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 Claims
This action is in reply to the amendment filed on 04/14/2026.
Claims 1, 3, 4, 18, 20 have been amended and are hereby entered.
Claims 1-20 are currently pending and have been examined.
This action is made final.
Effective Filing Date
This application does not claim priority to any other patent document and is thus afforded a priority date corresponding to the filing date of 10/09/24.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1-19 are drawn to a method, and Claim 20 is drawn to a system, both of which are within the four statutory categories. Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recites implementing the steps of:
determining an initial patient score relating to an initial psychological condition of the patient, comprising receiving information relating to the patient's initial psychological condition;
providing a conversational aspect of a care programme to a patient;
receiving conversational data from the patient in response to generated prompts as part of the conversational aspect of the care programme;
monitoring the patient's intermediate psychological condition during the care programme, comprising receiving information relating to the patient's intermediate psychological condition during the care programme and determining an intermediate patient score relating to the intermediate psychological condition of the patient during the care programme, and
monitoring, during the care programme, the patient's engagement and adherence with the care programme, comprising determining one or more engagement scores, the one or more engagement scores relating to measurements of the patient's interaction with the care programme.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Determining an initial score relating to an initial psychological condition of a patient, engaging in conversational interaction with the patient, monitoring the patient’s intermediate psychological condition and determining an intermediate score relating to the intermediate psychological condition of the patient, and determining patient engagement/adherence to the care programme are personal behaviors that may be performed by mental health professionals.
Independent claim 20 recites similar limitations and also recites an abstract idea under the same analysis.
The above claims are therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
user interface of a patient device as implementing the step of delivering the care programme and receiving free-text conversation data from the patient (Claim 1)
an application delivering the digital care programme, the application comprising an automated conversational agent as implementing the step of providing a conversational aspect of the care programme (Claim 1)
an automated conversational agent as implementing step of generating prompts for the patient to respond to (Claims 1, 20)
a patient device comprising a user interface, a communication interface and an application as implementing the step of delivering the care programme (Claim 20)
“digital” as the type of care programme (Claims 1, 20)
a digital care programme provider system comprising a network connection configured to communicate with the communication interface of the patient device as implementing the steps of determine an initial patient score relating to the initial psychological condition of the patient…, monitor the patients intermediate psychological condition during the digital care programme… and monitor, during the digital care programme, the patient's engagement and adherence with the digital care programme… (Claim 20)
free-text conversational data input as a means of electronically receiving patient conversation via an input device (Claims 1, 20)
the application as implementing the step of receiving free-text conversational data input by the patient (Claims 1, 20)
The broad recitation of the aforementioned general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools.
Regarding the user interface of a patient device / patient device comprising a user interface, a communication interface and an application, per page 20 lines 14-17 of specification, the patient device is understood to be a smartphone or computer. No particulars of the patient device are provided. It is therefore given its broadest reasonable interpretation as a general purpose computing device functioning in its ordinary capacity to implement the steps of the abstract idea. The specification does not appear to provide any particulars of the “user interface” or “communication interface”; Page 97 lines 24-30 disclose, “Display 995 may display a user interface controlled by the conversational agent and 25 provide the frontend introduced above. Tile user interface may allow the user to interact with the digital care programme. Input 996, in the form of a touchscreen or screen and keyboard and/or voice, may be used for user input. The user interface may be embodied as a user app (e.g., the application configured to deliver the care programme) shown on the display and optionally connected to the audio input/output of the user device for voice input and audio output”. Therefore, these elements are given their broadest reasonable interpretation as general purpose computing elements found on a smartphone/computer functioning in their ordinary capacities. Regarding the “application”, this is understood to amount to applying the abstract idea on a computer, e.g., using the application to deliver a care programme to a patient (page 97, lines 28-39, “The user interface may be embodied as a user app (e.g., the application configured to deliver the care programme)”; page 99 lines 28-30, “For example, the steps of the methods described in relation to FIGURE 1 may be performed by the computer code. Similarly, and the application for providing digital care may be executed using computer code”. These elements are therefore given their broadest reasonable interpretation as general purpose computing elements/mere instructions to apply the abstract idea on a computer.
Regarding an application delivering the digital care programme, the application comprising an automated conversational agent: with respect to “application delivering the digital care programme”, this is understood to amount to applying the abstract idea on a computer, e.g., using the application to provide a care programme to a patient (page 97, lines 28-39, “The user interface may be embodied as a user app (e.g., the application configured to deliver the care programme)”; page 99 lines 28-30, “For example, the steps of the methods described in relation to FIGURE 1 may be performed by the computer code. Similarly, and the application for providing digital care may be executed using computer code”. These elements are therefore given their broadest reasonable interpretation as general purpose computing elements/mere instructions to apply the abstract idea on a computer. With respect to “the application comprising an automated conversational agent”, this is understood to amount to applying the abstract idea on a computer; see page 20 line 31-page 21 line 6 (the conversational agent may use a combination of AI models/NLU, specific and tailored elements of Natural Language Generation and a dialogue management system; the conversational agent may interact with the user, primarily through on-screen text; it may ask the user about the relevance of an item or check their understanding; the user may type what they want to say and the conversational agent may employe natural language processing and machine learning techniques to understand and respond appropriately to the user; page 36 discloses that the conversational agent may include ML AI classifiers which may be large language models for interacting with the patient. Therefore, this element only amounts to applying the abstract idea using computing elements functioning in their ordinary capacities.
Regarding “digital” as the type of care programme, this is understood to amount to applying the abstract idea on a general purpose computer, e.g., providing a psychological treatment care programme via a computing device. Per page 20 lines 14-17 of specification, the digital care program may delivered by an application, through a user interface of a patient device such as a smartphone or computer.
Regarding a digital care programme provider system comprising a network connection configured to communicate with the communication interface of the patient device, the specification does not appear to disclose any structural particulars of the provider system. Page 11 line 34-page 12 line 1 merely reiterates the claim language. As discussed above, the communication interface of the patient device is understood to be a general purpose computer/smartphone functioning in its ordinary capacity (page 20 lines 14-17 of specification); page 98 lines 1-3 disclose using “a network, such as the internet” for connecting computing devices via the network. Therefore, these elements are given their broadest reasonable interpretation as general purpose computing elements functioning in their ordinary capacities.
Regarding “free-text conversational data input” this is understood to amount to receiving data electronically per page 20, lines 27-29 (free text may be delivered by text input on a keyboard or audio spoken by user) via a general purpose computing device, such as the patient device which is understood to be a smartphone or similar computer (page 20, lines 15-17).
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
The above claims, as a whole, are therefore directed to an abstract idea.
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 amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1 and 20 only recite the aforementioned computing elements as tools for performing the steps of 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. MPEP 2106.05(f).
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 conventional computer implementation.
Depending Claims
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. For example, Claims 2, 7, 8, 10, 14, 16, 17, 18 recite limitations which further narrow the scope of the independent claims. Claims 3-6, 9, 11-13, 15, 19 further recite limitations that are certain methods of organizing human activity.
