DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 73-92 are currently pending in this case and have been examined and
addressed below. This communication is a Non-Final Rejection in response to the
Amendment to the Claims and Remarks filed on 07/08/2025.
Claims 73-92 are new claims.
Claims 1-72 have been cancelled and will not be considered at this time.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/12/2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 73-92 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 73-92 are drawn to methods and a system, which are statutory categories of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 73 recites a system comprising (i) receive an identifier for said individual;(ii) associate said identifier with a first phase of a plurality of phases of a medical care encounter experienced by said individual;(iii) provide, to a first user, a first action to treat said individual during said first phase of said plurality of phases of said medical care encounter experienced by said individual; (i) receive said identifier for said individual;(ii) associate said identifier with a second phase of a plurality of phases of a medical care encounter experienced by said individual;(iii) provide, to a second user, a second action to treat said individual during said second phase of said plurality of phases of said medical care encounter experienced by said individual; and wherein said plurality of phases are selected from a group consisting of: an assessment phase, a diagnostic phase, a resuscitation phase, a pre-procedure phase, a procedure phase, a post-procedure phase, critical care phase, after care phase, or discharge.
Independent claim 82 recites a method comprising (a) receiving an identifier for said individual;(b) associating said identifier with each phase of a plurality of phases of a medical care encounter experienced by said individual; and (c) providing, to a user, an action to treat said individual during each phase of said plurality of phases of said medical care encounter experienced by said individual; wherein said plurality of phases are selected from a group consisting of: an assessment phase, a diagnostic phase, a resuscitation phase, a pre-procedure phase, a procedure phase, a post-procedure phase, critical care phase, after care phase, or discharge.
These steps amount to certain methods of organizing human activity which includes functions relating to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people – also note MPEP § 2106.04(a)(2)(II) stating certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping).
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
Claim 73 recites a first non-transitory computer readable medium encoded with first software configured to cause a first processor and a second non-transitory computer readable medium encoded with second software configured to cause a second processor. Claim 82 recites a computer.
These elements are recited at a high-level of generality such that it amounts to mere instructions to apply the exception because this is an example of applying the abstract idea by use of general-purpose computer which does not integrate the abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component.
Claim 73 recites a first non-transitory computer readable medium encoded with first software configured to cause a first processor and a second non-transitory computer readable medium encoded with second software configured to cause a second processor. Claim 82 recites a computer.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide generic computer implementation.
For the reasons stated, these claims fail to amount to significantly more than the abstract idea and are consequently rejected under 35 U.S.C. § 101.
Analysis of Dependent Claims
Dependent claim 76 and 83 recite wherein said identifier for said individual comprises a name or medical record number of said individual.
Dependent claim 78 and 84 recite wherein said first user or said second user comprises a healthcare professional selected from the group consisting of a physician, an emergency medical technician, a nurse, a paramedic, a nurse practitioner, a physician's assistant, a nurse's aide, and an x-ray technician.
Dependent claim 79 recites wherein said first user or said second user is not a healthcare provider.
Dependent claim 80 recites wherein said first action or said second action comprises at least one of a diagnosis, administering therapeutic, administering a dosage of said therapeutic, or a timing of delivery of said therapeutic.
Dependent claim 81 recites wherein said first action or said second action comprises a protocol comprising a hospital protocol; a protocol customized to said individual; an evidence-based protocol, or a combination thereof.
Dependent claim 85 recites wherein said first action or said second action comprises a diagnosis.
Dependent claim 86 recites wherein said action comprises at least one of administering a therapeutic, administering a dosage of said therapeutic, or a timing of delivery of said therapeutic.
Dependent claim 87 recites wherein said action comprises a protocol comprising a hospital protocol; a protocol customized to said individual; an evidence-based protocol, or a combination thereof.
Dependent claim 89 recites comprising providing to said user a first action in a first phase and a different user a second action in a second phase.
Dependent claim 90 recites comprising receiving an input from said first user which at least partially determines said second action.
Dependent claim 92 recites comprising tracking an outcome of said medical care encounter or whether said action is followed at each of said plurality of phases.
Each of these steps of the preceding dependent claims 76, 78-81, 83-87, 89-90, and 92 only serve to further limit or specify the features of independent claims 73 or 82 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim(s).
Dependent claim 74 recites wherein said first processor or said second processor is a component of a second computing device. The computing device is an additional element, which is mere instructions to apply the exception and does not provide a practical application or significantly more for the same reasons.
