment, wherein the plurality of antennas is configured to receive wireless signals from tags carried by one or more caregivers within the clinical care environment”. However, this is merely insignificant extra-solution activity. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are therefore still directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of “multiple monitoring devices”, a “plurality of antennas”, a “processing device”, a “memory device, and a “graphical user interface” to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. Further, the additional limitation of “a plurality of antennas positioned throughout a clinical care environment, wherein the plurality of antennas is configured to receive wireless signals from tags carried by one or more caregivers within the clinical care environment” is merely a conventional function as evidenced by at least Symantec which featured receiving or transmitting data over a network. The performance of conventional functions by generic computers does not provide an inventive concept. Therefore, the claims are not found to be patent eligible.
Claim 16 features limitations similar to those of claim 1, and is therefore also found to be directed to an abstract idea without significantly more.
Claims 2-15 are dependent on claim 1, and include all the limitations of claim 1. Claims 17-19 are dependent on claim 16, and include all the limitations of claim 16. Therefore, they are also found to be directed to an abstract idea. The dependent claims have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since they merely further narrow the abstract idea. Therefore, the dependent claims are found to be directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2161.01 I. recites in part:
"... original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV. .."
The following limitations define the invention in functional language, but the specification lacks the algorithm or steps/procedure for performing the functions or are not explained in sufficient detail:
Regarding claims 1 and 16, the limitations “multiple monitoring devices including sensors to capture aspects of a patient…” and “receive data from the at least one monitoring device, wherein the data includes a plurality of actions performed by one or more caregivers and real-time location data from antennas positioned throughout a clinical care environment that detect wireless signals from tags carried by the one or more caregivers, wherein the plurality of actions are correlated to locations of the one or more caregivers within the clinical care environment using the real-time location data” is not supported by the specification. The specification does not appear to provide any details regarding monitoring devices including sensors to capture aspects of a patient providing data including actions performed by a caregiver.
Regarding claims 1 and 16, the limitation “classify, using artificial intelligence, the alarms as true alarms or false alarms based on the data received from the multiple monitoring devices” lacks a proper written description. The Examiner points to paragraph [0024] of the specification which states, in part, “In some examples, the alarm manager 109 uses artificial intelligence such as machine learning to classify alarms as either true alarms or false alarms based on the data received from the monitoring devices in the patient environment 12.” This does not sufficiently describe how the artificial intelligence classifies the alarm as a true alarm or false alarm other than an undisclosed method of using data received from monitoring devices.
Regarding claims 1 and 16, the limitation “calculate a notification fatigue score that identifies problematic notifications associated with the alarms from the multiple monitoring devices, wherein the notification score is a component of the at least one composite healthcare score, and wherein the problematic notifications comprise the false alarms classified by the artificial intelligence” lacks a proper written description. While there is mention of a “notification fatigue score”, this appears to be unrelated to identifying problematic notifications (see Para. [0072] – “The caregiver satisfaction score 630 can include a notification fatigue score 632. The notification fatigue score 632 can be calculated analyzing the input data 400, using the alarm manager 109, to monitor the number of alarms that are transmitted to a caregiver C by one or more devices within the clinical care environment 10. In certain non-limiting examples, these devices include an infusion pump 107, the communications device 102, the caregiver call system 120, a bed exit alarm, the spot monitor 105, the audio system 126, and the camera system 128.”) Further, the language describing the calculation of the notification fatigue score is insufficient (i.e., how does analyzing input data to monitor the number of alarms that are transmitted to a caregiver result in a notification fatigue score?). Moreover, there does not appear to be any score at all related to identifying “problematic” notifications. Nor is there any indication of problematic notifications being comprised of false alarms classified by the artificial intelligence, as there is no mention of problematic notifications within the specification.
Regarding claims 1 and 16, the limitation “automatically adjust the multiple monitoring devices based upon the at least one composite healthcare score to reduce the problematic notifications from the multiple monitoring devices, including adjusting an event detection threshold of one or more of the multiple monitoring devices based upon the notification fatigue score” lacks a proper written description. There appears to be no language within the specification detailing how the adjustment of the event detection threshold is based upon the notification fatigue score.
