DETAILED ACTION
Response to Amendment
This action is in response to the amendment filed on August 15, 2025. Claims 1, 7, 13, 19, 25, 31, and 37-39 have been amended. Claim 40 has been added. Claims 1-40 have been examined and are currently 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 .
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Information Disclosure Statement
The Information Disclosure Statement filed on September 30, 2025 has been considered. An initialed copy of the Form 1449 is enclosed herewith.
Claim Objections
Claims 1, 7, 13, 19, 25, 31, and 37-39 are objected to because of the following informalities: The independent claims lack antecedent basis with respect to “the patient”. Appropriate correction is required.
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) 1-36 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Allred et al. US Publication 20210210185 A1 in view of Humphrys et al. US Publication 20190088353 A1 further in view of Chu et al. US Publication 20160026773 A1.
Claim 1:
As per claim 1, Allred teaches a non-transitory computer readable medium comprising:
obtaining, from the patient terminal, dispensing information associated with the electronic prescription information registered in the healthcare worker terminal, the dispensing information including a type of medicine, a timing at which the medicine should be taken, and a dose of the medicine (paragraph 0040 “In some embodiments, the system 105 is configured to receive and transmit prescription data 205 related to a medical prescription for a patient, which may comprise a variety of information. For example, the medical prescription may specify a medication being prescribed. The medical prescription may further indicate a dosage form of the medication, including but not limited to a particular strength of the medication, a preparation type (e.g., tablet, capsule, syrup, solution, cream, ointment, drops, suppository, and the like), and an indication of acceptability of generic substitutes. In some embodiments, the medical prescription may include a total amount of the medication, a dose, a number of administrations, a frequency of administration, a route of administration (e.g., oral, buccal, intravenous, intramuscular, intranasal, subcutaneous, topical, inhalation, rectal, and the like), and a number of refills. In some embodiments, the medical prescription may further include additional instructions regarding administration. For example, the prescriber may specify how to take the medication, such as taking with food or taking upon rising. In a further example, the prescriber may specify criteria for taking the medication, such as in response to one or more symptoms. In additional embodiments, the medical prescription may include patient-identifying information such as a name and/or a date of birth. In still additional embodiments, the medical prescription may include prescriber-identifying information such as a name, an address, a practice name, and/or an ID number (e.g., an NPI number or a DEA number). Additional information not explicitly described herein may be included in the prescription data 205 as is known to one having an ordinary level of skill in the art. In some embodiments, prescription data 205 is received from a prescriber (e.g., a physician) via the prescriber module 110. However, it is contemplated that the prescription data 205 may be acquired, either together or separately, through a variety of sources. For example, in some cases, a pharmacy and/or a patient may receive prescription data 205 directly from a physician and transmit to the system 105 through a pharmacy module 120 and/or a patient module 115.”);
Allred does not teach obtaining, from the patient terminal, medicine taking information on medicine actually taken by the patient. However, Humphrys teaches a Dynamic Medication and Protocol Manager for Home and further teaches, “In step 312, the child inputs the insulin dose actually administered via injection, along with the injection location;… Based on the preceding events, the child's device log for app 7a will be updated at step 317 and the parent's device log for app 6a is updated at step 319.” (paragraph 0050), “The bottommost portion of the display shown in FIG. 18 also shows a diagrammatic patient representation 1240 with the last three insulin injection sites indicated, so as to help the patient rotate injections in accordance with best practice. By selecting the right-arrow located to the right of the diagrammatic patient representation 1240, an enlarged version 1240 L of the patient representation 1240 is brought up, as shown in FIG. 19, via which insulin injection location information for the latest injection can be added by touching the appropriate location on diagram 1240L.” (paragraph 0061), and “With reference to FIGS. 20-23, an embodiment is described in which an insulin pump 1300 is used to administer the insulin. Optionally, the required insulin order may be sent directly to the insulin pump 1300 from the app 7a, as depicted in FIGS. 20-23. As seen in FIG. 20, the diagrammatic patient representation 1240 of FIG. 18 is replaced with a selection button 1250 labeled “Send Insulin Order to Pump”. FIG. 21 shows the display after selection of the button 1250 (where the insulin pump is identified as “OmniPod1”). As this is a therapeutic operation that delivers a drug (insulin) to the patient, the user must perform a confirmation operation as shown in FIG. 21. As shown in FIG. 22, upon confirmation the insulin order is communicated from the device 7 to the insulin pump 1300, and a confirmation message 1260 of the message transmission is displayed on the display of app 7a. FIG. 23 then shows a pop-up message window that is suitably displayed when the insulin pump 1300 sends a message back to the device 7 informing the app 7a that the insulin order has actually been received and executed by the insulin pump 1300.” (paragraph 0063). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include obtaining, from the patient terminal, medicine taking information on medicine actually taken by the patient as taught by Humphrys in order to ensure or validate has taken the prescribed medicine.
Allred and Humphrys do not teach associating the dispensing information and the medicine taking information with each other and creating integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “The monitoring sever 40 is a robust automated system that analyzes and communicates medication conditions, usage, and adherence data that are collected from the containers 20. The monitoring server 40 monitors, records, and quantifies multiple medication adherence data points providing accurate, comprehensive, and actionable information in real time. The monitoring server 40 also calculates medication usage and tracks and quantifies the effectiveness of the adherence communications between the various entities 60 and the patients 11.” (paragraph 0084), “The various patients 11 are enrolled into the system 10 by registering with the monitoring server 40 (e.g., via the browser-based interface or with an administrator 45 (e.g., in a non-electronic fashion)). The registration may include the patient 11 providing basic information (e.g., name, age, date of birth), contact information (e.g., phone number, email address, home address). The registration also includes entry of the medication that will be taken and the applicable dose information (e.g., dose time, dose amount, tablet, capsule or liquid form, mass or volume of medication, quantity).” (paragraph 0085), “One aspect monitored by the system 10 is adherence to medication dose. A dose of medication is defined as the amount of medication to be taken by a patient. The system 10 quantifies adherence to dose by comparing doses taken with doses prescribed. Adherence to a prescribed dose is expressed by a ratio of the actual amount of medication taken compared to the amount of medication prescribed. This ratio quantifies adherence to dose across dose times. Dose time is defined as the prescribed time of day when a dose is to be administered. Dose times can be multiple time periods within a day such as morning, noon, afternoon, evening, bedtime, or breakfast, lunch, dinner. Dose times can also be scheduled as exact times throughout the day. Dose times can also be daily, or per day, or per series of days. Quantifying dose adherence provides healthcare users with a real and actual measure of patient dosing, as well as dose adherence performance and behavior over time. Furthermore, since the system accounts for all doses taken by patients, the system can alert caregivers and patients when too much, or too little medication has been taken.” (paragraph 0088) and “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include associating the dispensing information and the medicine taking information with each other and creating integrated information as taught by Chu in order to analyze data collected or received.
Allred and Humphrys do not teach and causing the healthcare worker terminal or the patient terminal to display the integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “As illustrated in FIG. 18, the user is able to select one of the medications 202 (Sulfasalazine in the embodiment of FIG. 18) to open a medication adherence run chart 203 that outputs and displays dosing behavior. The chart includes a timeline with the one or more dose time windows 205 visually illustrated. FIG. 18 includes four dosing windows 205a (morning), 205b, (noon), 205c (evening), and 205d (bedtime). In one or more embodiments, the dosing windows 205 are displayed in a different color than the other times during the day. The display further indicates when the patient 11 has taken the medication. This provides for a straight-forward manner to visually observer non-compliant doses that were not taken during the proper times. Further, the visual display provides for an entity 60 to observer patterns in the behavior of the patient.” (paragraph 0216), “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217), “In one embodiment, the displayed information may visually indicate a pattern of patient behavior. A doctor or caregiver may be able to note this pattern and change one or more of the time windows 205 such that the patient is more likelihood to become adherent to the dosing times.” (paragraph 0220), and “A variety of different entities 60 may have access to some or all of the information at the monitoring server 40. This may include but is not limited to doctors, hospitals, insurance companies, drug manufacturers, pharmacies, patients, family members, patients, and caregivers. The entities 60 may access this information by accessing the server 49. In one or more embodiments, the monitoring server 40 may be configured for browser-based accessibility. The browser-based interface may support well-known browsers such as Internet Explorer and Mozilla Firefox, Safari, Chrome. Alternatively, or in conjunction with the browser-based interface, the monitoring server 40 may provide access to database 42 to requesting APIs over the PDN 55.” (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include causing the healthcare worker terminal or the patient terminal to display the integrated information as taught by Chu in order to display relevant data associated with a patient’s medicinal intake.
