DETAILED ACTION
This is responsive to application 19/361,943 filed on 10/17/2025 in which claims 1-33 are presented for examination.
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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?” Yes, it’s a method claim.
Step 2a Prong 1 (judicial exception)
Step 2A (1): “Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes , the claim comes under organizing human activity.
Claim 1 recites:
“A method for facilitating fulfillment of prescriptions for regulated drugs, comprising: operating a computer network platform including a communications port for implementing electronic communications in compliance with applicable regulations concerning electronic transmission of healthcare related information, wherein the operating comprises: first obtaining documentation information relating to a first fulfillment of a first prescription of a first patient for a first drug, said documentation information indicating document requirements concerning at least first and second parties involved in said first fulfillment; second obtaining patient information concerning said first patient; accessing a schema relating to said documentation requirements, said schema defining data, including defined fields of information concerning said first prescription, for use in populating documents associated with said documentation requirements; first extracting, from said patient information, first data corresponding to a first set of said defined fields of information concerning said first prescription; first electronically populating, using said first data, first data objects of a first document of said documents to provide a first populated document, said first populated document at least partially satisfying a first documentation requirement of said documentation requirements; first providing said first populated document to a first party involved in said first fulfillment; second extracting, from said patient information, second data corresponding to a second set of said defined fields of information, the same as or different than said first set of said defined fields of information, concerning said first prescription; second electronically populating, using said second data, second data objects of a second document of said documents to provide a second populated document, said second populated document at least partially satisfying a second documentation requirement of said documentation requirements; and second providing said second populated document to a second party involved in said first fulfillment; wherein said first and second populated documents facilitate fulfillment of said prescription in compliance with said first and second documentation requirements.”
All the limitations above are abstract idea related to organizing human activity with the exception of bold and underlined limitations. Claim language pertains to healthcare providers, hubs, pharmacies, and other parties handle the paperwork needed for drugs that may be subject to a REMS, controlled-substance rules, and other documentation requirements, which falls under commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations).
.
Step 2A(2): Prong Two: evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception. NO
The claim does recite additional elements; however they don’t integrate the exception into a practical application of the exception.
Computer network platform (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Communications port (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronic communications (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronic transmission (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronically populating (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Step 2B: evaluate whether the claim recites additional elements that amount to an inventive concept (aka “significantly more”) than the recited judicial exception? NO
As discussed previously with respect to Step 2A Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Dependent claims 2-17, 19, and 23-33 further narrows the abstract idea and add the additional elements of “computer system”, “electronic template”, “communications port”, “gate”, “computer network platform”, “external platform” .
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Regarding claim 18, it is rejected under the same rationale as claim 1. It is a system claim. The additional element in the claim is “system”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Dependent claims 20-22 further narrows the abstract idea defined in claim 18, and add the additional elements of “computer network platform”, “electronic communication”, “computer system”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claim Objections
Claims 16 and 32 are objected to because of the following informalities:
Claims 16 and 32, line 1, recites, “a third providing ”; which should be “a third party providing”. For the purpose of examining it is treated as “ a third party providing”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7, 9, 12, 15, 18, and 21 are rejected under 35 U.S.C. 102a(1) as anticipated by GREEN et al. (US 20110301982 A1)
Regarding claim 1, GREEN teaches a method for facilitating fulfillment of prescriptions for regulated drugs, comprising(see para, 0317):
operating a computer network platform including a communications port for implementing electronic communications in compliance with applicable regulations concerning electronic transmission of healthcare related information, wherein the operating comprises( see para 0154, 0070):
first obtaining documentation information relating to a first fulfillment of a first prescription of a first patient for a first drug, said documentation information indicating document requirements concerning at least first and second parties involved in said first fulfillment( para, “[0317] Authorized users may access the same patient record simultaneously to review patient medical history and vital signs; to capture the patient's history of present illness, review of systems, and physical exam; to document an assessment and plan; and to have orders and prescriptions automatically generated for fulfillment by labs and/or pharmacies. Patient information can be displayed in multiple views and formats, such as text, standard forms, tables, flow sheets, or graphs, to facilitate rapid chart review and determination of the context in which a patient's symptoms occur.”);
second obtaining patient information concerning said first patient(para, “[0177] The registration component 524 also supports patient registration, including the entry of new patient information and/or importing existing patient information from the legacy system database 520. Patient-specific information, such as financial responsibility and third party insurance coverage, is also captured during the registration process. The registration component 524 stores any information obtained for new patients and information modified for existing patients in the central database 516....”
Also, para “[0264] Within a sentence, text may be selected, options such as text entry fields or drop-down boxes may be specified, and appropriate responses may be included. Other text options include patient specific demographic information (e.g., patient name, age, and sex) or gender specific pronouns (e.g., he/she, him/her, himself/herself, and his/her) that will automatically flow from the registration component 524 to populate portions of the sentence when the associated clinical document is created for a patient. As shown, for example, in FIG. 18, if the user selects the topic name "Chronology", the sentence "The patient complains of ______ for the last ______." is suggested for that topic name. Those suggested sentences are pulled in from the template administration component 1300.” Note: Also, see para 0266);
accessing a schema relating to said documentation requirements, said schema defining data, including defined fields of information concerning said first prescription, for use in populating documents associated with said documentation requirements(para, “[0189] As discussed above with respect to FIG. 7, when composing a message to a selected patient, the corresponding patient frame 706 overlays in the body of the message. The patient frame 706 includes demographic data for the patient, such as name, patient ID, and age. And if there is a digital photograph available for the patient, that photo will also be displayed in patient frame 706 within the message. The message also includes a "Patient" field that will be automatically populated with the patient's name so that the message will be associated with that patient. All messages composed and sent by the user are audit logged, indicating that the logged action was a "sent message" and recording the patient ID, the sender and the recipient, and the time of that action. That audit logging is of particular usefulness for complying with the patient data access and disclosure requirements of HIPAA.”)
first extracting, from said patient information, first data corresponding to a first set of said defined fields of information concerning said first prescription(para, “[0172] Also in the example of FIG. 7, the user is creating a message (foreground) regarding medication refills using the messaging component 528 of the framework module 508, which is discussed in more detail below. After the user selects the patient name from the patient list, the message is automatically populated with demographic information for the patient that is retrieved from the registration component 524 of the framework module 508. The user may also choose a message template with form fields provided therein for automatically populating other data into the massage. For example, a form field can be provided in a message so that the patient's chief complaint and current medication information from the registration component 524 and/or the clinical module 512 will be also automatically populated in the message. “ Note: also, see para 0168.
Also, para “[0189] As discussed above with respect to FIG. 7, when composing a message to a selected patient, the corresponding patient frame 706 overlays in the body of the message. The patient frame 706 includes demographic data for the patient, such as name, patient ID, and age. And if there is a digital photograph available for the patient, that photo will also be displayed in patient frame 706 within the message. The message also includes a "Patient" field that will be automatically populated with the patient's name so that the message will be associated with that patient. All messages composed and sent by the user are audit logged, indicating that the logged action was a "sent message" and recording the patient ID, the sender and the recipient, and the time of that action. That audit logging is of particular usefulness for complying with the patient data access and disclosure requirements of HIPAA.”);
first electronically populating, using said first data, first data objects of a first document of said documents to provide a first populated document, said first populated document at least partially satisfying a first documentation requirement of said documentation requirements(para, “[0118] Support for associating and/or mapping the appropriate ICD, CPT, HCPCS, E&M, LOINC, and RxNorm codes to the correct data can be provided with coding search and compliance applications embedded or integrated into the systems of the IPI 100.............. Thus, in the example above, the diagnosis code "821.0" could be automatically populated into the associated field in a claim form in lieu of the written phrase "The patient fractured his femur." And when combined with the other data that can also be automatically populated using such form fields, entire claim forms can be completed automatically without the need for a user to actively input any information into the claim form. The manner in which data is associated with form fields is described in more detail below with respect to step 418 of the dynamic correlation process 400.”
