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 Claims
Claims 1-2 and 16-17 are currently amended.
Claims 3-5 and 10-15 have been canceled.
Claims 1-2, 6-9 and 16-20 are currently pending.
This is in response to amendments submitted on 09/02/2025.
Priority
The effective filing date for the present application is recognized as 05/30/2023.
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 1-2, 6-9 and 16-20 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 Analysis:
Claims 1-2, 6-9 and 16-20 are directed to a method, apparatus, or system for tracking and encouraging adherence to healthcare instructions and therefore falls into one of the four statutory categories.
(Step 1: Yes, the claim falls into one of the four statutory categories).
Step 2A analysis: Prong one:
The independent Claims 1 and 16, taking Claim 1 as an example, recite the following limitations:
Creating … a plurality of patient files including a patient file associated with a patient managing, … the plurality of patient files; inputting… healthcare instructions into the patient file:transmitting … an invitation to a … patient prompting… the patient to select a username and password and create a user account providing, …, a dashboard of active patients and statuses of the active patients: obtaining … a pre-populated healthcare template …acquiring… healthcare instructions for a patient from a healthcare provider; tracking… the patients' adherence to the healthcare instructions; calculating… an adherence score for the patient based on the patient's adherence to the healthcare instructions; and assigning… rewards to the patient proportional to the patient's adherence score.
The above claim describes a method for creating files, inputting instructions, transmitting an invitation, creating a user account, a dashboard of information, acquiring instructions, tracking adherence to instructions, calculating an adherence score, and assigning a reward to a patient and are thus grouped as “organizing human activity” which is an abstract idea.
The claims involve a series of steps for collecting data, analyzing it, and outputting the results by acquiring healthcare instructions, tracking patient adherence, calculating an adherence score to assign rewards based on adherence score. See MPEP 2106.04. The claims are interpreted to recite concepts relating to tracking or organizing information related to patient adherence data.
Dependent Claims 2, 6-9, and 17-20 are directed towards:
Rewards that come in the form of digital rewards, and healthcare instructions that include instructions for: taking medicines, wound care, dietary recommendations, therapy and activity recommendations as well as
Collecting data, analyzing data, and outputting a response based on the analysis by
implementing a portal with healthcare instructions, implementing a mobile application for tracking adherence to instructions, and prompting a patient to indicate adherence to instructions and are thus grouped as “organizing human activity” which is an abstract idea. Dependent claims 2-9 incorporate all the limitations of Claim 1, dependent claims 11-15 incorporate all the limitations of claim 10, and dependent claims 17-20 incorporate all the limitations of claim 16.
Accordingly, the claims recite “certain methods of organizing human activity,” which falls within the judicial exception of an abstract idea. (Step 2A – Prong one: Yes, the claim is abstract).
Step 2A analysis: Prong two:
Claims 1 and 16 recite additional elements beyond the abstract idea. The judicial exception is not integrated into a practical application. Claim 1 recites one or more processing elements, a mobile application and an administrator portal and Claim 16 recites an administrator portal, a mobile application, and a server.
These additional elements are recited at a high level of generality (i.e., as a generic processor performing generic computer functions), such that it amounts to no more than mere instructions to apply the exceptions using a generic computer component.
The applicant’s specification indicates “one or more processing elements” as “…a processing element, may be implemented as special purpose or as general purpose. For example, the processing element may comprise dedicated circuitry or logic that is permanently configured, such as an application-specific integrated circuit (ASIC), or indefinitely configured, such as an FPGA, to perform certain operations. The processing element may also comprise programmable logic or circuitry (e.g., as encompassed within a general-purpose processor or other programmable processor) that is temporarily configured by software to perform certain operations” (0067) and “Accordingly, the term "processing element" or equivalents should be understood to encompass a tangible entity, be that an entity that is physically constructed, permanently configured (e.g., hardwired), or temporarily configured (e.g., programmed) to operate in a certain manner or to perform certain operations described herein. Considering embodiments in which the processing element is temporarily configured (e.g., programmed), each of the processing elements need not be configured or instantiated at any one instance in time. For example, where the processing element comprises a general- purpose processor configured using software, the general-purpose processor may be configured as respective different processing elements at different times. Software may accordingly configure the processing element to constitute a hardware configuration at one instance of time and to constitute a different hardware configuration at a different instance” (0068) and “Computer hardware components, such as communication elements, memory elements, processing elements, and the like, may provide information to, and receive information from, other computer hardware components” (0069). The specification lacks specificity and technical detail regarding how the processor executes functions and performs operations. The statements describe typical computing operations.
