DETAILED ACTION
This is responsive to application 19/000,915 filed on 12/24/2024 in which claims 1-20 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 1-20 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.
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 comprising: receiving a plurality of codes pertaining to an event performed for a patient; mapping the plurality of codes to a taxonomy of data to determine a utilization unit; mapping the utilization unit to ontological data of a medical condition; mapping the ontological data to a knowledge fragment pertaining to the medical condition and the patient; and causing the knowledge fragment to be presented on a computing device of a medical personnel..”
All the limitations above are abstract idea related to organizing human activity with the exception of bold and underlined limitations. Claim language pertains to analyzing codes (e.g. for a medical service) to determine the correct procedure needed to perform for a specific medical condition and analyzing the guidelines associated with it.
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.
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.
Computing device (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))
receiving a plurality of codes (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g))
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 elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
Regarding limitation:
receiving a plurality of codes (i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); )
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.
claims 2-8 further describes the abstract idea recited above with regard to claim 1; in addition, claims contain additional elements of “data structure”, “computing device”, “electronic message”, “text message”, and “repository” , “computer-readable medium”, “processing device”, and “system”.
Under step 2A, prong two, the above recited additional limitations 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 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.
Claims 9-16 are rejected based on same rational as presented with regard to claims 1-8; claims 9-16 present “computer readable medium” claims that correspond to the method of claims 1-8. Claim 9 further includes additional limitation of “a tangible, non-transitory computer readable medium”, and “a processing device.”
Under step 2A, prong two, the above recited additional limitations 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 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.
Claims 17-20 are rejected based on same rational as presented with regard to claims 1-8; claims 17-20 present “system” claims that correspond to the method of claims 1-8. Claim 17 further includes additional limitation of “memory device”, and “a processing device.”
Under step 2A, prong two, the above recited additional limitations 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 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.
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 1-4, 7-12, and 15-20 are rejected under 35 U.S.C. 102a(1) as anticipated by DEW et al. ( US 20180301222 A1)
Regarding claim 1, DEW teaches a method comprising:
receiving a plurality of codes pertaining to an event performed for a patient (para, “ [0022] The present invention comprises an interactive method, platform and system for directing, integrating, documenting, and tracking steps taken by a medical provider during the patient encounter. A medical professional's actions are directed or guided by prescriptive protocols, guidelines, payor requirements, etc. comprising prompts for information that together with the responses create a path through a decision tree or decision engine. The tree comprises a plurality of nodes and a plurality of branches interconnecting the nodes. Each node is associated with an answer to a medical inquiry (clinical examination, medical test result, etc.) and each branch represents a conditional dependency or inquiry between two nodes. A graphical representation of the branches and nodes would appear as a tree. The decision tree can be easily updated as more current medical information becomes available. The invention thus offers optimal patient care (i.e., providing commonly accepted testing and treatment protocols), enters the necessary codes for each test, examination, etc. for the patient's specific medical condition, and documents to details of each patient encounter.”);
mapping the plurality of codes to a taxonomy of data to determine a utilization unit (para, “[0291] The collected data in the form can be mapped to appropriate codes of the ICD-10 classification system for diseases, signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases, thereby reducing the workload of the physician's staff.”
Also, para, [0313] Includes a clinical knowledge base [0314] Reduces risks associated with patient care [0315] Serves as an educational resource for the patient and the physician [0316] Includes radiographic documentation [0317] Includes a diagnosis and compliance engine to ensure that patient treatment is in compliance with payor/insurance carrier requirements [0318] For each medical specialty (e.g., pediatrics or orthopedics) and each condition within that specialty, the system includes all applicable codes, differential diagnoses, an overview of the condition, condition symptoms, examination findings, recommended diagnostic tests, recommended acute and chronic therapies and treatments, outcome and educational resources for use by the physician and the patient. Note: Also, see para 0289-0292, 0301-0310 and 0316-0326);
mapping the utilization unit to ontological data of a medical condition (para, “[0036] As discussed above, health care providers are now required to utilize a new classification system for coding a patient's health conditions and medical procedures. The new system, referred to as ICD-10, is intended to overcome the many administrative issues associated with medical care and payment by payors for that medical care. With the 69,000 codes in ICD-10 and about 14,000 codes in ICD-9, the former code structure is significantly more granular, thereby improving over the latter code structure by providing more information and more precise information, by providing better support for care management, quality measurement and analytics, and by offering improvements in the representation of risks and severity of medical conditions.”