Dependent claims are rejected as well since they inherit the limitations of the independent claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 16, the limitation “classify, using artificial intelligence, the alarms as true alarms or false alarms based on the data received from the multiple monitoring devices” is indefinite. Paragraph [0024] states, in part, “As discussed below with reference to FIGS. 5 and 8, the one or more monitoring devices within the patient environment 12 may issue alarms when the patient P requires attention from the caregiver C. Further, it is desirable to limit the number of false alarms ( also known as nuisance alarms and/or nuisance alerts) that are issued from the one or more monitoring devices.” (emphasis added) Based on this, it is unclear as to what constitutes a true or false alarm. For example, it is unclear if a false alarm is an alarm based on faulty information (i.e., alarm goes off despite monitored metric staying within threshold), or an alarm that is accurate but occurs “too much”.
Due to the featuring of a “notification score” that is dependent at least upon the aforementioned “false alarms”. The limitations “calculate a notification score that identifies problematic notifications associated with the alarms from the multiple monitoring devices, wherein the notification score is a component of the at least one composite healthcare score, and wherein the problematic notifications comprise the false alarms classified by the artificial intelligence” and “automatically adjust the multiple monitoring devices based upon the at least one composite healthcare score to reduce the problematic notifications from the multiple monitoring devices, including adjusting an event detection threshold of one or more of the multiple monitoring devices based upon the notification fatigue score” are indefinite as well.
Regarding claim 18, the limitation “identifying at least one benchmark clinical care environment including one or more benchmark clinical care characteristics that are within a range of benchmark threshold values” is indefinite. The manner in which the limitation is written renders it unclear as to what function is being performed. For example, it is unclear if it calls for the identification of benchmark clinical care environments as well as characteristics that are within a range of benchmark threshold values, or if it calls for the identification of benchmark clinical care environments having benchmark clinical care environment characteristics within a range of benchmark threshold values.
Regarding claim 18, the limitation "generating a benchmark composite healthcare score corresponding to the at least one benchmark clinical care environment" is indefinite. The limitation is preceded by "identify at least one benchmark clinical care environment including one or more benchmark clinical care environment characteristics that are within a range of benchmark threshold values". If benchmark threshold values are used to identify benchmark clinical care environments, this would imply that the benchmark clinical care environment already has a value/score associated with it.
Regarding claim 18, the limitation "issuing an alert when the at least one composite healthcare score is less than the benchmark composite healthcare score" is indefinite. The inclusion of the language "at least one" implies that multiple composite healthcare scores are considered in the comparison to the benchmark composite healthcare score. Based on this, it is unclear as to what triggers the issuing of the alert. For example, if two composite healthcare score are compared to the benchmark composite healthcare score, it is unclear if both composite healthcare scores are required to be below the benchmark composite healthcare score to trigger the alert, of if just one would suffice.
The Examiner notes that the issues related to claim 18 may be remedied by amending the language to that featured in claim 13.
Dependent claims are rejected as well since they inherit the limitations of the independent claims.
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.
Claim(s) 1-12, 15-17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maryland NURSE AIDE Written (or Oral) Examination & Skills Evaluation Candidate Handbook”, available February 2022, hereinafter referred to as Credentia, in view of Dring (US 2006/0264785), Rodgers (US 2007/0162304), and Dyell (US 2015/0364022).
Regarding claim 1, Credentia partially discloses A system for improving healthcare, the system comprising:
Multiple monitoring devices including sensors to capture aspects of a patient, wherein the multiple monitoring devices include at least one monitoring device connected to a network;
at least one processing device; and
a memory device storing instructions which, when executed by the at least one processing device, cause the at least one processing device to:
receive data from the at least one monitoring device, wherein the data includes a plurality of actions performed by one or more caregivers and real-time location data; (See page 2 – “At the Skills Evaluation you will be asked to perform five (5) randomly selected GNA skills. You will be given thirty (30) minutes to complete the five (5) skills. You will be rated on these skills by a Nurse Evaluator. A complete listing of the skills is shown on pages 24-38.” The Examiner asserts that by monitoring a healthcare worker performing a skill, that real-time location data is inherently received.)
calculate at least one composite healthcare score by analyzing the plurality of actions performed by the one or more caregivers and the locations for the plurality of actions; (See at least page 41 – “A sample of a Failing Score Report”, “Result: Fail”.)