Also, para “[0138] The content of various fields in electronic documents generated within the IPI 100 are determined by associating data with those fields as it is input/consumed. At step 418 of the dynamic correlation process 400, that data is associated with a specific control type so that it will be automatically populated into the field of an electronic document when that electronic document is created. For example, when a patient's age and/or date of birth is input into/consumed by the IPI 100, that age and/or date of birth will be automatically associated with any form field within the IPI 100 that requires the patient's age and/or date of birth (e.g., a date of birth entry in a clinical document) so that the corresponding field will be automatically populated (i.e., auto-filled) with that age and/or date of birth when the electronic document in which that form field appears is created. That functionality is particularly suited for data that typically does not change for a patient on a visit-to-visit basis (e.g., age, date of birth, sex, race, eye color, etc.).”);
first providing said first populated document to a first party involved in said first fulfillment(para, “[0383] The status of various clinical documents is determined by automatically reviewing and tracking incoming and pending order results so that fulfillment is documented and failure to fulfill is investigated and remedied. For example, a clinician can have orders and/or prescriptions automatically generated for fulfillment by labs and/or pharmacies using the EHR component 1306 as they complete a clinical document. The integrated ambulatory suite 500 will log that such an order and/or prescription has been generated as well as each step in the fulfillment process. Accordingly, a clinician or patient can check the status of such orders and prescriptions via the integrated ambulatory suite 500. Moreover, the integrated ambulatory suite 500 will provide reminders to the clinician and other staff members at the clinician's healthcare practice if the order and/or prescription is not fulfilled within a predetermined time (e.g., the clinician will receive a message via the messaging component 528).”
Also, para “[0362] The Facesheet 3900 also allows the clinician or staff member to edit and add to the summary information displayed in the Facesheet 3900 by clicking the "+" button 3918 to the right of each summary. For example, in FIG. 39 the clinician has chosen to add a new medication to the patient's medical record, which the clinician can do by selecting the "Add New Medication" option in the medication list toolbar 3920. As a result, a new prescription will be automatically generated and sent to a pharmacy for fulfillment. The clinician can automatically generate prescription refills from the Facesheet 3900 in a similar manner.”);
second extracting, from said patient information, second data corresponding to a second set of said defined fields of information, the same as or different than said first set of said defined fields of information, concerning said first prescription(para, “[0172] Also in the example of FIG. 7, the user is creating a message (foreground) regarding medication refills using the messaging component 528 of the framework module 508, which is discussed in more detail below. After the user selects the patient name from the patient list, the message is automatically populated with demographic information for the patient that is retrieved from the registration component 524 of the framework module 508. The user may also choose a message template with form fields provided therein for automatically populating other data into the massage. For example, a form field can be provided in a message so that the patient's chief complaint and current medication information from the registration component 524 and/or the clinical module 512 will be also automatically populated in the message. “ Note: also, see para 0168. Second data could be same as first set of defined fields as claimed in this limitation.
Also, para “[0189] As discussed above with respect to FIG. 7, when composing a message to a selected patient, the corresponding patient frame 706 overlays in the body of the message. The patient frame 706 includes demographic data for the patient, such as name, patient ID, and age. And if there is a digital photograph available for the patient, that photo will also be displayed in patient frame 706 within the message. The message also includes a "Patient" field that will be automatically populated with the patient's name so that the message will be associated with that patient. All messages composed and sent by the user are audit logged, indicating that the logged action was a "sent message" and recording the patient ID, the sender and the recipient, and the time of that action. That audit logging is of particular usefulness for complying with the patient data access and disclosure requirements of HIPAA.”);
second electronically populating, using said second data, second data objects of a second document of said documents to provide a second populated document, said second populated document at least partially satisfying a second documentation requirement of said documentation requirements(para, “[0118] Support for associating and/or mapping the appropriate ICD, CPT, HCPCS, E&M, LOINC, and RxNorm codes to the correct data can be provided with coding search and compliance applications embedded or integrated into the systems of the IPI 100.............. Thus, in the example above, the diagnosis code "821.0" could be automatically populated into the associated field in a claim form in lieu of the written phrase "The patient fractured his femur." And when combined with the other data that can also be automatically populated using such form fields, entire claim forms can be completed automatically without the need for a user to actively input any information into the claim form. The manner in which data is associated with form fields is described in more detail below with respect to step 418 of the dynamic correlation process 400.”
Also, para “[0138] The content of various fields in electronic documents generated within the IPI 100 are determined by associating data with those fields as it is input/consumed. At step 418 of the dynamic correlation process 400, that data is associated with a specific control type so that it will be automatically populated into the field of an electronic document when that electronic document is created. For example, when a patient's age and/or date of birth is input into/consumed by the IPI 100, that age and/or date of birth will be automatically associated with any form field within the IPI 100 that requires the patient's age and/or date of birth (e.g., a date of birth entry in a clinical document) so that the corresponding field will be automatically populated (i.e., auto-filled) with that age and/or date of birth when the electronic document in which that form field appears is created. That functionality is particularly suited for data that typically does not change for a patient on a visit-to-visit basis (e.g., age, date of birth, sex, race, eye color, etc.).”);
and second providing said second populated document to a second party involved in said first fulfillment (para, “[0383] The status of various clinical documents is determined by automatically reviewing and tracking incoming and pending order results so that fulfillment is documented and failure to fulfill is investigated and remedied. For example, a clinician can have orders and/or prescriptions automatically generated for fulfillment by labs and/or pharmacies using the EHR component 1306 as they complete a clinical document. The integrated ambulatory suite 500 will log that such an order and/or prescription has been generated as well as each step in the fulfillment process. Accordingly, a clinician or patient can check the status of such orders and prescriptions via the integrated ambulatory suite 500. Moreover, the integrated ambulatory suite 500 will provide reminders to the clinician and other staff members at the clinician's healthcare practice if the order and/or prescription is not fulfilled within a predetermined time (e.g., the clinician will receive a message via the messaging component 528).”
Also, para “[0362] The Facesheet 3900 also allows the clinician or staff member to edit and add to the summary information displayed in the Facesheet 3900 by clicking the "+" button 3918 to the right of each summary. For example, in FIG. 39 the clinician has chosen to add a new medication to the patient's medical record, which the clinician can do by selecting the "Add New Medication" option in the medication list toolbar 3920. As a result, a new prescription will be automatically generated and sent to a pharmacy for fulfillment. The clinician can automatically generate prescription refills from the Facesheet 3900 in a similar manner.”);
wherein said first and second populated documents facilitate fulfillment of said prescription in compliance with said first and second documentation requirements(para, “[0385] Via its integrated modules and interfaces with outside systems, the integrated ambulatory suite 500 also provides automated prescription and order fulfillment. That automation is provided by the real-time electronic transfer of prescriptions and/or orders to pharmacies and/or labs as those prescriptions and/or orders are generated with the integrated ambulatory suite 500. The pertinent information is transferred directly from clinical documents to the fulfillment source without the need to duplicate the instructions in an intervening document or data entry process. That functionality reduces the amount of processing that would otherwise be required for prescription and/or order fulfillment.”)
Regarding claim 2, GREEN teaches The method of claim 1.
GREEN further teaches further comprising entering said patient information via a computer system of a healthcare provider(para, “[0398] The data transformation performed by the speech understanding functionality includes taking the audio signals associated with spoken words and translating them into electronic commands/selections or into electronic text. That transformation can be performed by the processor of the client server 104 or a processor in another system being used by a clinician or other healthcare practice staff member to capture data at the healthcare provider's site 102 (e.g., a tablet computer or client workstation connected to the client server 104 at the healthcare provider's site 102). Or the audio signals can be streamed to a system outside of at the healthcare provider's site 102 for remote processing, such as by the enhanced services server 116 of an IPI provider system or the processor of an external system 142.....”)
Regarding claim 3, GREEN teaches The method of claim 2.