The applicant’s specification indicates an administrator portal as “…the computer programs implement an administrator portal on which a healthcare provider or administrator can create a patient file and input healthcare instructions for the patient” (0005) and “The administrator portal allows users to add and manage patient files at any time” (0040) and “Fig. 10 is a screen display that may be presented by the administrator portal” (0023). The specification lacks specificity and technical detail regarding how the administrator portal manages patient files.
The applicant’s specification recites about a mobile application: “The computer programs also implement mobile applications that are stored on and/or accessed by patients' mobile phones or other personal computing devices. Each mobile application displays a patient's healthcare instructions and prompts the patient to follow them. For example, the mobile application may notify the patient, via pop-up screens, alarms, etc. when to take prescribed medicines, when and how to perform wound care, when and how to perform prescribed exercises, etc. Notifications for healthcare instructions may be sent to the patient's mobile phone via SMS text, email, or other push notices” (0007) and “The mobile application also prompts or otherwise instructs the patient to record when they follow a prescribed healthcare instruction” (0008) and Figures 4-9 are examples of what the mobile application can display and “The computer programs also implement mobile applications that are stored on or accessed by patients via the mobile communication devices 16. Each mobile application displays a patient's healthcare instructions and prompts the patient to follow them. For example, the mobile application may notify the patient, via pop-up screens, alarms, or other ways, when to take prescribed medicines, when and how to perform wound care, when and how to perform prescribed exercises, etc. Notifications for healthcare instructions may be sent to the patient's mobile phone via SMS text, email, or other push notices” (0036). The specification lacks specificity and technical detail regarding how the mobile application displays information and prompts users to follow instructions.
The applicant’s specification recites about a server: “The server(s) 12 may include proxy servers, web servers, communications servers, routers, load balancers, and/or firewall servers, as are commonly known, and may comprise a cloud infrastructure and/or cloud services environment. The server(s) 12 may comprise domain controllers, application servers, database servers, file servers, mail servers, catalog servers or the like, or combinations thereof. The server(s) 12 generally implement a platform for managing receipt, storage, retrieval and analysis of patient data and healthcare instructions. The server(s) 14 may retain electronic data and may respond to requests to retrieve data as well as to store data. Each server 12 includes a processing element, a memory element, a transceiver or communication element, and one or more computer programs” (0026) and “One or more APIs may be maintained by the server(s) 12. The APIs may include and/or provide access to one or more pages or sets of data and/or other content accessed through the World Wide Web (e.g., through the communication network 18) and/or through the internal portion(s) of the network 18. The APIs may be hosted by or stored on a web server and/or database server of the server(s) 14, for example. The APIs may include and/or be access via top-level domains such as ".com", ".org", ".gov", and so forth. The APIs may be accessed using software such as a web browser, through execution of one or more script(s) for obtaining data, and/or by other means for interacting with the APIs without departing from the spirit of the present invention” (0027). The specification lacks specificity and technical detail regarding how the server manages data. These statements describe typical computing operations.
Accordingly, these additional elements when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore Claims 1 and 16 are directed to an abstract idea without practical application. (Step 2A – Prong two: No, the additional elements are not integrated into a practical application).
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements: (1) do not improve the functioning of a computer or any other technology or technical field, and (2) merely use the additional elements for implementing the abstract idea.
A. Improvements to the Functioning of a Computer or To Any Other Technology or Technical
Field. MPEP 2106.05(a)
The additional elements of Claims 1 and 16 do not integrate the abstract idea into a practical application and only use those elements for performing the abstract idea and not more than the judicial exception itself. None of the claims recite an “inventive concept” because the additional elements fail to improve the functioning of a computer or any other technology or technical field (See MPEP 2106.05(a)).
The applicant’s specification indicates “one or more processing elements” as “…a processing element, may be implemented as special purpose or as general purpose. For example, the processing element may comprise dedicated circuitry or logic that is permanently configured, such as an application-specific integrated circuit (ASIC), or indefinitely configured, such as an FPGA, to perform certain operations. The processing element may also comprise programmable logic or circuitry (e.g., as encompassed within a general-purpose processor or other programmable processor) that is temporarily configured by software to perform certain operations” (0067) and “Accordingly, the term "processing element" or equivalents should be understood to encompass a tangible entity, be that an entity that is physically constructed, permanently configured (e.g., hardwired), or temporarily configured (e.g., programmed) to operate in a certain manner or to perform certain operations described herein. Considering embodiments in which the processing element is temporarily configured (e.g., programmed), each of the processing elements need not be configured or instantiated at any one instance in time. For example, where the processing element comprises a general- purpose processor configured using software, the general-purpose processor may be configured as respective different processing elements at different times. Software may accordingly configure the processing element to constitute a hardware configuration at one instance of time and to constitute a different hardware configuration at a different instance” (0068) and “Computer hardware components, such as communication elements, memory elements, processing elements, and the like, may provide information to, and receive information from, other computer hardware components” (0069).