Dependent claim 75 recites wherein said first non-transitory medium or said second non- transitory medium is a component of a remote server. The remote server is an additional element, which is mere instructions to apply the exception and does not provide a practical application or significantly more for the same reasons.
Dependent claim 77 recites wherein said system further comprises a barcode reader and said software is configured to cause said first processor to receive said identifier from said barcode reader. The barcode reader is an additional element, which is mere instructions to apply the exception and does not provide a practical application or significantly more for the same reasons.
Dependent claim 88 recites comprising receiving an input from said user indicating that said user completed at least a portion of said protocol using a processor.
Dependent claim 91 recites wherein said method comprises a software configured to further cause said processor to receive data from an electronic medical record of said individual.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 91 and rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 91 recites the limitation "said processor" in Line 2. There is insufficient antecedent basis for this limitation in the claim. The claims from which they depend (Claim 82) make no mention of a processor. Furthermore, any mention of a processor in the Specification and in the claims is either referred to as a first processor or a second processor.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 73, 76-77, 80-83, and 85-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dettinger (US 20160086297 A1) in view of Chandrasenan (US 20140025392 A1).
REGARDING CLAIM 73
Dettinger teaches a system for treating an individual comprising:
(a) a first non-transitory computer readable medium encoded with first software configured to cause a first processor to: ([Para. 0007] a computer-readable storage medium storing instructions, which, when executed on a processor,)
(ii) associate said identifier with a first phase of a plurality of phases of a medical care encounter experienced by said individual; ([Para. 0048] The care provider 101 may enter a name and an identifier of a patient to associate with a care plan. [Para. 0031] Each care plan protocol may be divided into different phases. The phases may represent different stages of care for a particular condition, e.g., a recovery phase, a maintenance phase, etc., where each phase may include a respective set of tasks for the patient to perform, observation metrics to monitor, observation thresholds to detect when the monitored metrics satisfy specified conditions. For example, a care protocol for weight management may include several phases. A patient 103 may begin the care protocol at a weight loss phase (i.e. first phase), where tasks may include performing strenuous exercises frequently, and where thresholds may specify further actions that the care plan management application 111 takes if the patient 103 loses X amount of weight or gains Y amount of weight. Continuing the example, if the patient 103 loses X amount of weight during a given period, the care plan management application 111 may transition the care protocol to a weight maintenance phase (i.e. second phase), where tasks may include exercises that assist the patient 103 in maintaining the weight.)
(iii) provide, to a first user, a first suggestion for caring for said individual during said first phase of said plurality of phases of said medical care encounter experienced by said individual; ([Para. 0006] Generating a care plan that describes an overall treatment regimen for a patient. The method generally includes receiving, via a processor, a selection of one or more care protocol templates to assign to the patient. Each selected care protocol template is associated with a treatment regimen for a corresponding medical condition. A care plan is generated based on each of the selected care protocol templates. The care plan includes a plurality of items associated with each of the selected care protocol templates. [Para. 0019] A care plan protocol describes the treatment of a particular medical condition. For instance, a care plan could specify a set of specific tasks for a patient (i.e. first user) to follow to manage the particular medical condition and could divide the tasks by phases and schedules. Generally, different care plan protocols may be available for each of a variety of conditions, such as congestive heart failure, diabetes, sprained ankle, etc. In addition, the care protocol may specify metrics that the care platform monitors during the patient's treatment, thresholds to detect for each metric, and remedial actions to be taken in response to detecting such thresholds. One example metric is blood pressure. The blood pressure metric may be associated with thresholds indicating values and conditions in which the care platform performs some action in response to detecting such values and conditions, e.g., sending instructions to the patient to rest for a given period of time. [Para. 0031] A patient 103 may begin the care protocol at a weight loss phase (i.e. first phase), where tasks may include performing strenuous exercises (i.e. first action) frequently, and where thresholds may specify further actions that the care plan management application 111 takes if the patient 103 loses X amount of weight or gains Y amount of weight.)
(b) a second non-transitory computer readable medium encoded with second software configured to cause a second processor to: ([Para. 0072] The program(s) of the program product defines functions and can be contained on a variety of computer-readable storage media Examiner interprets program(s) to be indicative of more than one software (i.e. second software) variety to be indicative of more than one (i.e. second non-transitory computer readable medium). [Para. 0008] a processor.)