Claim 3 recites limitations pertaining to further comprising determining a final patient score relating to the final psychological condition of the patient after completing the care programme, comprising receiving information relating to the patient's final psychological condition comprising at least one of: an interview with the patient by a clinician; and responses by the patient to a questionnaire, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could determine a final score after the patient completes the care programme by reviewing information related to an interview or questionnaire responses. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 4 recites limitations pertaining to further comprising performing clinical escalation comprising intervention by a clinician if at least one of: the intermediate patient scores is below a threshold; and the difference between the initial patient score and the intermediate patient score is above a threshold, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could perform a clinical escalation of the patient based on determining whether the intermediate score is below a threshold or the difference between initial and intermediate scores is above a threshold. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 5 recites limitations pertaining to wherein the clinical escalation comprises direct communication between the clinician and the patient, comprising at least one of: messaging the patient; and communicating with the patient, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could perform a clinical escalation by messaging or communicating with the patient. Recitation of communicating “through the application” or telephone/video calling the patient only amounts to mere instructions to apply the abstract idea electronically. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 6 recites limitations pertaining to wherein the receiving information relating to the patient's intermediate psychological condition during the care programme comprises receiving input from the patient, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could receive information relating to the patient’s intermediate condition during the care program by receiving input from the patient. Recitation of digital programme/”within the application” only amounts to mere instructions to apply the abstract idea using a computer. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 9 recites limitations pertaining to wherein the monitoring the patient's intermediate psychological condition comprises receiving information relating to the patient's intermediate psychological condition at a plurality of pre-determined times during the care programme, and for each of said pre-determined times determining a respective intermediate patient score, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could receive information relating to the patient’s intermediate condition at a plurality of pre-determined times during the care program and determine a respective intermediate score. Recitation of digital programme only amounts to mere instructions to apply the abstract idea using a computer. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 11 recites limitations pertaining to further comprising prompting the patient to interact if the engagement score falls below a threshold, wherein the prompting the patient comprises at least a communication to the patient, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could prompt a patient to increase interaction if their engagement score falls below a threshold, wherein the prompting includes a communication to the patient. Recitation of the application, email, telephone/video call, and text message only amounts to mere instructions to apply the abstract idea electronically/using a computer. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 12 recites limitations pertaining to wherein the monitoring the patient's engagement and adherence with the care programme comprises retrieval of measurements of the patient's interaction with the care programme, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could prompt a obtain measurements of patient interaction with a care programme. Recitation of the digital programme, “automatic” retrieval, application, and patient device only amounts to mere instructions to apply the abstract idea electronically/using a computer. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 13 recites limitations pertaining to providing media content providing a non-conversational aspect of the care programme, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider provide non-conversational contents such as reading material (e.g., printed media) to a patient in a care programme. Recitation of the digital programme and application only amounts to mere instructions to apply the abstract idea electronically/using a computer. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 15 recites limitations pertaining to wherein the determining the engagement score comprises lowering the engagement score when the patient fails to interact completely with a session within an associated time window, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could lower an engagement score when a patient fails to interact completely within an associated time window. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 19 recites limitations pertaining to wherein the automated conversational agent additionally uses generative artificial intelligence to provide the prompts, which amounts to mere instructions to apply the abstract idea on a computer, e.g., using generative AI to provide prompts. Claim 19 further recites limitations pertaining to further comprising the automated conversational agent, in response to the free-text conversational data input by the patient: deciding whether to provide a generated acknowledgement to the patient in response to the free-text conversational data input using a filtering mechanism configured to avoid inappropriate acknowledgements; and responsive to a decision to provide the generated acknowledgement, outputting the generated acknowledgement produced by processing the input using a generative acknowledgement model, which also amounts to mere instructions to apply the abstract idea on a computer, e.g., using the conversational agent to implement the step of deciding whether to provide a generated acknowledgement to a patient in response to the free text conversational data received from the patient using a filter configured to avoid inappropriate acknowledgements, and subsequently outputting the generated acknowledgement. Recitation of “generative acknowledgement model” is understood to amount to mere instructions to apply the abstract idea on a computer. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
The dependent claims have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of claim 1. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Beyond the limitations which recite the abstract idea, the claims recite additional elements consistent with those identified above with respect to the independent claims which encompass adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The dependent claims recite additional subject matter which amounts to additional elements consistent with those identified in the analysis of Claim 1 above. As discussed above with respect to Claim 1 and integration of the abstract idea into a practical application, recitation of these additional elements only amounts to invoking computers as a tool to perform the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Dependent claims 2-19, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 1-20 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
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.
Claim(s) 1-13, 16-17, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darcy et. al. (US Publication 20250022573A1) in view of Saliman et. al. (US Publication 20170372029A1), and further in view of Bulaj et. al. (US Publication 20170326330A1).