GREEN further teaches, wherein said patient information is received at said computer network platform via an electronic communication between said computer system of said healthcare provider and said computer network platform in compliance with said applicable regulations concerning electronic transmission of said healthcare related information(para, “[0015] CDS systems are intended to help healthcare providers make decisions that enhance patient care by matching a patient's information to a clinical knowledge base and communicating the appropriate patient-specific assessments and/or recommendations to the healthcare provider at appropriate times during patient care. Some CDS systems include forms and templates for entering and documenting patient data as well as various alerts, reminders, and order sets (i.e., guideline-based interventions) for providing suggestions and other support that are intended to increase healthcare providers' adherence to evidence-based medical knowledge.”
Also, para “[0070] .....The client server 104 also controls communications with the other systems within the IPI 100 and locally stores data collected using the integrated ambulatory suite. The client server 104 is at the center of the EHR system and may be located at a central location at a healthcare provider's site 102 for local communication with each of the client workstations 106. In the alternative, as opposed to being hosted at the healthcare provider's site 102, all of the applications, controls, and data for the integrated ambulatory suite may be remotely hosted at a client server 120 located at a client data center 122......”
Also, para “[0061] The present invention provides a medical software system that integrates each of the systems required to manage the different activities performed at a healthcare practice (e.g., an EMR or EHR system, a CDS system, a patient registration system, a scheduling system, an account management system, a billing system, etc.) on a single technology platform so that duplicate and/or inconsistent data is not captured, stored, and managed by disparate, stand-alone systems. ....”)
Regarding claim 4, GREEN teaches The method of claim 2.
GREEN further teaches wherein said patient information is entered on said computer system using an electronic template that prompts a user to enter information items for a plurality of said defined fields of information concerning said prescription and is operative for associating metadata concerning said defined fields of information with said information items(para, “[0358] A Triage Note is yet another type of document that is generated with the template builder component 1302 and document builder component 1304 and completed with the EHR component 1306. Such a Triage Note will prompt a clinician to enter detailed triage data for a patient. It is designed to be the initial documentation point in a patient's visit and will usually be completed by a nurse before the patient starts the encounter with the clinician. All information entered into the Triage Note will be used in other sections of the clinical documentation generated as part of the patient's visit to the healthcare practice and will become part of his or her EHR. For example, the reason for visit is updated based on the information gathered by the registration component 524 of the framework module 508 during the patient check-in process. The information available for entry includes reason for visit, presenting symptoms, additional notes, vital signs (e.g., blood pressure, heart rate, respiratory rate, temperature, etc.), review of systems, orthostatic vital signs, etc” Note: here information is used for prescription, also , see para 0275)
Regarding claim 5, GREEN teaches The method of claim 4.
GREEN further teaches wherein said information items and said metadata are used in said first and second extracting(para, “[0172] Also in the example of FIG. 7, the user is creating a message (foreground) regarding medication refills using the messaging component 528 of the framework module 508, which is discussed in more detail below. After the user selects the patient name from the patient list, the message is automatically populated with demographic information for the patient that is retrieved from the registration component 524 of the framework module 508. The user may also choose a message template with form fields provided therein for automatically populating other data into the massage. For example, a form field can be provided in a message so that the patient's chief complaint and current medication information from the registration component 524 and/or the clinical module 512 will be also automatically populated in the message.”)
Regarding claim 6, GREEN teaches The method of claim 1.
GREEN further teaches wherein said computer network platform comprises logic, executed on a processor, for controlling transmissions in accordance with requirements under one or more of the United States Health Insurance Portability and Accountability Act (HIPAA) and other regulations concerning handling of healthcare related information(para, “[0220] Using that billing data in conjunction with other data captured with the integrated ambulatory suite 500, the service detail entry component 906 will automatically generate a bill, claim, and/or statement for use in obtaining payment from the patient for the procedures, services, and supplies enjoyed by that patient. For example, the service detail entry component 906 will automatically populate all of the required fields in an electronic claim (e.g., a CMS-1500 claim form) without any additional user interaction. Those form fields will be populated with the date of service, time of service, location of service, healthcare provider, patient demographic information, patient medical coverage information, diagnosis codes, billing codes, etc. in a HIPAA compliant format so the claim can be electronically transmitted to a claims clearinghouse 504 as it is completed.”)
Regarding claim 7, GREEN teaches The method of claim 1.
GREEN further teaches wherein one of said first and second populated documents comprises an enrollment form(para, “[0471] By simplifying and facilitating the interactions between research clients and research partners that are required to recruit research clients and get patients enrolled in clinical trials, the present invention provides for completing the enrollment process for a clinical trial in a matter of days instead of months. Accordingly, healthcare providers can quickly begin enrolling candidates, participating in the clinical trials, and receiving reimbursements form clinical trial sponsors or CROs via the functionality of the present invention. And in addition to recruiting research clients and enrolling patients for clinical trials, similar methods can also be utilized for recruiting research clients and enrolling patients for other types of medical research, such as disease registries and quality of care initiatives. Thus, the functionality of the present invention eliminates many, if not all, of the hurdles put in place by HIPAA that otherwise deter healthcare providers from participating in medical research.”)
Regarding claim 9, GREEN teaches The method of claim 1.
GREEN further teaches wherein one of said first and second populated electronic documents comprises a prescription form(para, “[0345] In the Medications subsection, the clinician fills in the dosage and amounts for the selected medications, which are used to automatically write a prescription for the patient. Prescriptions may also be written from scratch within the Medications subsection. Both types of prescription writing are facilitated via interaction with the drug information in the reference databases 518 (e.g., the First DataBank, Inc.'s NDDF PLUS brand drug database and the RxNorm coded classification system). That drug information includes descriptions of different drugs as well as unique identifiers and pricing information for each of those drugs. By selecting different drugs from the reference databases 518, the drug selected for the prescription will automatically be linked to its unique identifier and price for use in generating, electronically submitting, and fulfilling the prescription, and for use in generating a bill, claim, or statement for the prescription. The automated prescription process is discussed in more detail below.”)
Regarding claim 12, GREEN teaches The method of claim 1.
GREEN further teaches wherein said first party comprises one of a healthcare provider and a pharmacy(para, “[0317] Authorized users may access the same patient record simultaneously to review patient medical history and vital signs; to capture the patient's history of present illness, review of systems, and physical exam; to document an assessment and plan; and to have orders and prescriptions automatically generated for fulfillment by labs and/or pharmacies. Patient information can be displayed in multiple views and formats, such as text, standard forms, tables, flow sheets, or graphs, to facilitate rapid chart review and determination of the context in which a patient's symptoms occur.”)
Regarding claim 15, GREEN teaches the method of claim 1.
GREEN further teaches wherein said first party comprises a one of a payor and a prescription services entity(para, “[[0214] After each procedure, service, and supply is mapped to the corresponding billing data, the procedure/financial mapping component 904 will correlate that billing data with the fee schedules, contracts, and insurance plans maintained by the A/R administration component 900 to determine the actual costs (i.e., the amounts that will be billed) and allowed amounts (i.e., the portion of the allowed amounts that will be paid by a payor) for those procedures, services, and supplies. The procedure/financial mapping component 904 uses a patient's demographic data (e.g., date of birth and/or payor ID) captured by the registration component 524 of the framework module 508 to identify the correct fee schedule, contract, and/or insurance plan, if any, under which that patient's costs are covered.....”)
Regarding claim 18, GREEN teaches a system for facilitating fulfillment of prescriptions for regulated drugs, comprising(see para, 0317):
a computer network platform including a communications port for use in transmitting electronic communications in compliance with applicable regulations concerning electronic transmission of healthcare related information; said computer network platform being operative for ( see para 0154, 0070):
receiving patient information including data corresponding to defined fields of information concerning a prescription( para, “[0317] Authorized users may access the same patient record simultaneously to review patient medical history and vital signs; to capture the patient's history of present illness, review of systems, and physical exam; to document an assessment and plan; and to have orders and prescriptions automatically generated for fulfillment by labs and/or pharmacies. Patient information can be displayed in multiple views and formats, such as text, standard forms, tables, flow sheets, or graphs, to facilitate rapid chart review and determination of the context in which a patient's symptoms occur.”);
first extracting, from said patient information, first data corresponding to a first set of said defined fields of information concerning said prescription(para, “[0172] Also in the example of FIG. 7, the user is creating a message (foreground) regarding medication refills using the messaging component 528 of the framework module 508, which is discussed in more detail below. After the user selects the patient name from the patient list, the message is automatically populated with demographic information for the patient that is retrieved from the registration component 524 of the framework module 508. The user may also choose a message template with form fields provided therein for automatically populating other data into the massage. For example, a form field can be provided in a message so that the patient's chief complaint and current medication information from the registration component 524 and/or the clinical module 512 will be also automatically populated in the message. “ Note: also, see para 0168.
