DETAILED ACTION
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) submitted December 12, 2025. Claims 1 and 9 – 20 are amended. Claims 1 – 31 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 4, 2025 has been entered.
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, 6, and 20 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. The present claims recite “are associated with data other than a signal output from a sensor device”, “continuously collect real-time patient bio-metric information”, “continuously store the real-time patient biometric information to an electronic medical patient file”, and ” initiating the connecting of the sensor device to the patient to collect the real-time patient biometric data to the electronic medical patient file”. These features are not disclosed in the specification. For instance, the specification fails to recite a signal output from a sensor device in the limitation “are associated with data other than a signal output from a sensor device”; the specification merely discloses a signal such as a carrier wave or other transport mechanism (paragraph 28) and peripheral output devices (paragraph 35). In addition, the specification fails to disclose collecting and storing biometric information, as well as initiating the connecting of the sensor device to the patient to collect the real-time patient biometric data. The specification fails to disclose a sensor device, thus the limitations claimed above cannot be performed.
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 – 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step One
Claims 1 – 31 are drawn to a method, non-transitory media, and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1, 9, and 20 recite predicting medication induced respiratory depression comprising: monitoring, over a time period and prior to an intervention, a first set of information or a set of trigger events that are associated with data and corresponds to one or both of a clinical record and a clinical workflow; identifying and autonomously in response to the monitoring, a trigger event of the set of trigger events indicative of an admission event, a diagnosis event, a clinical event, or an order event corresponding the admission event, the diagnosis event, or the clinical event and to a patient, performing a set of multiple operations and autonomously in response to the identifying, wherein the performing the set of multiple operations is performed without user intervention and comprise: querying at least one of a record or workflow corresponding to the patient for a presence of one or more of a plurality of predefined data elements to identify at least a subset of predefined data elements, of the plurality of predefined data elements, within at least one of the record or workflow; based on values, assigned to each of the subset of predefined data elements within the at least one of the record or workflow, determining a representative element value of the patient; determining whether the representative element value meets a threshold; and in response to the representative element value being determined to meet the threshold, generating an information item, wherein the information item includes the representative element value and an instruction that corresponds to the intervention and is based on the total representative value.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that “the present disclosure relates to a method for predicting medication induced respiratory depression” (see: specification paragraph 4). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims present collected and analyzed data to a user, with instructions. Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “computer implemented”, “one or more hardware processors”, “medical-information computing system”, “a signal output from a sensor device configured to be connected to: (i) continuously collect real- time patient biometric information” and (ii) “continuously store the real-time patient biometric information to an electronic medical patient file”, “automatically”, “electronic”, “electronically transmitting”, “electronic interface”, “initiating the connecting of the sensor device to the patient to collect the real-time patient biometric information and to continuously store the real-time patient biometric information to the electronic medical patient file”
Claims 2 – 8, 22 – 29, 31: “computer implemented”
Claim 9: “computer storage device”, “non-transitory computer-readable media”, “program instructions, written on the one or more non-transitory computer readable media, when executed by one or more processors, cause the one or more processors to perform a plurality of operations”, “one or more hardware processors”, “medical-information computing system”, “a signal output from a sensor device configured to be connected to (i) continuously collect real- time patient biometric information and (ii) continuously store the real-time patient biometric information to an electronic medical patient file”, “automatically”, “electronic”, “electronically transmitting”, “electronic interface”, “initiating the connecting of the sensor device to the patient to collect the real-time patient biometric information and to continuously store the real-time patient biometric information to the electronic medical patient file”
Claim 10: “computer storage device”, “electronic”
Claims 11 – 14, 16 – 17: “computer storage device”
Claim 15: “computer storage device”, “transmitting”, “automatically”, “clinician device”
Claims 18 – 19: “computer storage device”, “electronic”, “automatically”
Claim 20: “computer system”, “one or more hardware processors”, “program instructions, written on the one or more non-transitory computer readable media, when executed by one or more processors, cause the one or more processors to perform a plurality of operations”, “medical-information computing system”, “a signal output from a sensor device configured to be connected to (i) continuously collect real- time patient biometric information, and (ii) to continuously store the real-time patient biometric information to an electronic medical patient file”, “automatically”, “electronic”, “electronically transmitting”, “electronic interface”, “initiating the connecting of the sensor device to the patient to collect the real-time patient biometric information and to continuously store the real-time patient biometric information to the electronic medical patient file”
Claim 21: “computer implemented”, “scan”, “electronic”
Claim 30: “computer implemented”, “electronic”
These features are additional elements that are recited at a high level of generality (e.g., the “non-transitory media having instructions that, when executed by one or more processors, cause the one or more processors to facilitate a plurality of operations” is no more than a statement that said instructions are executed) such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed (e.g., the ““non-transitory computer-readable storage medium having instructions embodied thereon, the instructions being executable by one or more processors to perform” language is incidental to what instructions are executed). Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, 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.
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0023] Beginning with FIG. 1, a computing environment 100 that is suitable for use in implementing aspects of the present invention is depicted. The computing environment 100 is merely an example of one suitable computing environment and is not intended to suggest any limitation as to the scope of use or functionality of the invention. Neither should the computing environment 100 be interpreted as having any dependency or requirement relating to any single component or combination of components illustrated therein. Generally, in aspects, the computing environment 100 is a medical-information computing-system environment. However, this is just one example and the computing environment 100 can be operational with other types, other kinds, or other-purpose computing system environments or configurations. Examples of computing systems, environments, and/or configurations that might be suitable for use with the present invention include personal computers, server computers, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, set top boxes, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments that include any of the above-mentioned systems or devices, and the like.
[0040] Turning now to FIGS. 2 and 3, methods are discussed that can be performed via one or more of the devices, components, and/or component interactions previously described in FIG. 1. It should be understood that the methods discussed herein can be implemented or performed via the execution of non-transitory computer-readable instructions and/or executable program code portions stored on computer readable media, using one or more processors. The computer-readable program code can correspond to the application, described above, wherein the application performs the methods, in some aspects. In aspects, the methods can be implemented and performed using a computerized application. As such, the methods can be computer-implemented methods, in some aspects, integrated with and executed to complement a computerized clinical workflow.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 8, 10 – 19, and 21 – 31 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
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 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 – 2, 4, 8 – 11, 14 – 27, and 29 – 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meger et al., herein after Meger (U.S. Publication Number 2024/0008751 A1) in view of McCallie, Jr. et al., herein after McCallie (U.S. Patent Number 8,239,216 B2) further in view of Joseph et al., herein after Joseph (U.S. Publication Number 2020/0352456 A1).