Regarding Claim 1, Darcy discloses:
determining an initial patient score relating to an initial psychological condition of the patient, comprising receiving information relating to the patient's initial psychological condition ([0295] teaches on obtaining baseline levels of depressive/anxiety symptoms (“initial psychological condition”) in study participants, scores were defined by a PHQ-8 score greater or equal to 10, and/or GAD-7 score greater or equal to 10; [0297] further discusses the baseline PHQ-8 and baseline GAD-7 scores – the PHQ-8/GAD-7 baseline scores are interpreted as initial patient scores);
providing, through a user-interface of a patient device, an application delivering the digital care programme ([0047] teaches on a therapeutic application of a user device administering determined digital therapeutic treatment to a user; [0063] teaches on administering, by the user device, therapeutic content as treatment to the user via one or more IPT or CBT tools to the graphical user interface of the user device; [0089], “the present disclosure is configured to treat one or more symptoms of anxiety or depression using particularly configured digital mental health interventions (DMHIs) that are administered to an individual during a prescribed or recommended dosing schedule”), the application comprising an automated conversational agent providing a conversational aspect of the digital care programme ([0078] with respect to Fig. 7, teaches on a process executed by an LLM-based conversation engine that comprises a “rules-based conversation agent” that can selectively interact with a LLM to increase the effectiveness of a digital therapeutic treatment; [0089], “the present disclosure is configured to treat one or more symptoms of anxiety or depression using particularly configured digital mental health interventions (DMHIs) that are administered to an individual during a prescribed or recommended dosing schedule”; [0090] teaches on the specifics of using a conversational agent to optimize engagement with the user, the user being a patient exhibiting symptom(s) of anxiety/depression; the agent can engage in natural language communication with the user; [0091] the conversational agent is configured to communicate with the user conversationally in a manner that exhibits a friendly personality to establish a relationship with the user; the agent is designed to use this relationship to develop a therapeutic alliance with the user; [0096], the conversation agent assists with the treatment of a user’s symptoms of anxiety/depression using a digital therapeutic; [0114] teaches on the conversational agent generating and providing “empathy communication” to the user which is a caring response to the user’s emotional state that expresses detection of the user’s anxiety/depression);
receiving, through a user-interface of the application, free-text conversational data input by the patient in response to prompts generated by the automated conversational agent as part of the conversational aspect of the digital care programme ([0103] teaches on a triggering engine configured to drive adherence of a user to a therapeutic treatment for symptoms of anxiety/depression; the trigger engine achieves this by initiating interactions with the user to determine an emotional state of the user; [0105] teaches on the conversation agent detecting that the user hasn’t interacted with the therapeutic application for more than a threshold period of time and generating a communication to the user, e.g., “Good morning, I have not heard from you for a few days. How are you doing today?” (interpreted as “prompt”) and the user can input a response to the communication into the therapeutic application (a response to the prompt generated by the conversational agent as part of the digital care programme); [0105] teaches on using a messaging application to show the dialogue between the user and the conversation engine, using a messaging application on a smartphone to input a response is interpreted as “free text conversation data”; [0165] further teaches on the system transmitting a survey to a user in the form of email/text message to obtain feedback from the user; the survey is interpreted as a prompt; the feedback engine can instruct the conversation engine to interact with the user of the user device in order to elicit feedback regarding the therapeutic treatment from the user; the conversation can provide all or a portion of the conversation thread to the feedback engine (“conversation thread” is interpreted as indicating a conversational aspect of the program/receiving free text from the patient); [0303] further describes this exploratory trial of an NLP-supported relational agent that “converses via text message”);
monitoring an [final] psychological condition of the patient [after] the digital care programme ([0298]-[0301] teach on monitoring the patient’s PHQ-8 and GAD-7 test scores at 9 weeks, the study endpoint), comprising receiving information relating to the patient's intermediate psychological condition [after] the digital care programme and determining [a final] patient score relating to the [final] psychological condition of the patient [after] the digital care programme ([0298] teaches on depressive symptoms, PHQ-8 scores of participants “significantly decreased” over the 9-week study period; [0299] teaches on PHQ-8 Week 9 score changes between baseline and Week 9 (endpoint), e.g., data regarding scores is known for Week 9 (final score) if it can be determined how scores changed; [0300] teach on average GAD-7 participant scores significantly increasing over the course of the study for anxiety symptoms; Examiner submits that PHQ-8 and GAD-7 are individually administered tests; if baseline values and study endpoint (9 week) data can be compared, it is understood that a final patient score relating to an final (study endpoint) psychological condition was determined in order to perform this comparison), and
monitoring, during the digital care programme, engagement and adherence of the patient with the digital care programme ([0110] teaches on an example of the conversation agent determining a user context of “no prior communication from the user for more than 24 hours” – interpreted as teaching that patient’s engagement is monitored as it is capable of determining patient has not communicated in 24 hours); [0327] teaches on measures of user experience with the generative and rules-based DMHIs including “user engagement” (number of sessions and conversational exchanges)”, which is understood to teach that engagement was monitored if it measured number of sessions and conversational exchanges of users; [0153] teaches on a dosing engine determining a particular duration of treatment should be prescribed for a patient, e.g., 3 times per week for at least 8 weeks; the therapeutic application can be configured to monitor the user’s adherence to the specified dosing schedule and intervene to the extent the user strays from the dosing schedule), comprising determining [engagement data] relating to measurements of interaction of the patient with the application ([0104] teaches on the conversation agent determining that the user has not interacted with the therapeutic application for more than a threshold period of time, e.g., 48 hours – e.g., measuring the patient’s interaction in a 48 hour timespan; [0153] teaches on monitoring adherence to a specified dosing schedule; upon determination that a user has strayed from the dosing schedule, the conversation engine can trigger an accountability conversation to get the user back on schedule).
Darcy discloses determining patient condition at baseline and after program completion (study endpoint) but does not teach on determining intermediate patient condition during the program.
Saliman, which is directed to determining a plurality of wellness scores for patients with regard to a medical condition/treatment teaches monitoring an intermediate condition during a treatment program, comprising receiving information relating to the patient's intermediate condition during the treatment program ([0108] teaches on the term treatment including medical interventions to address mental health issues; [0115] teaches on administering an “outcome measurement device” (OMD) to a patient (e.g., a questionnaire per [0153]); [0119] teaches on analyzing OMD responses to generate one or more scores for a patient such as a wellness score or treatment effectiveness score; [0231] teaches on one or more OMDs, typically in the form of questionnaires, being provided to the patient; See Figs. 17C-17E which provide sample questionnaires delivered to the patient for the patient to answer via the device/application, interpreted as information relating to the patient’s condition; Examiner submits that while the example provided pertains to a patient having a hip replacement treatment per [0108] the system may be used with interventions to address mental health issues; [0244] teaches on providing the same OMD (questionnaire) to the patient at a later timepoint to generate a second score; [0413] teaches on prescribed treatments having a frequency such as weekly, biweekly, daily, etc. – a treatment program; [0414] teaches on extracting a set of improvement scores over a 9 month period, see Fig. 24D; [0415] teaches on rendering a graph showing wellness score values determined in Oct 2015, Nov 2015, Jan 2016, Feb 2016, April 2016, July 2016 while a patient is undergoing treatments A, B, C; any wellness scores between and including Nov 2015-April 2016 are interpreted as indicating the intermediate condition of the patient during treatment); and determining an intermediate patient score relating to the intermediate condition of the patient during the treatment program (per [0021] the treatments may be any form of treatment, e.g., medication or physical therapy; [0413] teaches on prescribed treatments having a frequency such as weekly, biweekly, daily, etc.; [0414] teaches on extracting a set of improvement scores [0416] teaches on a provider viewing how wellness scores for a patient diagnosed with anxiety and depression have changed over a 1-year period; a graph showing the patient’s anxiety and wellness scores is provided; [0415] teaches on rendering a graph showing wellness score values determined in Oct 2015, Nov 2015, Jan 2016, Feb 2016, April 2016, July 2016 while a patient is undergoing treatments A, B, C – any one of the scores between and including Nov 2015 and April 2016 are interpreted as “intermediate” scores relating to the “intermediate” condition of the patient during treatment).
Therefore, 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 teachings of Darcy with these teachings of Saliman, to monitor the patient’s intermediate condition during the care program of Darcy and determine an intermediate score for the intermediate patient condition, with the motivation of tracking progress over time so that a healthcare provider can see how the patient’s condition has improved or deteriorated in response to the treatment and determine the overall effectiveness of the selected treatment on the patient’s medical condition/symptoms (Saliman [0414]).