(ii) associate said identifier with a second phase of a plurality of phases of a medical care encounter experienced by said individual; ([Para. 0048] The care provider 101 may enter a name and an identifier of a patient to associate with a care plan. [Para. 0031] Each care plan protocol may be divided into different phases. The phases may represent different stages of care for a particular condition, e.g., a recovery phase, a maintenance phase, etc., where each phase may include a respective set of tasks for the patient to perform, observation metrics to monitor, observation thresholds to detect when the monitored metrics satisfy specified conditions. [Para. 0008] Receiving a selection of one or more care protocol templates to assign to the patient. Each selected care protocol template is associated with a treatment regimen for a corresponding medical condition. A care plan is generated based on each of the selected care protocol templates.[Para. 0031] Continuing the example, if the patient 103 loses X amount of weight during a given period, the care plan management application 111 may transition the care protocol to a weight maintenance phase (i.e. second phase), where tasks may include exercises that assist the patient 103 in maintaining the weight.)
(iii)provide, to a second user, a second suggestion for caring for said individual during said second phase of said plurality of phases of said medical care encounter experienced by said individual; ([Para. 0028] The portal user interface 126 itself provides users 102 (e.g., the care providers 101) with access to the care platform server 110. Examiner interprets care providers to be indicative of more than one user (i.e. second user). [Para. 0008] Receiving a selection of one or more care protocol templates to assign to the patient. Each selected care protocol template is associated with a treatment regimen for a corresponding medical condition. A care plan is generated based on each of the selected care protocol templates. The care plan includes a plurality of items associated with each of the selected care protocol templates. Examiner interprets the second phase of said plurality of phases to be indicative of more than one care plan. [Para. 0031] Continuing the example, if the patient 103 loses X amount of weight during a given period, the care plan management application 111 may transition the care protocol to a weight maintenance phase (i.e. second phase), where tasks may include exercises that assist the patient 103 in maintaining the weight (i.e. second suggestion).)
wherein said plurality of phases are selected from a group consisting of: an assessment phase, a diagnostic phase, a resuscitation phase, a pre-procedure phase, a procedure phase, a post- procedure phase, critical care phase, after care phase, or discharge; ([Para. 0031] Each care plan protocol may be divided into different phases. The phases may represent different stages of care for a particular condition, e.g., a recovery phase (i.e. post-procedure phase), a maintenance phase (i.e. after care phase), etc., where each phase may include a respective set of tasks for the patient to perform, observation metrics to monitor, observation thresholds to detect when the monitored metrics satisfy specified conditions. [Para. 0031] For example, a care protocol for weight management may include several phases. A patient 103 may begin the care protocol at a weight loss phase (i.e. procedure phase, first phase), where tasks may include performing strenuous exercises frequently, and where thresholds may specify further actions that the care plan management application 111 takes if the patient 103 loses X amount of weight or gains Y amount of weight. If the patient 103 loses X amount of weight during a given period, the care plan management application 111 may transition the care protocol to a weight maintenance phase (i.e. post-procedure/after care phase, second phase), where tasks may include exercises that assist the patient 103 in maintaining the weight.)
Dettinger does not explicitly teach, however Chandrasenan teaches
(a)(i) receive said identifier for said individual; ([Para. 0013] receiving a treatment instruction and a patient identifier. [Para. 0038] The patient identifier may be a patient ID number, name, Social Security number, address.)
(b)(i) receive said identifier for said individual; ([Para. 0013] receiving a treatment instruction and a patient identifier. [Para. 0038] The patient identifier may be a patient ID number, name, Social Security number, address.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger and incorporate the patient identifier as taught by Chandrasenan, with the motivation of retrieving patient medical information related to the target patient based on the received patient identifier (Chandrasenan Para. 00012).
REGARDING CLAIM 76
Dettinger/ Chandrasenan teach the system of claim 73, Chandrasenan further teaches wherein said identifier for said individual comprises a name or medical record number of said individual. ([Para. 0038] The patient identifier may be a patient ID number, name, Social Security number, address.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger and incorporate the patient identifier as taught by Chandrasenan, with the motivation of retrieving patient medical information related to the target patient based on the received patient identifier (Chandrasenan Para. 00012).
REGARDING CLAIM 77
Dettinger/ Chandrasenan teach system of claim 73, Chandrasenan further teaches wherein said system further comprises a barcode reader and said software is configured to cause said first processor to receive said identifier from said barcode reader. ([Para. 0031] The target patient may be identified with a bar code reader (reading an identifying tag given to the patient). [Para. 0014] transmitting the patient identifier to the processor; and receiving validation information from the processor).
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger and incorporate a barcode reader as taught by Chandrasenan, with the motivation of retrieving patient medical information related to the target patient based on the received patient identifier (Chandrasenan Para. 00012).