identify at least one of the plurality of actions that negatively impacted the at least one composite healthcare score; (See at least page 41 – “In the following example (see top of next page), a candidate received a result of Unsatisfactory on the skill Hand Hygiene. The numbers 1, 5, and 10 printed below the skill refer to steps that were missed or performed incorrectly.”
generate at least one recommendation for improving the at least one composite healthcare score based on the at least one of the plurality of actions that negatively impacted the at least one composite healthcare score; (See at least page 41 – “To study for re-taking the Skills Evaluation, this candidate should turn to the Skills Listing in this handbook, look for the Hand Hygiene skill, and review all the steps, especially steps 1, 5, and 10.”) and
present a control on a graphical user interface that allows a caregiver of the one or more caregivers to view the at least one composite healthcare score and implement the at least one recommendation (See at least page 40 – “Score reports are provided online and are available for you to print or download.”
However, while Credentia discloses the performance of the claimed functions, Credentia does not disclose the claimed multiple monitoring devices including sensors to capture aspects of a patient, wherein the multiple monitoring devices include at least one monitoring device connected to a network; at least one processing device; and a memory device storing instructions, as well as receiv[ing] data from the at least one monitoring device. See at least Dring, Para. [0063] – “The database 39 stores data from each transmitter 40, 46, which can be time-stamped for analysis and interpretation. Through the use of data analysis processes executed by software (detailed below) meaningful indicators can be established to confirm caregiver activity and the associated subject movement relative to specified medical orders. The output data may be selectable so as to provide a morning report giving a brief overview of caregiver performance on targeted subject rotations.”, and Para. [0064] – “A facility manager may review a status report displayed on or printed through processor 38 upon his/her arrival at the beginning of the shift. Such a status report could show the performance of caregivers on the prior shift, as well as any movement of the subject 32.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Credentia to utilize the teachings of Dring since it would allow for the observation of caregivers without the physical presence of the evaluator/observer.
Credentia also does not disclose a plurality of antennas positioned throughout a clinical care environment, wherein the plurality of antennas is configured to receive wireless signals from tags carried by one or more caregivers within the clinical care environment, or real-time location data from the plurality of antennas positioned throughout the clinical care environment that is obtained from detection of the wireless signals from the tags carried by the one or more caregivers, and wherein the plurality of actions are correlated to locations of the one or more caregivers within the clinical care environment using the real-time location data. (See Rodgers, Para. [0102] – “By way of example, patients, staff, assets and visitors can be assigned an RFID device that can be tracked throughout a facility by means of an RFID detection system comprising a plurality of RFID detectors throughout the facility. The location of the RFID detectors and assignment of RFID devices can be recorded and maintained in a computer system. As patients, staff, assets and visitors move throughout the facility, the RFID detectors notify the computer system of RFID devices that are currently being detected. This computer system can correlate the location of each RFID device, as well as the duration of each RFID device at a specific location, and determine whether prescribed care and wellness routines or activities involving patients, staff, assets and/or visitors have been properly carried out.”, and Para. [0187] – “FIG. l0B further depicts a provider location client 1026 (e.g., an RFID device), a provider PDA 1028, a provider ID tag 1030 (e.g., an RFID device), other facility ID tag 1032 (e.g., an RFID device), and/or diagnostic equipment 1034 which have entered room 1000. Each of these devices can communicate with IRCC 1012 and/or a system-wide tracking system that communicates direct to a facility master computer (not shown) via various appropriate protocols (e.g., RF, IEEE 802.11 group, IEEE 802.15.4, etc.). IRCC 1012 can update pertinent patient information, such as, for example, provider ID, other personnel ID or diagnostic equipment and time of entry. Detecting the presence of personnel and devices inside room 1000 indicates that facility personnel and/or assets associated with these devices have likely entered room 1000, for example, in response to a predicted support exiting event, a patient initiated alarm, prescribed patient activities, and the like.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Credentia and Dring to utilize the teachings of Rodgers since it would enable the remote monitoring of caregivers.