Claim 7:
As per claim 7, Allred teaches an information processing apparatus comprising:
a hardware processor that (paragraph 0037 “As shown, the network 100 comprises a prescription processing system 105 including one or more processors that serves as a central hub for communicating data between one or more external modules.”):
obtains, from the patient terminal, dispensing information associated with the electronic prescription information registered in the healthcare worker terminal, the dispensing information including a type of medicine, a timing at which the medicine should be taken, and a dose of the medicine (paragraph 0040 “In some embodiments, the system 105 is configured to receive and transmit prescription data 205 related to a medical prescription for a patient, which may comprise a variety of information. For example, the medical prescription may specify a medication being prescribed. The medical prescription may further indicate a dosage form of the medication, including but not limited to a particular strength of the medication, a preparation type (e.g., tablet, capsule, syrup, solution, cream, ointment, drops, suppository, and the like), and an indication of acceptability of generic substitutes. In some embodiments, the medical prescription may include a total amount of the medication, a dose, a number of administrations, a frequency of administration, a route of administration (e.g., oral, buccal, intravenous, intramuscular, intranasal, subcutaneous, topical, inhalation, rectal, and the like), and a number of refills. In some embodiments, the medical prescription may further include additional instructions regarding administration. For example, the prescriber may specify how to take the medication, such as taking with food or taking upon rising. In a further example, the prescriber may specify criteria for taking the medication, such as in response to one or more symptoms. In additional embodiments, the medical prescription may include patient-identifying information such as a name and/or a date of birth. In still additional embodiments, the medical prescription may include prescriber-identifying information such as a name, an address, a practice name, and/or an ID number (e.g., an NPI number or a DEA number). Additional information not explicitly described herein may be included in the prescription data 205 as is known to one having an ordinary level of skill in the art. In some embodiments, prescription data 205 is received from a prescriber (e.g., a physician) via the prescriber module 110. However, it is contemplated that the prescription data 205 may be acquired, either together or separately, through a variety of sources. For example, in some cases, a pharmacy and/or a patient may receive prescription data 205 directly from a physician and transmit to the system 105 through a pharmacy module 120 and/or a patient module 115.”),
Allred does not teach obtains, from the patient terminal, medicine taking information on medicine actually taken by the patient. However, Humphrys teaches a Dynamic Medication and Protocol Manager for Home and further teaches, “In step 312, the child inputs the insulin dose actually administered via injection, along with the injection location;… Based on the preceding events, the child's device log for app 7a will be updated at step 317 and the parent's device log for app 6a is updated at step 319.” (paragraph 0050), “The bottommost portion of the display shown in FIG. 18 also shows a diagrammatic patient representation 1240 with the last three insulin injection sites indicated, so as to help the patient rotate injections in accordance with best practice. By selecting the right-arrow located to the right of the diagrammatic patient representation 1240, an enlarged version 1240 L of the patient representation 1240 is brought up, as shown in FIG. 19, via which insulin injection location information for the latest injection can be added by touching the appropriate location on diagram 1240L.” (paragraph 0061), and “With reference to FIGS. 20-23, an embodiment is described in which an insulin pump 1300 is used to administer the insulin. Optionally, the required insulin order may be sent directly to the insulin pump 1300 from the app 7a, as depicted in FIGS. 20-23. As seen in FIG. 20, the diagrammatic patient representation 1240 of FIG. 18 is replaced with a selection button 1250 labeled “Send Insulin Order to Pump”. FIG. 21 shows the display after selection of the button 1250 (where the insulin pump is identified as “OmniPod1”). As this is a therapeutic operation that delivers a drug (insulin) to the patient, the user must perform a confirmation operation as shown in FIG. 21. As shown in FIG. 22, upon confirmation the insulin order is communicated from the device 7 to the insulin pump 1300, and a confirmation message 1260 of the message transmission is displayed on the display of app 7a. FIG. 23 then shows a pop-up message window that is suitably displayed when the insulin pump 1300 sends a message back to the device 7 informing the app 7a that the insulin order has actually been received and executed by the insulin pump 1300.” (paragraph 0063). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include obtaining, from the patient terminal, medicine taking information on medicine actually taken by the patient as taught by Humphrys in order to ensure or validate has taken the prescribed medicine.
Allred and Humphrys do not teach associates the dispensing information and the medicine taking information with each other and creates integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “The monitoring sever 40 is a robust automated system that analyzes and communicates medication conditions, usage, and adherence data that are collected from the containers 20. The monitoring server 40 monitors, records, and quantifies multiple medication adherence data points providing accurate, comprehensive, and actionable information in real time. The monitoring server 40 also calculates medication usage and tracks and quantifies the effectiveness of the adherence communications between the various entities 60 and the patients 11.” (paragraph 0084), “The various patients 11 are enrolled into the system 10 by registering with the monitoring server 40 (e.g., via the browser-based interface or with an administrator 45 (e.g., in a non-electronic fashion)). The registration may include the patient 11 providing basic information (e.g., name, age, date of birth), contact information (e.g., phone number, email address, home address). The registration also includes entry of the medication that will be taken and the applicable dose information (e.g., dose time, dose amount, tablet, capsule or liquid form, mass or volume of medication, quantity).” (paragraph 0085), “One aspect monitored by the system 10 is adherence to medication dose. A dose of medication is defined as the amount of medication to be taken by a patient. The system 10 quantifies adherence to dose by comparing doses taken with doses prescribed. Adherence to a prescribed dose is expressed by a ratio of the actual amount of medication taken compared to the amount of medication prescribed. This ratio quantifies adherence to dose across dose times. Dose time is defined as the prescribed time of day when a dose is to be administered. Dose times can be multiple time periods within a day such as morning, noon, afternoon, evening, bedtime, or breakfast, lunch, dinner. Dose times can also be scheduled as exact times throughout the day. Dose times can also be daily, or per day, or per series of days. Quantifying dose adherence provides healthcare users with a real and actual measure of patient dosing, as well as dose adherence performance and behavior over time. Furthermore, since the system accounts for all doses taken by patients, the system can alert caregivers and patients when too much, or too little medication has been taken.” (paragraph 0088) and “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include associating the dispensing information and the medicine taking information with each other and creating integrated information as taught by Chu in order to analyze data collected or received.
Allred and Humphrys do not teach and causes to the healthcare worker terminal or the patient terminal to display the integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “As illustrated in FIG. 18, the user is able to select one of the medications 202 (Sulfasalazine in the embodiment of FIG. 18) to open a medication adherence run chart 203 that outputs and displays dosing behavior. The chart includes a timeline with the one or more dose time windows 205 visually illustrated. FIG. 18 includes four dosing windows 205a (morning), 205b, (noon), 205c (evening), and 205d (bedtime). In one or more embodiments, the dosing windows 205 are displayed in a different color than the other times during the day. The display further indicates when the patient 11 has taken the medication. This provides for a straight-forward manner to visually observer non-compliant doses that were not taken during the proper times. Further, the visual display provides for an entity 60 to observer patterns in the behavior of the patient.” (paragraph 0216), “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217), “In one embodiment, the displayed information may visually indicate a pattern of patient behavior. A doctor or caregiver may be able to note this pattern and change one or more of the time windows 205 such that the patient is more likelihood to become adherent to the dosing times.” (paragraph 0220), and “A variety of different entities 60 may have access to some or all of the information at the monitoring server 40. This may include but is not limited to doctors, hospitals, insurance companies, drug manufacturers, pharmacies, patients, family members, patients, and caregivers. The entities 60 may access this information by accessing the server 49. In one or more embodiments, the monitoring server 40 may be configured for browser-based accessibility. The browser-based interface may support well-known browsers such as Internet Explorer and Mozilla Firefox, Safari, Chrome. Alternatively, or in conjunction with the browser-based interface, the monitoring server 40 may provide access to database 42 to requesting APIs over the PDN 55.” (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include causing the healthcare worker terminal or the patient terminal to display the integrated information as taught by Chu in order to to display relevant data associated with a patient’s medicinal intake.