Claim 1 (Currently Amended). Meger teaches a computer-implemented method performed by one or more hardware processors for predicting medication induced respiratory depression (paragraph 40 discloses the control unit is configured to periodically receive the data indicative of the given physiological parameter of the patient (e.g. monitoring) by receiving the data at time intervals; paragraph 87 discloses a breathing pattern analysis module and heartbeat pattern analysis module configured to analyze the respective patters to predict an approaching clinical episode such as respiratory depression), the computer-implemented method comprising:
monitoring, by the one or more hardware processors over a time interval (paragraph 40 discloses the control unit is configured to periodically receive the data indicative of the given physiological parameter of the patient (e.g. monitoring) by receiving the data at time intervals of between 0.5 hours and 12 hours) and prior to an intervention (paragraph 20 discloses automatically generate, display, and/or input notices and clinical intervention orders into the computerized clinical workflow, in response to the autonomously made predictions and other determinations), a first set of information at a medical-information computing-system for a set of trigger events that:
(a) are associated with data other than a signal output from a sensor device (paragraph 39 discloses a sensor configured to continuously sense vital sign information of a patient and generate a sensor signal in response) configured to be connected to:
(i) continuously collect real- time patient biometric information (paragraph 18 discloses a motion sensor is configured to generate respiration related signal in response to sensing the motion of the patient and the control unit is configured to identify breathing of the patient as being rapid shallow breathing, in response to detecting (a) an increase in respiration rate, (b) a decrease in respiration motion signal size, and (c) that there has been no change in the posture of the patient; paragraph 21 discloses the control unit is configured to identify poor pulmonary function of the patient in response to identifying the breathing of the patient as being shallow breathing; paragraph 39 discloses a sensor configured to continuously sense vital sign information of a patient and generate a sensor signal in response; paragraph 90 discloses monitoring clinical parameters of the patient including, but not limited to, breathing rate; heart rate; coughing counts; expiration/inspiration ratios; amplitude, number, or frequency of augmented breaths; amplitude, number, or frequency of deep inspirations; amplitude, duration, or frequency of tremors, duration or frequency of sleep cycles, and amplitude, number, or frequency of restlessness patterns) and
(ii) continuously store the real-time patient biometric information to an electronic medical patient file (paragraph 101 discloses combining continuous readings such as heart or respiratory rates, with constant or slower changing information (age, gender or temperature), a dynamic score is generated; paragraph 339 discloses storing the amplitude of the patient’s cardioballistic signal over each block of time having a given period), and
(b) correspond to one or both of a clinical record and a clinical workflow (paragraph 86 discloses a breathing pattern analysis module which typically comprises a digital signal processor; paragraph 134 discloses continuously collected data on patient motion and other data may be manually entered by the clinician or read automatically from an electronic medical record system, or collected by additional sensors; paragraph 216 discloses the system may utilize data available in electronic medical record systems in order to identify if following an alert by the system, a medical intervention or further diagnostics was performed),
identifying, by the one or more hardware processors and autonomously in response to the monitoring, a trigger event of the set of trigger events indicative of an admission event, a diagnosis event, a clinical event, or an order event corresponding to the admission event, the diagnosis event, or the clinical event and to a patient (paragraph 87 discloses Breathing pattern analysis module and heartbeat pattern analysis module are configured to analyze the respective patterns in order to (a) predict an approaching clinical episode, such as an asthma attack, heart condition-related lung fluid buildup, sepsis, cardiac arrest, or respiratory depression, and/or (b) monitor the severity and progression of a clinical episode as it occurs and that when treating a hospitalized patient in a general care ward, for example, an earlier identification of patient deterioration may prevent the need to admit the patient to the ICU, shorten his length of stay, and increase the likelihood for successful recovery to discharge; paragraph 90 discloses a clinical parameter is a numerical parameter that can be measured in a clinical setting and that has clinical value (clinical event); paragraph 174 discloses the system collects some or all of the following information: heart rate, patient motion, bed angle, timing of medication, and/or meal intake (clinical events) such that if there is a change, the system alerts the clinician, thus initiating a plurality of operations, including manually measuring a patient’s temperature);
(e) in further response to the representative element value being determined to meet the threshold, initiating the connecting of the sensor device to the patient to collect the real-time patient biometric information and to continuously store the real-time patient biometric information to the electronic medical patient file (paragraph 70 discloses the sensor comprises a standard communication interface which enables connection to standard monitoring equipment; paragraph 195 discloses displaying a recommendation to the clinician to connect the patient to an ECG device (real-time biometric information)).