Also, para “[0189] As discussed above with respect to FIG. 7, when composing a message to a selected patient, the corresponding patient frame 706 overlays in the body of the message. The patient frame 706 includes demographic data for the patient, such as name, patient ID, and age. And if there is a digital photograph available for the patient, that photo will also be displayed in patient frame 706 within the message. The message also includes a "Patient" field that will be automatically populated with the patient's name so that the message will be associated with that patient. All messages composed and sent by the user are audit logged, indicating that the logged action was a "sent message" and recording the patient ID, the sender and the recipient, and the time of that action. That audit logging is of particular usefulness for complying with the patient data access and disclosure requirements of HIPAA.”);
first electronically populating, using said first data, first data objects of a first document to provide a first populated document, said first populated document at least partially satisfying a documentation requirement pertaining to said prescription(para, “[0118] Support for associating and/or mapping the appropriate ICD, CPT, HCPCS, E&M, LOINC, and RxNorm codes to the correct data can be provided with coding search and compliance applications embedded or integrated into the systems of the IPI 100.............. Thus, in the example above, the diagnosis code "821.0" could be automatically populated into the associated field in a claim form in lieu of the written phrase "The patient fractured his femur." And when combined with the other data that can also be automatically populated using such form fields, entire claim forms can be completed automatically without the need for a user to actively input any information into the claim form. The manner in which data is associated with form fields is described in more detail below with respect to step 418 of the dynamic correlation process 400.”
Also, para “[0138] The content of various fields in electronic documents generated within the IPI 100 are determined by associating data with those fields as it is input/consumed. At step 418 of the dynamic correlation process 400, that data is associated with a specific control type so that it will be automatically populated into the field of an electronic document when that electronic document is created. For example, when a patient's age and/or date of birth is input into/consumed by the IPI 100, that age and/or date of birth will be automatically associated with any form field within the IPI 100 that requires the patient's age and/or date of birth (e.g., a date of birth entry in a clinical document) so that the corresponding field will be automatically populated (i.e., auto-filled) with that age and/or date of birth when the electronic document in which that form field appears is created. That functionality is particularly suited for data that typically does not change for a patient on a visit-to-visit basis (e.g., age, date of birth, sex, race, eye color, etc.).”);
first providing said first populated document to a first party involved in fulfillment of said prescription( para, “[0383] The status of various clinical documents is determined by automatically reviewing and tracking incoming and pending order results so that fulfillment is documented and failure to fulfill is investigated and remedied. For example, a clinician can have orders and/or prescriptions automatically generated for fulfillment by labs and/or pharmacies using the EHR component 1306 as they complete a clinical document. The integrated ambulatory suite 500 will log that such an order and/or prescription has been generated as well as each step in the fulfillment process. Accordingly, a clinician or patient can check the status of such orders and prescriptions via the integrated ambulatory suite 500. Moreover, the integrated ambulatory suite 500 will provide reminders to the clinician and other staff members at the clinician's healthcare practice if the order and/or prescription is not fulfilled within a predetermined time (e.g., the clinician will receive a message via the messaging component 528).”
Also, para “[0362] The Facesheet 3900 also allows the clinician or staff member to edit and add to the summary information displayed in the Facesheet 3900 by clicking the "+" button 3918 to the right of each summary. For example, in FIG. 39 the clinician has chosen to add a new medication to the patient's medical record, which the clinician can do by selecting the "Add New Medication" option in the medication list toolbar 3920. As a result, a new prescription will be automatically generated and sent to a pharmacy for fulfillment. The clinician can automatically generate prescription refills from the Facesheet 3900 in a similar manner.”);
second extracting, from said patient information, second data corresponding to a second set of said defined fields of information, the same as or different than said first set of said defined fields of information, concerning said prescription(para, “[0172] Also in the example of FIG. 7, the user is creating a message (foreground) regarding medication refills using the messaging component 528 of the framework module 508, which is discussed in more detail below. After the user selects the patient name from the patient list, the message is automatically populated with demographic information for the patient that is retrieved from the registration component 524 of the framework module 508. The user may also choose a message template with form fields provided therein for automatically populating other data into the massage. For example, a form field can be provided in a message so that the patient's chief complaint and current medication information from the registration component 524 and/or the clinical module 512 will be also automatically populated in the message. “ Note: also, see para 0168.
Also, para “[0189] As discussed above with respect to FIG. 7, when composing a message to a selected patient, the corresponding patient frame 706 overlays in the body of the message. The patient frame 706 includes demographic data for the patient, such as name, patient ID, and age. And if there is a digital photograph available for the patient, that photo will also be displayed in patient frame 706 within the message. The message also includes a "Patient" field that will be automatically populated with the patient's name so that the message will be associated with that patient. All messages composed and sent by the user are audit logged, indicating that the logged action was a "sent message" and recording the patient ID, the sender and the recipient, and the time of that action. That audit logging is of particular usefulness for complying with the patient data access and disclosure requirements of HIPAA.”);
second electronically populating, using said second data, second data objects of a second document to provide a second populated document, said second populated document at least partially satisfying a second documentation requirement pertaining to said prescription para, “[0118] Support for associating and/or mapping the appropriate ICD, CPT, HCPCS, E&M, LOINC, and RxNorm codes to the correct data can be provided with coding search and compliance applications embedded or integrated into the systems of the IPI 100.............. Thus, in the example above, the diagnosis code "821.0" could be automatically populated into the associated field in a claim form in lieu of the written phrase "The patient fractured his femur." And when combined with the other data that can also be automatically populated using such form fields, entire claim forms can be completed automatically without the need for a user to actively input any information into the claim form. The manner in which data is associated with form fields is described in more detail below with respect to step 418 of the dynamic correlation process 400.”
Also, para “[0138] The content of various fields in electronic documents generated within the IPI 100 are determined by associating data with those fields as it is input/consumed. At step 418 of the dynamic correlation process 400, that data is associated with a specific control type so that it will be automatically populated into the field of an electronic document when that electronic document is created. For example, when a patient's age and/or date of birth is input into/consumed by the IPI 100, that age and/or date of birth will be automatically associated with any form field within the IPI 100 that requires the patient's age and/or date of birth (e.g., a date of birth entry in a clinical document) so that the corresponding field will be automatically populated (i.e., auto-filled) with that age and/or date of birth when the electronic document in which that form field appears is created. That functionality is particularly suited for data that typically does not change for a patient on a visit-to-visit basis (e.g., age, date of birth, sex, race, eye color, etc.).”);
and second transmitting said second populated document to a second party, the same as or different than said first party, involved in fulfillment of said prescription((para, “[0383] The status of various clinical documents is determined by automatically reviewing and tracking incoming and pending order results so that fulfillment is documented and failure to fulfill is investigated and remedied. For example, a clinician can have orders and/or prescriptions automatically generated for fulfillment by labs and/or pharmacies using the EHR component 1306 as they complete a clinical document. The integrated ambulatory suite 500 will log that such an order and/or prescription has been generated as well as each step in the fulfillment process. Accordingly, a clinician or patient can check the status of such orders and prescriptions via the integrated ambulatory suite 500. Moreover, the integrated ambulatory suite 500 will provide reminders to the clinician and other staff members at the clinician's healthcare practice if the order and/or prescription is not fulfilled within a predetermined time (e.g., the clinician will receive a message via the messaging component 528).”