Credentia also does not disclose:
Monitor alarms transmitted from the multiple monitoring devices on the network;
Classify, using artificial intelligence, the alarms as true alarms or false alarms based on the data received from the multiple monitoring devices;
Calculate a notification score that identifies problematic notifications associated with the alarms from the multiple monitoring devices, wherein the notification score is a component of the at least one composite healthcare score, and wherein the problematic notifications comprise the false alarms classified by the artificial intelligence; and
Automatically adjust the multiple monitoring devices based upon the at least one composite healthcare score to reduce the problematic notifications from the multiple monitoring devices, including adjusting an event detection threshold of one or more of the multiple monitoring devices based upon the notification fatigue score
In light of the 112 rejections above, Dyell teaches these limitations. See Dyell, Para. [0021] – “Status data 27 can also include an amount of user-directed alarms ( e.g., the number of alarms the user has had to respond to), alarm response time data (e.g., the user's time to respond), alarm severity for at least one user-directed alarm, a number of repeated alarms (e.g., the number of alarms that have had to be repeated due to a delayed response or lack of a response), a number of missed alarms, a number of simultaneous alarms, a number of false alarms, etc.”, Para. [0036] – “For example, alarm indicator 34 and/or status data 27 indicative of a false alarm can be aggregated over a period of time allowing a machine learning algorithm executing in alarm management engine 12 to learn when an alarm is more or less likely to be a false alarm.”, Para. [0037] – “In some embodiments, alarm management engine 12 can implement one or more machine learning algorithms to develop prediction models for alarms. For example, alarm management engine 12 can provide a projected number of false alarms for a particular shift and it can take the calculated projected number of false alarms into account by creating rules for generating alarms throughout that shift.”, and Para. [0089] – “An alarm management engine 300 performs step 306 by determining alarm fatigue based on status data collected from one or more medical devices 302 and performs step 308 by adjusting alarm conditions of one or more medical devices 302 based on the one or more user fatigue levels. In some embodiments, instead of simply altering alarms based on user fatigue levels, alarm management engine 300 is configured to alter alarm conditions of one or more medical devices 302. An advantage of altering alarm conditions of a medical device is that each individual device 310, 312, 314, 316 can be modified to indicate an alarm based on one or more nonstandard operational parameters. For example, if a particular medical device is prone to issuing excessive alarms because a threshold for meeting an alarm condition is too low ( e.g., when a heart rate drops below 50 BPM, an alarm condition is met), the threshold comprising the alarm condition can be altered ( e.g., such that the alarm condition is met only when the heart rate drops below 30 BPM), thus reducing a number of alarms generated by that particular medical device.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Credentia, Dring, and Rodgers to utilize the teachings of Dyell since it would ensure that the assessment of a caregiver’s performance is related to relevant instances of care.
Regarding claim 2, Credentia does not explicitly disclose The system of claim 1, wherein the at least one monitoring device includes at least one of a real-time location system, a caregiver call system, a camera system, an audio system, a patient bed, a spot monitor, or an infusion pump. (See at least Dring, Para. [0080] – “The Patient, Monitor and Room Status Reports, 130, 140, and 150 (see FIGS. 24-26) are displays which provide the accurate and up to date information for the system 31. Patient Status Report 130 provides the location of the patient by both room and overall grouping. This insures that the information to be also tied back to the specific caregivers' responsible for these specific room groupings. The Monitor Status Report 140 advises which monitors are available for use within the facility and also which units are currently in service at the patient bedside.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Credentia to utilize the teachings of Dring since it would allow for the observation of caregivers without the physical presence of the evaluator/observer.
Regarding claim 3, Credentia discloses The system of claim 1, wherein the at least one of the plurality of actions that negatively impacted the at least one composite healthcare score is identified when the at least one composite healthcare score is less than a threshold value. (See at least page 41 - “A failed skill will show the reason for the failure. You may not have performed the steps of a skill correctly, or you may have forgotten a step, especially a Critical Element Step.”
Regarding claim 4, Credentia discloses The system of claim 1, wherein the at least one composite healthcare score is calculated based on one or more sub-composite healthcare scores. (See at least page 41, “A sample of a Failing Score Report” which features the overall result of “Fail” and the listing of “Skills Performance” and their associated results of “Satisfactory” or “Unsatisfactory”.)
Regarding claim 5, Credentia discloses The system of claim 4, wherein the one or more sub-composite healthcare scores include at least one of a safety score, an efficiency score, a quality score, and a caregiver satisfaction score. (See at least Page 26 which features “Skill 3”, “step 9” – “ Stands facing client positioning self to ensure safety of candidate and client during transfer. Counts to three (or says other prearranged signal) to alert client to begin standing.” Skill 3 is one of the possible skills that may be evaluated to receive a score of satisfactory or unsatisfactory.