Claims 13 and 25:
As per claim 13 and 25, Allred teaches a non-transitory computer readable medium comprising:
obtaining, from the electronic prescription server, dispensing information associated with the electronic prescription information registered in the healthcare worker terminal, the dispensing information including a type of medicine, a timing at which the medicine should be taken, and a dose of the medicine (paragraph 0040 “In some embodiments, the system 105 is configured to receive and transmit prescription data 205 related to a medical prescription for a patient, which may comprise a variety of information. For example, the medical prescription may specify a medication being prescribed. The medical prescription may further indicate a dosage form of the medication, including but not limited to a particular strength of the medication, a preparation type (e.g., tablet, capsule, syrup, solution, cream, ointment, drops, suppository, and the like), and an indication of acceptability of generic substitutes. In some embodiments, the medical prescription may include a total amount of the medication, a dose, a number of administrations, a frequency of administration, a route of administration (e.g., oral, buccal, intravenous, intramuscular, intranasal, subcutaneous, topical, inhalation, rectal, and the like), and a number of refills. In some embodiments, the medical prescription may further include additional instructions regarding administration. For example, the prescriber may specify how to take the medication, such as taking with food or taking upon rising. In a further example, the prescriber may specify criteria for taking the medication, such as in response to one or more symptoms. In additional embodiments, the medical prescription may include patient-identifying information such as a name and/or a date of birth. In still additional embodiments, the medical prescription may include prescriber-identifying information such as a name, an address, a practice name, and/or an ID number (e.g., an NPI number or a DEA number). Additional information not explicitly described herein may be included in the prescription data 205 as is known to one having an ordinary level of skill in the art. In some embodiments, prescription data 205 is received from a prescriber (e.g., a physician) via the prescriber module 110. However, it is contemplated that the prescription data 205 may be acquired, either together or separately, through a variety of sources. For example, in some cases, a pharmacy and/or a patient may receive prescription data 205 directly from a physician and transmit to the system 105 through a pharmacy module 120 and/or a patient module 115.”);
Allred does not teach obtaining, from the patient terminal, medicine taking information on medicine actually taken by the patient. However, Humphrys teaches a Dynamic Medication and Protocol Manager for Home and further teaches, “In step 312, the child inputs the insulin dose actually administered via injection, along with the injection location;… Based on the preceding events, the child's device log for app 7a will be updated at step 317 and the parent's device log for app 6a is updated at step 319.” (paragraph 0050), “The bottommost portion of the display shown in FIG. 18 also shows a diagrammatic patient representation 1240 with the last three insulin injection sites indicated, so as to help the patient rotate injections in accordance with best practice. By selecting the right-arrow located to the right of the diagrammatic patient representation 1240, an enlarged version 1240 L of the patient representation 1240 is brought up, as shown in FIG. 19, via which insulin injection location information for the latest injection can be added by touching the appropriate location on diagram 1240L.” (paragraph 0061), and “With reference to FIGS. 20-23, an embodiment is described in which an insulin pump 1300 is used to administer the insulin. Optionally, the required insulin order may be sent directly to the insulin pump 1300 from the app 7a, as depicted in FIGS. 20-23. As seen in FIG. 20, the diagrammatic patient representation 1240 of FIG. 18 is replaced with a selection button 1250 labeled “Send Insulin Order to Pump”. FIG. 21 shows the display after selection of the button 1250 (where the insulin pump is identified as “OmniPod1”). As this is a therapeutic operation that delivers a drug (insulin) to the patient, the user must perform a confirmation operation as shown in FIG. 21. As shown in FIG. 22, upon confirmation the insulin order is communicated from the device 7 to the insulin pump 1300, and a confirmation message 1260 of the message transmission is displayed on the display of app 7a. FIG. 23 then shows a pop-up message window that is suitably displayed when the insulin pump 1300 sends a message back to the device 7 informing the app 7a that the insulin order has actually been received and executed by the insulin pump 1300.” (paragraph 0063). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include obtaining, from the patient terminal, medicine taking information on medicine actually taken by the patient as taught by Humphrys in order to ensure or validate has taken the prescribed medicine.
Allred and Humphrys do not teach associating the dispensing information and the medicine taking information with each other and creating integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “The monitoring sever 40 is a robust automated system that analyzes and communicates medication conditions, usage, and adherence data that are collected from the containers 20. The monitoring server 40 monitors, records, and quantifies multiple medication adherence data points providing accurate, comprehensive, and actionable information in real time. The monitoring server 40 also calculates medication usage and tracks and quantifies the effectiveness of the adherence communications between the various entities 60 and the patients 11.” (paragraph 0084), “The various patients 11 are enrolled into the system 10 by registering with the monitoring server 40 (e.g., via the browser-based interface or with an administrator 45 (e.g., in a non-electronic fashion)). The registration may include the patient 11 providing basic information (e.g., name, age, date of birth), contact information (e.g., phone number, email address, home address). The registration also includes entry of the medication that will be taken and the applicable dose information (e.g., dose time, dose amount, tablet, capsule or liquid form, mass or volume of medication, quantity).” (paragraph 0085), “One aspect monitored by the system 10 is adherence to medication dose. A dose of medication is defined as the amount of medication to be taken by a patient. The system 10 quantifies adherence to dose by comparing doses taken with doses prescribed. Adherence to a prescribed dose is expressed by a ratio of the actual amount of medication taken compared to the amount of medication prescribed. This ratio quantifies adherence to dose across dose times. Dose time is defined as the prescribed time of day when a dose is to be administered. Dose times can be multiple time periods within a day such as morning, noon, afternoon, evening, bedtime, or breakfast, lunch, dinner. Dose times can also be scheduled as exact times throughout the day. Dose times can also be daily, or per day, or per series of days. Quantifying dose adherence provides healthcare users with a real and actual measure of patient dosing, as well as dose adherence performance and behavior over time. Furthermore, since the system accounts for all doses taken by patients, the system can alert caregivers and patients when too much, or too little medication has been taken.” (paragraph 0088) and “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include associating the dispensing information and the medicine taking information with each other and creating integrated information as taught by Chu in order to analyze data collected or received.
Allred and Humphrys do not teach and causing the healthcare worker terminal or the patient terminal to display the integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “As illustrated in FIG. 18, the user is able to select one of the medications 202 (Sulfasalazine in the embodiment of FIG. 18) to open a medication adherence run chart 203 that outputs and displays dosing behavior. The chart includes a timeline with the one or more dose time windows 205 visually illustrated. FIG. 18 includes four dosing windows 205a (morning), 205b, (noon), 205c (evening), and 205d (bedtime). In one or more embodiments, the dosing windows 205 are displayed in a different color than the other times during the day. The display further indicates when the patient 11 has taken the medication. This provides for a straight-forward manner to visually observer non-compliant doses that were not taken during the proper times. Further, the visual display provides for an entity 60 to observer patterns in the behavior of the patient.” (paragraph 0216), “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217), “In one embodiment, the displayed information may visually indicate a pattern of patient behavior. A doctor or caregiver may be able to note this pattern and change one or more of the time windows 205 such that the patient is more likelihood to become adherent to the dosing times.” (paragraph 0220), and “A variety of different entities 60 may have access to some or all of the information at the monitoring server 40. This may include but is not limited to doctors, hospitals, insurance companies, drug manufacturers, pharmacies, patients, family members, patients, and caregivers. The entities 60 may access this information by accessing the server 49. In one or more embodiments, the monitoring server 40 may be configured for browser-based accessibility. The browser-based interface may support well-known browsers such as Internet Explorer and Mozilla Firefox, Safari, Chrome. Alternatively, or in conjunction with the browser-based interface, the monitoring server 40 may provide access to database 42 to requesting APIs over the PDN 55.” (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include causing the healthcare worker terminal or the patient terminal to display the integrated information as taught by Chu in order to display relevant data associated with a patient’s medicinal intake.
Claims 19 and 31:
As per claims 19 and 31, Allred teach the information processing apparatus and healthcare worker terminal comprising:
a hardware processor that (paragraph 0037 “As shown, the network 100 comprises a prescription processing system 105 including one or more processors that serves as a central hub for communicating data between one or more external modules.”):
obtains, from the electronic prescription server, dispensing information associated with the electronic prescription information registered in the healthcare worker terminal, the dispensing information including a type of medicine, a timing at which the medicine should be taken, and a dose of the medicine (paragraph 0040 “In some embodiments, the system 105 is configured to receive and transmit prescription data 205 related to a medical prescription for a patient, which may comprise a variety of information. For example, the medical prescription may specify a medication being prescribed. The medical prescription may further indicate a dosage form of the medication, including but not limited to a particular strength of the medication, a preparation type (e.g., tablet, capsule, syrup, solution, cream, ointment, drops, suppository, and the like), and an indication of acceptability of generic substitutes. In some embodiments, the medical prescription may include a total amount of the medication, a dose, a number of administrations, a frequency of administration, a route of administration (e.g., oral, buccal, intravenous, intramuscular, intranasal, subcutaneous, topical, inhalation, rectal, and the like), and a number of refills. In some embodiments, the medical prescription may further include additional instructions regarding administration. For example, the prescriber may specify how to take the medication, such as taking with food or taking upon rising. In a further example, the prescriber may specify criteria for taking the medication, such as in response to one or more symptoms. In additional embodiments, the medical prescription may include patient-identifying information such as a name and/or a date of birth. In still additional embodiments, the medical prescription may include prescriber-identifying information such as a name, an address, a practice name, and/or an ID number (e.g., an NPI number or a DEA number). Additional information not explicitly described herein may be included in the prescription data 205 as is known to one having an ordinary level of skill in the art. In some embodiments, prescription data 205 is received from a prescriber (e.g., a physician) via the prescriber module 110. However, it is contemplated that the prescription data 205 may be acquired, either together or separately, through a variety of sources. For example, in some cases, a pharmacy and/or a patient may receive prescription data 205 directly from a physician and transmit to the system 105 through a pharmacy module 120 and/or a patient module 115.”),
Allred does not teach obtains, from the patient terminal, medicine taking information on medicine actually taken by the patient. However, Humphrys teaches a Dynamic Medication and Protocol Manager for Home and further teaches, “In step 312, the child inputs the insulin dose actually administered via injection, along with the injection location;… Based on the preceding events, the child's device log for app 7a will be updated at step 317 and the parent's device log for app 6a is updated at step 319.” (paragraph 0050), “The bottommost portion of the display shown in FIG. 18 also shows a diagrammatic patient representation 1240 with the last three insulin injection sites indicated, so as to help the patient rotate injections in accordance with best practice. By selecting the right-arrow located to the right of the diagrammatic patient representation 1240, an enlarged version 1240 L of the patient representation 1240 is brought up, as shown in FIG. 19, via which insulin injection location information for the latest injection can be added by touching the appropriate location on diagram 1240L.” (paragraph 0061), and “With reference to FIGS. 20-23, an embodiment is described in which an insulin pump 1300 is used to administer the insulin. Optionally, the required insulin order may be sent directly to the insulin pump 1300 from the app 7a, as depicted in FIGS. 20-23. As seen in FIG. 20, the diagrammatic patient representation 1240 of FIG. 18 is replaced with a selection button 1250 labeled “Send Insulin Order to Pump”. FIG. 21 shows the display after selection of the button 1250 (where the insulin pump is identified as “OmniPod1”). As this is a therapeutic operation that delivers a drug (insulin) to the patient, the user must perform a confirmation operation as shown in FIG. 21. As shown in FIG. 22, upon confirmation the insulin order is communicated from the device 7 to the insulin pump 1300, and a confirmation message 1260 of the message transmission is displayed on the display of app 7a. FIG. 23 then shows a pop-up message window that is suitably displayed when the insulin pump 1300 sends a message back to the device 7 informing the app 7a that the insulin order has actually been received and executed by the insulin pump 1300.” (paragraph 0063). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include obtaining, from the patient terminal, medicine taking information on medicine actually taken by the patient as taught by Humphrys in order to ensure or validate has taken the prescribed medicine.