Darcy discloses determining patient engagement relating to measurements of a patient’s interaction with a digital therapeutics application, but does not explicitly disclose determining an engagement score relating to measurements of a patient’s interaction with a digital therapeutics application. Bulaj, which is directed to digital therapeutic system, teaches:
one or more engagement scores relating to measurements of a patient’s interaction with a digital therapeutics application ([0035] teaches on determining and displaying an engagement score showing the user’s level of engagement with a digital treatment application; the engagement score may be based on usage consistency or level of adherence to a prescribed treatment regimen; it may be a numerical value).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Darcy/Saliman with these teachings of Bulaj to incorporate an engagement score relating to a patient’s interaction with the digital therapeutics application of Darcy/Saliman, with the motivation of providing a quantified score of patient’s engagement to motivate the patient to stay engaged with the treatment application (Fig. 2/[0035]).
Regarding Claim 2, Darcy/Saliman/Bulaj teach the limitations of Claim 1. Darcy further discloses wherein the receiving information relating to the patient's initial psychological condition comprises at least one of: an interview with the patient by a clinician; and responses by the patient to a questionnaire ([0295] teaches on obtaining “baseline levels” of depressive and anxiety symptoms via PHQ-8 and GAD-7, interpreted as questionnaires to which patients provide answers).
Regarding Claim 3, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses further comprising determining a final patient score relating to a final psychological condition of the patient after completing the digital care programme, comprising receiving information relating to the patient's final psychological condition comprising at least one of: an interview with the patient by a clinician; and responses by the patient to a questionnaire ([0297] teaches on completing an “end of study” PHQ-8 and GAD-7 assessment at 9 weeks, which are understood to be questionnaires presented to patients to measure depression/anxiety; [0298]-[0301] teach on details and breakdown of data obtained from PHQ-8 and GAD-7 at 9 week (“9 week score changes”); the patient’s PHQ-8 and GAD-7 test scores at 9 weeks using a PHQ-8 or GAD-7 are interpreted as “responses by the patient to a questionnaire” after completing the digital care programme)
Regarding Claim 4, Darcy/Saliman/Bulaj teach the limitations of Claim 1. Darcy does not disclose, but Saliman further teaches further comprising performing clinical escalation comprising intervention by a clinician if at least one of: the patient score is below a threshold ([0007] teaches on determining that the wellness score falls below a minimum threshold and generating a notification indicating the score is below the threshold to communicate to the electronic device operated by a treatment provider (“clinician”); the notification may include the contact information of the patient and/or link to the patient’s personal electronic device and/or contact information so that the treatment provider may directly call, email or otherwise contact the patient); and the difference between the initial patient score and the intermediate patient score is above a threshold.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the teachings of Darcy/Saliman/Bulaj with these teachings of Saliman, to escalate clinical intervention from a clinician when a patient score is below a threshold, as a lower score may indicate that a patient’s symptoms are relatively more severe than a higher score (Saliman [0127]).
Regarding Claim 5, Darcy/Saliman/Bulaj teach the limitations of Claim 4. Darcy does not disclose, but Saliman further teaches: wherein the clinical escalation comprises direct communication between the clinician and the patient, comprising at least one of: messaging the patient through the application; and telephone or video calling the patient ([0007] teaches on determining that the wellness score falls below a minimum threshold and generating a notification indicating the score is below the threshold to communicate to the electronic device operated by a treatment provider (“clinician”); the notification may include the contact information of the patient and/or link to the patient’s personal electronic device and/or contact information so that the treatment provider may directly call the patient – interpreted as direct communication where the clinician is directly telephone calling the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the teachings of Darcy/Saliman/Bulaj with these teachings of Saliman, to escalate clinical intervention by having the clinician directly call the patient when the score is below a threshold, as a lower score may indicate that a patient’s symptoms are relatively more severe than a higher score (Saliman [0127]).
Regarding Claim 6, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy does not disclose, but Saliman further teaches wherein the receiving information relating to the patient's intermediate condition during the care programme comprises receiving input from the patient within the application ([0014] teaches on providing a medical questionnaire (interpreted as input from the patient) at a plurality of time points, e.g., daily, weekly, monthly, quarterly, biannually (interpreted as “predetermined times during the care program”; see Figs. 17C-17E for receiving information relating to patient’s intermediate condition during a care program which involves receiving input from the patient within the application).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the teachings of Darcy/Saliman/Bulaj with these teachings of Saliman, to receive input from the patient regarding the patient’s condition in response to a questionnaire delivered at pre-determined times during the digital care programme of Darcy/Saliman/Bulaj, in which the condition is the psychological condition of Darcy, with the motivation of obtaining patient-reported treatment outcomes (Saliman [0153]).
Regarding Claim 7, Darcy/Saliman/Bulaj teach the limitations of Claim 6. Darcy does not disclose, but Saliman further teaches wherein the input from the patient within the application comprises input from the patient in response to a questionnaire delivered at pre-determined times during the digital care programme ([0014] teaches on providing a medical questionnaire (interpreted as input from the patient) at a plurality of time points, e.g., daily, weekly, monthly, quarterly, biannually (interpreted as “predetermined times during the care program”; [0170] teaches on a patient receiving OMDs (questionnaires) at post-surgery, 2-, 4-, and 6-week timepoints; [0232] teaches on a schedule of OMDs (questionnaires) being established for a patient based on the treatment plan the patient will receive – interpreted as “pre-determined times”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the teachings of Darcy/Saliman/Bulaj with these teachings of Saliman, to receive input from the patient in response to a questionnaire delivered at pre-determined times during the digital care programme of Darcy/Saliman/Bulaj, with the motivation of monitoring the patient’s wellness over time (Saliman [0014]).
Regarding Claim 8, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses wherein the receiving information relating to the patient's intermediate psychological condition comprises the free-text conversational data input by the patient in response to prompts generated by the automated conversational agent as part of the conversational aspect of the digital care programme ([0092] teaches on a persistent symptom mitigation engine which monitors an individual’s mood/changes in mood/trends in changes in mood after treatment has begun (interpreted as intermediate psychological condition if it is obtained after treatment has begun); the symptom mitigation engine evaluates feedback such as a “natural language response” (interpreted as free text conversation data input by the patient) after administration of a digital therapeutic; based on the evaluation of the received feedback, the symptom mitigation engine can determine changes/trends in mood or ([0093]) can dynamically adjust treatment/dosing schedule based on individual’s response to initial treatment; ([0105] teaches on using a messaging application to show the dialogue between the user and the conversation engine, using a messaging application on a smartphone to input a response is interpreted as “free text conversation data”; [0165] further teaches on the system transmitting a survey to a user in the form of email/text message to obtain feedback from the user; the survey is interpreted as a prompt; the feedback engine can instruct the conversation engine to interact with the user of the user device in order to elicit feedback regarding the therapeutic treatment from the user; the conversation can provide all or a portion of the conversation thread to the feedback engine (interpreted as indicating a conversational aspect of the program/receiving free text from the patient); [0303] further describes this exploratory trial of an NLP-supported relational agent that “converses via text message”).