Regarding claim 6, Credentia discloses The system of claim 5, wherein the safety score is calculated based on at least one of a quantity of adverse patient events and a protocol compliance percentage. (See at least page 21 – “Critical Element Steps are important steps that must be performed correctly for you to pass the skill. If you leave out a Critical Element Step or do not perform a Critical Element Step properly, you will not pass the skill. However, if you perform only the Critical Element Step correctly in a skill, you do not automatically pass that skill. You must also correctly demonstrate enough steps to meet the passing standard (or cut score) for each skill.”)
Claims 7-9 are dependent on claim 5 and are considered to be optional steps at least due to claim 5’s language “…at least one of…”. In light of this, the claims are anticipated by Credentia (see at least pages 10 and 12).
Regarding claim 10, Credentia discloses The system of claim 1, wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to: calculate a caregiver recommendation compliance percentage based on a rate that the caregiver complies with the at least one recommendation. (See at least page 41 – “In the following example (see top of next column), a candidate received a result of Unsatisfactory on the skill Hand Hygiene. The numbers 1, 5, and 10 printed below the skill refer to steps that were missed or performed incorrectly. To study for re-taking the Skills Evaluation, this candidate should turn to the Skills Listing in this handbook, look for the Hand Hygiene skill, and review all the steps, especially steps 1, 5, and 10.” The Examiner asserts that re-taking the Skills Evaluation based on steps that were determined to have been missed or performed incorrectly, and receiving an updated test result, equates to calculating a caregiver recommendation compliance percentage (i.e., the results of the retaken Skills Evaluation).)
Regarding claim 11, Credentia discloses The system of claim 10, wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to: issue an alert when the caregiver recommendation compliance percentage is less than a threshold value. (See at least page 40, “You will receive a notification email from CNA365 when a new exam score has been posted to your online account.”, and “If you do not pass the Skills Evaluation, you will receive a Failing Score Report. The score report will list the five (5) skills that you performed and a score of Satisfactory or Unsatisfactory for each skill. Any skill with an Unsatisfactory result is considered a failed skill. You must receive a Satisfactory result on all five (5) skills to pass the Skills Evaluation.”)
Regarding claim 12, Credentia discloses The system of claim 1, wherein the at least one composite healthcare score is generated for at least one of the clinical care environment, at least one department within the clinical care environment, and at least one caregiver assigned to the at least one department. (See page 40 – “Credentia will provide you with your official examination results within a few hours after a testing event is completed for the day. Score reports are provided online and are available for you to print or download. Examinations results will not be given over the telephone, nor can they be sent by Credentia to your employer.”)
Regarding claim 15, Credentia discloses The system of claim 1, wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to: calculate an efficiency rating corresponding to the at least one recommendation, wherein the efficiency rating measures an estimated improvement in the at least one composite healthcare score per unit of time for the caregiver to implement the at least one recommendation. (See page 40 – “If you fail all or part of the NNAAP Examination, your Score Report will tell you how to apply for re-testing. By state and federal regulations, you are permitted to take the NNAAP Examination up to four (4) times within twenty-four (24) months immediately after your nursing assistant training completion date.” The Examiner asserts that the results of retaking a failed test equates to an efficiency rating.”
Claim 16 features limitations similar to those of claim 1, and is therefore rejected using the same rationale.
Claim 17 features limitations similar to those of claim 10, and is therefore rejected using the same rationale. The Examiner asserts that calculating a caregiver recommendation compliance percentage based on a rate that the caregiver complies with the at least one recommendation indicates that the caregiver is monitored to detect when the caregiver complies with the at least one recommendation.
Regarding claim 19 Credentia does not explicitly disclose The method of claim 16, further comprising:
identifying the at least one monitoring device associated with the plurality of actions; (See Dring, Para. [0080] – “The Monitor Status Report 140 advises which monitors are available for use within the facility and also which units are currently in service at the patient bedside.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Credentia to utilize the teachings of Dring since it may be used to determine if a caregiver has performed a task at a particular location.
Credentia and Dring do not explicitly disclose:
issuing a monitoring device alert when the at least one monitoring device is associated with a number of events that exceed an event threshold value; and
adjusting an event detection threshold value for the at least one monitoring device to reduce a quantity of events that are detected by the at least one monitoring device.