• The applicant’s specification indicates an administrator portal as “…the computer programs implement an administrator portal on which a healthcare provider or administrator can create a patient file and input healthcare instructions for the patient” (0005) and “The administrator portal allows users to add and manage patient files at any time” (0040) and “Fig. 10 is a screen display that may be presented by the administrator portal” (0023).
• The applicant’s specification recites about a mobile application: “The computer programs also implement mobile applications that are stored on and/or accessed by patients' mobile phones or other personal computing devices. Each mobile application displays a patient's healthcare instructions and prompts the patient to follow them. For example, the mobile application may notify the patient, via pop-up screens, alarms, etc. when to take prescribed medicines, when and how to perform wound care, when and how to perform prescribed exercises, etc. Notifications for healthcare instructions may be sent to the patient's mobile phone via SMS text, email, or other push notices” (0007) and “The mobile application also prompts or otherwise instructs the patient to record when they follow a prescribed healthcare instruction” (0008) and Figures 4-9 are examples of what the mobile application can display and “The computer programs also implement mobile applications that are stored on or accessed by patients via the mobile communication devices 16. Each mobile application displays a patient's healthcare instructions and prompts the patient to follow them. For example, the mobile application may notify the patient, via pop-up screens, alarms, or other ways, when to take prescribed medicines, when and how to perform wound care, when and how to perform prescribed exercises, etc. Notifications for healthcare instructions may be sent to the patient's mobile phone via SMS text, email, or other push notices” (0036).
• The applicant’s specification recites about a server: “The server(s) 12 may include proxy servers, web servers, communications servers, routers, load balancers, and/or firewall servers, as are commonly known, and may comprise a cloud infrastructure and/or cloud services environment. The server(s) 12 may comprise domain controllers, application servers, database servers, file servers, mail servers, catalog servers or the like, or combinations thereof. The server(s) 12 generally implement a platform for managing receipt, storage, retrieval and analysis of patient data and healthcare instructions. The server(s) 14 may retain electronic data and may respond to requests to retrieve data as well as to store data. Each server 12 includes a processing element, a memory element, a transceiver or communication element, and one or more computer programs” (0026) and “One or more APIs may be maintained by the server(s) 12. The APIs may include and/or provide access to one or more pages or sets of data and/or other content accessed through the World Wide Web (e.g., through the communication network 18) and/or through the internal portion(s) of the network 18. The APIs may be hosted by or stored on a web server and/or database server of the server(s) 14, for example. The APIs may include and/or be access via top-level domains such as ".com", ".org", ".gov", and so forth. The APIs may be accessed using software such as a web browser, through execution of one or more script(s) for obtaining data, and/or by other means for interacting with the APIs without departing from the spirit of the present invention” (0027).
The claimed additional elements are used in a conventional manner to receive data, retrieve data, process data, store data, update data, etc., and the specification does not disclose any specific technical improvement in how these functions are performed.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing.
There is no indication in the claims or specification that the invention improves the performance, efficiency, security, or functionality of a computer system beyond using generic components to perform a judicial exception. The claims do not improve how computers store, retrieve, transmit, or process data, nor do they enhance any other technical field.
Thus, because the claims fail to recite an improvement to the functioning of a computer or any other technology or technical field, they do not amount to significantly more than the judicial exception itself.
B. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The additional elements of Claims 1 and 16 do not integrate the abstract idea into a practical application and only use those elements for performing the abstract idea and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea (See MPEP 2106.05(f)).
The requirement to execute the claimed steps/functions using one or more processing elements, an administrator portal, a mobile application, a server, etc., are equivalent to adding the words “apply it” on a generic computer and/or mere instructions to implement the abstract idea on a generic computer.
Similarly, the limitations of using a one or more processing elements, an administrator portal, a mobile application, a server, etc., (Claims 1-2, 6-9 and 16-20) are recited at a high level of generality and amount to no more than mere instructions to apply the exception using generic computer components. This/these limitation(s) do/does not impose any meaningful limits on practicing the abstract idea, and therefore do/does not integrate the abstract idea into a practical application (See MPEP 2106.05(f)). (Step 2B: No, the claims do not provide significantly more).