Also, para, “[0037] To accurately code a fracture according to ICD-10, codes related to the site, laterality, type and location of the fracture must be entered. For an angioplasty condition, ICD-9 lists a single code whereas ICD-10 lists 854 codes.” Note: see [0432] for ontology. Also, see para, 0022-0026, and 0432-0442);
mapping the ontological data to a knowledge fragment pertaining to the medical condition and the patient(para, “[0022] The present invention comprises an interactive method, platform and system for directing, integrating, documenting, and tracking steps taken by a medical provider during the patient encounter. A medical professional's actions are directed or guided by prescriptive protocols, guidelines, payor requirements, etc. comprising prompts for information that together with the responses create a path through a decision tree or decision engine. The tree comprises a plurality of nodes and a plurality of branches interconnecting the nodes. Each node is associated with an answer to a medical inquiry (clinical examination, medical test result, etc.) and each branch represents a conditional dependency or inquiry between two nodes. A graphical representation of the branches and nodes would appear as a tree. The decision tree can be easily updated as more current medical information becomes available. The invention thus offers optimal patient care (i.e., providing commonly accepted testing and treatment protocols), enters the necessary codes for each test, examination, etc. for the patient's specific medical condition, and documents to details of each patient encounter. Note: Also, see para, 0432-0442 );
and causing the knowledge fragment to be presented on a computing device of a medical personnel(para, “[0030] The processor is further programmed to; (f) display one or more screens that show a rendering of the selected anatomical subregion and possible findings associated with a condition of the patient as related to the selected anatomical subregion. The renderings depict normal and abnormal conditions of the selected anatomical subregion to assist the user with selecting one or more findings. The processor presents more-detailed renderings (in a drill-down fashion) responsive to the user rolling a cursor or touch screen, for example, over selected regions of the rendering”
Also, para, “[0326] The system of the invention further comprises methods and hardware elements to generate and display a dashboard comprising various elements of the patient encounter. The dashboard may include quality-related metrics regarding: (1) situation awareness components (i.e., determining the relevant prompts for a patient encounter based on knowledge of the patient, e.g., do not ask a male patient about a mammogram); …..”Note: Also, see para , 0326, 0432-0432)
Regarding claim 2, DEW teaches the method of claim 1.
DEW further teaches wherein mapping the plurality of codes to the taxonomy of the data to determine the utilization unit further comprises: performing a stepwise heuristic of adding different portions of the taxonomy of the data during the mapping until a confidence threshold is satisfied(para, “[0022]……. A graphical representation of the branches and nodes would appear as a tree. The decision tree can be easily updated as more current medical information becomes available. The invention thus offers optimal patient care (i.e., providing commonly accepted testing and treatment protocols), enters the necessary codes for each test, examination, etc. for the patient's specific medical condition, and documents to details of each patient encounter.”
Also, para, “[0440] The invention may be considered a diagnosis platform as in one embodiment it provides a diagnosis of the patient's presented condition. The diagnosis is based on symptoms and examination findings that are presented during the patient encounter or based on later-conducted tests. The invention or its constituent rules engine suggests/prompts for additional information to ensure the correct diagnosis is reached. The invention further provides ICD10 coding, Medicare coverage determinations and places all the information into properly structured and categorized registries and dashboards (for example, dashboards to measure the quality of the patient encounter” Note: Also, see para, 0432-0442)
Regarding claim 3, DEW teaches the method of claim 1.
DEW further teaches further comprising determining whether the utilization unit is correctly mapped by setting indicators for the utilization unit based on the ontological data of the medical condition(para, “[0026] For example, a diagnosis based on specific symptoms, findings and other patient medical information (e.g., findings or results from one or more of medical tests, medical procedures, clinical examinations and from other sources that provide patient medical information that is relevant to determining a diagnosis and developing a treatment plan) is more likely to be correct only if all the required elements related to that diagnosis have been entered and entered correctly. Also, compliance with payor coverage rules is assured only if all elements related to payor coverage requirements have been accurately and completely entered (e.g., have all the required medical protocols and guidelines been followed) and the correct diagnostic or treatment codes assigned. In one embodiment these ICD codes are automatically identified and recorded in real time as the user completes the form.” Note: Also, see para, 0301-0310 ).
Regarding claim 4, DEW teaches the method of claim 3.
DEW further teaches further comprising:
responsive to determining the utilization unit is correctly mapped, mapping the utilization unit to the ontological data of the medical condition(para, “[0026] For example, a diagnosis based on specific symptoms, findings and other patient medical information (e.g., findings or results from one or more of medical tests, medical procedures, clinical examinations and from other sources that provide patient medical information that is relevant to determining a diagnosis and developing a treatment plan) is more likely to be correct only if all the required elements related to that diagnosis have been entered and entered correctly. Also, compliance with payor coverage rules is assured only if all elements related to payor coverage requirements have been accurately and completely entered (e.g., have all the required medical protocols and guidelines been followed) and the correct diagnostic or treatment codes assigned. In one embodiment these ICD codes are automatically identified and recorded in real time as the user completes the form.” Note: Also, see para 0279-0288);
and responsive to determining the utilization unit is incorrectly mapped, remapping the plurality of codes to the taxonomy of data to determine another utilization unit(para, “[0283] During data entry, if an item is selected that invalidates a previously selected item a warning message appears on the screen and automatically de-selects the incorrectly selected item. The warning message also explains why the pop up occurred.”