Allred and Humphrys do not teach associates the dispensing information and the medicine taking information with each other and creates integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “The monitoring sever 40 is a robust automated system that analyzes and communicates medication conditions, usage, and adherence data that are collected from the containers 20. The monitoring server 40 monitors, records, and quantifies multiple medication adherence data points providing accurate, comprehensive, and actionable information in real time. The monitoring server 40 also calculates medication usage and tracks and quantifies the effectiveness of the adherence communications between the various entities 60 and the patients 11.” (paragraph 0084), “The various patients 11 are enrolled into the system 10 by registering with the monitoring server 40 (e.g., via the browser-based interface or with an administrator 45 (e.g., in a non-electronic fashion)). The registration may include the patient 11 providing basic information (e.g., name, age, date of birth), contact information (e.g., phone number, email address, home address). The registration also includes entry of the medication that will be taken and the applicable dose information (e.g., dose time, dose amount, tablet, capsule or liquid form, mass or volume of medication, quantity).” (paragraph 0085), “One aspect monitored by the system 10 is adherence to medication dose. A dose of medication is defined as the amount of medication to be taken by a patient. The system 10 quantifies adherence to dose by comparing doses taken with doses prescribed. Adherence to a prescribed dose is expressed by a ratio of the actual amount of medication taken compared to the amount of medication prescribed. This ratio quantifies adherence to dose across dose times. Dose time is defined as the prescribed time of day when a dose is to be administered. Dose times can be multiple time periods within a day such as morning, noon, afternoon, evening, bedtime, or breakfast, lunch, dinner. Dose times can also be scheduled as exact times throughout the day. Dose times can also be daily, or per day, or per series of days. Quantifying dose adherence provides healthcare users with a real and actual measure of patient dosing, as well as dose adherence performance and behavior over time. Furthermore, since the system accounts for all doses taken by patients, the system can alert caregivers and patients when too much, or too little medication has been taken.” (paragraph 0088) and “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include associating the dispensing information and the medicine taking information with each other and creating integrated information as taught by Chu in order to analyze data collected or received.
Allred and Humphrys do not teach and causes the healthcare worker terminal or the patient terminal to display the integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “As illustrated in FIG. 18, the user is able to select one of the medications 202 (Sulfasalazine in the embodiment of FIG. 18) to open a medication adherence run chart 203 that outputs and displays dosing behavior. The chart includes a timeline with the one or more dose time windows 205 visually illustrated. FIG. 18 includes four dosing windows 205a (morning), 205b, (noon), 205c (evening), and 205d (bedtime). In one or more embodiments, the dosing windows 205 are displayed in a different color than the other times during the day. The display further indicates when the patient 11 has taken the medication. This provides for a straight-forward manner to visually observer non-compliant doses that were not taken during the proper times. Further, the visual display provides for an entity 60 to observer patterns in the behavior of the patient.” (paragraph 0216), “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217), “In one embodiment, the displayed information may visually indicate a pattern of patient behavior. A doctor or caregiver may be able to note this pattern and change one or more of the time windows 205 such that the patient is more likelihood to become adherent to the dosing times.” (paragraph 0220), and “A variety of different entities 60 may have access to some or all of the information at the monitoring server 40. This may include but is not limited to doctors, hospitals, insurance companies, drug manufacturers, pharmacies, patients, family members, patients, and caregivers. The entities 60 may access this information by accessing the server 49. In one or more embodiments, the monitoring server 40 may be configured for browser-based accessibility. The browser-based interface may support well-known browsers such as Internet Explorer and Mozilla Firefox, Safari, Chrome. Alternatively, or in conjunction with the browser-based interface, the monitoring server 40 may provide access to database 42 to requesting APIs over the PDN 55.” (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include causing the healthcare worker terminal or the patient terminal to display the integrated information to display as taught by Chu in order to relevant data associated with a patient’s medicinal intake.
Claims 2, 8, 14, 20, 26, and 32:
As per claims 2, 8, 14, 20, 26, and 32, Allred, Humphrys, and Chu teach the record medium, information processing apparatus, healthcare worker terminal of claims 1, 7, 13, 19, 25, and 31 as described above and Humphrys further teaches wherein the instructions cause the computer to execute:
obtaining vital information from the patient terminal (paragraph 0059). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include obtaining vital information from the patient terminal as taught by Humphrys in order to determine a patient’s current health readings.
and the integrated information includes the vital information (paragraph 0066). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include the integrated information includes the vital information as taught by Humphrys in order to provide general information about a patient’s health.
Claims 3, 9, 15, 21, 27, and 33:
As per claims 3, 9, 15, 21, 27, and 33, Allred, Humphrys, and Chu teach the recording medium, information processing apparatus, healthcare worker terminal of claims 1, 7, 13, 19, 25, and 31 as described above and Chu further teaches, wherein the instructions cause the computer to execute:
generating statistical information based on the integrated information (paragraph 0085). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include generating statistical information based on the integrated information as taught by Chu in order to analyze the received information from the patient.
and outputting the statistical information (paragraphs 0216-0217 and Figures 7-14). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include outputting the statistical information as taught by Chu in order to display the analyzed information to the medical professionals or the patient.
Claims 4 and 10:
As per claims 4 and 10, Allred, Humphrys, and Chu teach the recording medium, information processing apparatus of claims 1 and 7 as described above and Allred further teaches
wherein the healthcare worker terminal includes a first healthcare worker terminal and a second healthcare worker terminal (paragraphs 0037 and 0040);
and the instructions cause the computer to execute: obtaining, from the second healthcare worker terminal via the patient terminal, the dispensing information associated with the electronic prescription information (paragraph 0040);
Chu further teaches outputting the integrated information to the first healthcare worker terminal (paragraphs 0217 and 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include outputting the integrated information to the first healthcare worker terminal as taught by Chu in order to display relevant patient information.
Claims 5 and 11:
As per claims 5 and 11, Allred, Humphrys, and Chu teach the record medium, information processing apparatus of claims 4 and 10 as described above and Allred further teaches wherein the instructions cause the computer to execute:
obtaining, from the first healthcare worker terminal, the dispensing information associated with the electronic prescription information (paragraphs 0037 and 0040);
obtaining, from the second healthcare worker terminal via the patient terminal, the dispensing information associated with the electronic prescription information (paragraph 0040);
Chu further teaches and outputting the integrated information to the first healthcare worker terminal (paragraphs 0217 and 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include outputting the integrated information to the first healthcare worker terminal as taught by Chu in order to display relevant patient information.
Claims 6 and 12:
As per claims 6 and 12, Allred, Humphrys, and Chu teach the recording medium, information processing apparatus of claims 4 and 10 as described above and Chu further teaches wherein the first healthcare worker terminal is a terminal used by a first medical facility (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include wherein the first healthcare worker terminal is a terminal used by a first medical facility as taught by Chu in order to allow different medical facilities to have access to patient information.
and the second healthcare worker terminal is a terminal used by a second medical facility (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include the second healthcare worker terminal is a terminal used by a second medical facility as taught by Chu in order to allow different medical facilities to have access to patient information.