In conclusion, the claims are directed to the abstract idea for managing data and to receive data, retrieve data, process data, store data, update data, transmit data, etc.. The claims do not provide an inventive concept, because the claims do not recite additional elements or a combination of elements that amount to significantly more than the judicial exception of the claims. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology or contains instructions to implement the judicial exception, and the collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, the claims are nonetheless rejected under 35 U.S.C. 101 as being directed to nonstatutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 6 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over US Publication No. 2015/0100343 (“Siedlecki”).
With respect to Claim 1,
Siedlecki teaches A computer-implemented method for tracking and encouraging adherence to healthcare instructions, the method comprising: Siedlecki abstract “A computer-based system and related methods for improving and sustaining patient adherence, compliance and persistence with a medication plan, regimen or regime”).
creating, via one or more processing elements, a plurality of patient files including a patient file associated with a patient (Siedlecki [0026-27] and [0096-97] discloses creating a plurality of patient records associated with a patient, Also see figure 18 – 20 and related text.)
managing, via the one or more processing elements, the plurality of patient files;(Siedlecki [0026-27] and [0096-97] discloses managing a plurality of patient records associated with a patient.)
inputting, via the one or more processing elements, healthcare instructions into the patient file (Siedlecki [0103-110] discloses inputting healthcare instructions into the patient file.)
transmitting, via the one or more processing elements, an invitation to a mobile communication device of the patient to download a mobile application (Siedlecki [0111-112] discloses providing a link to the user to download the system application to their smart phone. Also see figures 1-2 and related text.)
prompting, via the one or more processing elements, the patient to select a username and password and create a user account providing, via an administrator portal, a dashboard of active patients and statuses of the active patients: (Siedlecki [0111-112] discloses that “Patient connects first time to the system through system application, creates final password, verifies data and digitally signs any remaining legal documents.” Also see figures 1-2 and 6 and related text.)
obtaining, via the one or more processing elements, a pre-populated healthcare template: (Siedlecki [0026-27] discloses obtain a pre-populated healthcare template in a mobile application. Also see [0009-0013].)
acquiring, via the one or more processing elements, healthcare instructions for the patient from a healthcare provider; (Siedlecki [0009-0013] discloses acquiring healthcare instructions for the patient from a healthcare provider. Also see [0026-27, 0107].)
the healthcare instructions including at least one of medication lists, medication timing, dietary instructions, dietary timing, activity limitations, activity timing, wound care instructions, and wound care timing; ; (Siedlecki [0009-0013] discloses the healthcare instructions medication lists and medication timing. Also see [0026-27] and figures 7-14 and related text.)
creating, via the one or more processing elements, a patient-specific healthcare plan based on the pre-populated healthcare template and the healthcare instructions for the patient adding, via the one or more processing elements, drug names, drug details, (Siedlecki [0009-0016] discloses the healthcare plan for the patient that includes medication names and details. Also see [0026-27] and figures 7-14 and related text.)
prescribing provider, dosage, start date, end date, and frequency information to the patient-specific healthcare plan: (Siedlecki [0009-0016] discloses prescribing provider, dosage, start date, end date, and frequency information to the patient-specific healthcare plan. Also see [0026-27] and figures 7-14 and related text.)
updating, via the one or more processing elements, the pre-populated healthcare template: (Siedlecki [0009-0016] discloses updating the healthcare plan. Also see [0026-27] and figures 7-14 and related text.)
prompting the patient to check a box next to each healthcare instruction after the instruction is completed listing each drug the patient is supposed to take each day: (Siedlecki [0062-66] and figure 4A-B and 5A-C and related text discloses prompting the user to click a button next to the healthcare instruction. Also see [0026-27] and figures 7-14 and related text. Examiner notes the clicking a button is obvious because it is a substitution of art recognized equivalent to checking a box and is taught in the art to be useful for the same purpose (MPEP 2144.06).)
prompting the patient to indicate when each drug is taken (Siedlecki [0013-15, 0062-66] and figures 4A-B and 5A-C and related text discloses prompting the patient to indicate when each drug is taken. Also see [0026-27] and figures 7-14 and related text.)
tracking, with the one or more processing elements, the patient’s adherence to the healthcare instructions; (Siedlecki [0015-20, 0067, 0088, 0114-117] and figures 3A-B, 7-8 and 12 and related text discloses tracking the patient’s adherence to the healthcare instructions. Also see [0016, 0070] and figures 7-14 and related text.)