Also, para, “[0440] The invention may be considered a diagnosis platform as in one embodiment it provides a diagnosis of the patient's presented condition. The diagnosis is based on symptoms and examination findings that are presented during the patient encounter or based on later-conducted tests. The invention or its constituent rules engine suggests/prompts for additional information to ensure the correct diagnosis is reached. The invention further provides ICD10 coding, Medicare coverage determinations and places all the information into properly structured and categorized registries and dashboards (for example, dashboards to measure the quality of the patient encounter”. Note: Also, see para 0432-0442.)
Regarding claim 7 , DEW teaches the method of claim 1.
DEW further teaches further comprising mapping the plurality of codes to the taxonomy of data to determine a utilization unit comprises mapping a relationship between the plurality codes and the taxonomy of the data to obtain the utilization unit( para, “[0291] The collected data in the form can be mapped to appropriate codes of the ICD-10 classification system for diseases, signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases, thereby reducing the workload of the physician's staff.
Also, para, “[0289]…….. Mapping of the collected data to knowledge data bases of various health conditions can assist the physician or the computer with the diagnosis process. Note: Also, see para, 0316-0326, 0289-0292)
Regarding claim 8, DEW teaches the method of claim 1.
DEW further teaches wherein the knowledge fragment is provided as input from the computing device associated of the medical personnel, from an electronic medical record system, from a repository of evidence-based guidelines, from a repository of clinical trial results, or some combination thereof(para, “[0047] According to another aspect, the invention comprises and also creates (as described further below) web-based forms that embody a knowledge base, the contents of which are hierarchically presented in a context-sensitive manner. As the form is completed (i.e., the data entered by the user during the patient encounter, for example), the inventive platform performs real-time error checking and data entry validation, and produces standardized reports that can be easily attached to electronic records, used as an input file for a database, or used in a health information exchange. …….”
Also, para, “[0030] The processor is further programmed to; (f) display one or more screens that show a rendering of the selected anatomical subregion and possible findings associated with a condition of the patient as related to the selected anatomical subregion. The renderings depict normal and abnormal conditions of the selected anatomical subregion to assist the user with selecting one or more findings…..” Note: Also, see para, 0432-0442)
Regarding claim 9, DEW teaches a tangible, non-transitory computer-readable medium storing instructions that, when executed, cause a processing device to(see para, 0295):
receive a plurality of codes pertaining to an event performed for a patient(para, “ [0022] The present invention comprises an interactive method, platform and system for directing, integrating, documenting, and tracking steps taken by a medical provider during the patient encounter. A medical professional's actions are directed or guided by prescriptive protocols, guidelines, payor requirements, etc. comprising prompts for information that together with the responses create a path through a decision tree or decision engine. The tree comprises a plurality of nodes and a plurality of branches interconnecting the nodes. Each node is associated with an answer to a medical inquiry (clinical examination, medical test result, etc.) and each branch represents a conditional dependency or inquiry between two nodes. A graphical representation of the branches and nodes would appear as a tree. The decision tree can be easily updated as more current medical information becomes available. The invention thus offers optimal patient care (i.e., providing commonly accepted testing and treatment protocols), enters the necessary codes for each test, examination, etc. for the patient's specific medical condition, and documents to details of each patient encounter.”);
map the plurality of codes to a taxonomy of data to determine a utilization unit(para, “[0291] The collected data in the form can be mapped to appropriate codes of the ICD-10 classification system for diseases, signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases, thereby reducing the workload of the physician's staff.”
Also, para, [0313] Includes a clinical knowledge base [0314] Reduces risks associated with patient care [0315] Serves as an educational resource for the patient and the physician [0316] Includes radiographic documentation [0317] Includes a diagnosis and compliance engine to ensure that patient treatment is in compliance with payor/insurance carrier requirements [0318] For each medical specialty (e.g., pediatrics or orthopedics) and each condition within that specialty, the system includes all applicable codes, differential diagnoses, an overview of the condition, condition symptoms, examination findings, recommended diagnostic tests, recommended acute and chronic therapies and treatments, outcome and educational resources for use by the physician and the patient. );
map the utilization unit to ontological data of a medical condition(para, “[0036] As discussed above, health care providers are now required to utilize a new classification system for coding a patient's health conditions and medical procedures. The new system, referred to as ICD-10, is intended to overcome the many administrative issues associated with medical care and payment by payors for that medical care. With the 69,000 codes in ICD-10 and about 14,000 codes in ICD-9, the former code structure is significantly more granular, thereby improving over the latter code structure by providing more information and more precise information, by providing better support for care management, quality measurement and analytics, and by offering improvements in the representation of risks and severity of medical conditions.”