Claims 16, 22, 28, and 34:
As per claims 16, 22, 28, and 34, Allred, Humphrys, and Chu teach the recording medium, information processing apparatus, healthcare worker terminal of claims 13, 19, 25, and 31 as described above and Allred further teaches wherein the healthcare worker terminal includes a first healthcare worker terminal and a second healthcare worker terminal (paragraphs 0037 and 0040)
and the instructions cause the computer to execute: obtaining, from the second healthcare worker terminal via the electronic prescription server, the dispensing information associated with the electronic prescription information (paragraph 0040);
Chu further teaches and outputting the integrated information to the first healthcare worker terminal (paragraphs 0217 and 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include outputting the integrated information to the first healthcare worker terminal as taught by Chu in order to display relevant patient information.
Claims 17, 23, 29, and 35:
As per claims 17, 23, 29, and 35, Allred, Humphrys, and Chu teach the recording medium, information processing apparatus, healthcare worker terminal of claims 16, 22, 28, and 34 as described above and Allred further teaches wherein the instructions cause the computer to execute:
obtaining, from the first healthcare worker terminal, the dispensing information associated with the electronic prescription information (paragraphs 0037 and 0040);
obtaining, from the second healthcare worker terminal via the electronic prescription server, the dispensing information associated with the electronic prescription information ((paragraph 0040);
Chu further teaches and outputting the integrated information to the first healthcare worker terminal (paragraphs 0217 and 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include outputting the integrated information to the first healthcare worker terminal as taught by Chu in order to display relevant patient information.
Claims 18, 24, 30, and 36:
As per claims 18, 24, 30, and 36, Allred, Humphrys, and Chu teach the recording medium, information processing apparatus, healthcare worker terminal of claims 16, 22, 28, and 34 as described above and Chu further teaches wherein the first healthcare worker terminal is a terminal used by a first medical facility (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include wherein the first healthcare worker terminal is a terminal used by a first medical facility as taught by Chu in order to allow different medical facilities to have access to patient information.
and the second healthcare worker terminal is a terminal used by a second medical facility (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include the second healthcare worker terminal is a terminal used by a second medical facility as taught by Chu in order to allow different medical facilities to have access to patient information.
Claim 40:
As per claim 40, Allred, Humphrys, and Chu teach the recording medium of claim 1 as described above and Chu further teaches wherein the instructions cause the computer to further execute:
based on the dispensing information, delivering to the patient terminal an alarm informing a patient of the timing at which the medicine should be taken (paragraphs 0186 and 0189-0190). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include based on the dispensing information, delivering to the patient terminal an alarm informing a patient of the timing at which the medicine should be taken as taught by Chu in order to assist the patient taking their medicine in a timely manner.
Claim(s) 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Allred et al. US Publication 20210210185 A1 in view of Simmons et al. US Publication 20130238119 A1 in view of Humphrys et al. US Publication 20190088353 A1 further in view of Chu et al. US Publication 20160026773 A1.
Claim 37:
As per claim 37, Allred teaches an information processing system comprising:
and a hardware processor that (paragraph 0037 “As shown, the network 100 comprises a prescription processing system 105 including one or more processors that serves as a central hub for communicating data between one or more external modules.”):
obtains, from the patient terminal, the dispensing information associated with the electronic prescription information registered in the healthcare worker terminal, the dispensing information including a type of medicine, a timing at which the medicine should be taken, and a dose of the medicine (paragraph 0040 “In some embodiments, the system 105 is configured to receive and transmit prescription data 205 related to a medical prescription for a patient, which may comprise a variety of information. For example, the medical prescription may specify a medication being prescribed. The medical prescription may further indicate a dosage form of the medication, including but not limited to a particular strength of the medication, a preparation type (e.g., tablet, capsule, syrup, solution, cream, ointment, drops, suppository, and the like), and an indication of acceptability of generic substitutes. In some embodiments, the medical prescription may include a total amount of the medication, a dose, a number of administrations, a frequency of administration, a route of administration (e.g., oral, buccal, intravenous, intramuscular, intranasal, subcutaneous, topical, inhalation, rectal, and the like), and a number of refills. In some embodiments, the medical prescription may further include additional instructions regarding administration. For example, the prescriber may specify how to take the medication, such as taking with food or taking upon rising. In a further example, the prescriber may specify criteria for taking the medication, such as in response to one or more symptoms. In additional embodiments, the medical prescription may include patient-identifying information such as a name and/or a date of birth. In still additional embodiments, the medical prescription may include prescriber-identifying information such as a name, an address, a practice name, and/or an ID number (e.g., an NPI number or a DEA number). Additional information not explicitly described herein may be included in the prescription data 205 as is known to one having an ordinary level of skill in the art. In some embodiments, prescription data 205 is received from a prescriber (e.g., a physician) via the prescriber module 110. However, it is contemplated that the prescription data 205 may be acquired, either together or separately, through a variety of sources. For example, in some cases, a pharmacy and/or a patient may receive prescription data 205 directly from a physician and transmit to the system 105 through a pharmacy module 120 and/or a patient module 115.”),
Allred does not teach an information processing apparatus that processes information obtained from a patient terminal connectable to a healthcare worker terminal and to an electronic prescription server that stores electronic prescription information. However, Simmons teaches an Apparatus, System, and Method for Accurate Dispensing of Prescription Medications and further teaches, “The remote sever 404 may include a memory to store the software or other machine-readable instructions and data. The memory may include volatile and/or non-volatile memory. Additionally, the remote server 404 may also include a communications system to communicate via a wireline and/or wireless communications, such as through the Internet, an intranet, an Ethernet network, a wireline network, a wireless network, a mobile communications network, and/or another communication network, such as communications network 406. The remote server 404 may include a database and/or data store 408 containing Patient Information corresponding to a plurality of patients, their prescribed medications, their health care providers, and the like. In one embodiment, the dispensing apparatus 10 may communicate with the remote server 404 and may, for example, query the database 408 for updated information regarding potential undesirable interactions with other prescribed medications--including medication prescribed after the patient first received a prescription for the stored medication--or side effects, perhaps taking into account more current information regarding a patients medical condition. In another embodiment, the dispensing apparatus 10 may communicate with the remote server 404 to store information regarding a user's dispensing of the prescribed medication. For example, in one embodiment, the remote server 404 and/or the database 408 may include EHRs for one or more patients. Each EHR may contain various types of patient identifiers (medical and otherwise), insurance carriers, health parameters, health history, existing allergies, attending physicians, past and present prescribed medications, dosages, dispensing schedules and medication compliance history; these EHR formats may be layered fields menu driven for efficient data access and sorting.” (paragraph 0034) and “The information, such as Patient Information, stored at the remote server 404, may be made accessible to the user's health care provider, insurance provider, pharmacy, clinic, hospital, and/or any other individual or entity with authorized access to such data or to data on a class of patients taking certain medications, whether by allowing the health care provider and/or others referenced above to access the database 408 or by transmitting the data to a processing device, such as user device(s) 410, which may be a personal computer, work station, server, mobile device, mobile phone, tablet device, processor, and/or other processing device operated by or on behalf of the provider of such parties.” (paragraph 0035). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include an information processing apparatus that processes information obtained from a patient terminal connectable to a healthcare worker terminal and to an electronic prescription server that stores electronic prescription information as taught by Simmons in order for the exchange and storage of information.
Allred and Simmons do not teach obtains, from the patient terminal, medicine taking information on medicine actually taken by the patient. However, Humphrys teaches a Dynamic Medication and Protocol Manager for Home and further teaches, “In step 312, the child inputs the insulin dose actually administered via injection, along with the injection location;… Based on the preceding events, the child's device log for app 7a will be updated at step 317 and the parent's device log for app 6a is updated at step 319.” (paragraph 0050), “The bottommost portion of the display shown in FIG. 18 also shows a diagrammatic patient representation 1240 with the last three insulin injection sites indicated, so as to help the patient rotate injections in accordance with best practice. By selecting the right-arrow located to the right of the diagrammatic patient representation 1240, an enlarged version 1240 L of the patient representation 1240 is brought up, as shown in FIG. 19, via which insulin injection location information for the latest injection can be added by touching the appropriate location on diagram 1240L.” (paragraph 0061), and “With reference to FIGS. 20-23, an embodiment is described in which an insulin pump 1300 is used to administer the insulin. Optionally, the required insulin order may be sent directly to the insulin pump 1300 from the app 7a, as depicted in FIGS. 20-23. As seen in FIG. 20, the diagrammatic patient representation 1240 of FIG. 18 is replaced with a selection button 1250 labeled “Send Insulin Order to Pump”. FIG. 21 shows the display after selection of the button 1250 (where the insulin pump is identified as “OmniPod1”). As this is a therapeutic operation that delivers a drug (insulin) to the patient, the user must perform a confirmation operation as shown in FIG. 21. As shown in FIG. 22, upon confirmation the insulin order is communicated from the device 7 to the insulin pump 1300, and a confirmation message 1260 of the message transmission is displayed on the display of app 7a. FIG. 23 then shows a pop-up message window that is suitably displayed when the insulin pump 1300 sends a message back to the device 7 informing the app 7a that the insulin order has actually been received and executed by the insulin pump 1300.” (paragraph 0063). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include obtaining, from the patient terminal, medicine taking information on medicine actually taken by the patient as taught by Humphrys in order to ensure or validate has taken the prescribed medicine.