Meger fails to explicitly teach the following limitations met by McCallie as cited:
performing a set of multiple operations, by the one or more hardware processors (column 4, line 59 through column 5, line 3 discloses personal computers, server computers, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, mainframe computers, distributed computing environments) and autonomously in response to the identifying, wherein performing the set of multiple operations is performed automatically and without user intervention and comprises:
querying at least one of an electronic record or workflow corresponding to the patient for a presence of one or more of a plurality of predefined data elements (Figures 4 and 6; column 2, lines 9 – 18 discloses preparing an electronic medical record for electronic searching, including identifying clinical concepts within the electronic medical record, where the clinical concept is related to a person’s health; column 3, lines 33 – 35 discloses allowing a user to submit a search query through an interface and return search results that are responsive to the search query; column 7, line 47 through column 8, line 13 discloses the clinical concept component may identify clinical-concepts within a search query and components of an EMR, in one embodiment, SNOMED is used as the clinical concept ontology) to identify at least a subset of predefined data elements, of the plurality of predefined data elements, within the at least one of the electronic record or workflow (column 8, lines 48 – 61 discloses the particular use of a clinical concept may be assigned a pre-defined clinical concept category, where the clinical usage context may be determined by ascertaining what part of a document the clinical concept is used; column 16, lines 4 – 23 discloses each clinical concept may be categorized into a pre-defined group of clinical concept categorized, which may include a presenting complaint section, patient history, family history, physical exam record, prescription, order, lab result, vital sign, diagnosis, and a procedure record);
based on values, assigned to each of the subset of predefined data elements within the at least one of the electronic record or workflow, determining a representative element value of the patient (Figure 9; column 3, lines 33 – 54 discloses allowing a user to submit a search query through an interface and return search results that are responsive to the search query, the search results may be ordered according to a query-responsiveness score so that the most important matching components of the electronic medical record can be quickly located at the top of the result lists; column 4, lines 10 – 33 discloses the search results are ordered according to a query responsiveness score that is calculated for each match search result, and can be calculated by combining a set of clinical importance scores with a set of boost factors, a boost factor measures the responsiveness of a search result using information related to the query and are assigned to produce a good fit between the query and the potential search results for the component of the EMR; column 11, lines 1 – 18 discloses different categories of clinical usage content may be given different values to plug into the calculation of the clinical importance score, the more closely the clinical concept is related to the patient, the higher the score; column 13, lines 11 – 49 discloses a closeness boost factor which may be calculated for each matching combination of clinical concepts when the primary clinical concept in the query is expanded; column 17, lines 34- 47 discloses the clinical importance score could be recorded as a numerical value that is the result of a calculation).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Meger to further include searching an electronic record by receiving a search query from a user to search the electronic medical record associated with a patient, and identifying one or more components of the medical record that contain text which matches the search query, and determining a query responsiveness score for each of the matching components as disclosed by McCallie.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Meger in this way since to provide a clinical concept data store which contains one or more clinical-concept ontologies, which is based on a combination of SNOMED CT (to represent clinical conditions, symptoms, therapy, organisms, etc.) and RxNorm (to represent medications) (McCallie: column 14, lines 40 – 47);
Meger and McCallie fail to explicitly teach the following limitations met by Joseph as cited:
determining whether the representative element value meets a threshold (paragraph 146 discloses a total risk score based on a sum of the respective risk scores for acute respiratory distress may be calculated and compared against at least one predetermined total risk threshold for acute respiratory distress); and
in response to the representative element value being determined to meet the threshold (paragraph 146 discloses a total risk score based on a sum of the respective risk scores for acute respiratory distress may be calculated and compared against at least one predetermined total risk threshold for acute respiratory distress), automatically generating an information item and electronically transmitting via the one or more hardware processors the information item to an electronic interface, wherein: the information item includes the representative element value and an instruction that corresponds to the intervention and that is based on the representative element value (Figure 10; paragraph 26 discloses assigning a second value of a likelihood of an adverse event based on a measured tidal volume, and generating an alert if a sum of the first value, second value, third value and fourth value exceeds a predetermined risk score threshold; paragraph 88 discloses the monitoring system may have progressive alerts and alarms to the patient’s cell phone, a care giver, and/or 911 emergency personnel; paragraph 116 discloses the wireless transmitter may transmit the measurement of the respiratory rate, tidal volume, heart rate, and other vital sign data to a remote controller, where the remote controller may be in the form of a smartphone, tablet, smartwatch, Echo device, Alexa, cable box, or other mobile communication device that may be relayed to the controller for real-time processing; paragraph 146 discloses a respective risk score for acute respiratory distress for each of the calculated minute ventilation, respiratory rate, tidal volume, measured heart rate, blood oxygen saturation, and temperature is calculated based on the comparison between the measured or calculated parameters and the respective predetermined thresholds, indicating more than one threshold (a threshold for each of calculated parameters); paragraph 148 discloses at least one alert (notice) may be generated if the total risk score deviates from at least one predetermine total risk threshold for acute respiratory distress – if the calculated total risk score is less than the lower threshold, the controller is configured to generate an alert notifying the patient to self-medicate; If the calculated total risk is greater than the lower threshold, but less than the higher threshold, the controller is configured to generate an alert notifying the patient to contact a physician, and If the calculated total risk is greater than the higher threshold, the controller is configured to generate an alert for the patient to go to the hospital (intervention), indicating instructions based on the total element value).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Meger and McCallie to further include a method and system for a non-invasive real-time monitoring system with diagnostic algorithms that continuously quantify and analyze the pattern of an ambulatory person’s respiratory rate, tidal volume, degree of upper airway obstruction, body activity level, and other physiological conditions as disclosed by Joseph.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Meger and McCallie in this way by allowing hospital clinicians to use the acoustic ventilation monitoring system (AVMS) real time minute ventilation, heart rate, body activity, and temperature trend data to manage inpatient medical therapy in a more efficient, effective, and timely manner, leading to improved clinical outcomes and decreased costs (Joseph: paragraph 70).
Claim 2 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger fails to explicitly teach the following limitations met by McCallie as cited:
wherein the plurality of predefined data elements correspond to data that encodes one or more of:
an ICD-10 code for one or more of pulmonary disease, heart failure, or sleep apnea; or
a SNOMED code for one or more of pulmonary disease, heart failure, or sleep apnea (Figure 9 discloses the SNOMED code for myocardial infarction; column 7, line 47 through column 8, line 13 discloses the clinical concept component may identify clinical-concepts within a search query and components of an EMR, in one embodiment, SNOMED is used as the clinical concept ontology).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 4 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1. Meger teaches wherein the plurality of predefined data elements correspond to a first age range of 60 to 69 years, a second age range of 70 to 79 years, or a third age range of 80 years or greater (paragraph 125 discloses the motion data acquisition module adapts the spectral filtering based on the age of the patient, typically children have higher breathing and heart rates, although Meger does not explicitly disclose specific age ranges, it would be obvious to include specific age ranges of patients in the plurality of predetermined elements).
Claim 8 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger and McCallie fail to explicitly teach the following limitations met by Joseph as cited:
wherein the instruction specifies performance of an end tidal CO2 (EtCO2) protocol for the patient (paragraph 27 discloses a method of predicting an opioid overdose with an acoustic measurement device having a sound transducer configured to measure sound associated with airflow, correlating the measured sound into a measurement of tidal volume, and generating an alert or alarm if the measure tidal volume falls outside of a predetermined range; paragraph 119 discloses the controller is
configured to compare the measurement of at least one of the respiratory rate and the tidal volume to a respective predetermined threshold, which may be a range or value, or patient baseline with the RIS (risk index score) discussed).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 10 (Currently Amended). Meger, McCallie, and Joseph teach the computer storage device (paragraph 86 discloses EEPROM) of claim 9.