calculating, with the one or more processing elements, an adherence score for the patient based on the patient's adherence to the healthcare instructions; (Siedlecki [0015-20, 0067, 0088, 0114-117] and figures 3A-B, 7-8 and 12 and related text discloses calculating an adherence score for the patient based on the patient's adherence to the healthcare instructions. Also see [0016, 0070] and figures 9 and 13-14 and related text.)
if the patient indicates they have taken a prescribed drug or medication within a prescribed time minute window, awarding the patient a pre-defined number of points to an adherence score of the patient adding points to the patient's adherence score each time the patient takes a medication on time: (Siedlecki [0018, 0028, 0058, 0088, 0114-117] and figures 3A-B, 7-8 and 12 and related text discloses awarding the patient points for taking medication and adding to their adherence score for taking medication on time. Also see [0007, 0092, 0097-98] and figures 7-14 and related text.)
implementing a color-coding system in association with the adherence score such that a first color indicates excellent adherence, a second color indicates good adherence, a third color indicates fair adherence, and a fourth color indicates bad adherence to the healthcare plan; (Siedlecki [0067] and figure 12 and related text discloses “The compliance status summary table provides a numerical or percentage score to indicate the user's compliance ratings or status for a variety of measures (e.g., overall compliance, 7-day compliance trend, on-time compliance, critical medications compliance, number of system (Shamrock) alerts, comprehensive system (Shamrock) compliance score). Color (green, yellow, red) and/or indicators (thumbs-up, thumbs-down, plus, minus) may be used to provide visual indications of whether each particular rating or score is good, okay, or needing improvement.” Siedlecki does not expressly disclose four colors as visual indicators, however Siedlecki discloses a combination of colors and/or other indicators to visually indicate the level of the rating and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use any number of colors and/or indicators to visually indicate the level of adherence to the healthcare plan because trying three colors and/or other visual indicators or four colors are predictable solutions for visually distinguishing compliance status and either one has a reasonable expectation of success. Therefore, using a check box or a button is a design choice that is an arbitrary selection from known alternatives that would have been obvious to a person of ordinary skill in the art.)
indicating the current day's adherence to the healthcare instructions in percentage and an aggregate total number of points awarded to the patient (Siedlecki [0018, 0028, 0030, 0058, 0088, 0114-117] and figures 3A-B, 7-8 and 12 and related text discloses continuously updating the patient points for taking medication and indicating their adherence score for taking medication on time including co-pay dollars and total rewards points earned versus potential. Also see [0007, 0092, 0097-98] and figures 9 and 13-14 and related text.)
assigning, with the one or more processing elements, digital rewards to the patient proportional to the patient's adherence score. (Siedlecki [0018, 0028, 0030, 0058, 0088, 0114-117] and figures 3A-B, 7-8 and 12 and related text discloses continuously updating the patient points for taking medication and indicating their adherence score for taking medication on time including co-pay dollars and total rewards points earned versus potential. Also see [0007, 0092, 0097-98] and figures 9 and 13-14 and related text.)
sending daily notifications and reminders of the healthcare instructions to the patient's mobile device: and (Siedlecki [abstract, 0025, 0028, 0030, 0061, 0081] discloses real-time reminders and alerts at the correct point in time for each scheduled medication dose. Also see [0011, 0078, 0095, 0098, 0100] and figures 7-14 and related text.)
displaying the patient's adherence score alongside an associated maximum digital rewards available for successful adherence to the healthcare instructions. (Siedlecki [0018, 0028, 0030, 0058, 0088, 0114-117] and figures 3A-B, 7-14 and related text discloses continuously updating the patient points for taking medication and indicating their adherence score for taking medication on time including co-pay dollars and total rewards points earned versus potential. Also see [0007, 0092, 0097-98].)
PNG
media_image1.png
569
772
media_image1.png
Greyscale
With respect to Claims 2 and 17,
Siedlecki teaches the limitations of Claim 1 and claim 16 respectively
wherein the rewards are digital currencies. (Siedlecki [0018, 0028, 0030, 0058, 0088, 0114-117] and figures 3A-B, 7-8 and 12 and related text discloses continuously updating the patient points for taking medication and indicating their adherence score for taking medication on time including co-pay dollars and total rewards points earned versus potential. Also see [0007, 0092, 0097-98] and figures 9 and 13-14 and related text.)
With respect to Claim 6,
Siedlecki teaches the limitations of Claim 1
wherein the healthcare instructions include instructions for taking medicines. (Siedlecki [0015-20, 0067, 0088, 0114-117] and figures 3A-B, 7-14 and related text discloses tracking the patient’s adherence to the healthcare instructions including taking medications.)