Also, para, “[0037] To accurately code a fracture according to ICD-10, codes related to the site, laterality, type and location of the fracture must be entered. For an angioplasty condition, ICD-9 lists a single code whereas ICD-10 lists 854 codes.” Note: see [0432] for ontology. );
map the ontological data to a knowledge fragment pertaining to the medical condition and the patient([0022] The present invention comprises an interactive method, platform and system for directing, integrating, documenting, and tracking steps taken by a medical provider during the patient encounter. A medical professional's actions are directed or guided by prescriptive protocols, guidelines, payor requirements, etc. comprising prompts for information that together with the responses create a path through a decision tree or decision engine. The tree comprises a plurality of nodes and a plurality of branches interconnecting the nodes. Each node is associated with an answer to a medical inquiry (clinical examination, medical test result, etc.) and each branch represents a conditional dependency or inquiry between two nodes. A graphical representation of the branches and nodes would appear as a tree. The decision tree can be easily updated as more current medical information becomes available. The invention thus offers optimal patient care (i.e., providing commonly accepted testing and treatment protocols), enters the necessary codes for each test, examination, etc. for the patient's specific medical condition, and documents to details of each patient encounter.);
and cause the knowledge fragment to be presented on a computing device of a medical personnel (para, “[0030] The processor is further programmed to; (f) display one or more screens that show a rendering of the selected anatomical subregion and possible findings associated with a condition of the patient as related to the selected anatomical subregion. The renderings depict normal and abnormal conditions of the selected anatomical subregion to assist the user with selecting one or more findings. The processor presents more-detailed renderings (in a drill-down fashion) responsive to the user rolling a cursor or touch screen, for example, over selected regions of the rendering”
Also, para, “[0326] The system of the invention further comprises methods and hardware elements to generate and display a dashboard comprising various elements of the patient encounter. The dashboard may include quality-related metrics regarding: (1) situation awareness components (i.e., determining the relevant prompts for a patient encounter based on knowledge of the patient, e.g., do not ask a male patient about a mammogram); …..”)
Regarding claim 10, DEW teaches the computer-readable medium of claim 9.
DEW further teaches wherein to map the plurality of codes to the taxonomy of the data to determine the utilization unit, the processing device is further to: perform a stepwise heuristic of adding different portions of the taxonomy of the data during the mapping until a confidence threshold is satisfied(“[0022]……. A graphical representation of the branches and nodes would appear as a tree. The decision tree can be easily updated as more current medical information becomes available. The invention thus offers optimal patient care (i.e., providing commonly accepted testing and treatment protocols), enters the necessary codes for each test, examination, etc. for the patient's specific medical condition, and documents to details of each patient encounter.”
Also, para, “[0440] The invention may be considered a diagnosis platform as in one embodiment it provides a diagnosis of the patient's presented condition. The diagnosis is based on symptoms and examination findings that are presented during the patient encounter or based on later-conducted tests. The invention or its constituent rules engine suggests/prompts for additional information to ensure the correct diagnosis is reached. The invention further provides ICD10 coding, Medicare coverage determinations and places all the information into properly structured and categorized registries and dashboards (for example, dashboards to measure the quality of the patient encounter”))
Regarding claim 11, DEW teaches the computer-readable medium of claim 10.
DEW further teaches wherein the processing device is further to determine whether the utilization unit is correctly mapped by setting indicators for the utilization unit based on the ontological data of the medical condition(para, “[0026] For example, a diagnosis based on specific symptoms, findings and other patient medical information (e.g., findings or results from one or more of medical tests, medical procedures, clinical examinations and from other sources that provide patient medical information that is relevant to determining a diagnosis and developing a treatment plan) is more likely to be correct only if all the required elements related to that diagnosis have been entered and entered correctly. Also, compliance with payor coverage rules is assured only if all elements related to payor coverage requirements have been accurately and completely entered (e.g., have all the required medical protocols and guidelines been followed) and the correct diagnostic or treatment codes assigned. In one embodiment these ICD codes are automatically identified and recorded in real time as the user completes the form.”)
Regarding claim 12, DEW teaches the computer-readable medium of claim 9.
DEW further teaches wherein the processing device is further to:
determine whether the utilization unit is correctly mapped(para, “[0026] For example, a diagnosis based on specific symptoms, findings and other patient medical information (e.g., findings or results from one or more of medical tests, medical procedures, clinical examinations and from other sources that provide patient medical information that is relevant to determining a diagnosis and developing a treatment plan) is more likely to be correct only if all the required elements related to that diagnosis have been entered and entered correctly. Also, compliance with payor coverage rules is assured only if all elements related to payor coverage requirements have been accurately and completely entered (e.g., have all the required medical protocols and guidelines been followed) and the correct diagnostic or treatment codes assigned. In one embodiment these ICD codes are automatically identified and recorded in real time as the user completes the form.”).);
responsive to determining the utilization unit is incorrectly mapped, remap the plurality of codes to the taxonomy of data to determine another utilization unit(para, “[0283] During data entry, if an item is selected that invalidates a previously selected item a warning message appears on the screen and automatically de-selects the incorrectly selected item. The warning message also explains why the pop up occurred.)