REGARDING CLAIM 80
Dettinger/ Chandrasenan teach the system of claim 73, Dettinger further teaches wherein said first suggestion or said second suggestion comprises a diagnosis, a therapeutic, a dosage of said therapeutic, a timing of delivery of said therapeutic, or a combination thereof. ([Para. 0030] A care plan 115 may be created based on one or more care protocols, with each of the care protocols relating to a respective medical condition the patient has been diagnosed with. A care protocol is a set of tasks that a patient 103 follows to manage a certain condition, metrics that the care plan management application 111 monitors, objectives for the patient to meet, and the like. For instance, a care protocol may target recovery from a heart attack (i.e. diagnosis). Another care protocol may treat diabetes (i.e. diagnosis). Tasks associated with a care protocol may include steps such as exercising for a specified duration or taking medication at a certain time of day. [Para. 0035] a care protocol for high blood pressure may include a task instructing a patient to take 75 milligrams of aspirin three times a day, while another care protocol for a sprained ankle includes a task instructing the patient to take 100 milligrams of aspirin three times a day.)
REGARDING CLAIM 81
Dettinger/ Chandrasenan teach the system of claim 73, Dettinger further teaches wherein said first suggestion or said second suggestion comprises a protocol comprising a hospital protocol; a protocol customized to said individual; an evidence-based protocol, or a combination thereof. ([Para. 0006] generating a care plan that describes an overall treatment regimen for a patient. The method generally includes receiving, via a processor, a selection of one or more care protocol templates to assign to the patient. Each selected care protocol template is associated with a treatment regimen for a corresponding medical condition. A care plan is generated based on each of the selected care protocol templates. The care plan includes a plurality of items associated with each of the selected care protocol templates. The method also includes applying a received customization to at least one of the plurality of items in the care plan. [Para. 0031] A care plan 115 may be created based on one or more care protocols, with each of the care protocols relating to a respective medical condition the patient has been diagnosed with. A care protocol is a set of tasks that a patient 103 follows to manage a certain condition, metrics that the care plan management application 111 monitors, objectives for the patient to meet, and the like. [Para. 0034] each customization may be subject to comply with policy information 112 and such compliance may be enforced by the care plan management application 111 during the creation of the care plan. Policy information 112 may include various guidelines (e.g., set by a hospital, standards organization, insurance companies, etc.) that each care protocol must adhere to. For instance, the policy information 112 may specify milligram ranges for certain medications that may be assigned to a patient 103 in a care protocol. The care plan management application 111 may enforce such policy information 112 to ensure a care provider 101 configuring a care plan does not customize tasks beyond the bounds of the policy information 112. [Para. 0057] generating a health care plan that may be customized for an individual.)
REGARDING CLAIM 82
Dettinger teaches a computer implemented method for treating an individual, comprising:
(b) associating said identifier with each phase of a plurality of phases of a medical care encounter experienced by said individual; ([Para. 0048] The care provider 101 may enter a name and an identifier of a patient to associate with a care plan. [Para. 0031] Each care plan protocol may be divided into different phases. The phases may represent different stages of care for a particular condition, e.g., a recovery phase, a maintenance phase, etc., where each phase may include a respective set of tasks for the patient to perform, observation metrics to monitor, observation thresholds to detect when the monitored metrics satisfy specified conditions.)
and (c) providing, to a user, a suggestion for caring for said individual during each phase of said plurality of phases of said medical care encounter experienced by said individual; ([Para. 0006] Generating a care plan that describes an overall treatment regimen for a patient. The method generally includes receiving, via a processor, a selection of one or more care protocol templates to assign to the patient. Each selected care protocol template is associated with a treatment regimen for a corresponding medical condition. A care plan is generated based on each of the selected care protocol templates. The care plan includes a plurality of items associated with each of the selected care protocol templates. [Para. 0019] A care plan protocol describes the treatment of a particular medical condition. For instance, a care plan could specify a set of specific tasks for a patient (i.e. user) to follow to manage the particular medical condition and could divide the tasks by phases and schedules. Generally, different care plan protocols may be available for each of a variety of conditions, such as congestive heart failure, diabetes, sprained ankle, etc. In addition, the care protocol may specify metrics that the care platform monitors during the patient's treatment, thresholds to detect for each metric, and remedial actions to be taken in response to detecting such thresholds. One example metric is blood pressure. The blood pressure metric may be associated with thresholds indicating values and conditions in which the care platform performs some action in response to detecting such values and conditions, e.g., sending instructions to the patient to rest for a given period of time.)