With respect to Claim 16,
A computer system for tracking and encouraging adherence to healthcare instructions, (Siedlecki [0006] discloses “the present invention comprises a system and related methods for improving and sustaining patient adherence, compliance and persistence with a medication plan, regimen or regime”)
the system comprising: an administrator portal programmed acquire healthcare instructions for a patient from a healthcare provider; (Siedlecki [0009-0013, 0103-110] discloses acquiring healthcare instructions for the patient from a healthcare provider portal. Also see [0026-27].)
a mobile application programmed to receive and display the healthcare instructions and to track the patients' adherence to the healthcare instructions; (Siedlecki [0015-20, 0067, 0088, 0114-117] and figures 3A-B, 7-8 and 12 and related text [0028] discloses “the system communicates with the patient on a secure two-way around-the clock ("24/7") real-time basis via smartphone, desktop personal computer, tablet computer, or other mobile device. It provides medication dosing reminders and alerts, adherence barrier solutions, adherence performance scores, and continuous updates regarding co-pay dollars and rewards points earned versus potential.” Also see figures 1A-17 and related text.)
a server, in communication with the administrator portal and the mobile application, programmed to calculate an adherence score for the patient based on the patient's adherence to the healthcare instructions (Siedlecki [0015-20, 0067, 0088, 0114-117] and figures 3A-B, 7-8 and 12 and related text discloses calculating an adherence score for the patient based on the patient's adherence to the healthcare instructions. Further, in [0103-110] Siedlecki discloses inputting healthcare instructions into the patient file in an administrator portal. Also see [0016, 0070] and figures 9 and 13-14 and related text.)
and to assign rewards to the patient proportional to the patient's adherence score. (Siedlecki [0018, 0028, 0058, 0088, 0114-117] and figures 3A-B, 7-8 and 12 and related text discloses awarding the patient points for taking medication and adding to their adherence score for taking medication on time. Also see [0007, 0092, 0097-98] and figures 7-14 and related text.)
wherein the server is configured to implement a color-coding system in association with the adherence score such that dark green indicates excellent adherence, green indicates good adherence, yellow indicates fair adherence, and red color indicates bad adherence to the healthcare plan. (Siedlecki [0067] and figure 12 and related text discloses “The compliance status summary table provides a numerical or percentage score to indicate the user's compliance ratings or status for a variety of measures (e.g., overall compliance, 7-day compliance trend, on-time compliance, critical medications compliance, number of system (Shamrock) alerts, comprehensive system (Shamrock) compliance score). Color (green, yellow, red) and/or indicators (thumbs-up, thumbs-down, plus, minus) may be used to provide visual indications of whether each particular rating or score is good, okay, or needing improvement.” Siedlecki does not expressly disclose four colors as visual indicators, however Siedlecki discloses a combination of colors and/or other indicators to visually indicate the level of the rating and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use any number of colors and/or indicators to visually indicate the level of adherence to the healthcare plan because trying three colors and/or other visual indicators or four colors are predictable solutions for visually distinguishing compliance status and either one has a reasonable expectation of success. Therefore, using a check box or a button is a design choice that is an arbitrary selection from known alternatives that would have been obvious to a person of ordinary skill in the art.)
With respect to Claim 18,
Siedlecki teaches the limitations of Claim 16
wherein the mobile application is programmed to prompt the patient to indicate the patient's adherence to the healthcare instructions via the mobile application. (Siedlecki [0013-15, 0062-66] and figures 4A-B and 5A-C and related text discloses prompting the patient to indicate adherence to healthcare instructions via the mobile application. Also see [0026-27] and figures 7-14 and related text.)
With respect to Claim 19,
Siedlecki teaches the limitations of Claim 16
wherein the mobile application is programmed to display the adherence score. (Siedlecki [0018, 0028, 0030, 0058, 0088, 0114-117] and figures 3A-B, 7-14 and related text discloses continuously updating the patient points for taking medication and indicating their adherence score for taking medication on time including co-pay dollars and total rewards points earned versus potential. Also see [0007, 0092, 0097-98].)
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US Publication No. 2015/0100343 (“Siedlecki”) in view of US Patent Publication No. 2022/0130504 A1 (“Burch”).