Also, para, “[0440] The invention may be considered a diagnosis platform as in one embodiment it provides a diagnosis of the patient's presented condition. The diagnosis is based on symptoms and examination findings that are presented during the patient encounter or based on later-conducted tests. The invention or its constituent rules engine suggests/prompts for additional information to ensure the correct diagnosis is reached. The invention further provides ICD10 coding, Medicare coverage determinations and places all the information into properly structured and categorized registries and dashboards (for example, dashboards to measure the quality of the patient encounter”)
Regarding claim 15 , DEW teaches the computer-readable medium of claim 9.
DEW further teaches wherein the processing device is further to map the plurality of codes to the taxonomy of data to determine a utilization unit comprises mapping a relationship between the plurality codes and the taxonomy of the data to obtain the utilization unit ( para, “[0291] The collected data in the form can be mapped to appropriate codes of the ICD-10 classification system for diseases, signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases, thereby reducing the workload of the physician's staff.
Also, para, “[0289]…….. Mapping of the collected data to knowledge data bases of various health conditions can assist the physician or the computer with the diagnosis process.)
Regarding claim 16 , DEW teaches the computer-readable medium of claim 9.
DEW further teaches wherein the knowledge fragment is provided as input from the computing device associated of the medical personnel, from an electronic medical record system, from a repository of a evidence-based guidelines, from a repository of clinical trial results, or some combination thereof(para, “[0047] According to another aspect, the invention comprises and also creates (as described further below) web-based forms that embody a knowledge base, the contents of which are hierarchically presented in a context-sensitive manner. As the form is completed (i.e., the data entered by the user during the patient encounter, for example), the inventive platform performs real-time error checking and data entry validation, and produces standardized reports that can be easily attached to electronic records, used as an input file for a database, or used in a health information exchange. …….”
Also, para, “[0030] The processor is further programmed to; (f) display one or more screens that show a rendering of the selected anatomical subregion and possible findings associated with a condition of the patient as related to the selected anatomical subregion. The renderings depict normal and abnormal conditions of the selected anatomical subregion to assist the user with selecting one or more findings…..”)
Regarding claim 17, DEW teaches a system comprising:
a memory device storing instructions(see para, 0295);
a processing device communicatively coupled to the memory device, the processing device executes the instructions to (see para, 0295):
receive a plurality of codes pertaining to an event performed for a patient (para, “ [0022] The present invention comprises an interactive method, platform and system for directing, integrating, documenting, and tracking steps taken by a medical provider during the patient encounter. A medical professional's actions are directed or guided by prescriptive protocols, guidelines, payor requirements, etc. comprising prompts for information that together with the responses create a path through a decision tree or decision engine. The tree comprises a plurality of nodes and a plurality of branches interconnecting the nodes. Each node is associated with an answer to a medical inquiry (clinical examination, medical test result, etc.) and each branch represents a conditional dependency or inquiry between two nodes. A graphical representation of the branches and nodes would appear as a tree. The decision tree can be easily updated as more current medical information becomes available. The invention thus offers optimal patient care (i.e., providing commonly accepted testing and treatment protocols), enters the necessary codes for each test, examination, etc. for the patient's specific medical condition, and documents to details of each patient encounter.”);
map the plurality of codes to a taxonomy of data to determine a utilization unit(para, “[0291] The collected data in the form can be mapped to appropriate codes of the ICD-10 classification system for diseases, signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases, thereby reducing the workload of the physician's staff.”
Also, para, [0313] Includes a clinical knowledge base [0314] Reduces risks associated with patient care [0315] Serves as an educational resource for the patient and the physician [0316] Includes radiographic documentation [0317] Includes a diagnosis and compliance engine to ensure that patient treatment is in compliance with payor/insurance carrier requirements [0318] For each medical specialty (e.g., pediatrics or orthopedics) and each condition within that specialty, the system includes all applicable codes, differential diagnoses, an overview of the condition, condition symptoms, examination findings, recommended diagnostic tests, recommended acute and chronic therapies and treatments, outcome and educational resources for use by the physician and the patient. );
map the utilization unit to ontological data of a medical condition(para, “[0036] As discussed above, health care providers are now required to utilize a new classification system for coding a patient's health conditions and medical procedures. The new system, referred to as ICD-10, is intended to overcome the many administrative issues associated with medical care and payment by payors for that medical care. With the 69,000 codes in ICD-10 and about 14,000 codes in ICD-9, the former code structure is significantly more granular, thereby improving over the latter code structure by providing more information and more precise information, by providing better support for care management, quality measurement and analytics, and by offering improvements in the representation of risks and severity of medical conditions.”