wherein said plurality of phases are selected from a group consisting of: an assessment phase, a diagnostic phase, a resuscitation phase, a pre-procedure phase, a procedure phase, a post- procedure phase, critical care phase, after care phase, or discharge. ([Para. 0031] Each care plan protocol may be divided into different phases. The phases may represent different stages of care for a particular condition, e.g., a recovery phase, a maintenance phase, etc., where each phase may include a respective set of tasks for the patient to perform, observation metrics to monitor, observation thresholds to detect when the monitored metrics satisfy specified conditions. [Para. 0031] For example, a care protocol for weight management may include several phases. A patient 103 may begin the care protocol at a weight loss phase (i.e. assessment phase, first phase), where tasks may include performing strenuous exercises frequently, and where thresholds may specify further actions that the care plan management application 111 takes if the patient 103 loses X amount of weight or gains Y amount of weight. If the patient 103 loses X amount of weight during a given period, the care plan management application 111 may transition the care protocol to a weight maintenance phase (i.e. after care phase, second phase), where tasks may include exercises that assist the patient 103 in maintaining the weight.)
Dettinger does not explicitly teach, however Chandrasenan teaches
receiving an identifier for said individual; ([Para. 0013] receiving a treatment instruction and a patient identifier. [Para. 0038] The patient identifier may be a patient ID number, name, Social Security number, address.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger and incorporate the patient identifier as taught by Chandrasenan, with the motivation of retrieving patient medical information related to the target patient based on the received patient identifier (Chandrasenan Para. 00012).
REGARDING CLAIM 83
Dettinger/ Chandrasenan teach the method of claim 82, Chandrasenan further teaches wherein said identifier for said individual comprises a name or medical record number of said individual. ([Para. 0038] The patient identifier may be a patient ID number, name, Social Security number, address)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger and incorporate the patient identifier as taught by Chandrasenan, with the motivation of retrieving patient medical information related to the target patient based on the received patient identifier (Chandrasenan Para. 00012).
REGARDING CLAIM 85
Dettinger/ Chandrasenan teach the method of claim 82, Dettinger further teaches wherein said first action or said second action comprises a diagnosis. ([Para. 0030] A care plan 115 may be created based on one or more care protocols, with each of the care protocols relating to a respective medical condition the patient has been diagnosed with. A care protocol is a set of tasks that a patient 103 follows to manage a certain condition, metrics that the care plan management application 111 monitors, objectives for the patient to meet, and the like. For instance, a care protocol may target recovery from a heart attack (i.e. diagnosis). Another care protocol may treat diabetes (i.e. diagnosis). Tasks associated with a care protocol may include steps such as exercising for a specified duration or taking medication at a certain time of day.)
REGARDING CLAIM 86
Dettinger/ Chandrasenan teach method of claim 82, Dettinger further teaches wherein said action comprises at least one of administering a therapeutic, administering a dosage of said therapeutic, or a timing of delivery of said therapeutic. ([Para. 0030] A care plan 115 may be created based on one or more care protocols, with each of the care protocols relating to a respective medical condition the patient has been diagnosed with. A care protocol is a set of tasks that a patient 103 follows to manage a certain condition, metrics that the care plan management application 111 monitors, objectives for the patient to meet, and the like. For instance, a care protocol may target recovery from a heart attack (i.e. diagnosis). Another care protocol may treat diabetes (i.e. diagnosis). Tasks associated with a care protocol may include steps such as exercising for a specified duration or taking medication at a certain time of day. [Para. 0030] Another care protocol may treat diabetes. Tasks associated with a care protocol may include steps such as exercising for a specified duration or taking medication at a certain time of day (i.e. timing of delivery of said therapeutic). [Para. 0035] a care protocol for high blood pressure may include a task instructing a patient to take 75 milligrams of aspirin three times a day, while another care protocol for a sprained ankle includes a task instructing the patient to take 100 milligrams of aspirin three times a day.)