With respect to Claim 7,
Siedlecki teaches the limitations of Claim 1
Siedlecki does not teach the limitations taught by Burch
wherein the healthcare instructions include instructions for wound care. (Burch [0024] discloses "A healthcare plan may be any regimen, schedule, activity relating to healthcare and includes, without limitation, any one or more of activities such as administering medication, performing exercises (physical and/or mental), physical therapy, speech therapy, wound care, doctor or other healthcare professional office visits, and in-home visitation from clinicians, nurses, or any other healthcare professional.")
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Siedlecki to include the implementation of wound care in the healthcare instructions as taught by Burch with the motivation to decrease utilization of health care resources, as well as positively affect the quality of life and safety of patients and their informal caregivers (Burch [0005]). In the combination of elements, it would have been obvious to one of ordinary skill in the art to add wound care instructions.
With respect to Claim 9,
Siedlecki teaches the limitations of Claim 1
Siedlecki does not teach the limitations taught by Burch
wherein the healthcare instructions include therapy and/or activity recommendations. (Burch [0024] discloses "A healthcare plan may be any regimen, schedule, activity relating to healthcare and includes, without limitation, any one or more of activities such as administering medication, performing exercises (physical and/or mental), physical therapy, speech therapy, wound care, doctor or other healthcare professional office visits, and in-home visitation from clinicians, nurses, or any other healthcare professional.")
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Siedlecki to include the implementation of therapy and activity recommendations in the healthcare instructions as taught by Burch with the motivation to decrease utilization of health care resources, as well as positively affect the quality of life and safety of patients and their informal caregivers (Burch [0005]). In the combination of elements, it would have been obvious to one of ordinary skill in the art to add therapy and activity recommendations instructions.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US Publication No. 2015/0100343 (“Siedlecki”) in view of US Patent Application Publication No. 2010/0088120 A1 (“Gonzalvo”).
With respect to Claim 8,
Siedlecki teaches the limitations of Claim 1
Siedlecki does not teach the limitations taught by Gonzalvo
Gonzalvo teaches wherein the healthcare instructions include dietary recommendations. ("MedTrackSystem will look into the member 102 height and weight (determines whether the member is obese or not), exercises routines adopted if any, types of food being ingested (meat, fruit, vegetables, type of breads), consumption of alcoholic beverages or the like. From this member surveyed data, MedTrackSystem provides a list of evidence based treatment or treatments to member 102 that may include suggestions that member could start eating more fruits, vegetables, whole wheat bread instead regular enriched bread, avoid drinking sodas or alcoholic beverages, drinking green tea instead, adopt exercise regimens daily or weekly and be re-tested again to see if any improvement in test results have occurred, then the process goes back up to step 3006, where provider 104 MedTrackSystem re-examines the test results again then the control moves down to step 3008 again until the processes finally ends in step 3018.") (Gonzalvo [0156])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Siedlecki to include dietary recommendations as taught by Gonzalvo with the motivation “of preventing a disease in getting into its worse condition but at the same time reduces our health care cost” (Gonzalvo [0168]). In the combination of elements, it would have been obvious to one of ordinary skill in the art to add dietary recommendations.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over US Publication No. 2015/0100343 (“Siedlecki) in view of US Patent Publication No. 2022/0130504 A1 (“Burch”) in view of US Patent Application Publication No. 2010/0088120 A1 (“Gonzalvo”).
With respect to Claim 20,
Siedlecki teaches the limitations of Claim 16
wherein the healthcare instructions include instructions for taking medicines; (Siedlecki [0015-20, 0067, 0088, 0114-117] and figures 3A-B, 7-14 and related text discloses tracking the patient’s adherence to the healthcare instructions including taking medications.)
Siedlecki does not teach the limitations taught by Burch
Burch teaches instructions for wound care; ("A healthcare plan may be any regimen, schedule, activity relating to healthcare and includes, without limitation, any one or more of activities such as administering medication, performing exercises (physical and/or mental), physical therapy, speech therapy, wound care, doctor or other healthcare professional office visits, and in-home visitation from clinicians, nurses, or any other healthcare professional.") (Burch [0024]) (Examiner note: Wound care, therapy, taking medication, physical activity)
Burch does not teach dietary recommendations;
Burch teaches and therapy and/or activity recommendations. ("A healthcare plan may be any regimen, schedule, activity relating to healthcare and includes, without limitation, any one or more of activities such as administering medication, performing exercises (physical and/or mental), physical therapy, speech therapy, wound care, doctor or other healthcare professional office visits, and in-home visitation from clinicians, nurses, or any other healthcare professional.") (Burch [0024]) (Examiner note: Wound care, therapy, taking medication, physical activity)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Siedlecki to include instructions for wound care, and therapy and activity recommendations, as taught by Burch with the motivation to decrease utilization of health care resources, as well as positively affect the quality of life and safety of patients and their informal caregivers (Burch [0005]). In the combination of elements, it would have been obvious to one of ordinary skill in the art to add wound care instructions and therapy and activity recommendations.