Regarding Claim 9, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy does not disclose, but Saliman further teaches wherein the monitoring the patient's intermediate condition comprises receiving information relating to the patient's intermediate condition at a plurality of pre-determined times during the care programme, and for each of said pre-determined times determining a respective intermediate patient score ([0108] teaches on the term treatment including medical interventions to address mental health issues; [0115] teaches on administering an “outcome measurement device” (OMD) to a patient (e.g., a questionnaire per [0153]); [0119] teaches on analyzing OMD responses to generate one or more scores for a patient such as a wellness score or treatment effectiveness score; [0231] teaches on one or more OMDs, typically in the form of questionnaires, being provided to the patient; See Figs. 17C-17E which provide sample questionnaires delivered to the patient for the patient to answer via the device/application, interpreted as receiving information relating to the patient’s condition; Examiner submits that while the example provided pertains to a patient having a hip replacement treatment per [0108] the system may be used with interventions to address mental health issues; [0244] teaches on providing the same OMD (questionnaire) to the patient at a later timepoint to generate a second score; [0413] teaches on prescribed treatments having a frequency such as weekly, biweekly, daily, etc. which is interpreted as indicating the treatment program is ongoing; [0414] teaches on extracting a set of improvement scores over a 9 month period for a patient, see Fig. 24D; [0415] teaches on rendering a graph showing wellness score values determined in Oct 2015, Nov 2015, Jan 2016, Feb 2016, April 2016, July 2016 while a patient is undergoing treatments A, B, C; any wellness scores between and including Nov 2015-April 2016 are interpreted as indicating the respective intermediate scores for the intermediate condition of the patient; [0014] teaches on providing a medical questionnaire (interpreted as input from the patient) at a plurality of time points, e.g., daily, weekly, monthly, quarterly, biannually (interpreted as “predetermined times during the care program”; [0170] teaches on a patient receiving OMDs (questionnaires) at post-surgery, 2-, 4-, and 6-week timepoints; [0232] teaches on a schedule of OMDs (questionnaires) being established for a patient based on the treatment plan the patient will receive – interpreted as “pre-determined times”).
Therefore, 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 teachings of Darcy with these teachings of Saliman, to monitor the patient’s intermediate condition during the care program of Darcy by receiving information at a plurality of pred-determined times and determining respective scores for each timepoint, with the motivation of tracking progress over time so that a healthcare provider can see how the patient’s condition has improved or deteriorated in response to the treatment and determine the overall effectiveness of the selected treatment on the patient’s medical condition/symptoms (Saliman [0414]).
Regarding Claim 10, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses wherein the measurements of the patient's interaction with the application comprises at least one of time spent using the application ([0153] teaches on a patient being prescribed a “dosing schedule” of 3 times per week for 8 weeks; the system may monitor the user’s adherence and determine the user has “strayed from the dosing schedule” which is interpreted as indicating that their time spent using the application (times per week) is being monitored); frequency of uses of the application ([0106] teaches on the rules-based conversation agent determining a current user context which may include “frequency of user interaction with the therapeutic application”); progress through the digital care programme (0146] teaches on the system determining that a user of the device has recently completed more than a threshold number of therapeutic lessons, e.g., progress through the care programme); and usage patterns of different aspects of the application.
Regarding Claim 11, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses. further comprising prompting the patient to interact with the application if the engagement falls below a threshold ([0104] teaches on the conversation agent determining that the user has not interacted with the therapeutic application (“engaged”) for more than a threshold amount of time, e.g., 48 hours, the system can generate a general inquiry to the patient such as “Good morning, I have not heard from you for a few days. How are you doing today?”), wherein the prompting the patient comprises at least one of: a communication to the patient via the application ([0104] teaches on the conversation agent determining that the patient has not engaged and sending a general inquiry “Good morning, I have not heard from you for a few days. How are you doing today?”; such communication may be transmitted to the user as a communication and operate as a general inquiry which is transmitted to the user device); and a communication to the patient via email; a communication to the patient via telephone or video call from a clinician; a communication to the patient via text message.
Darcy does not disclose an “engagement score”, but Bulaj further teaches engagement score (Bulaj [0035] teaches on determining and displaying an engagement score showing the user’s level of engagement with a digital treatment application; the engagement score may be based on usage consistency or level of adherence to a prescribed treatment regimen; it may be a numerical value).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify Darcy/Saliman/Bulaj with these teachings of Bulaj to incorporate an engagement score relating to a patient’s interaction with the digital therapeutics application, with the motivation of providing a quantified score of patient’s engagement to motivate the patient to stay engaged with the treatment application (Fig. 2/[0035]).
Regarding Claim 12, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses, wherein the monitoring the patient's engagement and adherence with the digital care programme comprises automatic retrieval from the patient device of the measurements of the patient's interaction with the application ([0104] teaches on determining that the user has not interacted with the conversational therapeutic application for more than a threshold period of time, e.g. 48 hours – a measurement of time between interactions on device; [0146] teaches on the system evaluating the number of recent lessons completed by the user of the device; the system can determine that the user of the user device has consumed (watched/listened/read therapeutic content) more than a threshold number of therapeutic lessons; [0153] teaches on the therapeutic application can be configured to monitor the user’s adherence to the specified dosing schedule (sessions/week for specified duration of treatment) and trigger an accountability conversation when the user has strayed from dosing schedule).
Regarding Claim 13, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses the application further comprising media content providing a non-conversational aspect of the digital care programme ([0146] teaches on the system determining that the system has “consumed” (e.g., watched therapeutic content, listened to therapeutic content, read therapeutic content, or a combination thereof) more than a threshold number of recent therapeutic lessons; content that is watched/listened to/read by the user is interpreted as being a “non-conversational aspect of the digital care programme”).
Regarding Claim 16, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses wherein the mental health disorder is at least one of Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), stress, and worry ([0133] teaches on the CPT tools being configured to treat “stress”; [0295] teaches on a subset of patients having “severe range” PHQ-8 scores above 15 and patients with severe range GAD-7 scores, which are interpreted as reading on major depressive disorder and generalized anxiety disorder, respectively).
Regarding Claim 17, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses wherein the psychotherapy treatment protocol is based on at least one of: cognitive behavioural therapy (CBT) ([0061] teaches on the therapeutic content provided to patients may include one or more CBT tools), acceptance and commitment therapy (ACT), cognitive therapy, behavioural therapy, rational emotive behavioural therapy, exposure therapy, emotional schema therapy, schema therapy, mindfulness based cognitive therapy, compassion focussed therapy, dialectical behaviour therapy, metacognitive therapy, interpersonal psychotherapy (IPT) ([0061] teaches on the therapeutic content provided to patients may include one or more IPT tools) and psychodynamic therapy (PDT).