Meger fails to explicitly teach the following limitations met by McCallie as cited:
wherein the information item includes each of the plurality of predefined data elements that were located in at least one of the electronic patient record or the clinical workflow (column 2, lines 4 – 8 discloses presenting search results based on the query-responsiveness score associated with each document within the electronic medical record in which the clinical concept is used; column 2, lines 9 – 18 discloses preparing an electronic medical record for electronic searching, including identifying clinical concepts within the electronic medical record, where the clinical concept is related to a person’s health; column 8, lines 48 – 61 discloses the particular use of a clinical concept may be assigned a pre-defined clinical concept category, where the clinical usage context may be determined by ascertaining what part of a document the clinical concept is used; column 16, lines 4 – 23 discloses each clinical concept may be categorized into a pre-defined group of clinical concept categorized, which may include a presenting complaint section, patient history, family history, physical exam record, prescription, order, lab result, vital sign, diagnosis, and a procedure record), and the corresponding assigned value of each of the plurality of predefined data elements that were located (column 11, lines 1 – 18 discloses different categories of clinical usage content may be given different values to plug into the calculation of the clinical importance score, the more closely the clinical concept is related to the patient, the higher the score; column 17, lines 34- 47 discloses the clinical importance score could be recorded as a numerical value that is the result of a calculation).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 11 (Currently Amended). Meger, McCallie, and Joseph teach the computer storage device (paragraph 86 discloses EEPROM) of claim 9.
Meger fails to explicitly teach the following limitations met by McCallie as cited:
wherein the plurality of predefined data elements include diagnosis codes specific to at least one of pulmonary disease, heart failure, or sleep apnea (Figure 9 discloses the SNOMED code for myocardial infarction; column 7, line 47 through column 8, line 13 discloses the clinical concept component may identify clinical-concepts within a search query and components of an EMR, in one embodiment, SNOMED is used as the clinical concept ontology; column 8, lines 48 – 61 discloses the particular use of a clinical concept may be assigned a pre-defined clinical concept category, where the clinical usage context may be determined by ascertaining what part of a document the clinical concept is used; column 16, lines 4 – 23 discloses each clinical concept may be categorized into a pre-defined group of clinical concept categorized, which may include a presenting complaint section, patient history, family history, physical exam record, prescription, order, lab result, vital sign, diagnosis, and a procedure record).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 14 (Currently Amended). Meger, McCallie, and Joseph teach the computer storage device (paragraph 86 discloses EEPROM) of claim 9.
Meger and McCallie fail to explicitly teach the following limitations met by Joseph as cited:
wherein when the representative element value meets a third threshold that is greater than a second threshold, the second threshold is greater than the threshold, the information item includes a particular recommended high-risk intervention corresponding to performance of an end tidal CO2 (EtCO2) protocol for the patient (paragraph 26 discloses “a controller is in communication with the acoustic measurement device, the controller being configured to: correlate the measured sound energy into a measurement of the patient's tidal volume and respiratory rate in real-time, assign a first value of a likelihood of an adverse event based on the measured respiratory rate, assign a second value of a likelihood of the adverse event based on the measured tidal volume, calculate a rate of change of the measured respiratory rate and tidal volume over time, assign a third value of a likelihood of the adverse event based on the calculated rate of change of the measured respiratory rate, assign a fourth value of a likelihood of the adverse event based on the calculated rate of change of the measured tidal volume, multiply the third value and the fourth value by a predetermined weighing factor, and generate an alert if a sum of the first value, the second value, the third value, and the fourth value, exceeds a predetermined risk score threshold.” The Examiner interprets the different values (first through fourth) to be calculations of adverse events based on the patient measurements over time; paragraph 37 discloses an alarm is generated if the calculated rate of change and trend direction of the tidal volume falls outside the predetermined range, the duration the measured tidal volume exceeds a threshold produces and alert and alarm; paragraph 91 discloses the remote controller compares the measurement from at least one of the respiratory rate and tidal volume to a respective fixed or dynamic threshold to determine an adverse event in real time if the measurement deviates from the predetermined threshold by a predetermined amount – the dynamic threshold indicates it is continuously changing/updated, thus providing multiple thresholds).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 15 (Currently Amended). Meger, McCallie, and Joseph teach the computer storage device (paragraph 86 discloses EEPROM) of claim 9. Meger teaches wherein the information item includes a particular recommended intervention (paragraph 175 discloses if an increase in the average respiratory rate over a period of 5 minutes to 3 hours (for example, 30 minutes) is identified without a corresponding increase in the patient’s activity level, a deterioration of the patient’s respiratory condition is identified, and interventions, including changing of the backrest angle, patient rotation, and/or providing vibration and percussion treatment is applied), and wherein the plurality of operations further comprise:
determining that the particular recommended intervention is not performed within a predetermined period of time from the transmitting of the information item based on an absence of documentation for the particular recommended intervention being logged in the clinical workflow (paragraph 131 discloses the system displays a counter of time since the last time a clinician turned the patient and when the time reaches the above threshold, the system alerts the clinician to turn the patient – in some applications, the clinician has input means to indicate the patient has actually been turned and the system verifies that the turn was actually detected, all times of patient turns by clinicians are documented, if one or more turns were not verified, the system has to option to alert a clinician; indicating an absence of documentation for the recommended intervention); and
automatically sending another information item to a clinician device to complete the particular recommended intervention (paragraph 63 discloses the control unit and/or user interface are implemented in a mobile device (clinician device); paragraph 87 discloses the user interface is configured to notify patient and/or a clinician of the predicted or occurring episode; paragraph 216 discloses the system may communicate to a manager (an additional notice) when alerts have not been responded to in a timely way; paragraph 245 discloses if no movement by the clinician is identified within a defined length of time (for example 10 seconds), the clinician is notified again, and/or additional clinicians are alerted as well).
Claim 16 (Currently Amended). Meger, McCallie, and Joseph teach the computer storage device (paragraph 86 discloses EEPROM) of claim 9.
Meger and McCallie fail to explicitly teach the following limitations met by Joseph as cited:
wherein the plurality of operations further comprise determining whether the admission event, the diagnosis event, the clinical event, or the order event include one or more items that correspond to at least one element from a group comprising:
a surgical event with anesthesia occurring within previous 24 hours;
an order for or administration of an opioid antagonist within previous 24 hours;
an order for or administration of a sedative;
an order for or administration of an opioid (paragraph 76 discloses elderly patients undergoing a hip or knee replacement surgery are routinely discharged from the hospital 24 – 48 hours post-operatively, with a prescription for an oral opioid medication); or
an order for or administration of three or more liters of oxygen.
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 17 (Currently Amended). Meger, McCallie, and Joseph teach the computer storage device (paragraph 86 discloses EEPROM) of claim 16.