Siedlecki and Burch do not teach the limitation taught by Gonzalvo
Gonzalvo teaches dietary recommendations; ("MedTrackSystem will look into the member 102 height and weight (determines whether the member is obese or not), exercises routines adopted if any, types of food being ingested (meat, fruit, vegetables, type of breads), consumption of alcoholic beverages or the like. From this member surveyed data, MedTrackSystem provides a list of evidence based treatment or treatments to member 102 that may include suggestions that member could start eating more fruits, vegetables, whole wheat bread instead regular enriched bread, avoid drinking sodas or alcoholic beverages, drinking green tea instead, adopt exercise regimens daily or weekly and be re-tested again to see if any improvement in test results have occurred, then the process goes back up to step 3006, where provider 104 MedTrackSystem re-examines the test results again then the control moves down to step 3008 again until the processes finally ends in step 3018.") (Gonzalvo [156]) (Examiner note: Dietary recommendations)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Siedlecki and Burch to include dietary recommendations as taught by Gonzalvo with the motivation “of preventing a disease in getting into its worse condition but at the same time reduces our health care cost” (Gonzalvo [0168]). In the combination of elements, it would have been obvious to one of ordinary skill in the art to add dietary recommendations.
Response to Arguments
Applicant’s arguments with respect to the claims rejection under 35 USC 112 have been fully considered and are persuasive. The rejection of claims 1-15 under 35 USC 112 has been withdrawn.
Applicant's arguments relating to the 35 USC 101 rejection have been fully considered but they are not persuasive.
First, Applicant argues that “the specific combination of managing patient files, creating a patient-specific healthcare plan based on a pre-populated healthcare template and the healthcare instructions for the patient, updating the pre-populated healthcare template, and implementing a color-coding system in association with the adherence score such that a first color indicates excellent adherence, a second color indicates good adherence, a third color indicates fair adherence, and a fourth color indicates bad adherence to the healthcare plan correspond to the specific way in McRo of solving the problem of producing accurate and realistic lip synchronization and facial expressions in animated characters, rather than merely claiming the idea of a solution or outcome, and thus are also not directed to an abstract idea. Applicant further respectfully submits implementing a color-coding system in association with the adherence score such that dark green indicates excellent adherence, green indicates good adherence, yellow indicates fair adherence, and red color indicates bad adherence to the healthcare plan, as recited in claim 16 as amended, correspond to the specific way in McRo of solving the problem of producing accurate and realistic lip synchronization and facial expressions in animated characters, rather than merely claiming the idea of a solution or outcome, and thus are also not directed to an abstract”, Examiner disagrees. Adding color to indicate adherence to healthcare instructions is an abstract idea because it is a method of organizing human activity. The colors are to give a person a visual indicator of their compliance to encourage them to be compliant which is clearly organizing human activity. These claims could arguable additionally be directed to a mental process which is also an abstract idea. Adding color to indicate adherence to healthcare instructions in does not correspond to McRo of solving the problem of producing accurate and realistic lip synchronization and facial expressions in animated characters. Adding color to indicate adherence to healthcare instructions is automating a human process using a computer but there is no improvement to the computer or any technology. Applicant has automated a human process without improving the computer and there is nothing in the claim that amounts to significantly more than the abstract idea as shown in the rejection above.
Applicant's arguments With regard to the rejection under 35 USC 103 fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Further, Applicant’s arguments with respect to the rejection under 35 USC 103 are moot because a new ground of rejection has been applied to the claims due to the extensive nature of the amendments to the claims.
Conclusion
The prior art made of Record and not relied upon is considered pertinent to applicant’s disclosure.
Varadan (US 20230181121 A1) describes systems and methods to predict and manage post-surgical recovery
Derrick (US 20210319887 A1) describes a method of treating diabetes informed by social determinants of health
Cohen (WO 2024/137888 A1) describes systems and methods for remote monitoring, engagement, scoring, and feedback for therapy exercise and activities.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA H MUNSON whose telephone number is (571)270-5396. The examiner can normally be reached M-Th 7:30am-5:30pm.
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, Tariq Hafiz can be reached at 571-272-5350. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PATRICIA H MUNSON/Supervisory Patent Examiner, Art Unit 3624