Regarding Claim 19, Darcy/Saliman/Bulaj teach the limitations of claim 18. Darcy further discloses wherein the automated conversational agent additionally uses generative artificial intelligence to provide the prompts, ([0309] teaches on using generative AI such as a LLM and rules-based versions of a relational agent-based digital intervention were combined to treat a user’s depression using a digital therapeutic; [0320] teaches on using a generative AI version of Woebot for Mood and Anxiety (“therapeutic application”)) and further comprising the automated conversational agent, in response to the free-text conversational data input by the patient ([0322], teaches on how the study implemented guardrails to “handle participant inputs”; all “free-text user inputs” were processed by a concerning language detection classifier”): deciding whether to provide a generated acknowledgement to the patient in response to the free-text conversational data input using a filtering mechanism configured to avoid inappropriate acknowledgements ([0322] teaches on processing free-text user inputs using a concerning-language detection classifier, e.g., a filtering mechanism; any inputs classified as concerning language were not sent to an LLM – deciding whether to provide a generated acknowledgement to the patient in response to the free-text conversation; [0324] teaches on using a built-in content filtering layer which processes both the prompt and completion through an ensemble of classification models that aim to detect and prevent output of harmful content; categories that are checked as part of the filter include hate and fairness, sexual, violence, and self-harm language. This step helped ensure that we did not send a reply that would be considered inappropriate. In every prompt sent to an LLM, we provided a succinct set of rules constraining the model that we found empirically worked well. These rules included information on how the LLM should format their response as well as guidance on specific behaviors, created with guidance from trained clinicians); and responsive to a decision to provide the generated acknowledgement, outputting the generated acknowledgement produced by processing the input using a generative acknowledgement model ([0324], “These rules included information on how the LLM should format their response as well as guidance on specific behaviors, created with guidance from trained clinicians. Examples of behavior rules included: do not diagnose, do not provide medical advice, do not use offensive language, even when repeating back user messages, and if you can't answer something, just say “Sorry, let's try again.” and repeat your request. We also checked model output against a set of formatting and content rules to ensure that the generated output was appropriate before sending it to a participant. These rules validated that the output was properly formatted as instructed using XML tags and checked for any words within a banned words list” (interpreted as responsive to a decision to provide generated acknowledgement, outputting the acknowledgement produced by processing the user’s input using a generative acknowledgement model).
Regarding Claim 20, Darcy discloses:
a patient device comprising a user interface ([0101] user device can include a smartphone, tablet, laptop or desktop computer, all of which are interpreted as having an interface; further, [0105] teaches on displaying messages to the user of the user device in an interface in a messaging application; see also [0272], computing device includes a GUI to display graphical information), a communication interface ([0277], [0282]) teach on the computing device having a communication interface) and an application configured to deliver the digital care programme ([0047] teaches on a therapeutic application of a user device administering determined digital therapeutic treatment to a user; [0063] teaches on administering, by the user device, therapeutic content as treatment to the user via one or more IPT or CBT tools to the graphical user interface of the user device; [0089], “the present disclosure is configured to treat one or more symptoms of anxiety or depression using particularly configured digital mental health interventions (DMHIs) that are administered to an individual during a prescribed or recommended dosing schedule”), the application comprising an automated conversation agent configured to provide a conversational aspect of the digital care programme([0078] with respect to Fig. 7, teaches on a process executed by an LLM-based conversation engine that comprises a rules-based conversation agent that can selectively interact with a LLM to increase the effectiveness of a digital therapeutic treatment; [0089], “the present disclosure is configured to treat one or more symptoms of anxiety or depression using particularly configured digital mental health interventions (DMHIs) that are administered to an individual during a prescribed or recommended dosing schedule”; [0090] teaches on the specifics of using a conversational agent to optimize engagement with the user, a patient exhibiting symptom(s) of anxiety/depression; the agent can engage in natural language communication with the user; [0091] the conversational agent is configured to communicate with the user conversationally in a manner that exhibits a friendly personality to establish a relationship with the user; the agent is designed to use this relationship to develop a therapeutic alliance with the user; [0096], the conversation agent assists with the treatment of a user’s symptoms of anxiety/depression using a digital therapeutic; [0114] teaches on the conversational agent generating and providing “empathy communication” to the user which is a caring response to the user’s emotional state that expresses detection of the user’s anxiety/depression), the application configured to receive free-text conversational data input by the patient in response to prompts generated by the automated conversational agent as part of the conversational aspect of the digital care programme([0103] teaches on a triggering engine configured to drive adherence of a user to a therapeutic treatment for symptoms of anxiety/depression; the trigger engine achieves this by initiating interactions with the user to determine an emotional state of the user; [0105] teaches on the conversation agent detecting that the user hasn’t interacted with the therapeutic application for more than a threshold period of time and generating a communication to the user, e.g., “Good morning, I have not heard from you for a few days. How are you doing today?” (interpreted as “prompt”) and the user can input a response to the communication into the therapeutic application (a response to the prompt generated by the conversational agent as part of the digital care programme); [0105] teaches on using a messaging application to show the dialogue between the user and the conversation engine, using a messaging application on a smartphone to input a response is interpreted as “free text conversation data”; [0165] further teaches on the system transmitting a survey to a user in the form of email/text message to obtain feedback from the user; the survey is interpreted as a prompt; the feedback engine can instruct the conversation engine to interact with the user of the user device in order to elicit feedback regarding the therapeutic treatment from the user; the conversation can provide all or a portion of the conversation thread to the feedback engine (interpreted as indicating a conversational aspect of the program/receiving free text from the patient); [0303] further describes this exploratory trial of an NLP-supported relational agent that “converses via text message”); and
a digital care programme provider system comprising a network connection configured to communicate with the communication interface of the patient device, the digital care programme provider system configured to ([0100]-[0101], a system for generating, dosing and administering digital therapeutic to treat anxiety/depression; the system 100 (interpreted as digital care programme provider system) comprises a user device, network and application server; application server includes one or more computers configured to store and execute respective modules of the system; the server can interact with databases by communicating lessons from the database to a user device as part of the digital therapeutic program):
determine an initial patient score relating to the initial psychological condition of the patient, comprising receiving information relating to the patient's initial psychological condition ([0295] teaches on obtaining baseline levels of depressive/anxiety symptoms (“initial psychological condition”) defined by a PHQ-8 score greater or equal to 10, and/or GAD-7 score greater or equal to 10 – the PHQ-8/GAD-7 baseline scores are interpreted as initial patient scores);
monitor an [final] psychological condition of the patient [after] the digital care programme ([0298]-[0301] teach on monitoring the patient’s PHQ-8 and GAD-7 test scores at 9 weeks), comprising receiving information relating to the patient's intermediate psychological condition [after] the digital care programme and determining an [final] patient score relating to the [final] psychological condition of the patient [after] the digital care programme ([0298] teaches on depressive symptoms, PHQ-8 scores of participants “significantly decreased” over the 9-week study period; [0299] teaches on PHQ-8 Week 9 score changes between baseline and Week 9, e.g., data regarding scores is known for Week 9 (final score); [0300] teach on average GAD-7 participant scores significantly increasing over the course of the study for anxiety symptoms; Examiner submits that PHQ-9 and GAD-7 are individually administered tests; if baseline values and study endpoint (9 week) data can be compared, it is understood that a final patient score relating to an final (study endpoint) psychological condition was determined in order to perform this comparison): and
monitor, during the digital care programme, engagement and adherence of the patient with the digital care programme ([0110] teaches on an example of the conversation agent determining a user context of “no prior communication from the user for more than 24 hours” – interpreted as teaching that patient’s engagement is monitored as it is capable of determining patient has not communicated in 24 hours); [0327] teaches on measures of user experience with the generative and rules-based DMHIs including “user engagement” (number of sessions and conversational exchanges)”, which is understood to teach that engagement was monitored if it measured number of sessions and conversational exchanges of users; [0153] teaches on a dosing engine determining a particular duration of treatment should be prescribed for a patient, e.g., 3 times per week for at least 8 weeks; the therapeutic application can be configured to monitor the user’s adherence to the specified dosing schedule and intervene to the extent the user strays from the dosing schedule), comprising determining [engagement data] relating to measurements of the patient's interaction with the application ([0153] teaches on monitoring adherence to a specified dosing schedule; upon determination that a user has strayed from the dosing schedule, the conversation engine can trigger an accountability conversation to get the user back on schedule; [0104] teaches on determining the user has not interacted with the therapeutic application for more than a threshold, e.g., 48 hours).