Also, para, “[0037] To accurately code a fracture according to ICD-10, codes related to the site, laterality, type and location of the fracture must be entered. For an angioplasty condition, ICD-9 lists a single code whereas ICD-10 lists 854 codes.” Note: see [0432] for ontology. );;
map the ontological data to a knowledge fragment pertaining to the medical condition and the patient(para, “[0022] The present invention comprises an interactive method, platform and system for directing, integrating, documenting, and tracking steps taken by a medical provider during the patient encounter. A medical professional's actions are directed or guided by prescriptive protocols, guidelines, payor requirements, etc. comprising prompts for information that together with the responses create a path through a decision tree or decision engine. The tree comprises a plurality of nodes and a plurality of branches interconnecting the nodes. Each node is associated with an answer to a medical inquiry (clinical examination, medical test result, etc.) and each branch represents a conditional dependency or inquiry between two nodes. A graphical representation of the branches and nodes would appear as a tree. The decision tree can be easily updated as more current medical information becomes available. The invention thus offers optimal patient care (i.e., providing commonly accepted testing and treatment protocols), enters the necessary codes for each test, examination, etc. for the patient's specific medical condition, and documents to details of each patient encounter.);
and cause the knowledge fragment to be presented on a computing device of a medical personnel(para, “[0030] The processor is further programmed to; (f) display one or more screens that show a rendering of the selected anatomical subregion and possible findings associated with a condition of the patient as related to the selected anatomical subregion. The renderings depict normal and abnormal conditions of the selected anatomical subregion to assist the user with selecting one or more findings. The processor presents more-detailed renderings (in a drill-down fashion) responsive to the user rolling a cursor or touch screen, for example, over selected regions of the rendering”
Also, para, “[0326] The system of the invention further comprises methods and hardware elements to generate and display a dashboard comprising various elements of the patient encounter. The dashboard may include quality-related metrics regarding: (1) situation awareness components (i.e., determining the relevant prompts for a patient encounter based on knowledge of the patient, e.g., do not ask a male patient about a mammogram); …..”)
Regarding claim 18, DEW teaches the system of claim 17.
DEW further teaches wherein to map the plurality of codes to the taxonomy of the data to determine the utilization unit, the processing device is further to: perform a stepwise heuristic of adding different portions of the taxonomy of the data during the mapping until a confidence threshold is satisfied(para, “[0022]……. A graphical representation of the branches and nodes would appear as a tree. The decision tree can be easily updated as more current medical information becomes available. The invention thus offers optimal patient care (i.e., providing commonly accepted testing and treatment protocols), enters the necessary codes for each test, examination, etc. for the patient's specific medical condition, and documents to details of each patient encounter.”
Also, para, “[0440] The invention may be considered a diagnosis platform as in one embodiment it provides a diagnosis of the patient's presented condition. The diagnosis is based on symptoms and examination findings that are presented during the patient encounter or based on later-conducted tests. The invention or its constituent rules engine suggests/prompts for additional information to ensure the correct diagnosis is reached. The invention further provides ICD10 coding, Medicare coverage determinations and places all the information into properly structured and categorized registries and dashboards (for example, dashboards to measure the quality of the patient encounter”)
Regarding claim 19, DEW teaches the system of claim 18.
DEW further teaches wherein the processing device is further to determine whether the utilization unit is correctly mapped by setting indicators for the utilization unit based on the ontological data of the medical condition(para, “[0026] For example, a diagnosis based on specific symptoms, findings and other patient medical information (e.g., findings or results from one or more of medical tests, medical procedures, clinical examinations and from other sources that provide patient medical information that is relevant to determining a diagnosis and developing a treatment plan) is more likely to be correct only if all the required elements related to that diagnosis have been entered and entered correctly. Also, compliance with payor coverage rules is assured only if all elements related to payor coverage requirements have been accurately and completely entered (e.g., have all the required medical protocols and guidelines been followed) and the correct diagnostic or treatment codes assigned. In one embodiment these ICD codes are automatically identified and recorded in real time as the user completes the form.”).
Regarding claim 20, DEW teaches the system of claim 17.
DEW further teaches wherein the processing device is further to:
determine whether the utilization unit is correctly mapped(para, “[0026] For example, a diagnosis based on specific symptoms, findings and other patient medical information (e.g., findings or results from one or more of medical tests, medical procedures, clinical examinations and from other sources that provide patient medical information that is relevant to determining a diagnosis and developing a treatment plan) is more likely to be correct only if all the required elements related to that diagnosis have been entered and entered correctly. Also, compliance with payor coverage rules is assured only if all elements related to payor coverage requirements have been accurately and completely entered (e.g., have all the required medical protocols and guidelines been followed) and the correct diagnostic or treatment codes assigned. In one embodiment these ICD codes are automatically identified and recorded in real time as the user completes the form.”).);
responsive to determining the utilization unit is incorrectly mapped, remap the plurality of codes to the taxonomy of data to determine another utilization unit (para, “[0283] During data entry, if an item is selected that invalidates a previously selected item a warning message appears on the screen and automatically de-selects the incorrectly selected item. The warning message also explains why the pop up occurred.