REGARDING CLAIM 87
Dettinger/ Chandrasenan teach the method of claim 82, Dettinger further teaches wherein said suggestion comprises a protocol comprising a hospital protocol; a protocol customized to said individual; an evidence-based protocol, or a combination thereof. ([Para. 0006] generating a care plan that describes an overall treatment regimen for a patient. The method generally includes receiving, via a processor, a selection of one or more care protocol templates to assign to the patient. Each selected care protocol template is associated with a treatment regimen for a corresponding medical condition. A care plan is generated based on each of the selected care protocol templates. The care plan includes a plurality of items associated with each of the selected care protocol templates. The method also includes applying a received customization to at least one of the plurality of items in the care plan. [Para. 0031] A care plan 115 may be created based on one or more care protocols, with each of the care protocols relating to a respective medical condition the patient has been diagnosed with. A care protocol is a set of tasks that a patient 103 follows to manage a certain condition, metrics that the care plan management application 111 monitors, objectives for the patient to meet, and the like. [Para. 0034] each customization may be subject to comply with policy information 112 and such compliance may be enforced by the care plan management application 111 during the creation of the care plan. Policy information 112 may include various guidelines (e.g., set by a hospital, standards organization, insurance companies, etc.) that each care protocol must adhere to. For instance, the policy information 112 may specify milligram ranges for certain medications that may be assigned to a patient 103 in a care protocol. The care plan management application 111 may enforce such policy information 112 to ensure a care provider 101 configuring a care plan does not customize tasks beyond the bounds of the policy information 112. [Para. 0057] generating a health care plan that may be customized for an individual.)
REGARDING CLAIM 88
Dettinger/ Chandrasenan teach the method of claim 87, Dettinger further teaches comprising receiving input from said user indicating that said user completed at least a portion of said protocol using said processor. ([Para. 0006] via a processor. [Para. 0031] A patient 103 may begin the care protocol at a weight loss phase, where tasks may include performing strenuous exercises frequently, and where thresholds may specify further actions that the care plan management application 111 takes if the patient 103 loses X amount of weight or gains Y amount of weight. [Para. 0039] When the patient 103 performs a task, the patient 103 records progress in the patient care application 136. The patient care application 136 relays this information to the care plan management application 111. Doing so allows the care provider 101 to monitor vitals of the patient 103 and adherence to the care plan. Further, depending on how the patient 103 responds to the care plan 137, the care plan management application 111 may adjust certain tasks.)
REGARDING CLAIM 89
Dettinger/ Chandrasenan teach the method of claim 82, Dettinger further teaches comprising providing to said user a first action in a first phase and a different user a second action in a second phase. ([Para. 0006] generating a care plan that describes an overall treatment regimen for a patient. The method generally includes receiving, via a processor, a selection of one or more care protocol templates to assign to the patient. Each selected care protocol template is associated with a treatment regimen for a corresponding medical condition. A care plan is generated based on each of the selected care protocol templates. The care plan includes a plurality of items associated with each of the selected care protocol templates. [Para. 0019] a care plan protocol describes the treatment of a particular medical condition. For instance, a care plan could specify a set of specific tasks for a patient to follow to manage the particular medical condition and could divide the tasks by phases and schedules. Generally, different care plan protocols may be available for each of a variety of conditions, such as congestive heart failure, diabetes, sprained ankle, etc. In addition, the care protocol may specify metrics that the care platform monitors during the patient's treatment, thresholds to detect for each metric, and remedial actions to be taken in response to detecting such thresholds. One example metric is blood pressure. The blood pressure metric may be associated with thresholds indicating values and conditions in which the care platform performs some action in response to detecting such values and conditions, e.g., sending instructions to the patient to rest for a given period of time. [Para. 0028] The portal user interface 126 itself provides users 102 (e.g., the care providers 101) with access to the care platform server 110. Examiner interprets care providers to be indicative of more than one user (i.e. second user). [Para. 0008] receiving a selection of one or more care protocol templates to assign to the patient. Each selected care protocol template is associated with a treatment regimen for a corresponding medical condition. A care plan is generated based on each of the selected care protocol templates. The care plan includes a plurality of items associated with each of the selected care protocol templates. Examiner interprets the second phase of said plurality of phases to be indicative of more than one care plan.)
REGARDING CLAIM 90
Dettinger/ Chandrasenan teach the method of claim 82, Dettinger further teaches comprising receiving input from said first user which at least partially determines said second action. ([Para. 0031] a care protocol for weight management may include several phases. A patient 103 may begin the care protocol at a weight loss phase, where tasks may include performing strenuous exercises frequently, and where thresholds may specify further actions that the care plan management application 111 takes if the patient 103 loses X amount of weight or gains Y amount of weight. For example, if the metrics indicate that the patient 103 gained Y amount of weight after a period at which the patient 103 had a Z average activity level, the care plan management application 111 may instruct the patient 103 to watch an educational video in response. Continuing the example, if the patient 103 loses X amount of weight during a given period, the care plan management application 111 may transition the care protocol to a weight maintenance phase, where tasks may include exercises that assist the patient 103 in maintaining the weight. [Para. 0039] When the patient 103 performs a task, the patient 103 records progress in the patient care application 136. The patient care application 136 relays this information to the care plan management application 111. Doing so allows the care provider 101 to monitor vitals of the patient 103 and adherence to the care plan. Further, depending on how the patient 103 responds to the care plan 137, the care plan management application 111 may adjust certain tasks.)