Also, para “[0362] The Facesheet 3900 also allows the clinician or staff member to edit and add to the summary information displayed in the Facesheet 3900 by clicking the "+" button 3918 to the right of each summary. For example, in FIG. 39 the clinician has chosen to add a new medication to the patient's medical record, which the clinician can do by selecting the "Add New Medication" option in the medication list toolbar 3920. As a result, a new prescription will be automatically generated and sent to a pharmacy for fulfillment. The clinician can automatically generate prescription refills from the Facesheet 3900 in a similar manner.”);
wherein said first and second populated documents enable fulfillment of said prescription in compliance with said first and second documentation requirements(para, “[0385] Via its integrated modules and interfaces with outside systems, the integrated ambulatory suite 500 also provides automated prescription and order fulfillment. That automation is provided by the real-time electronic transfer of prescriptions and/or orders to pharmacies and/or labs as those prescriptions and/or orders are generated with the integrated ambulatory suite 500. The pertinent information is transferred directly from clinical documents to the fulfillment source without the need to duplicate the instructions in an intervening document or data entry process. That functionality reduces the amount of processing that would otherwise be required for prescription and/or order fulfillment.”)
Regarding claim 21, GREEN teaches the system of claim 18.
GREEN further teaches wherein said patient information is entered on said computer system using an electronic template that prompts a user to enter information items for a plurality of said defined fields of information concerning said prescription and is operative for associating metadata concerning said defined fields of information with said information items(para, “[0358] A Triage Note is yet another type of document that is generated with the template builder component 1302 and document builder component 1304 and completed with the EHR component 1306. Such a Triage Note will prompt a clinician to enter detailed triage data for a patient. It is designed to be the initial documentation point in a patient's visit and will usually be completed by a nurse before the patient starts the encounter with the clinician. All information entered into the Triage Note will be used in other sections of the clinical documentation generated as part of the patient's visit to the healthcare practice and will become part of his or her EHR. For example, the reason for visit is updated based on the information gathered by the registration component 524 of the framework module 508 during the patient check-in process. The information available for entry includes reason for visit, presenting symptoms, additional notes, vital signs (e.g., blood pressure, heart rate, respiratory rate, temperature, etc.), review of systems, orthostatic vital signs, etc” Note: here information is used for prescription, also , see para 0275)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8, 10-11,13-14 are rejected under 35 U.S.C. 103 as being unpatentable over GREEN in view of Duffy et al. (US 20220139517 A1)
Regarding claim 8, GREEN teaches The method of claim 7.
GREEN does not explicitly teach wherein said enrollment form comprises one of a Risk Evaluation and Mitigation Strategy (REMS) enrollment form, a hub enrollment form, and a patient support services enrollment form.
Duffy teaches wherein said enrollment form comprises one of a Risk Evaluation and Mitigation Strategy (REMS) enrollment form, a hub enrollment form, and a patient support services enrollment form(para, “[0013] Improvement: The improvement in this method involves the role of a monitoring hub to coordinate the work process. The improved method comprises one or more of the following steps. The monitoring hub has one or more personnel who are enrolled in the REMS program as a prescriber designee for the clinician. The patient's prescription information is transmitted to the monitoring hub (e.g. by the clinician or the pharmacy). Information about the safety monitoring plan is also transmitted to the monitoring hub (e.g. by the clinician or the laboratory).”)
It would have been obvious for a person of ordinary skill in the art to incorporate Risk Evaluation and Mitigation Strategy (REMS) teachings of Duffy into the teachings of GREEN at the time the application was filed in order to transmit patient’s prescription information. (para, para, “[0013] Improvement: The improvement in this method involves the role of a monitoring hub to coordinate the work process. The improved method comprises one or more of the following steps. The monitoring hub has one or more personnel who are enrolled in the REMS program as a prescriber designee for the clinician. The patient's prescription information is transmitted to the monitoring hub (e.g. by the clinician or the pharmacy). Information about the safety monitoring plan is also transmitted to the monitoring hub (e.g. by the clinician or the laboratory).”)
Regarding claim 10, GREEN teaches the method of claim 9.
GREEN does not explicitly teach wherein said prescription form comprises a form required under a Risk Evaluation and Mitigation Strategy (REMS).
Duffy teaches wherein said prescription form comprises a form required under a Risk Evaluation and Mitigation Strategy (REMS)( para, “[0013] Improvement: The improvement in this method involves the role of a monitoring hub to coordinate the work process. The improved method comprises one or more of the following steps. The monitoring hub has one or more personnel who are enrolled in the REMS program as a prescriber designee for the clinician. The patient's prescription information is transmitted to the monitoring hub (e.g. by the clinician or the pharmacy). Information about the safety monitoring plan is also transmitted to the monitoring hub (e.g. by the clinician or the laboratory).”)
It would have been obvious for a person of ordinary skill in the art to incorporate Risk Evaluation and Mitigation Strategy (REMS) teachings of Duffy into the teachings of GREEN at the time the application was filed in order to transmit patient’s prescription information. (para, para, “[0013] Improvement: The improvement in this method involves the role of a monitoring hub to coordinate the work process. The improved method comprises one or more of the following steps. The monitoring hub has one or more personnel who are enrolled in the REMS program as a prescriber designee for the clinician. The patient's prescription information is transmitted to the monitoring hub (e.g. by the clinician or the pharmacy). Information about the safety monitoring plan is also transmitted to the monitoring hub (e.g. by the clinician or the laboratory).”)
Regarding claim 11, GREEN teaches the method of claim 1.
GREEN does not explicitly teach wherein one of said first and second populated documents comprises information identifying a pharmacy for fulfillment of said prescription.
Duffy teaches wherein one of said first and second populated documents comprises information identifying a pharmacy for fulfillment of said prescription.
(para, “[0031] For the first dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, and that patient's 52 treatment is not interrupted or discontinued. For subsequent dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, that a ‘patient status form’ has been completed in the last 37 days, and that patient's 52 treatment is not interrupted or discontinued. Pharmacy 58 fills the clozapine medication and has it ready for pick-up. A pharmacy transportation service picks-up the clozapine and delivers it to the nursing home for administration to the patient 52.”)
It would have been obvious for a person of ordinary skill in the art to apply identifying a pharmacy teachings of Duffy into the teachings of GREEN at the time the application was filed in order to verify that treatment is not interrupted or discontinued. ((para, “[0031] For the first dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, and that patient's 52 treatment is not interrupted or discontinued. For subsequent dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, that a ‘patient status form’ has been completed in the last 37 days, and that patient's 52 treatment is not interrupted or discontinued. Pharmacy 58 fills the clozapine medication and has it ready for pick-up. A pharmacy transportation service picks-up the clozapine and delivers it to the nursing home for administration to the patient 52.”)
Regarding claim 13, GREEN teaches the method of claim 12.
GREEN does not explicitly teach wherein said pharmacy comprises a certified pharmacy under a REMS.
Duffy teaches wherein said pharmacy comprises a certified pharmacy under a REMS(para, “[0031] For the first dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, and that patient's 52 treatment is not interrupted or discontinued. For subsequent dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, that a ‘patient status form’ has been completed in the last 37 days, and that patient's 52 treatment is not interrupted or discontinued. Pharmacy 58 fills the clozapine medication and has it ready for pick-up. A pharmacy transportation service picks-up the clozapine and delivers it to the nursing home for administration to the patient 52.”))
It would have been obvious for a person of ordinary skill in the art to apply identifying a pharmacy teachings of Duffy into the teachings of GREEN at the time the application was filed in order to verify that treatment is not interrupted or discontinued. ((para, “[0031] For the first dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, and that patient's 52 treatment is not interrupted or discontinued. For subsequent dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, that a ‘patient status form’ has been completed in the last 37 days, and that patient's 52 treatment is not interrupted or discontinued. Pharmacy 58 fills the clozapine medication and has it ready for pick-up. A pharmacy transportation service picks-up the clozapine and delivers it to the nursing home for administration to the patient 52.”)
Regarding claim 14, GREEN teaches the method of claim 12.
GREEN does not explicitly teach wherein said second party comprises one of a REMS Administrator and a hub.