Darcy discloses determining patient condition at baseline and after program completion (study endpoint) but does not teach on determining intermediate patient condition during the program.
Saliman, which is directed to determining a plurality of wellness scores for patients with regard to a medical condition/treatment teaches monitoring an intermediate condition of the patient during a treatment program, comprising receiving information relating to the patient's intermediate condition during the treatment program ([0108] teaches on the term treatment including medical interventions to address mental health issues; [0115] teaches on administering an “outcome measurement device” (OMD) to a patient (e.g., a questionnaire per [0153]); [0119] teaches on analyzing OMD responses to generate one or more scores for a patient such as a wellness score or treatment effectiveness score; [0231] teaches on one or more OMDs, typically in the form of questionnaires, being provided to the patient; See Figs. 17C-17E which provide sample questionnaires delivered to the patient for the patient to answer via the device/application, interpreted as information relating to the patient’s condition; Examiner submits that while the example provided pertains to a patient having a hip replacement treatment per [0108] the system may be used with interventions to address mental health issues; [0244] teaches on providing the same OMD (questionnaire) to the patient at a later timepoint to generate a second score; [0413] teaches on prescribed treatments having a frequency such as weekly, biweekly, daily, etc. – a treatment program; [0414] teaches on extracting a set of improvement scores over a 9 month period, see Fig. 24D; [0415] teaches on rendering a graph showing wellness score values determined in Oct 2015, Nov 2015, Jan 2016, Feb 2016, April 2016, July 2016 while a patient is undergoing treatments A, B, C; any wellness scores between and including Nov 2015-April 2016 are interpreted as indicating the intermediate condition of the patient during treatment); and determining an intermediate patient score relating to the intermediate condition of the patient during the treatment program (per [0021] the treatments may be any form of treatment, e.g., medication or physical therapy; [0413] teaches on prescribed treatments having a frequency such as weekly, biweekly, daily, etc.; [0414] teaches on extracting a set of improvement scores [0416] teaches on a provider viewing how wellness scores for a patient diagnosed with anxiety and depression have changed over a 1-year period; a graph showing the patient’s anxiety and wellness scores is provided; [0415] teaches on rendering a graph showing wellness score values determined in Oct 2015, Nov 2015, Jan 2016, Feb 2016, April 2016, July 2016 while a patient is undergoing treatments A, B, C – any one of the scores between and including Nov 2015 and April 2016 are interpreted as “intermediate” scores relating to the “intermediate” condition of the patient during treatment).
Therefore, 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 teachings of Darcy with these teachings of Saliman, to monitor the patient’s intermediate condition during the care program of Darcy and determine an intermediate score for the intermediate patient condition, with the motivation of tracking progress over time so that a healthcare provider can see how the patient’s condition has improved or deteriorated in response to the treatment and determine the overall effectiveness of the selected treatment on the patient’s medical condition/symptoms (Saliman [0414]).
Darcy discloses determining patient engagement relating to measurements of a patient’s interaction with a digital therapeutics application, but does not explicitly disclose determining an engagement score relating to measurements of a patient’s interaction with a digital therapeutics application. Bulaj, which is directed to digital therapeutic system, teaches:
one or more engagement scores relating to measurements of interaction of the patient with a digital therapeutics application ([0035] teaches on determining and displaying an engagement score showing the user’s level of engagement with a digital treatment application; the engagement score may be based on usage consistency or level of adherence to a prescribed treatment regimen; it may be a numerical value).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Darcy/Saliman with these teachings of Bulaj to incorporate an engagement score relating to a patient’s interaction with the digital therapeutics application of Darcy/Saliman, with the motivation of providing a quantified score of patient’s engagement to motivate the patient to stay engaged with the treatment application (Fig. 2/[0035]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darcy et. al. (US Publication 20250022573A1) in view of Saliman et. al. (US Publication 20170372029A1), and further in view of Bulaj et. al. (US Publication 20170326330A1) as applied to Claim 1 above, and further in view of Paull et. al. (WIPO Publication WO2022086781A1).
Regarding Claim 14, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses wherein the digital care programme comprises sessions, each session providing a part of the digital care programme ([0152] teaches on the dosing engine determining a dosing schedule of therapeutic treatment for a patient, which indicates a frequency and/or duration of treatment, for example, number of treatments per specific time period; an example is provided of “consume the prescribed content at least 3 times per week for duration of 2 to 8 weeks”; Examiner interprets each treatment per period to be a “session” which is part of the digital care programme (e.g., 2-8 weeks of treatment)).
Darcy does not explicitly disclose the following, but Paull, which is directed to treating health conditions using prescription digital therapeutics, teaches:
the sessions arranged in a pre-determined order ([0072] teaches on a therapy may include a series of modules, lessons, questionnaires, and exercises, and a related protocol may dictate the order, speed, and/or frequency in which various modules, lessons, exercises and questionnaires are presented to a patient. A protocol may also dictate the specific layout, content and general presentation of the various lessons, exercises and questionnaires; [0192] teaches on the interactive lesson modules arranged in a “particular sequence”; controls may be used to encourage/require users to progress through a particular sequence of modules in a prescribed order).and each session associated with a particular time ([0194] teaches on sizes of lesson modules; modules may be designed so they may be completed in a specific time frame, e.g., no more than 20 minutes of continuous user interaction), wherein respective sessions are made available to the patient based on at least one of: the patient interacting completely with a previous session ([0192] teaches on the system requiring a user to progress through a particular sequence of lesson modules in a prescribed order; the system my restrict access to lesson modules occurring later in the sequence until others have been completed first); and the elapsing of the particular time associated with a respective session.