Also, para, “[0440] The invention may be considered a diagnosis platform as in one embodiment it provides a diagnosis of the patient's presented condition. The diagnosis is based on symptoms and examination findings that are presented during the patient encounter or based on later-conducted tests. The invention or its constituent rules engine suggests/prompts for additional information to ensure the correct diagnosis is reached. The invention further provides ICD10 coding, Medicare coverage determinations and places all the information into properly structured and categorized registries and dashboards (for example, dashboards to measure the quality of the patient encounter”)
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 5-6, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over DEW in view of Ofek et al. (US 20120215560 A1)
Regarding claim 5, DEW teaches the method of claim 1.
DEW further teaches wherein mapping the ontological data to the knowledge fragment pertaining to the medical condition and the patient further comprises:
mapping the ontological data to a difference between the ontological data and a data structure pertaining to the patient and the medical condition(para, “[0308] Audit protection is provided by automatically assigning the correct diagnostic and procedural codes to each diagnosis and procedure and by raising “red flags” when required input information is not entered”);
determining the knowledge fragment based on the difference(para, “[0440] The invention may be considered a diagnosis platform as in one embodiment it provides a diagnosis of the patient's presented condition. The diagnosis is based on symptoms and examination findings that are presented during the patient encounter or based on later-conducted tests. The invention or its constituent rules engine suggests/prompts for additional information to ensure the correct diagnosis is reached.”);
DEW does not explicitly teach
and performing, based on the first knowledge fragment, an intervention.
Ofek teaches:
and performing, based on the first knowledge fragment, an intervention (para, “[0991] "Manual Intervention" typically includes a set of features in the Smart Agent which enable the system to locate, within a patient record, an item of information that may be relevant for the end user in the context of the workflow. As an example, a health provider-user may be prescribing a new medication to the patient. According to certain embodiments, capturing the prescribed medication enables to search for a drug interaction or an allergy within the HIE patient record. It is appreciated that finding the relation between the prescribed medication in a given EMR and the ability to identify kind of relations to other clinical artifacts within the patient record, are not trivial, e.g. because the clinical concepts terminology is unknown to the HIE. Also, since the terminology used for the medication is unknown, there may be no ability to manage the relations to other clinical concepts.”
It would have been obvious for a person of ordinary skill in the art to apply intervention teachings of Ofek into the teachings of DEW at the time the application was filed in order to enable the provider to prescribe a medication to the patient. (Ofek , para, “[0991] "Manual Intervention" typically includes a set of features in the Smart Agent which enable the system to locate, within a patient record, an item of information that may be relevant for the end user in the context of the workflow. As an example, a health provider-user may be prescribing a new medication to the patient. According to certain embodiments, capturing the prescribed medication enables to search for a drug interaction or an allergy within the HIE patient record…”)
Regarding claim 6, DEW teaches the method of claim 1.
DEW does not explicitly teach further comprising performing an intervention based on the knowledge fragment, wherein the intervention comprises transmitting an action instruction to a display of a computing device, transmitting an electronic message, transmitting a text message, making a telephone call, dispatching a person, or some combination thereof.
Ofek teaches performing an intervention based on the knowledge fragment, wherein the intervention comprises transmitting an action instruction to a display of a computing device, transmitting an electronic message, transmitting a text message, making a telephone call, dispatching a person, or some combination thereof(para, [0997] If some or all of features 1-3 above are provided, the SmartAgent is typically operative to present the user with an alert on an allergy to a prescribed medication by intercepting the medication name, locating its concepts in the CTS terminology as a local concept, locating the baseline ontology concept it relates to, locating the related ontology concepts of allergy and, using a given VPO, resolving if an individual patient meets this intervention rule. This is an example of use of the semantics framework provided in the commercially available dbMotion health information exchange system, in order to perform workflow context interception.
Also, para, “[0530]…………. 16. Action's result urgency level: Actions taken and resulting messages may include an urgency level property indicating the urgency with which the message may be treated. An outgoing message should be marked with a proper urgency level indicating the impact of the delivery of that message. SmartWatch findings may be life-saving, but may also be less urgent, and may be treated accordingly. Urgency level may also be a subscription parameter (wants to be notified for very important items) or influence the delivery method (e.g. sometimes must send an SMS in a life-threatening issue).”
It would have been obvious for a person of ordinary skill in the art to apply intervention teachings of Ofek into the teachings of DEW at the time the application was filed in order to enable the provider to prescribe a medication to the patient. (Ofek , para, “[0991] "Manual Intervention" typically includes a set of features in the Smart Agent which enable the system to locate, within a patient record, an item of information that may be relevant for the end user in the context of the workflow. As an example, a health provider-user may be prescribing a new medication to the patient. According to certain embodiments, capturing the prescribed medication enables to search for a drug interaction or an allergy within the HIE patient record…”)
Regarding claim 13, DEW teaches the computer-readable medium of claim 9.