Duffy teaches wherein said second party comprises one of a REMS Administrator and a hub(para, “[0013] Improvement: The improvement in this method involves the role of a monitoring hub to coordinate the work process. The improved method comprises one or more of the following steps. The monitoring hub has one or more personnel who are enrolled in the REMS program as a prescriber designee for the clinician. The patient's prescription information is transmitted to the monitoring hub (e.g. by the clinician or the pharmacy). Information about the safety monitoring plan is also transmitted to the monitoring hub (e.g. by the clinician or the laboratory).”)
It would have been obvious for a person of ordinary skill in the art to incorporate Risk Evaluation and Mitigation Strategy (REMS) teachings of Duffy into the teachings of GREEN at the time the application was filed in order to transmit patient’s prescription information. (para, para, “[0013] Improvement: The improvement in this method involves the role of a monitoring hub to coordinate the work process. The improved method comprises one or more of the following steps. The monitoring hub has one or more personnel who are enrolled in the REMS program as a prescriber designee for the clinician. The patient's prescription information is transmitted to the monitoring hub (e.g. by the clinician or the pharmacy). Information about the safety monitoring plan is also transmitted to the monitoring hub (e.g. by the clinician or the laboratory).”)
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over GREEN in view of FOTSCH et al. (US 20210313032 A1)
Regarding claim 16, GREEN teaches the method of claim 1.
GREEN further teaches storing said patient information(para, “[0207] The patient information component 902 supports the management and maintenance of patient information, including access, retrieval, and storage. For example, if a user wishes to access and retrieve patient demographic information (e.g., patient name, date of birth, and payor ID), the patient information component 902 communicates with the registration component 524 of the framework module 508, which is used to capture that information during a registration or check-in process and/or to import that information from a legacy system database 520. And to accesses and retrieve specific coverage information (e.g., amounts covered by payor), the patient information component 902 communicates with the A/R administration component 900, which is used to capture that information from the sources that maintain it (e.g., Medicare, insurance companies, etc.).”)
GREEN does not explicitly teach :
receiving an indication of a change to a new pharmacy, and third providing a third populated document to said new pharmacy.
FOTSCH teaches :
receiving an indication of a change to a new pharmacy, and third providing a third populated document to said new pharmacy(para, “[0012] Described herein are methods and systems for controlling the operation of one or more prescription cost savings systems, including methods and systems for the interactive and dynamic generation of Drug Savings Reports. Specifically, described herein are methods and systems that enable the efficient and cost-effective creation of Drug Savings Reports (“DSRs”) (by Pharmacist or other authorized users) to identify therapeutic alternatives for existing prescription medications including costs, from a variety of distributed third party sources of information, including incorporating Pharmacist, Payer coverage rules and provider preferences. These systems and methods (e.g., computer-operated methods, including software) may aggregated, configure and schedule inquiries (“queries”) into a diverse set of third-party databases in order to generate on or a number (including very large numbers) of DSRs that may include current medications as found in payer claims files and may include them in the DSR for medication reconciliation purposes including comparison to the EHR-based medication list. These systems may also be configured to incorporate pharmacist and provider preferences and in particular, may allow interactive inclusion of alternative drugs that are always presented or always excluded either in general or on a patient-specific basis. Preferences may be identified automatically through claims data or cost transparency transactions to include alternatives selected by Providers and those not selected. The DSR may also identify a lower cost pharmacy for the patient to fill existing medications including the ability for pharmacies to interactively insert coupons or rewards into the DSR to motivate patients to change to the new pharmacy. The DSR may include a Shared Patient Savings (SPS) payment or reward for the patient that further aligns the financial interest of the patient with that of the Plan to optimize the use of cost-effective medications.”)
It would have been obvious for a person of ordinary skill in the art to incorporate changing pharmacy teachings of FOTSCH into the teachings of GREEN at the time the application was filed in order to lower cost of prescription.(para, “[0012]..... Preferences may be identified automatically through claims data or cost transparency transactions to include alternatives selected by Providers and those not selected. The DSR may also identify a lower cost pharmacy for the patient to fill existing medications including the ability for pharmacies to interactively insert coupons or rewards into the DSR to motivate patients to change to the new pharmacy. The DSR may include a Shared Patient Savings (SPS) payment claim 26that of the Plan to optimize the use of cost-effective medications.”)
Claims 17,19-20, 22- 25, 28, 30-31 and 33 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over GREEN in view of Knudson et al. (US 20250276249 A1)
Regarding claim 17 GREEN teaches the method of claim 1.
GREEN does not explicitly teach wherein said communications port comprises logic for controlling communications between said computer network platform and external platforms.
Knudson teaches wherein said communications port comprises logic for controlling communications between said computer network platform and external platforms (para, “[0016] For the purposes of this disclosure, a computing platform may include an instrumentality or aggregate of instrumentalities operable to compute, classify, process, transmit, receive, retrieve, originate, switch, store, display, manifest, detect, record, reproduce, handle, or utilize various forms of information, intelligence, or data for business, scientific, control, entertainment, or other purposes. For example, a computing platform may be a personal computer, a PDA, a consumer electronic device, a network storage device, or another suitable device and may vary in size, shape, performance, functionality, and price. The computing platform may include memory, one or more processing resources such as a central processing unit (CPU) or hardware or software control logic. Additional components of the computing platform may include one or more storage devices, one or more communications ports for communicating with external devices as well as various input and output (I/O) devices, such as a keyboard, a mouse, and a video display. The computing platform may also include one or more buses operable to transmit communication between the various hardware components.”)
It would have been obvious for a person of ordinary skill in the art to apply communications control teachings of Knudson into the teachings of GREEN at the time the application was filed in order to transmit communication between different platforms. (Para, ““[0016] .. Additional components of the computing platform may include one or more storage devices, one or more communications ports for communicating with external devices as well as various input and output (I/O) devices, such as a keyboard, a mouse, and a video display. The computing platform may also include one or more buses operable to transmit communication between the various hardware components.” )
Examiner Note: The primary reference already teaches the communication between entities, thus it is inherent that communication control is being provided; however, to teach explicitly that one or more communication port communicate with external platforms, the reference is introduced.
Regarding claim 19, GREEN as modified by Knudson teaches the system of claim 17.
GREEN further teaches further comprising a computer system of a healthcare provider operative for entering said patient information(para, “[0398] The data transformation performed by the speech understanding functionality includes taking the audio signals associated with spoken words and translating them into electronic commands/selections or into electronic text. That transformation can be performed by the processor of the client server 104 or a processor in another system being used by a clinician or other healthcare practice staff member to capture data at the healthcare provider's site 102 (e.g., a tablet computer or client workstation connected to the client server 104 at the healthcare provider's site 102). Or the audio signals can be streamed to a system outside of at the healthcare provider's site 102 for remote processing, such as by the enhanced services server 116 of an IPI provider system or the processor of an external system 142.....”)
Regarding claim 20, GREEN as modified by Knudson teaches the system of claim 17.
GREEN further teaches wherein said patient information is received at said computer network platform via an electronic communication between said computer system of said healthcare provider and said computer network platform in compliance with said applicable regulations concerning electronic transmission of said healthcare related information(para, “[0015] CDS systems are intended to help healthcare providers make decisions that enhance patient care by matching a patient's information to a clinical knowledge base and communicating the appropriate patient-specific assessments and/or recommendations to the healthcare provider at appropriate times during patient care. Some CDS systems include forms and templates for entering and documenting patient data as well as various alerts, reminders, and order sets (i.e., guideline-based interventions) for providing suggestions and other support that are intended to increase healthcare providers' adherence to evidence-based medical knowledge.”
Also, para “[0070] .....The client server 104 also controls communications with the other systems within the IPI 100 and locally stores data collected using the integrated ambulatory suite. The client server 104 is at the center of the EHR system and may be located at a central location at a healthcare provider's site 102 for local communication with each of the client workstations 106. In the alternative, as opposed to being hosted at the healthcare provider's site 102, all of the applications, controls, and data for the integrated ambulatory suite may be remotely hosted at a client server 120 located at a client data center 122......”