Meger fails to explicitly teach the following limitations met by McCallie as cited:
wherein the plurality of operations further comprise triggering the querying in response to determining that the admission event, the diagnosis event, the clinical event for the patient, or the order event includes at least one of the one or more of the items (Figures 4 and 6; column 2, lines 9 – 18 discloses preparing an electronic medical record for electronic searching, including identifying clinical concepts within the electronic medical record, where the clinical concept is related to a person’s health; column 3, lines 33 – 35 discloses allowing a user to submit a search query through an interface and return search results that are responsive to the search query; column 7, line 47 through column 8, line 13 discloses the clinical concept component may identify clinical-concepts within a search query and components of an EMR, in one embodiment, SNOMED is used as the clinical concept ontology).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 18 (Currently Amended). Meger, McCallie, and Joseph teach the computer storage device (paragraph 86 discloses EEPROM) of claim 9. Meger discloses wherein the electronic record or workflow is automatically queried from a most recent admission event to present time and date (paragraph 274 discloses a hospital computerized Admit Transfer Discharge (ADT) system to automatically receive patient information which could include any admission dates and times).
Claim 19 (Currently Amended). Meger, McCallie, and Joseph teach the computer storage device (paragraph 86 discloses EEPROM) of claim 9. Meger teaches wherein the plurality of operations comprise:
receiving a subsequent indication of another admission event, diagnosis event, clinical event, or order event for the patient (paragraph 90 discloses a clinical parameter is a numerical parameter that can be measured in a clinical setting and that has clinical value (clinical event); paragraph 173 discloses medication and/or food has been administered to the patient (clinical event)).
Meger fails to explicitly teach the following limitations met by McCallie as cited:
in response to the subsequent indication, automatically querying the electronic record or workflow for the plurality of predefined data elements (Figures 4 and 6; column 2, lines 9 – 18 discloses preparing an electronic medical record for electronic searching, including identifying clinical concepts within the electronic medical record, where the clinical concept is related to a person’s health; column 3, lines 33 – 35 discloses allowing a user to submit a search query through an interface and return search results that are responsive to the search query; column 7, line 47 through column 8, lines 48 – 61 discloses the particular use of a clinical concept may be assigned a pre-defined clinical concept category, where the clinical usage context may be determined by ascertaining what part of a document the clinical concept is used; column 8, line 13 discloses the clinical concept component may identify clinical-concepts within a search query and components of an EMR, in one embodiment, SNOMED is used as the clinical concept ontology; column 16, lines 4 – 23 discloses each clinical concept may be categorized into a pre-defined group of clinical concept categorized, which may include a presenting complaint section, patient history, family history, physical exam record, prescription, order, lab result, vital sign, diagnosis, and a procedure record);
determining a new total element value by summing the assigned values of each of the plurality of predefined data elements that are located in at least one of the electronic record or workflow (column 11, lines 1 – 18 discloses different categories of clinical usage content may be given different values to plug into the calculation of the clinical importance score, the more closely the clinical concept is related to the patient, the higher the score; column 17, lines 34- 47 discloses the clinical importance score could be recorded as a numerical value that is the result of a calculation).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Meger to further include searching an electronic record by receiving a search query from a user to search the electronic medical record associated with a patient, and identifying one or more components of the medical record that contain text which matches the search query, and determining a query responsiveness score for each of the matching components as disclosed by McCallie.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Meger in this way since to provide a clinical concept data store which contains one or more clinical-concept ontologies, which is based on a combination of SNOMED CT (to represent clinical conditions, symptoms, therapy, organisms, etc.) and RxNorm (to represent medications) (McCallie: column 14, lines 40 – 47).
Meger and McCallie fail to explicitly teach the following limitations met by Joseph as cited:
determining when the new total element value meets the first, second, or third threshold (paragraph 146 discloses a total risk score based on a sum of the respective risk scores for acute respiratory distress may be calculated and compared against at least one predetermined total risk threshold for acute respiratory distress, and discloses different thresholds (minute ventilation, SpO2, temperature), indicating a first, second or third threshold, where the predetermined threshold may be modified based on a particular patient and may also be relative ranges and not absolute values); and
when the new total element value meets the first, second, or third threshold, automatically generating a new set of information and sending the new set of information, wherein the new set of information includes the new total element value and the warning of potential over sedation of the patient (paragraph 146 discloses different thresholds (minute ventilation, SpO2, temperature), indicating a first, second or third threshold, where the predetermined threshold may be modified based on a particular patient and may also be relative ranges and not absolute values; paragraph 148 discloses at least one alert (notice) may be generated if the total risk score deviates from at least one predetermine total risk threshold for acute respiratory distress – if the calculated total risk score is less than the lower threshold, the controller is configured to generate an alert notifying the patient to self-medicate; If the calculated total risk is greater than the lower threshold, but less than the higher threshold, the controller is configured to generate an alert notifying the patient to contact a physician; and If the calculated total risk is greater than the higher threshold, the controller is configured to generate an alert for the patient to go to the hospital, indicating instructions based on the total element value).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 21 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger fails to explicitly teach the following limitations met by McCallie as cited:
wherein the electronic record or workflow is queried to concurrently scan and search both structured data and unstructured data associated with the electronic record or workflow (column 3, lines 40 – 45 discloses a component of the EMR may be any text within the EMR including a document in the EMR, or any structured and/or codified element of information contained within the EMR).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 22 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger and McCallie fail to explicitly teach the following limitations met by Joseph as cited:
further comprising: responsive to the representative element value meeting the threshold, inputting a clinical intervention order into the workflow (paragraph 148 discloses at least one alert (notice) may be generated if the total risk score deviates from at least one predetermine total risk threshold for acute respiratory distress – if the calculated total risk score is less than the lower threshold, the controller is configured to generate an alert notifying the patient to self-medicate, if the calculated total risk is greater than the lower threshold, but less than the higher threshold, the controller is configured to generate an alert notifying the patient to contact a physician; and If the calculated total risk is greater than the higher threshold, the controller is configured to generate an alert for the patient to go to the hospital, indicating instructions based on the total element value where alerting the patient to go to the hospital is interpreted as a clinical intervention).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 23 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger and McCallie fail to explicitly teach the following limitations met by Joseph as cited:
wherein a data element that is associated with decreasing a patient's risk, for a clinical condition associated with one or more of pulmonary disease, heart failure, or sleep apnea, is assigned a negative numerical value in an index of predefined values (paragraph 139 discloses the RIS for opioid induced hypoventilation has a more positive value (more risk) when an increase in snoring and number/duration of apnea episodes are measured, the RIS for opioid induced hypoventilation has a more negative value (less risk) with normal breathing and talking, the real-time RIS is updated every 20-30 seconds and the controller may recognize the vital sign pattern early enough to prevent permanent injury or death).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 24 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1. Meger teaches a method wherein the information item indicates a level at which the patient is at risk for over-sedation/medication induced respiratory depression, and wherein increasing total value thresholds indicate greater risks (paragraph 215 discloses the system may analyze patient trends and identify a trend of decreasing respiratory rate that reaches respiratory rates that are lower than 8 breaths per minute, which may indicate that the patient is at risk of respiratory depression).