REGARDING CLAIM 91
Dettinger/ Chandrasenan teach the method of claim 82, Dettinger further teaches wherein said method comprises a software configured to further cause said processor to receive data from an electronic medical record of said individual. ([Para. 0007] a computer-readable storage medium storing instructions (i.e. software), which, when executed on a processor, perform an operation for generating a care plan that describes an overall treatment regimen for a patient. The operation itself includes receiving, via a processor, a selection of one or more care protocol templates to assign to the patient. Each selected care protocol template is associated with a treatment regimen for a corresponding medical condition. [0071] Patient information includes patient medical histories and charts. Such histories and charts may provide treatment information that the plan generation component may use.)
REGARDING CLAIM 92
Dettinger/ Chandrasenan teach the method of claim 82, Dettinger further teaches comprising tracking an outcome of said medical care encounter or whether said suggestion is followed at each of said plurality of phases. ([Para. 0032] Each care plan protocol may also include observation thresholds associated with monitored metrics and could further specify an action(s) to be taken responsive to an observation threshold being satisfied. The care platform server 110 may monitor the adherence of a patient 103 through various sensor devices 140 that can measure heart rate, weight, blood pressure, and the like. The care platform server 110 may take specified actions if one of the metrics crosses a corresponding threshold, e.g., if a patient 103 gains 1.5 pounds after a day, the platform server 110 may report the weight gain to the care provider 101. [Para. 0039] When the patient 103 performs a task, the patient 103 records progress in the patient care application 136. The patient care application 136 relays this information to the care plan management application 111. Doing so allows the care provider 101 to monitor vitals of the patient 103 and adherence to the care plan.)
Claim(s) 74 and 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dettinger (US 20160086297 A1) in view of Chandrasenan (US 20140025392 A1) in view of Allen (US 20190074073 A1).
REGARDING CLAIM 74
Dettinger/ Chandrasenan teach the system of claim 73, however Allen teaches wherein said first processor or said second processor is a component of a second computing device. ([Para. 0066] one or more computing devices 104A-D (comprising one or more processors).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger, the patient identifier as taught by Chandrasenan, and incorporate the processors of computing devices as taught by Allen, with the motivation of outputting a treatment recommendation (Allen Abstract).
REGARDING CLAIM 75
Dettinger/ Chandrasenan teach the system of claim 73, however Allen teaches wherein said first non-transitory medium or said second non- transitory medium is a component of a remote server. ([Para. 0029] The computer readable program instructions may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. )
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger, the patient identifier as taught by Chandrasenan, and incorporate teaches a non-transitory medium as taught by Allen, with the motivation of outputting a treatment recommendation (Allen Abstract).
Claim(s) 78-79 and 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dettinger (US 20160086297 A1) in view of Chandrasenan (US 20140025392 A1) in view of Shetty (US 20190057776 A1).
REGARDING CLAIM 78
Dettinger/ Chandrasenan teach the system of claim 73, however Shetty teaches wherein said first user or said second user comprises a healthcare professional selected from the group consisting of a physician, an emergency medical technician, a nurse, a paramedic, a nurse practitioner, a physician's assistant, a nurse's aide, and an x-ray technician. ([Para. 0084] A user 610 can access one or more of the plurality of patient-care applications from clinical application store 602 to provide patient-care in accordance with standard of care clinical protocols. A user 610 accessing clinical applications store 602 can be any one of, a doctor, a physician, a nurse, a care giver, a patient, a practitioner, a lab assistant, a healthcare professional, a clinical expert, a clinical specialist, a software or application developer, an administrator or any other user.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger, the patient identifier as taught by Chandrasenan, and incorporate wherein facilitating delivery of patient-care in adherence with a standard of care clinical protocol as taught by Shetty, with the motivation of encourage adherence and/or drive treatment actions back toward the clinical protocol when divergence is detected (Shetty Para. 0006).