Allred, Simmons, and Humphrys do not teach associates the dispensing information and the medicine taking information with each other and creates integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “The monitoring sever 40 is a robust automated system that analyzes and communicates medication conditions, usage, and adherence data that are collected from the containers 20. The monitoring server 40 monitors, records, and quantifies multiple medication adherence data points providing accurate, comprehensive, and actionable information in real time. The monitoring server 40 also calculates medication usage and tracks and quantifies the effectiveness of the adherence communications between the various entities 60 and the patients 11.” (paragraph 0084), “The various patients 11 are enrolled into the system 10 by registering with the monitoring server 40 (e.g., via the browser-based interface or with an administrator 45 (e.g., in a non-electronic fashion)). The registration may include the patient 11 providing basic information (e.g., name, age, date of birth), contact information (e.g., phone number, email address, home address). The registration also includes entry of the medication that will be taken and the applicable dose information (e.g., dose time, dose amount, tablet, capsule or liquid form, mass or volume of medication, quantity).” (paragraph 0085), “One aspect monitored by the system 10 is adherence to medication dose. A dose of medication is defined as the amount of medication to be taken by a patient. The system 10 quantifies adherence to dose by comparing doses taken with doses prescribed. Adherence to a prescribed dose is expressed by a ratio of the actual amount of medication taken compared to the amount of medication prescribed. This ratio quantifies adherence to dose across dose times. Dose time is defined as the prescribed time of day when a dose is to be administered. Dose times can be multiple time periods within a day such as morning, noon, afternoon, evening, bedtime, or breakfast, lunch, dinner. Dose times can also be scheduled as exact times throughout the day. Dose times can also be daily, or per day, or per series of days. Quantifying dose adherence provides healthcare users with a real and actual measure of patient dosing, as well as dose adherence performance and behavior over time. Furthermore, since the system accounts for all doses taken by patients, the system can alert caregivers and patients when too much, or too little medication has been taken.” (paragraph 0088) and “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include associating the dispensing information and the medicine taking information with each other and creating integrated information as taught by Chu in order to analyze data collected or received.
Allred, Simmons, and Humphrys do not teach and causes the healthcare worker terminal or the patient terminal to display the integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “As illustrated in FIG. 18, the user is able to select one of the medications 202 (Sulfasalazine in the embodiment of FIG. 18) to open a medication adherence run chart 203 that outputs and displays dosing behavior. The chart includes a timeline with the one or more dose time windows 205 visually illustrated. FIG. 18 includes four dosing windows 205a (morning), 205b, (noon), 205c (evening), and 205d (bedtime). In one or more embodiments, the dosing windows 205 are displayed in a different color than the other times during the day. The display further indicates when the patient 11 has taken the medication. This provides for a straight-forward manner to visually observer non-compliant doses that were not taken during the proper times. Further, the visual display provides for an entity 60 to observer patterns in the behavior of the patient.” (paragraph 0216), “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217), “In one embodiment, the displayed information may visually indicate a pattern of patient behavior. A doctor or caregiver may be able to note this pattern and change one or more of the time windows 205 such that the patient is more likelihood to become adherent to the dosing times.” (paragraph 0220), and “A variety of different entities 60 may have access to some or all of the information at the monitoring server 40. This may include but is not limited to doctors, hospitals, insurance companies, drug manufacturers, pharmacies, patients, family members, patients, and caregivers. The entities 60 may access this information by accessing the server 49. In one or more embodiments, the monitoring server 40 may be configured for browser-based accessibility. The browser-based interface may support well-known browsers such as Internet Explorer and Mozilla Firefox, Safari, Chrome. Alternatively, or in conjunction with the browser-based interface, the monitoring server 40 may provide access to database 42 to requesting APIs over the PDN 55.” (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include causing the healthcare worker terminal or the patient terminal to display the integrated information as taught by Chu in order to display relevant data associated with a patient’s medicinal intake.
Claim 38:
As per claim 38, Allred teaches an information processing apparatus comprising:
and a hardware processor that (paragraph 0037 “As shown, the network 100 comprises a prescription processing system 105 including one or more processors that serves as a central hub for communicating data between one or more external modules.”):
obtains, from the electronic prescription server, dispensing information associated with the electronic prescription information registered in the healthcare worker terminal, the dispensing information including a type of medicine, a timing at which the medicine should be taken, and a dose of the medicine (paragraph 0040 “In some embodiments, the system 105 is configured to receive and transmit prescription data 205 related to a medical prescription for a patient, which may comprise a variety of information. For example, the medical prescription may specify a medication being prescribed. The medical prescription may further indicate a dosage form of the medication, including but not limited to a particular strength of the medication, a preparation type (e.g., tablet, capsule, syrup, solution, cream, ointment, drops, suppository, and the like), and an indication of acceptability of generic substitutes. In some embodiments, the medical prescription may include a total amount of the medication, a dose, a number of administrations, a frequency of administration, a route of administration (e.g., oral, buccal, intravenous, intramuscular, intranasal, subcutaneous, topical, inhalation, rectal, and the like), and a number of refills. In some embodiments, the medical prescription may further include additional instructions regarding administration. For example, the prescriber may specify how to take the medication, such as taking with food or taking upon rising. In a further example, the prescriber may specify criteria for taking the medication, such as in response to one or more symptoms. In additional embodiments, the medical prescription may include patient-identifying information such as a name and/or a date of birth. In still additional embodiments, the medical prescription may include prescriber-identifying information such as a name, an address, a practice name, and/or an ID number (e.g., an NPI number or a DEA number). Additional information not explicitly described herein may be included in the prescription data 205 as is known to one having an ordinary level of skill in the art. In some embodiments, prescription data 205 is received from a prescriber (e.g., a physician) via the prescriber module 110. However, it is contemplated that the prescription data 205 may be acquired, either together or separately, through a variety of sources. For example, in some cases, a pharmacy and/or a patient may receive prescription data 205 directly from a physician and transmit to the system 105 through a pharmacy module 120 and/or a patient module 115.”),
Allred does not teach an information processing apparatus that processes obtained information and is connected to a patient terminal, to a healthcare worker terminal, and to an electronic prescription server that stores electronic prescription information. However, Simmons teaches an Apparatus, System, and Method for Accurate Dispensing of Prescription Medications and further teaches, “The remote sever 404 may include a memory to store the software or other machine-readable instructions and data. The memory may include volatile and/or non-volatile memory. Additionally, the remote server 404 may also include a communications system to communicate via a wireline and/or wireless communications, such as through the Internet, an intranet, an Ethernet network, a wireline network, a wireless network, a mobile communications network, and/or another communication network, such as communications network 406. The remote server 404 may include a database and/or data store 408 containing Patient Information corresponding to a plurality of patients, their prescribed medications, their health care providers, and the like. In one embodiment, the dispensing apparatus 10 may communicate with the remote server 404 and may, for example, query the database 408 for updated information regarding potential undesirable interactions with other prescribed medications--including medication prescribed after the patient first received a prescription for the stored medication--or side effects, perhaps taking into account more current information regarding a patients medical condition. In another embodiment, the dispensing apparatus 10 may communicate with the remote server 404 to store information regarding a user's dispensing of the prescribed medication. For example, in one embodiment, the remote server 404 and/or the database 408 may include EHRs for one or more patients. Each EHR may contain various types of patient identifiers (medical and otherwise), insurance carriers, health parameters, health history, existing allergies, attending physicians, past and present prescribed medications, dosages, dispensing schedules and medication compliance history; these EHR formats may be layered fields menu driven for efficient data access and sorting.” (paragraph 0034) and “The information, such as Patient Information, stored at the remote server 404, may be made accessible to the user's health care provider, insurance provider, pharmacy, clinic, hospital, and/or any other individual or entity with authorized access to such data or to data on a class of patients taking certain medications, whether by allowing the health care provider and/or others referenced above to access the database 408 or by transmitting the data to a processing device, such as user device(s) 410, which may be a personal computer, work station, server, mobile device, mobile phone, tablet device, processor, and/or other processing device operated by or on behalf of the provider of such parties.” (paragraph 0035). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include an information processing apparatus that processes obtained information and is connected to a patient terminal, to a healthcare worker terminal, and to an electronic prescription server that stores electronic prescription information as taught by Simmons in order for the exchange and storage of information.