Claim 25 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1. Meger teaches a method wherein the information item indicates that the patient is at risk for medication induced respiratory depression based on the total representative value being determined, in real-time, dynamically in response to a query triggered by an indication of an admission, diagnosis, order, or clinical event (paragraph 98 discloses a dynamically changing score of clinical parameter data (clinical event) generated from one or more of analysis modules; paragraph 101 discloses combining continuous readings such as heart or respiratory rates, with constant or slower changing information (age, gender or temperature), a dynamic score is generated).
Claim 26 (Currently Amended). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1. Meger teaches a method wherein the total representative value reflects a current state of the patient with regard to risk for medication induced respiratory depression (paragraph 94 discloses the combine score (total element value) is compared to one or more threshold values to determine whether an episode is predicted, currently occurring, or neither predicted nor occurring, and/or to monitor the severity and progression of an occurring episode).
Claim 27 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1. Meger teaches a method wherein determining the total representative value comprises identifying, in the admission event, the diagnosis event, the clinical event, or the order event, a predetermined or prespecified time interval (paragraph 98 discloses a dynamically changing score of clinical parameter data (clinical event) generated from one or more of analysis modules, as well as data that is received periodically (at specific time intervals) such that the system can calculate a dynamically changing score (total element value) based on data that is only received periodically).
Claim 29 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger fails to explicitly teach the following limitations met by McCallie as cited:
wherein each of the plurality of predefined data elements has an assigned value corresponding to a risk of a clinical condition (column 11, lines 1 – 18 discloses different categories of clinical usage content may be given different values to plug into the calculation of the clinical importance score, the more closely the clinical concept is related to the patient, the higher the score; column 13, lines 11 – 49 discloses a closeness boost factor which may be calculated for each matching combination of clinical concepts when the primary clinical concept in the query is expanded; column 17, lines 34- 47 discloses the clinical importance score could be recorded as a numerical value that is the result of a calculation).
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 30 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger fails to explicitly teach the following limitations met by McCallie as cited:
wherein: the instruction based on the representative element value further corresponds to: a particular treatment is administered to the patient to treat a particular disease or medical condition (Figure 9 discloses the SNOMED code for myocardial infarction; column 7, line 47 through column 8, line 13 discloses the clinical concept component may identify clinical-concepts within a search query and components of an EMR, in one embodiment, SNOMED is used as the clinical concept ontology), and one or both of
(a) the subset of predefined data elements within the at least one of the electronic record or workflow (column 2, lines 9 – 18 discloses preparing an electronic medical record for electronic searching, including identifying clinical concepts within the electronic medical record, where the clinical concept is related to a person’s health; column 8, lines 48 – 61 discloses the particular use of a clinical concept may be assigned a pre-defined clinical concept category, where the clinical usage context may be determined by ascertaining what part of a document the clinical concept is used; column 16, lines 4 – 23 discloses each clinical concept may be categorized into a pre-defined group of clinical concept categorized, which may include a presenting complaint section, patient history, family history, physical exam record, prescription, order, lab result, vital sign, diagnosis, and a procedure record) and (b) the representative element value of the patient facilitate the particular treatment of the particular disease or medical condition.
The motivation to combine the teachings of Meger, McCallie, and Joseph is discussed in the rejection of claim 1, and incorporated herein.
Claim 31 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1. Meger teaches a method wherein a particular treatment is administered to the patient to treat a particular disease or medical condition (paragraph 10 discloses techniques for monitoring vital and nonvital signs using automated sensors and electronic signal processing, in order to detect and characterize the onset of a physiological event, and, for some applications, to treat the event, such as with therapy or medication) selected from a group comprising at least pulmonary disease (paragraph 13 discloses identifying poor pulmonary function of the patient), heart failure (paragraph 321 discloses identifying the deterioration in the condition of chronic patient suffering from chronic respiratory or cardiac conditions), and sleep apnea (paragraph 41 discloses identifying that a subject has sleep apnea).
Storage and System claims 9 and 20 repeat the subject matter of claim 1. As the underlying processes of claims 9 and 20 have been shown to be fully disclosed by the teachings of Meger, McCallie, and Joseph in the above rejection of claim 1; as such, these limitations (9 and 20) are rejected for the same reasons given above for claim 1 and incorporated herein.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meger et al., herein after Meger (U.S. Publication Number 2024/0008751 A1) in view of McCallie, Jr. et al., herein after McCallie (U.S. Patent Number 8,239,216 B2) further in view of Joseph et al., herein after Joseph (U.S. Publication Number 2020/0352456 A1) further in view of Jolley et al., herein after Jolley (Jolley, R. J., Liang, Z., Peng, M., Pendharkar, S. R., Tsai, W., Chen, G., Eastwood, C. A., Quan, H., & Ronksley, P. E. (2018). Identifying cases of sleep disorders through International Classification of Diseases (ICD) Codes in administrative data. International Journal of Population Data Science, 3(13), 1-11. http://dx.doi.org/10.23889/ijpds.v3i1.448).
Claim 3 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger, McCallie, and Joseph fail to explicitly teach the following limitations met by Jolley as cited:
wherein the plurality of predefined data elements correspond to data that encodes one or more of:
a body mass index equal to or greater than 30 (page 4, column 1, paragraph 3 discloses a body mass index of 30.7 ± 7.7 for a sleep apnea study; page 5, Table 1);
a result indicating renal impairment;
a surgical event with anesthesia occurring within previous 24 hours;
an order for or administration of an opioid antagonist within previous 24 hours;
an order for or administration of a sedative;
an order for or administration of an opioid; or
an order for or administration of three or more liters of oxygen.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Meger, McCallie, and Joseph to further include administrative data to provide representation of larger population estimates of a disease by developing and validating a set of ICD-10 codes to define sleep disorders including narcolepsy, insomnia, and obstructive sleep apnea in the administrative data as disclosed by Jolley.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Meger, McCallie, and Joseph in this way by optimizing administrative data case definitions through data linkage, by including patients diagnosed with a sleep disorder and the various parameters associated with that patient, such as BMI, chronic obstructive pulmonary disorder/emphysema, depression, diabetes, kidney disease, myocardial infarction, previous heart failure, and hypertension (Jolley: page 4, column 1, paragraph 3).