Also, para “[0061] The present invention provides a medical software system that integrates each of the systems required to manage the different activities performed at a healthcare practice (e.g., an EMR or EHR system, a CDS system, a patient registration system, a scheduling system, an account management system, a billing system, etc.) on a single technology platform so that duplicate and/or inconsistent data is not captured, stored, and managed by disparate, stand-alone systems. ....”)
Regarding claim 22, GREEN as modified by Knudson teaches the system of claim 20.
GREEN further teaches wherein said information items and said metadata are used in said first and second extracting(para, “[0172] Also in the example of FIG. 7, the user is creating a message (foreground) regarding medication refills using the messaging component 528 of the framework module 508, which is discussed in more detail below. After the user selects the patient name from the patient list, the message is automatically populated with demographic information for the patient that is retrieved from the registration component 524 of the framework module 508. The user may also choose a message template with form fields provided therein for automatically populating other data into the massage. For example, a form field can be provided in a message so that the patient's chief complaint and current medication information from the registration component 524 and/or the clinical module 512 will be also automatically populated in the message.”)
Regarding claim 23, GREEN as modified by Knudson teaches the system of claim 17.
GREEN further teaches wherein said computer network platform comprises logic, executed on a processor, for controlling transmissions in accordance with requirements under one or more of HIPAA and other regulations concerning handling of healthcare related information(para, “[0220] Using that billing data in conjunction with other data captured with the integrated ambulatory suite 500, the service detail entry component 906 will automatically generate a bill, claim, and/or statement for use in obtaining payment from the patient for the procedures, services, and supplies enjoyed by that patient. For example, the service detail entry component 906 will automatically populate all of the required fields in an electronic claim (e.g., a CMS-1500 claim form) without any additional user interaction. Those form fields will be populated with the date of service, time of service, location of service, healthcare provider, patient demographic information, patient medical coverage information, diagnosis codes, billing codes, etc. in a HIPAA compliant format so the claim can be electronically transmitted to a claims clearinghouse 504 as it is completed.”)
Regarding claim 24, GREEN as modified by Knudson teaches the system of claim 17.
GREEN further teaches wherein one of said first and second populated documents comprises a patient support services enrollment form(para, “[0471] By simplifying and facilitating the interactions between research clients and research partners that are required to recruit research clients and get patients enrolled in clinical trials, the present invention provides for completing the enrollment process for a clinical trial in a matter of days instead of months. Accordingly, healthcare providers can quickly begin enrolling candidates, participating in the clinical trials, and receiving reimbursements form clinical trial sponsors or CROs via the functionality of the present invention. And in addition to recruiting research clients and enrolling patients for clinical trials, similar methods can also be utilized for recruiting research clients and enrolling patients for other types of medical research, such as disease registries and quality of care initiatives. Thus, the functionality of the present invention eliminates many, if not all, of the hurdles put in place by HIPAA that otherwise deter healthcare providers from participating in medical research.”)
Regarding claim 25, GREEN as modified by Knudson teaches the system of claim 17.
GREEN further teaches wherein one of said first and second populated documents comprises a prescription form((para, “[0345] In the Medications subsection, the clinician fills in the dosage and amounts for the selected medications, which are used to automatically write a prescription for the patient. Prescriptions may also be written from scratch within the Medications subsection. Both types of prescription writing are facilitated via interaction with the drug information in the reference databases 518 (e.g., the First DataBank, Inc.'s NDDF PLUS brand drug database and the RxNorm coded classification system). That drug information includes descriptions of different drugs as well as unique identifiers and pricing information for each of those drugs. By selecting different drugs from the reference databases 518, the drug selected for the prescription will automatically be linked to its unique identifier and price for use in generating, electronically submitting, and fulfilling the prescription, and for use in generating a bill, claim, or statement for the prescription. The automated prescription process is discussed in more detail below.”)
Regarding claim 28, GREEN as modified by Knudson teaches the system of claim 17.
GREEN further teaches wherein one of said first and second parties comprises a pharmacy(para, “[0317] Authorized users may access the same patient record simultaneously to review patient medical history and vital signs; to capture the patient's history of present illness, review of systems, and physical exam; to document an assessment and plan; and to have orders and prescriptions automatically generated for fulfillment by labs and/or pharmacies. Patient information can be displayed in multiple views and formats, such as text, standard forms, tables, flow sheets, or graphs, to facilitate rapid chart review and determination of the context in which a patient's symptoms occur.”)
Regarding claim 30, GREEN as modified by Knudson teaches the system of claim 17.
GREEN further teaches wherein one of said first and second parties comprises a healthcare provider((para, “[0317] Authorized users may access the same patient record simultaneously to review patient medical history and vital signs; to capture the patient's history of present illness, review of systems, and physical exam; to document an assessment and plan; and to have orders and prescriptions automatically generated for fulfillment by labs and/or pharmacies. Patient information can be displayed in multiple views and formats, such as text, standard forms, tables, flow sheets, or graphs, to facilitate rapid chart review and determination of the context in which a patient's symptoms occur.”)
Regarding claim 31, GREEN as modified by Knudson teaches The system of claim 17.
GREEN further teaches wherein one of said first and second parties comprises a prescription assistance program entity(para, “[0484] The information provides rapid and concise malpractice proof to help the user defend against malpractice claims and HCFA audits. The system also offers the clinician prescription assistance with brand name and generic pricing and dosage, national drug codes, medication lists, allergy cross-checks (drug-drug, drug-food, drug-disease interactions), and side affects. The entry of charges is automated and the resulting documentation is checked for compliance with billing and claims filings”)
Regarding claim 33 , GREEN as modified by Knudson teaches the system of claim 17.
GREEN Knudson does not explicitly teaches wherein said communications port comprises logic for controlling communications between said computer network platform and external platforms.
Knudson further teaches wherein said communications port comprises logic for controlling communications between said computer network platform and external platforms(para, “[0016] For the purposes of this disclosure, a computing platform may include an instrumentality or aggregate of instrumentalities operable to compute, classify, process, transmit, receive, retrieve, originate, switch, store, display, manifest, detect, record, reproduce, handle, or utilize various forms of information, intelligence, or data for business, scientific, control, entertainment, or other purposes. For example, a computing platform may be a personal computer, a PDA, a consumer electronic device, a network storage device, or another suitable device and may vary in size, shape, performance, functionality, and price. The computing platform may include memory, one or more processing resources such as a central processing unit (CPU) or hardware or software control logic. Additional components of the computing platform may include one or more storage devices, one or more communications ports for communicating with external devices as well as various input and output (I/O) devices, such as a keyboard, a mouse, and a video display. The computing platform may also include one or more buses operable to transmit communication between the various hardware components.”)
It would have been obvious for a person of ordinary skill in the art to apply communications control teachings of Knudson into the teachings of GREEN as modified by Knudson at the time the application was filed in order to transmit communication between different platforms. (Para, ““[0016] .. Additional components of the computing platform may include one or more storage devices, one or more communications ports for communicating with external devices as well as various input and output (I/O) devices, such as a keyboard, a mouse, and a video display. The computing platform may also include one or more buses operable to transmit communication between the various hardware components.” )
Examiner Note: The primary reference already teaches the communication between entities, thus it is inherent that communication control is being provided; however, to teach explicitly that one or more communication port communicate with external platforms, the reference is introduced.
Claims 26-27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over GREEN as modified by Knudson and in view of Duffy et al.(US 20220139517 A1)
Regarding claim 26, GREEN as modified by Knudson teaches the system of claim 25.
GREEN as modified by Knudson does not explicitly teach wherein said prescription form comprises a form required under a Risk Evaluation and Mitigation Strategy (REMS).
Duffy teaches wherein said prescription form comprises a form required under a Risk Evaluation and Mitigation Strategy (REMS)( para, “[0013] Improvement: The improvement in this method involves the role of a monitoring hub to coordinate the work process. The improved method comprises one or more of the following steps. The monitoring hub has one or more personnel who are enrolled in the REMS program as a prescriber designee for the clinician. The patient's prescription information is transmitted to the monitoring hub (e.g. by the clinician or the pharmacy). Information about the safety monitoring plan is also transmitted to the monitoring hub (e.g. by the clinician or the laboratory).”)