Allred and Simmons do not teach obtains, from the patient terminal, medicine taking information on medicine actually taken by the patient. However, Humphrys teaches a Dynamic Medication and Protocol Manager for Home and further teaches, “In step 312, the child inputs the insulin dose actually administered via injection, along with the injection location;… Based on the preceding events, the child's device log for app 7a will be updated at step 317 and the parent's device log for app 6a is updated at step 319.” (paragraph 0050), “The bottommost portion of the display shown in FIG. 18 also shows a diagrammatic patient representation 1240 with the last three insulin injection sites indicated, so as to help the patient rotate injections in accordance with best practice. By selecting the right-arrow located to the right of the diagrammatic patient representation 1240, an enlarged version 1240 L of the patient representation 1240 is brought up, as shown in FIG. 19, via which insulin injection location information for the latest injection can be added by touching the appropriate location on diagram 1240L.” (paragraph 0061), and “With reference to FIGS. 20-23, an embodiment is described in which an insulin pump 1300 is used to administer the insulin. Optionally, the required insulin order may be sent directly to the insulin pump 1300 from the app 7a, as depicted in FIGS. 20-23. As seen in FIG. 20, the diagrammatic patient representation 1240 of FIG. 18 is replaced with a selection button 1250 labeled “Send Insulin Order to Pump”. FIG. 21 shows the display after selection of the button 1250 (where the insulin pump is identified as “OmniPod1”). As this is a therapeutic operation that delivers a drug (insulin) to the patient, the user must perform a confirmation operation as shown in FIG. 21. As shown in FIG. 22, upon confirmation the insulin order is communicated from the device 7 to the insulin pump 1300, and a confirmation message 1260 of the message transmission is displayed on the display of app 7a. FIG. 23 then shows a pop-up message window that is suitably displayed when the insulin pump 1300 sends a message back to the device 7 informing the app 7a that the insulin order has actually been received and executed by the insulin pump 1300.” (paragraph 0063). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include obtaining, from the patient terminal, medicine taking information on medicine actually taken by the patient as taught by Humphrys in order to ensure or validate has taken the prescribed medicine.
Allred, Simmons, and Humphrys do not teach associates the dispensing information and the medicine taking information with each other and creates integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “The monitoring sever 40 is a robust automated system that analyzes and communicates medication conditions, usage, and adherence data that are collected from the containers 20. The monitoring server 40 monitors, records, and quantifies multiple medication adherence data points providing accurate, comprehensive, and actionable information in real time. The monitoring server 40 also calculates medication usage and tracks and quantifies the effectiveness of the adherence communications between the various entities 60 and the patients 11.” (paragraph 0084), “The various patients 11 are enrolled into the system 10 by registering with the monitoring server 40 (e.g., via the browser-based interface or with an administrator 45 (e.g., in a non-electronic fashion)). The registration may include the patient 11 providing basic information (e.g., name, age, date of birth), contact information (e.g., phone number, email address, home address). The registration also includes entry of the medication that will be taken and the applicable dose information (e.g., dose time, dose amount, tablet, capsule or liquid form, mass or volume of medication, quantity).” (paragraph 0085), “One aspect monitored by the system 10 is adherence to medication dose. A dose of medication is defined as the amount of medication to be taken by a patient. The system 10 quantifies adherence to dose by comparing doses taken with doses prescribed. Adherence to a prescribed dose is expressed by a ratio of the actual amount of medication taken compared to the amount of medication prescribed. This ratio quantifies adherence to dose across dose times. Dose time is defined as the prescribed time of day when a dose is to be administered. Dose times can be multiple time periods within a day such as morning, noon, afternoon, evening, bedtime, or breakfast, lunch, dinner. Dose times can also be scheduled as exact times throughout the day. Dose times can also be daily, or per day, or per series of days. Quantifying dose adherence provides healthcare users with a real and actual measure of patient dosing, as well as dose adherence performance and behavior over time. Furthermore, since the system accounts for all doses taken by patients, the system can alert caregivers and patients when too much, or too little medication has been taken.” (paragraph 0088) and “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include associating the dispensing information and the medicine taking information with each other and creating integrated information as taught by Chu in order to analyze data collected or received.
Allred, Simmons, and Humphrys do not teach and causes the healthcare worker terminal or the patient terminal to display the integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “As illustrated in FIG. 18, the user is able to select one of the medications 202 (Sulfasalazine in the embodiment of FIG. 18) to open a medication adherence run chart 203 that outputs and displays dosing behavior. The chart includes a timeline with the one or more dose time windows 205 visually illustrated. FIG. 18 includes four dosing windows 205a (morning), 205b, (noon), 205c (evening), and 205d (bedtime). In one or more embodiments, the dosing windows 205 are displayed in a different color than the other times during the day. The display further indicates when the patient 11 has taken the medication. This provides for a straight-forward manner to visually observer non-compliant doses that were not taken during the proper times. Further, the visual display provides for an entity 60 to observer patterns in the behavior of the patient.” (paragraph 0216), “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217), “In one embodiment, the displayed information may visually indicate a pattern of patient behavior. A doctor or caregiver may be able to note this pattern and change one or more of the time windows 205 such that the patient is more likelihood to become adherent to the dosing times.” (paragraph 0220), and “A variety of different entities 60 may have access to some or all of the information at the monitoring server 40. This may include but is not limited to doctors, hospitals, insurance companies, drug manufacturers, pharmacies, patients, family members, patients, and caregivers. The entities 60 may access this information by accessing the server 49. In one or more embodiments, the monitoring server 40 may be configured for browser-based accessibility. The browser-based interface may support well-known browsers such as Internet Explorer and Mozilla Firefox, Safari, Chrome. Alternatively, or in conjunction with the browser-based interface, the monitoring server 40 may provide access to database 42 to requesting APIs over the PDN 55.” (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include causing the healthcare worker terminal or the patient terminal to display the integrated information as taught by Chu in order to display relevant data associated with a patient’s medicinal intake.
Claim 39:
As per claim 39, Allred teaches a healthcare worker system comprising:
and a hardware processor that (paragraph 0037 “As shown, the network 100 comprises a prescription processing system 105 including one or more processors that serves as a central hub for communicating data between one or more external modules.”):
obtains, from the electronic prescription server, dispensing information associated with the electronic prescription information registered in the healthcare worker terminal, the dispensing information including a type of medicine, a timing at which the medicine should be taken, and a dose of the medicine (paragraph 0040 “In some embodiments, the system 105 is configured to receive and transmit prescription data 205 related to a medical prescription for a patient, which may comprise a variety of information. For example, the medical prescription may specify a medication being prescribed. The medical prescription may further indicate a dosage form of the medication, including but not limited to a particular strength of the medication, a preparation type (e.g., tablet, capsule, syrup, solution, cream, ointment, drops, suppository, and the like), and an indication of acceptability of generic substitutes. In some embodiments, the medical prescription may include a total amount of the medication, a dose, a number of administrations, a frequency of administration, a route of administration (e.g., oral, buccal, intravenous, intramuscular, intranasal, subcutaneous, topical, inhalation, rectal, and the like), and a number of refills. In some embodiments, the medical prescription may further include additional instructions regarding administration. For example, the prescriber may specify how to take the medication, such as taking with food or taking upon rising. In a further example, the prescriber may specify criteria for taking the medication, such as in response to one or more symptoms. In additional embodiments, the medical prescription may include patient-identifying information such as a name and/or a date of birth. In still additional embodiments, the medical prescription may include prescriber-identifying information such as a name, an address, a practice name, and/or an ID number (e.g., an NPI number or a DEA number). Additional information not explicitly described herein may be included in the prescription data 205 as is known to one having an ordinary level of skill in the art. In some embodiments, prescription data 205 is received from a prescriber (e.g., a physician) via the prescriber module 110. However, it is contemplated that the prescription data 205 may be acquired, either together or separately, through a variety of sources. For example, in some cases, a pharmacy and/or a patient may receive prescription data 205 directly from a physician and transmit to the system 105 through a pharmacy module 120 and/or a patient module 115.”),
Allred does not teach a healthcare worker terminal that processes information obtained from a patient terminal and from an electronic prescription server that stores electronic prescription information. However, Simmons teaches an Apparatus, System, and Method for Accurate Dispensing of Prescription Medications and further teaches, “The remote sever 404 may include a memory to store the software or other machine-readable instructions and data. The memory may include volatile and/or non-volatile memory. Additionally, the remote server 404 may also include a communications system to communicate via a wireline and/or wireless communications, such as through the Internet, an intranet, an Ethernet network, a wireline network, a wireless network, a mobile communications network, and/or another communication network, such as communications network 406. The remote server 404 may include a database and/or data store 408 containing Patient Information corresponding to a plurality of patients, their prescribed medications, their health care providers, and the like. In one embodiment, the dispensing apparatus 10 may communicate with the remote server 404 and may, for example, query the database 408 for updated information regarding potential undesirable interactions with other prescribed medications--including medication prescribed after the patient first received a prescription for the stored medication--or side effects, perhaps taking into account more current information regarding a patients medical condition. In another embodiment, the dispensing apparatus 10 may communicate with the remote server 404 to store information regarding a user's dispensing of the prescribed medication. For example, in one embodiment, the remote server 404 and/or the database 408 may include EHRs for one or more patients. Each EHR may contain various types of patient identifiers (medical and otherwise), insurance carriers, health parameters, health history, existing allergies, attending physicians, past and present prescribed medications, dosages, dispensing schedules and medication compliance history; these EHR formats may be layered fields menu driven for efficient data access and sorting.” (paragraph 0034) and “The information, such as Patient Information, stored at the remote server 404, may be made accessible to the user's health care provider, insurance provider, pharmacy, clinic, hospital, and/or any other individual or entity with authorized access to such data or to data on a class of patients taking certain medications, whether by allowing the health care provider and/or others referenced above to access the database 408 or by transmitting the data to a processing device, such as user device(s) 410, which may be a personal computer, work station, server, mobile device, mobile phone, tablet device, processor, and/or other processing device operated by or on behalf of the provider of such parties.” (paragraph 0035). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include a healthcare worker terminal that processes information obtained from a patient terminal and from an electronic prescription server that stores electronic prescription information as taught by Simmons in order for the exchange and storage of information.