Claim(s) 5 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meger et al., herein after Meger (U.S. Publication Number 2024/0008751 A1) in view of McCallie, Jr. et al., herein after McCallie (U.S. Patent Number 8,239,216 B2) further in view of Joseph et al., herein after Joseph (U.S. Publication Number 2020/0352456 A1) further in view of Freeman et al., herein after Freeman (U.S. Publication Number 2018/0098739 A1).
Claim 5 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger, McCallie, and Joseph fail to explicitly teach the following limitations met by Freeman as cited:
wherein the information item includes a warning of potential over sedation of the patient (paragraph 221 discloses MV (minute ventilation), TV (tidal volume), and/or RR (respiratory rate) become part of an existing early warning scoring system either as a replacement of or in addition to the standard respiratory rate that is currently a part of most EWS (early warning score) system, for use to help prevent or predict evolving patient compromise, disease state, or distress including over sedation).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Meger, McCallie, and Joseph to further include a method and devices for adjusting non-invasive ventilation therapy based on impedance measurements of the patient, where a computing device provides an assessment of minute ventilation, tidal volume, and respiratory rate of the patient based on the analyzed bioelectrical impedance signal as disclosed by Freeman.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Meger, McCallie, and Joseph in this way by allowing the MV, TV, and/or RR to become one of the foundational pieces of a new, improved early warning scoring system upon which a predictive algorithm is based for use to help prevent or predict evolving patient compromise, disease state, or distress (Freeman: paragraph 222).
Claim 28 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger, McCallie, and Joseph fail to explicitly teach the following limitations met by Freeman as cited:
wherein the predefined data elements correspond to items associated with one or both of (a) risk for over sedation and (b) risk for medication induced respiratory depression (paragraph 221 discloses MV (minute ventilation), TV (tidal volume), and/or RR (respiratory rate) become part of an existing early warning scoring system either as a replacement of or in addition to the standard respiratory rate that is currently a part of most EWS (early warning score) system, for use to help prevent or predict evolving patient compromise, disease state, or distress including over sedation).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Meger, McCallie, and Joseph to further include a method and devices for adjusting non-invasive ventilation therapy based on impedance measurements of the patient, where a computing device provides an assessment of minute ventilation, tidal volume, and respiratory rate of the patient based on the analyzed bioelectrical impedance signal as disclosed by Freeman.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Meger, McCallie, and Joseph in this way by allowing the MV, TV, and/or RR to become one of the foundational pieces of a new, improved early warning scoring system upon which a predictive algorithm is based for use to help prevent or predict evolving patient compromise, disease state, or distress (Freeman: paragraph 222).
Claim(s) 6 – 7 and 12 – 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meger et al., herein after Meger (U.S. Publication Number 2024/0008751 A1) in view of McCallie, Jr. et al., herein after McCallie (U.S. Patent Number 8,239,216 B2) further in view of Joseph et al., herein after Joseph (U.S. Publication Number 2020/0352456 A1) further in view of Taube (U.S. Publication Number 2008/0183057 A1).
Claim 6 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger, McCallie, and Joseph fail to explicitly teach the following limitations met by Taube as cited:
wherein the instruction specifies a medical order for administration of pulse oxygen every n of hours and monitoring of vital signs for the patient (paragraph 2 discloses an oxygen control system for providing supplemental oxygen therapy to patients recovering from respiratory distress, and in particular, an adaptive oxygen control system that utilizes SpO2 feedback from a pulse oximeter to derive the fraction of inspired oxygen delivered to a patient; paragraph 17 discloses a moving histogram display of essential parameters that include SpO2, pulse rate, and calculated FiO2, where these parameters are displayed using 5 minute, one hour, eight hour, or 24 hour increments).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Meger, McCallie, and Joseph to further include an oxygen control system for providing oxygen therapy to patients recovering from respiratory distress, in particular, an adaptive oxygen control system that utilizes SpO2 feedback from a pulse oximeter to derive the fraction of inspired oxygen delivered to a patient as disclosed by Taube.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Meger, McCallie, and Joseph in this way by providing a method of diagnostic and/or therapeutic care for long-term oxygen therapy, sleep apnea, oxygen/helium mixture, continuous positive airway pressure, and supplemental oxygen weaning applications (Taube: paragraph 19).
Claim 7 (Previously Presented). Meger, McCallie, and Joseph teach the computer-implemented method of claim 1.
Meger, McCallie, and Joseph fail to explicitly teach the following limitations met by Taube as cited:
wherein the instruction specifies a medical order for administration of continuous pulse oxygen for the patient (paragraph 2 discloses an oxygen control system for providing supplemental oxygen therapy to patients recovering from respiratory distress, and in particular, an adaptive oxygen control system that utilizes SpO2 feedback from a pulse oximeter to derive the fraction of inspired oxygen delivered to a patient; paragraph 17 discloses a moving histogram display of essential parameters that include SpO2, pulse rate, and calculated FiO2, where these parameters are displayed using 5 minute, one hour, eight hour, or 24 hour increments).
The motivation to combine the teachings of Meger, McCallie, Joseph, and Taube is discussed in the rejection of claim 6 and incorporated herein.
Claim 12 (Previously Presented). Meger, McCallie, and Joseph teach the one or more non-transitory media (paragraph 86 discloses EEPROM) of claim 9.
Meger, McCallie, and Joseph fail to explicitly teach the following limitations met by Taube as cited:
wherein when the representative value meets the threshold, the information item includes a particular recommended low-risk intervention corresponding to a medical order for administration of pulse oxygen every n of hours and monitoring of vital signs for the patient (paragraph 2 discloses an oxygen control system for providing supplemental oxygen therapy to patients recovering from respiratory distress, and in particular, an adaptive oxygen control system that utilizes SpO2 feedback from a pulse oximeter to derive the fraction of inspired oxygen delivered to a patient; paragraph 17 discloses a moving histogram display of essential parameters that include SpO2, pulse rate, and calculated FiO2, where these parameters are displayed using 5 minute, one hour, eight hour, or 24 hour increments).