See at least Rodgers Para. [0096] – “A decision algorithm can be used to adjust parameter values that will cause an actionable event. If an actionable event is appropriately detected (a positive), parameters can be made more restrictive such that the standard is lowered for detecting the actionable event in the future. For example, if a patient has fallen when exiting a bed, the values for detecting a bed exit can be made more restrictive. On the other hand, if an actionable event is inappropriately detected (a false positive), parameters can be made less restrictive such that the standard is raised for causing or detecting the actionable event in the future.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Credentia and Dring to utilize the teachings of Rodgers since it would reduce any false positives reported by the transmitters of Dring regarding patient rotations performed by caregivers. Also see Skill 17 of Credentia (Positions on Side).
Claim(s) 13, 14, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maryland NURSE AIDE Written (or Oral) Examination & Skills Evaluation Candidate Handbook”, available February 2022, hereinafter referred to as Credentia, in view of Dring (US 2006/0264785), Rodgers (US 2007/0162304), and Dyell (US 2015/0364022), and in further view of “AAMC’s Hospital Compare Benchmark Report” by Matt Baker, available July 2020, hereinafter referred to as Baker.
Regarding claim 13, Credentia, Dring Rodgers, and Dyell do not explicitly disclose The system of claim 12, wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to:
identify at least one benchmark clinical care environment having one or more benchmark clinical care environment characteristics that are within a range of benchmark threshold values;
generate a benchmark composite healthcare score corresponding to the at least one benchmark clinical care environment based on benchmark data collected from the at least one benchmark clinical care environment; and
issue an alert when the at least one composite healthcare score is less than the benchmark composite healthcare score.
Baker features a chart comparing how rates of a particular hospital compare to national, COTH, and state rates (see at least time 1:10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Credentia, Dring, Rodgers, and Dyell to utilize the teachings of Baker since it would allow caregivers to determine how they measure up to others.
Regarding claim 14, Credentia, Dring, Rodgers, and Dyell do not explicitly disclose The system of claim 13, wherein the one or more benchmark clinical care environment characteristics include at least one of a number of rooms available to patients, a square-foot area of the at least one benchmark clinical care environment, an age of the at least one benchmark clinical care environment, a location of the at least one benchmark clinical care environment, patient demographics within the at least one benchmark clinical care environment, or specialty care offered within the at least one benchmark clinical care environment. (Baker teaches the comparison of rates of a particular hospital to rates of hospitals in a state (see State: CT). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Credentia, Dring, Rodgers, and Dyell to utilize the teachings of Baker since it would allow caregivers to determine how they measure up to others.
Claim 181 features limitations similar to those of claim 13, and is therefore rejected using the same rationale.
Response to Arguments
Applicant's arguments regarding claims rejected under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that the claims reflect an improvement to technology by “provid[ing] improved transparency and accountability by continuously generating composite healthcare scores that measure metrics relating to safety, efficiency, and quality of healthcare in a manner that removes subjectivity and internal biases”. The Examiner respectfully disagrees, as this does not present an improvement to technology. The generation of scores offers no improvements to any involved computing devices, including the now positively recited plurality of antennas. If anything, the claims merely present an improvement to a business method via computer implementation.
Applicant’s arguments that the claims are similar to Ex Parte Desjardins are not persuasive. As stated above, the claims do not offer a technological improvement. The measurement of caregiver performance does not provide any improvement to the functioning of any of the involved computing components. The functional capabilities (i.e., processing speed, processing power, etc.) of the recited “multiple monitoring devices”, “plurality of antennas”, “processing device”, “memory device, and “graphical user interface” remain unchanged.
Applicant’s arguments that the claims “address the well-recognized technical problem of alarm fatigue in healthcare environments” is not persuasive as alarm fatigue is not a technical problem since it is not a concrete issue.
Applicant’s arguments regarding the claims being analogous to Example 46 due to “tak[ing] a specific corrective action on specific physical hardware in a particular way” is not persuasive. The claims state that the multiple monitoring devices are adjusted “to reduce the problematic notifications from the multiple monitoring devices, including adjusting an event detection threshold of one or more of the multiple monitoring devices based upon the notification fatigue score” yet provides no mechanism for doing so. The claims merely recite an undisclosed method of classifying alarms using AI, calculating a notification fatigue score, and adjusting the monitoring devices based upon the notification fatigue score. As evidenced by the 112a and b issues above, the claims are deficient in properly describing 1) how the system classifies the false alarms that are used in calculating the notification fatigue score, and 2) the specific manner in which the monitoring devices are adjusted based on the notification fatigue score to somehow reduce problematic notifications.