REGARDING CLAIM 79
Dettinger/ Chandrasenan teach the system of claim 73, however Shetty teaches wherein said first user or said second user is not a healthcare provider. ([Para. 0084] A user 610 can access one or more of the plurality of patient-care applications from clinical application store 602 to provide patient-care in accordance with standard of care clinical protocols. A user 610 accessing clinical applications store 602 can be a patient. As Examiner has previously identified the first user as the patient, Examiner interprets the patient to be indicative of said first user is not a healthcare provider.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger, the patient identifier as taught by Chandrasenan, and incorporate wherein facilitating delivery of patient-care in adherence with a standard of care clinical protocol as taught by Shetty, with the motivation of encourage adherence and/or drive treatment actions back toward the clinical protocol when divergence is detected (Shetty Para. 0006).
REGARDING CLAIM 84
Dettinger/ Chandrasenan teach the method of claim 82, however Shetty teaches wherein said user comprises a healthcare professional selected from the group consisting of a physician, an emergency medical technician, a nurse, a paramedic, a nurse practitioner, a physician's assistant, a nurse's aide, and an x-ray technician. ([Para. 0084] A user 610 can access one or more of the plurality of patient-care applications from clinical application store 602 to provide patient-care in accordance with standard of care clinical protocols. A user 610 accessing clinical applications store 602 can be any one of, a doctor, a physician, a nurse, a care giver, a patient, a practitioner, a lab assistant, a healthcare professional, a clinical expert, a clinical specialist, a software or application developer, an administrator or any other user.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of creating individually tailored care plans as taught by Dettinger, the patient identifier as taught by Chandrasenan, and incorporate wherein facilitating delivery of patient-care in adherence with a standard of care clinical protocol as taught by Shetty, with the motivation of encourage adherence and/or drive treatment actions back toward the clinical protocol when divergence is detected (Shetty Para. 0006).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hanov et al. (US 20100179825 A1), which discloses computerized methods in a clinical computing environment for presenting previously customized, patient-specific healthcare plans, orders, phases and/or portions thereof, in association with subsequent patient encounters are provided. The method includes receiving a patient identifier associated with a patient and a particular encounter; receiving an indicator of a condition/diagnosis associated with the patient and the particular encounter; determining that the patient has presented with the condition/diagnosis in association with at least one previous encounter; and presenting at least one order, healthcare plan, phase of a healthcare plan, or portion thereof associated with the at least one previous encounter, wherein the presented at least one order, healthcare plan, phase of a healthcare plan, or portion thereof includes at least one patient-specific customization.
Ensey et al. (US 20180181712 A1), which disclose certain examples provide systems and methods for patient-provider engagement. An example apparatus includes a workflow processor to identify a patient and determine a workflow for patient care, the workflow processor to divide a workflow into phases, each phase associating rules from a rules engine with at least one role, each phase including at least one activity specified by the rules, each activity involving at least one role and at least one associated task, alert, or suggestion for the at least one role specified by the rules, wherein the rules connect the activities of the phases of the workflow to an electronic medical record to automatically provide and receive data for a patient in each phase of the workflow. The example apparatus includes a phase monitor to monitor execution of the phases of the workflow and trigger at least one of the associated task, alert or suggestion.
Kumar et al. (US 20170091421 A1), which discloses mechanisms are provided for implementing a personalized patient care plan (PPCP) system. The PPCP system obtains personal and medical information about the patient and generates a patient registry record in a patient registry. The PPCP system generates a PPCP for the patient, comprising a sequence of goals for the patient, based on an analysis of the obtained personal and medical information. Each goal has an associated patient action to be performed by the patient. The PPCP system monitors performance of the goals to determine, for each goal, whether the associated patient action is performed by the patient. In response to determining that the patient did not perform an associated patient action, the PPCP system modifies a goal of the personalized patient care plan to replace the associated patient action with a replacement patient action that is more likely to be performed by the patient.
Murphy, Clinical decision support: effectiveness in improving quality processes and clinical outcomes and factors that may influence success, which discloses the integration of Clinical Decision Support Systems (CDSS) into the computerized record, providing up-to-date medical knowledge and evidence-based guidance to the physician at the point of care. As reimbursement is increasingly tied to process and clinical outcomes, CDSS will be integral to future medical practice. Studies of CDSS indicate improvement in preventive services, appropriate care, and clinical and cost outcomes with strong evidence for CDSS effectiveness in process measures. Increasing provider adherence to CDSS recommendations is essential in improving CDSS effectiveness, and factors that influence adherence are currently under study.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia K Edouard whose telephone number is (571)272-6084. The examiner can normally be reached Monday - Friday 7:30 AM - 5:00 PM.
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, Peter H Choi can be reached at 469-295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.K.E./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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