The motivation to combine the teachings of Meger, McCallie, Joseph, and Taube is discussed in the rejection of claim 6 and incorporated herein.
Claim 13 (Previously Presented). Meger, McCallie, and Joseph teach the one or more non-transitory media (paragraph 86 discloses EEPROM) of claim 9.
Meger, McCallie, and Joseph fail to explicitly teach the following limitations met by Taube as cited:
wherein when the representative value meets a second threshold that is greater than the threshold, the information item includes a particular recommended moderate-risk intervention corresponding to a medical order for administration of continuous pulse oxygen for the patient (paragraph 2 discloses an oxygen control system for providing supplemental oxygen therapy to patients recovering from respiratory distress, and in particular, an adaptive oxygen control system that utilizes SpO2 feedback from a pulse oximeter to derive the fraction of inspired oxygen delivered to a patient; paragraph 17 discloses a moving histogram display of essential parameters that include SpO2, pulse rate, and calculated FiO2, where these parameters are displayed using 5 minute, one hour, eight hour, or 24 hour increments).
The motivation to combine the teachings of Meger, McCallie, Joseph, and Taube is discussed in the rejection of claim 6 and incorporated herein.
Response to Arguments
Applicant's arguments filed December 4, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Rejections under 35 USC § 101
The Applicant argues the present claims do not fail within the abstract-idea grouping of certain methods of organizing human activity. The Examiner disagrees. Under its broadest reasonable interpretation, the Applicant’s claims are an abstract idea that falls into the grouping of “Certain Methods of Organizing Human Activity” which covers fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people. The Examiner respectfully submits that the PEG (Patent Eligibility Guidelines) of January 2019 recite that “Certain Methods of Organizing Human Activity” include managing personal behavior or relationships or interactions between people, including social activities, teaching, and following rules or instructions. The present claims recite the abstract idea of predicting medication induced respiratory depression. The present claims recite predicting medication induced respiratory depression comprising: monitoring, over a time period and prior to an intervention, a first set of information or a set of trigger events that are associated with data and corresponds to one or both of a clinical record and a clinical workflow; identifying and autonomously in response to the monitoring, a trigger event of the set of trigger events indicative of an admission event, a diagnosis event, a clinical event, or an order event corresponding the admission event, the diagnosis event, or the clinical event and to a patient, performing a set of multiple operations and autonomously in response to the identifying, wherein the performing the set of multiple operations is performed without user intervention and comprise: querying at least one of a record or workflow corresponding to the patient for a presence of one or more of a plurality of predefined data elements to identify at least a subset of predefined data elements, of the plurality of predefined data elements, within at least one of the record or workflow; based on values, assigned to each of the subset of predefined data elements within the at least one of the record or workflow, determining a representative element value of the patient; determining whether the representative element value meets a threshold; and in response to the representative element value being determined to meet the threshold, generating an information item, wherein the information item includes the representative element value and an instruction that corresponds to the intervention and is based on the total representative value. These features describe interactions with people by providing notice information and instructions based on the total element result to a user or clinician (see paragraph 5 of the published specification), thus “Certain Methods of Organizing Human Activity”. Thus, if a claim limitation, under its broadest reasonable interpretation, covers interactions with people, but for the recitation of generic components, then it is still in the “Certain Methods of Organizing Human Activity” grouping.
The Applicant argues claim 1 integrates the judicial exception into a practical application including hardware electronic microprocessors creating unique data elements, generating notice information from analyzing the uniquely created information, and transmitting the notice information to an electronic interface. The Examiner respectfully disagrees. The additional elements of the present claims fail to integrate the exception into a practical application of the exception. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
The Applicant argues claim 1 recites significantly more than the judicial exception. The Examiner respectfully disagrees. The Applicant’s specification states
“Beginning with FIG. 1, a computing environment 100 that is suitable for use in implementing aspects of the present invention is depicted. The computing environment 100 is merely an example of one suitable computing environment and is not intended to suggest any limitation as to the scope of use or functionality of the invention. Neither should the computing environment 100 be interpreted as having any dependency or requirement relating to any single component or combination of components illustrated therein. Generally, in aspects, the computing environment 100 is a medical-information computing-system environment. However, this is just one example and the computing environment 100 can be operational with other types, other kinds, or other-purpose computing system environments or configurations. Examples of computing systems, environments, and/or configurations that might be suitable for use with the present invention include personal computers, server computers, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, set top boxes, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments that include any of the above-mentioned systems or devices, and the like.” (paragraph 23 of the published specification). The generic computer cited by the Applicant is a general link to execute the abstract idea. The processors, as used in the recited claims, is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
Rejections under 35 USC § 103
The Applicant argues Meger fails to disclose monitoring for a trigger event as recited in claim 1. The Examiner respectfully disagrees. The Examiner submits Meger discloses breathing pattern analysis module and heartbeat pattern analysis module are configured to analyze the respective patterns in order to (a) predict an approaching clinical episode, such as an asthma attack, heart condition-related lung fluid buildup, sepsis, cardiac arrest, or respiratory depression, and/or (b) monitor the severity and progression of a clinical episode as it occurs and that when treating a hospitalized patient in a general care ward, for example, an earlier identification of patient deterioration may prevent the need to admit the patient to the ICU, shorten his length of stay, and increase the likelihood for successful recovery to discharge (paragraph 87), where discharge is cited as a trigger event in the present claims. In addition, the control unit is configured to periodically receive the data indicative of the given physiological parameter of the patient (e.g. monitoring) by receiving the data at time intervals of between 0.5 hours and 12 hours (paragraph 40). Meger also discloses where the system may utilize data available in electronic medical record systems in order to identify if following an alert by the system, a medical intervention or further diagnostics was performed (paragraph 216) which indicates monitoring of the electronic medical record (in order to determine if a medical intervention or further diagnostics was performed). Thus, Applicant’s argument is not persuasive and the rejection is maintained.
The Applicant argues the combination of the cited references (Meger, McCallie, Joseph, Jolley, and Taube) fail to disclose or suggest the specific combination of elements in claim 1. In response to applicant's argument that there is no suggestion to combine the references, the examiner recognizes that obviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). In this case, it has been clearly set forth above in the 35 U.S.C. 103(a) rejections of the claims that there is motivation for combining the references and therefore the Office takes the position that a prima facie case of obviousness has been made.
Conclusion
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KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682