Allred and Simmons do not teach obtains, from the patient terminal, medicine taking information on medicine actually taken by the patient. However, Humphrys teaches a Dynamic Medication and Protocol Manager for Home and further teaches, “In step 312, the child inputs the insulin dose actually administered via injection, along with the injection location;… Based on the preceding events, the child's device log for app 7a will be updated at step 317 and the parent's device log for app 6a is updated at step 319.” (paragraph 0050), “The bottommost portion of the display shown in FIG. 18 also shows a diagrammatic patient representation 1240 with the last three insulin injection sites indicated, so as to help the patient rotate injections in accordance with best practice. By selecting the right-arrow located to the right of the diagrammatic patient representation 1240, an enlarged version 1240 L of the patient representation 1240 is brought up, as shown in FIG. 19, via which insulin injection location information for the latest injection can be added by touching the appropriate location on diagram 1240L.” (paragraph 0061), and “With reference to FIGS. 20-23, an embodiment is described in which an insulin pump 1300 is used to administer the insulin. Optionally, the required insulin order may be sent directly to the insulin pump 1300 from the app 7a, as depicted in FIGS. 20-23. As seen in FIG. 20, the diagrammatic patient representation 1240 of FIG. 18 is replaced with a selection button 1250 labeled “Send Insulin Order to Pump”. FIG. 21 shows the display after selection of the button 1250 (where the insulin pump is identified as “OmniPod1”). As this is a therapeutic operation that delivers a drug (insulin) to the patient, the user must perform a confirmation operation as shown in FIG. 21. As shown in FIG. 22, upon confirmation the insulin order is communicated from the device 7 to the insulin pump 1300, and a confirmation message 1260 of the message transmission is displayed on the display of app 7a. FIG. 23 then shows a pop-up message window that is suitably displayed when the insulin pump 1300 sends a message back to the device 7 informing the app 7a that the insulin order has actually been received and executed by the insulin pump 1300.” (paragraph 0063). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include obtaining, from the patient terminal, medicine taking information on medicine actually taken by the patient as taught by Humphrys in order to ensure or validate has taken the prescribed medicine.
Allred, Simmons, and Humphrys do not teach associates the dispensing information and the medicine taking information with each other and creates integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “The monitoring sever 40 is a robust automated system that analyzes and communicates medication conditions, usage, and adherence data that are collected from the containers 20. The monitoring server 40 monitors, records, and quantifies multiple medication adherence data points providing accurate, comprehensive, and actionable information in real time. The monitoring server 40 also calculates medication usage and tracks and quantifies the effectiveness of the adherence communications between the various entities 60 and the patients 11.” (paragraph 0084), “The various patients 11 are enrolled into the system 10 by registering with the monitoring server 40 (e.g., via the browser-based interface or with an administrator 45 (e.g., in a non-electronic fashion)). The registration may include the patient 11 providing basic information (e.g., name, age, date of birth), contact information (e.g., phone number, email address, home address). The registration also includes entry of the medication that will be taken and the applicable dose information (e.g., dose time, dose amount, tablet, capsule or liquid form, mass or volume of medication, quantity).” (paragraph 0085), “One aspect monitored by the system 10 is adherence to medication dose. A dose of medication is defined as the amount of medication to be taken by a patient. The system 10 quantifies adherence to dose by comparing doses taken with doses prescribed. Adherence to a prescribed dose is expressed by a ratio of the actual amount of medication taken compared to the amount of medication prescribed. This ratio quantifies adherence to dose across dose times. Dose time is defined as the prescribed time of day when a dose is to be administered. Dose times can be multiple time periods within a day such as morning, noon, afternoon, evening, bedtime, or breakfast, lunch, dinner. Dose times can also be scheduled as exact times throughout the day. Dose times can also be daily, or per day, or per series of days. Quantifying dose adherence provides healthcare users with a real and actual measure of patient dosing, as well as dose adherence performance and behavior over time. Furthermore, since the system accounts for all doses taken by patients, the system can alert caregivers and patients when too much, or too little medication has been taken.” (paragraph 0088) and “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include associating the dispensing information and the medicine taking information with each other and creating integrated information as taught by Chu in order to analyze data collected or received.
Allred, Simmons, and Humphrys do not teach and causes the healthcare worker terminal or the patient terminal to display the integrated information. However, Chu teaches Methods and Systems of Real-Time Medication Adherence Monitoring and further teaches, “As illustrated in FIG. 18, the user is able to select one of the medications 202 (Sulfasalazine in the embodiment of FIG. 18) to open a medication adherence run chart 203 that outputs and displays dosing behavior. The chart includes a timeline with the one or more dose time windows 205 visually illustrated. FIG. 18 includes four dosing windows 205a (morning), 205b, (noon), 205c (evening), and 205d (bedtime). In one or more embodiments, the dosing windows 205 are displayed in a different color than the other times during the day. The display further indicates when the patient 11 has taken the medication. This provides for a straight-forward manner to visually observer non-compliant doses that were not taken during the proper times. Further, the visual display provides for an entity 60 to observer patterns in the behavior of the patient.” (paragraph 0216), “The display further visually differentiates when the patient 11 has taken correct doses at correct times, correct doses at incorrect times, incorrect doses at incorrect times, incorrect doses at correct times, missed doses, partial doses, and extra doses. The system is configured to output and display medication adherence charting within a time period such as within a select amount of days, weeks, months, quarters or years. In one or more embodiments, the run chart 203 displays as a default setting the last thirty (30) days. The embodiment of FIG. 18 displays medication adherence data within two week periods (i.e., the chart 203 includes information for the last fourteen days). By scrolling or selecting points in time, the user can view stored medication adherence data. The display also includes a refill chart 204 indicating the date of refill and amount of refilled medication, the daily count of remaining medication, and when refill alerts were sent. The system further provides for the user to provide an input (e.g., moving the cursor 71 over the various icons) to display detailed medication adherence information such as action that has been taken by the patient, detailed time and date, alerts and messages sent as well as interventions performed, annotations, results from patient surveys and conversion information.” (paragraph 0217), “In one embodiment, the displayed information may visually indicate a pattern of patient behavior. A doctor or caregiver may be able to note this pattern and change one or more of the time windows 205 such that the patient is more likelihood to become adherent to the dosing times.” (paragraph 0220), and “A variety of different entities 60 may have access to some or all of the information at the monitoring server 40. This may include but is not limited to doctors, hospitals, insurance companies, drug manufacturers, pharmacies, patients, family members, patients, and caregivers. The entities 60 may access this information by accessing the server 49. In one or more embodiments, the monitoring server 40 may be configured for browser-based accessibility. The browser-based interface may support well-known browsers such as Internet Explorer and Mozilla Firefox, Safari, Chrome. Alternatively, or in conjunction with the browser-based interface, the monitoring server 40 may provide access to database 42 to requesting APIs over the PDN 55.” (paragraph 0083). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Allred to include causing the healthcare worker terminal or the patient terminal to display the integrated information as taught by Chu in order to display relevant data associated with a patient’s medicinal intake.
Response to Arguments
Applicant’s arguments, see pages 14-19, filed August 15, 2025, with respect to the rejection(s) of claim(s) 1-39 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Allred, Humphrys, and Chu for claims 1-36 and 40 and Allred, Simmons, Humphrys, and Chu for claims 37-39.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Whitworth et al. US Publication 20240358597 A1 Live Monitoring Pill Dispensing Device
Whitworth discloses a tamper-resistant pill dispensing device that utilizes live data to regulate pill consumption and send virtual flags to physicians if patterns of dependence are triggered. The device contains two separate components. The first is a live monitoring dispensing device assembly that detects and collects data as to whether the device has been tampered with. This smart device uses a microcontroller and timer to track data in real time and control circuitry to release pills during the exact times the physician instructed. The second component is a disposable capsule assembly that is compatible with current pharmacist pill-loading practices. The disposable capsule assembly attaches to the dispensing device assembly and once connected cannot be disconnected until instructed by a physician. Once connected, a patient can use various user interfaces and physical devices to better regulate their prescription pill consumption.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
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/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3681
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