Applicant’s argument that the claims are integrated into a practical application by improving caregiver satisfaction and the ability to provide quality care to patients is not persuasive since these are not technical improvements.
Applicant’s argues that the claims are eligible under Step 2B due to “The combination of a plurality of antennas configured to receive wireless signals from caregiver-worn tags, real-time location data received from those antennas over the network, correlation of caregiver actions with specific locations using that data, artificial intelligence classification of alarms from multiple monitoring devices as true or false alarms based on data received from those devices, calculation of a notification fatigue score identifying the false alarms as the problematic notifications as a component of the composite healthcare score, and automatic adjustment of event detection thresholds of one or more specific monitoring devices based upon the notification fatigue score is not a well-understood, routine, or conventional combination of activities.” The Examiner respectfully disagrees. All but the “combination of a plurality of antennas configured to receive wireless signals from caregiver-worn tags” are part of the abstract idea itself. Further, this particular limitation was found to be conventional as stated in the body of the 101 rejection above.
Based on at least the above, the 101 rejection is maintained.
Applicant's arguments regarding claims rejected under 35 U.S.C. 112(a) have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that the limitation “classify, using artificial intelligence, the alarms as true alarms or false alarms based on the data received from the multiple monitoring devices” is supported by paragraph [0024] of the specification. The Examiner respectfully disagrees. Paragraph [0024] states, in part, “The alarm manager 109 can automatically adjust the event detection threshold for a monitoring device to reduce a quantity of events detected by the monitoring device to reduce false alarms and mitigate alarm fatigue when the monitoring device issues a number of alarms that exceed a threshold. In some examples, the alarm manager 109 uses artificial intelligence such as machine learning to classify alarms as either true alarms or false alarms based on the data received from the monitoring devices in the patient environment 12. Additionally, in some further examples, the alarm manager 109 uses artificial intelligence to automatically adjust one or more event detection thresholds for one or more monitoring devices in the patient environment 12 to reduce false alarms triggered by the one or more monitoring devices, and thereby mitigate alarm fatigue in the patient environment 12.” The paragraph merely indicates that artificial intelligence is used to somehow classify the alarms based on data received from the monitoring device. There is no indication of how said data is used to classify the alarms. Therefore, the limitation lacks proper support.
Further, Applicant’s arguments concerning “problematic notifications” being defined as the false alarms classified by the artificial intelligence is not persuasive at least in part due to the indefiniteness of the term “false alarm”.
Applicant argues that the limitation “automatically adjust the multiple monitoring devices based upon the at least one composite healthcare score to reduce the problematic notifications from the multiple monitoring devices, including adjusting an event detection threshold of one or more of the multiple monitoring devices based upon the notification fatigue score” is supported by paragraphs [0075] and [0087]. The Examiner respectfully disagrees as the cited paragraphs are silent in regards to how the notification fatigue score is used to adjust an event detection threshold.
Applicant's arguments regarding claims rejected under 35 U.S.C. 112(b) have been fully considered and are persuasive. However new grounds of rejection have been introduced.
Applicant's arguments regarding claims rejected under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant agues that reference Rodgers does not disclose “a plurality of antennas…”. This is not persuasive as Rodgers was found to disclose this feature in at least paragraph [0102] (see body of rejection above).
Applicant’s arguments concerning Dyell are not persuasive. In light of the multiple 112 issues introduced, Dyell was found to disclose the limitations in question.
Based on at least the above, the 103 rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
healthgrades.com (available March 3, 2022) teaches ratings for hospitals (see rating of 73% for Banner – University Medical Center Phoenix), ratings for particular departments (see ratings under Cardiac), and ratings for individual providers.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 Examiner failed to include claim 18 in the 112b rejection of claim 13 of the previous action of 08/25/2025 despite featuring similar language. Examiner has interpreted non-amended claim 18 as featuring similar language as amended claim 13 despite still featuring indefinite language.
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