DEW further teaches wherein to map the ontological data to the knowledge fragment pertaining to the medical condition and the patient, the processing device is further to:
map the ontological data to a difference between the ontological data and a data structure pertaining to the patient and the medical condition (para, “[0308] Audit protection is provided by automatically assigning the correct diagnostic and procedural codes to each diagnosis and procedure and by raising “red flags” when required input information is not entered”);
determine the knowledge fragment based on the difference(para, “[0440] The invention may be considered a diagnosis platform as in one embodiment it provides a diagnosis of the patient's presented condition. The diagnosis is based on symptoms and examination findings that are presented during the patient encounter or based on later-conducted tests. The invention or its constituent rules engine suggests/prompts for additional information to ensure the correct diagnosis is reached.”);
DEW does not explicitly teach:
and perform, based on the first knowledge fragment, an intervention.
Ofek teaches:
and perform, based on the first knowledge fragment, an intervention(para, “[0991] "Manual Intervention" typically includes a set of features in the Smart Agent which enable the system to locate, within a patient record, an item of information that may be relevant for the end user in the context of the workflow. As an example, a health provider-user may be prescribing a new medication to the patient. According to certain embodiments, capturing the prescribed medication enables to search for a drug interaction or an allergy within the HIE patient record. It is appreciated that finding the relation between the prescribed medication in a given EMR and the ability to identify kind of relations to other clinical artifacts within the patient record, are not trivial, e.g. because the clinical concepts terminology is unknown to the HIE. Also, since the terminology used for the medication is unknown, there may be no ability to manage the relations to other clinical concepts.”
It would have been obvious for a person of ordinary skill in the art to apply intervention teachings of Ofek into the teachings of DEW at the time the application was filed in order to enable the provider to prescribe a medication to the patient (Ofek , para, “[0991] "Manual Intervention" typically includes a set of features in the Smart Agent which enable the system to locate, within a patient record, an item of information that may be relevant for the end user in the context of the workflow. As an example, a health provider-user may be prescribing a new medication to the patient. According to certain embodiments, capturing the prescribed medication enables to search for a drug interaction or an allergy within the HIE patient record…”)
Regarding claim 14, DEW teaches the computer-readable medium of claim 9.
DEW does not explicitly teach wherein the processing device is further to perform an intervention based on the knowledge fragment, wherein the intervention comprises transmitting an action instruction to a display of a computing device, transmitting an electronic message, transmitting a text message, making a telephone call, dispatching a person, or some combination thereof.
Ofek teaches perform an intervention based on the knowledge fragment, wherein the intervention comprises transmitting an action instruction to a display of a computing device, transmitting an electronic message, transmitting a text message, making a telephone call, dispatching a person, or some combination thereof. para, [0997] If some or all of features 1-3 above are provided, the SmartAgent is typically operative to present the user with an alert on an allergy to a prescribed medication by intercepting the medication name, locating its concepts in the CTS terminology as a local concept, locating the baseline ontology concept it relates to, locating the related ontology concepts of allergy and, using a given VPO, resolving if an individual patient meets this intervention rule. This is an example of use of the semantics framework provided in the commercially available dbMotion health information exchange system, in order to perform workflow context interception.
Also, para, “[0530]…………. 16. Action's result urgency level: Actions taken and resulting messages may include an urgency level property indicating the urgency with which the message may be treated. An outgoing message should be marked with a proper urgency level indicating the impact of the delivery of that message. SmartWatch findings may be life-saving, but may also be less urgent, and may be treated accordingly. Urgency level may also be a subscription parameter (wants to be notified for very important items) or influence the delivery method (e.g. sometimes must send an SMS in a life-threatening issue).”
It would have been obvious for a person of ordinary skill in the art to apply intervention teachings of Ofek into the teachings of DEW at the time the application was filed in order to enable the provider to prescribe a medication to the patient. (Ofek , para, “[0991] "Manual Intervention" typically includes a set of features in the Smart Agent which enable the system to locate, within a patient record, an item of information that may be relevant for the end user in the context of the workflow. As an example, a health provider-user may be prescribing a new medication to the patient. According to certain embodiments, capturing the prescribed medication enables to search for a drug interaction or an allergy within the HIE patient record…”)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20110301982 A1 “An integrated medical software system with embedded transcription functionality is disclosed. The system comprises a clinical module for capturing clinical data for a patient in a first electronic document and a communication component that communicates the clinical data to a rule-based clinical decision support (CDS) system and receives at least one of an alert, warning, reminder, and recommendation back from the CDS system based on the clinical data. The CDS system is configured to compare the clinical data against a knowledge base to identify the at least one of an alert, warning, reminder, and recommendation; the clinical data is serialized into a standardized database language and placed into a first electronic clinical document defined by a clinical document exchange standard before being communicated to the CDS system; and the at least one of an alert, warning, reminder, and recommendation is provided in a second electronic clinical document defined by the clinical document exchange standard when received back from the CDS system.”
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/HUMA WASEEM/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686