It would have been obvious for a person of ordinary skill in the art to incorporate Risk Evaluation and Mitigation Strategy (REMS) teachings of Duffy into the teachings of GREEN as modified by Knudson at the time the application was filed in order to transmit patient’s prescription information. (para, para, “[0013] Improvement: The improvement in this method involves the role of a monitoring hub to coordinate the work process. The improved method comprises one or more of the following steps. The monitoring hub has one or more personnel who are enrolled in the REMS program as a prescriber designee for the clinician. The patient's prescription information is transmitted to the monitoring hub (e.g. by the clinician or the pharmacy). Information about the safety monitoring plan is also transmitted to the monitoring hub (e.g. by the clinician or the laboratory).”)
Regarding claim 27, GREEN as modified by Knudson teaches the system of claim 17.
GREEN as modified by Knudson does not explicitly teach wherein one of said first and second populated documents comprises information identifying a source pharmacy for fulfillment of said prescription.
Duffy teaches wherein one of said first and second populated documents comprises information identifying a source pharmacy for fulfillment of said prescription(para, “[0031] For the first dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, and that patient's 52 treatment is not interrupted or discontinued. For subsequent dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, that a ‘patient status form’ has been completed in the last 37 days, and that patient's 52 treatment is not interrupted or discontinued. Pharmacy 58 fills the clozapine medication and has it ready for pick-up. A pharmacy transportation service picks-up the clozapine and delivers it to the nursing home for administration to the patient 52.”)
It would have been obvious for a person of ordinary skill in the art to apply identifying a pharmacy teachings of Duffy into the teachings of GREEN as modified by Knudson at the time the application was filed in order to verify that treatment is not interrupted or discontinued. ((para, “[0031] For the first dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, and that patient's 52 treatment is not interrupted or discontinued. For subsequent dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, that a ‘patient status form’ has been completed in the last 37 days, and that patient's 52 treatment is not interrupted or discontinued. Pharmacy 58 fills the clozapine medication and has it ready for pick-up. A pharmacy transportation service picks-up the clozapine and delivers it to the nursing home for administration to the patient 52.”)
Regarding claim 29, GREEN as modified by Knudson and Duffy teaches the system of claim 27.
GREEN as modified by Knudson and Duffy does not explicitly teach wherein said source pharmacy comprises a certified pharmacy under a Risk Evaluation and Mitigation Strategy (REMS).
Duffy further teaches wherein said source pharmacy comprises a certified pharmacy under a Risk Evaluation and Mitigation Strategy (REMS)(para, “[0031] For the first dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, and that patient's 52 treatment is not interrupted or discontinued. For subsequent dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, that a ‘patient status form’ has been completed in the last 37 days, and that patient's 52 treatment is not interrupted or discontinued. Pharmacy 58 fills the clozapine medication and has it ready for pick-up. A pharmacy transportation service picks-up the clozapine and delivers it to the nursing home for administration to the patient 52.”)
It would have been obvious for a person of ordinary skill in the art to apply identifying a pharmacy teachings of Duffy into the teachings of GREEN as modified by Knudson and Duffy at the time the application was filed in order to verify that treatment is not interrupted or discontinued. ((para, “[0031] For the first dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, and that patient's 52 treatment is not interrupted or discontinued. For subsequent dispensing, the REMS program 90 could verify that pharmacy 58 is certified, that patient 52 is enrolled, that a ‘patient status form’ has been completed in the last 37 days, and that patient's 52 treatment is not interrupted or discontinued. Pharmacy 58 fills the clozapine medication and has it ready for pick-up. A pharmacy transportation service picks-up the clozapine and delivers it to the nursing home for administration to the patient 52.”)
Claims 32, are rejected under 35 U.S.C. 103 as being unpatentable over GREEN as modified by Knudson and in view of FOTSCH et al. (US 20210313032 A1)
Regarding claim 32, GREEN as modified by Knudson teaches the system of claim 17.
GREEN further teaches wherein said computer network platform is further operative for storing said patient information( para, “[0207] The patient information component 902 supports the management and maintenance of patient information, including access, retrieval, and storage. For example, if a user wishes to access and retrieve patient demographic information (e.g., patient name, date of birth, and payor ID), the patient information component 902 communicates with the registration component 524 of the framework module 508, which is used to capture that information during a registration or check-in process and/or to import that information from a legacy system database 520. And to accesses and retrieve specific coverage information (e.g., amounts covered by payor), the patient information component 902 communicates with the A/R administration component 900, which is used to capture that information from the sources that maintain it (e.g., Medicare, insurance companies, etc.).”)
GREEN as modified by Knudson does not explicitly teach :
receiving an indication of a change to a new pharmacy, and third providing a third populated document to said new pharmacy.
FOTSCH teaches :
receiving an indication of a change to a new pharmacy, and third providing a third populated document to said new pharmacy para, “[0012] Described herein are methods and systems for controlling the operation of one or more prescription cost savings systems, including methods and systems for the interactive and dynamic generation of Drug Savings Reports. Specifically, described herein are methods and systems that enable the efficient and cost-effective creation of Drug Savings Reports (“DSRs”) (by Pharmacist or other authorized users) to identify therapeutic alternatives for existing prescription medications including costs, from a variety of distributed third party sources of information, including incorporating Pharmacist, Payer coverage rules and provider preferences. These systems and methods (e.g., computer-operated methods, including software) may aggregated, configure and schedule inquiries (“queries”) into a diverse set of third-party databases in order to generate on or a number (including very large numbers) of DSRs that may include current medications as found in payer claims files and may include them in the DSR for medication reconciliation purposes including comparison to the EHR-based medication list. These systems may also be configured to incorporate pharmacist and provider preferences and in particular, may allow interactive inclusion of alternative drugs that are always presented or always excluded either in general or on a patient-specific basis. Preferences may be identified automatically through claims data or cost transparency transactions to include alternatives selected by Providers and those not selected. The DSR may also identify a lower cost pharmacy for the patient to fill existing medications including the ability for pharmacies to interactively insert coupons or rewards into the DSR to motivate patients to change to the new pharmacy. The DSR may include a Shared Patient Savings (SPS) payment or reward for the patient that further aligns the financial interest of the patient with that of the Plan to optimize the use of cost-effective medications.”)
It would have been obvious for a person of ordinary skill in the art to incorporate changing pharmacy teachings of FOTSCH into the teachings of GREEN as modified by Knudson at the time the application was filed in order to lower cost of prescription.(para, “[0012]..... Preferences may be identified automatically through claims data or cost transparency transactions to include alternatives selected by Providers and those not selected. The DSR may also identify a lower cost pharmacy for the patient to fill existing medications including the ability for pharmacies to interactively insert coupons or rewards into the DSR to motivate patients to change to the new pharmacy. The DSR may include a Shared Patient Savings (SPS) payment or reward for the patient that further aligns the financial interest of the patient with that of the Plan to optimize the use of cost-effective medications.”)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10170204 B1 “The inventions disclosed herein include methods, systems, and tools for use in processing prescriptions. Among the benefits of these methods, systems, and tools are promotion of efficiency in filling prescriptions and reduction of errors. A heightened analysis element may be established that alerts a pharmaceutical professional to a particular component of a prescription (a prescription element) for special attention. An insignificant differences notice may de-emphasize certain prescription elements to inform a pharmaceutical professional that the information of such prescription elements is less critical. Methods of the present invention may be used to designate a prescription as a renewal, partial renewal, or partially equivalent renewal. The disclosed inventions include methods of creating and/or using such heightened analysis elements, insignificant differences notices, and/or designation of a prescription as a renewal, partial renewal, or partially equivalent renewal..”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HUMA WASEEM whose telephone number is (571)272-1316. The examiner can normally be reached Monday-Friday(9:00 am - 5 pm) EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason B. Dunham can be reached on (571) 272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HUMA WASEEM/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
Prosecution Insights