Therefore, 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 teachings of Darcy/Saliman/Bulaj with these teachings of Paull, to arrange sessions in a predetermined order where sessions are associated with a particular time, and to only make respective sessions available based on a patient completing a previous session, with the motivations of providing “bite size” lessons (sessions) that are designed to facilitate retention (Paull [0194]); requiring a user to initially acquire and learn a new skill before proceeding to the next skill (Paull [0193]); and providing the user with an estimated approximate time they are expected to spend with individual sessions (Paull [0194]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darcy et. al. (US Publication 20250022573A1) in view of Saliman et. al. (US Publication 20170372029A1), and further in view of Bulaj et. al. (US Publication 20170326330A1) as applied to Claim 1 above, and further in view of Shepherd et. al (US Publication 20150154291 A1).
Regarding Claim 15, Darcy/Saliman/Bulaj teach the limitations of claim 14. Darcy does not disclose the following, but Shepherd, which is directed to managing behavior in a virtual collaboration session, teaches: wherein the determining the engagement score comprises lowering the engagement score when the patient fails to interact completely with a session within an associated time window ([0087] teaches on “positive engagement” activities such as participation, taking notes or viewing material and “negative engagement” such as reading unrelated email, web surfing on unrelated topic, or not taking any action, e.g., not looking at the screen; if no positive engagement activities are performed over some time period, the engagement score may decrease).
Therefore, 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 teachings of Darcy/Saliman/Bulaj with these teachings of Shepherd, to lower an engagement score the patient of Darcy/Saliman/Bulaj fails to interact completely within an associated time window, with the motivation of calculating and providing a current engagement score to a user which can be compared with previous engagement scores (Shepherd [0092]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darcy et. al. (US Publication 20250022573A1) in view of Saliman et. al. (US Publication 20170372029A1), and further in view of Bulaj et. al. (US Publication 20170326330A1) as applied to Claim 1 above, and further in view of Weir. et. al. (“Dartmouth researchers look to meld therapy apps with modern AI” article).
Regarding Claim 18, Darcy/Saliman/Bulaj teach the limitations of claim 1. Darcy further discloses wherein the automated conversational agent uses machine learning natural language processing to provide the prompts ([0136] teaches on the CBT tool comprising natural language conversation back and forth between the user and the conversation engine; [0215] teaches on using machine learning to process user response data and generate output data corresponding to the user’s mood based on processing of the user’s response data) , wherein the automated conversational agent provides content [with guidance from] a clinician or clinical team ([0324] teaches on a built-in content filtering layer; in every prompt sent to an LLM, a succinct set of rules constraining the models was provided regarding how the LLM should format the response and guidance on specific behaviors, created with guidance from trained clinicians, e.g., rules such as do not diagnose, do not provide medical advice, do not use offensive language).
Darcy teaches that the content responses are created based on a set of rules and “guidance” from trained clinicians, but does not teach that the content is pre-written by a clinician/clinical team. Weir teaches on a conversational agent providing content that is pre-written by a clinician or clinical team (per page 2, bottom paragraph, Jacobson, a clinically trained psychologist and his team have been building and finessing the Therabot AI program; page 3, third paragraph teaches that “the team”, which is understood to include Jacobson, writing their own hypothetical therapy transcripts that reflected productive therapy sessions and training the model on that in-house data; if a clinically trained psychologist and his team wrote the therapy transcripts for the conversational agent, it is interpreted that the content was “pre-written” by a clinician/clinical team).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Darcy/Saliman/Bulaj with these teachings of Weir, to use pre-written content from a clinician/clinical team for the conversational agent, with the motivation of incorporating a broad repertoire of content areas that a real therapist would work in, including common mental health problems that patients manifest, so that the conversational agent can be ready to treat those (Page 3, first paragraph).
Response to Applicant’s Remarks/Arguments
Please note: When referencing page numbers of Applicant’s response, references are to page numbers as printed.
Claim Objections
The objections to Claims 1, 3, 4, 18, 20 and corresponding dependent claims are withdrawn in view of Applicant’s amendments to the claims.
Drawing Objections
The objections to Figs. 3, 4, and 11A for being blurry/illegible are withdrawn in view of Applicant’s submission of replacement drawings.
Rejections under 35 USC 101
Applicant’s remarks have been fully considered but are not persuasive.
Applicant argues:
The Claimed Invention Does Not Recite a Judicial Exception (Step 2A Prong I)
Regarding (A), the Examiner respectfully disagrees. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of personal behaviors that a mental healthcare provider, with or without the aid of a computer, would engage in to provide a therapeutic care program to a patient and determine patient engagement/adherence with the care program and as such, the claimed invention is directed to an abstract idea.
Regarding remarks at page 1 pertaining to “specific technical system” and “specific technical features”, Examiner notes the following statement from Applicant at page 14 of remarks: “Instead, the claims recite a specific technical system comprising an automated conversational agent that uses machine learning natural language processing to interact with patients, automatically monitors patient psychological conditions through intermediate patient scores, and automatically determines engagement scores based on measurements of patient interaction with the application” (emphasis Examiner). Examiner submits that the emphasized portions – interacting with patients, monitoring patient psychological conditions through scores, and determining engagement scores based on measurements of engagement – are all personal behaviors that may be performed by a mental healthcare provider. The “specific technical system comprising an automated conversational agent using machine learning NLP only” amounts to using a general purpose computer to apply the abstract idea, e.g., using the computer to interact with patients, monitoring patient psychological conditions, and determine engagement scores. Per Applicant’s specification [0110], the digital care program is delivered via a smartphone or other device such as a computer, e.g., a general purpose computing device. Regarding “automatically” monitoring patient psychological conditions and “automatically” determining engagement scores, Examiner notes that per MPEP 2106.05(a), “mere automation of manual processes” does not automatically confer subject matter eligibility.
(See MPEP 2106.05(a)(I), example (iii) under “Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality”). Regarding the machine learning/natural language processing steps, Examiner submits that Applicant has not invented a new form of machine learning or NLP, but rather, is applying existing, known methods to a particular field of use (psychotherapy), e.g., para. [0196] discloses “The conversational agent may include Machine Learning Artificial intelligence classifiers, which may be large language models LLMs…”
Regarding remarks in last paragraph on page 14, Examiner respectfully submits that the 4 steps outlined by Applicant all amount to limitations within the scope of the abstract idea but for recitation of general purpose computing elements, e.g., (1) “providing a conversational aspect of a care program” amounts to a therapist engaging with a patient in therapy; recitation of the “application comprising an automated conversational agent” and “digital” program only amount to mere instructions to apply the abstract idea on a computer. Similarly, (2) “receiving free-text conversational data” from a patient in response to generated prompts amounts to a therapist receiving free-text responses in a conversation in response to prompts the therapist gave the patient. Regarding (3) and (4), determining an intermediate patient score and determining one or more engagement scores are personal behaviors that could be performed by a therapist.
Regarding remarks at page 15, “These features describe a technical solution to a technical problem-namely, the problem of poor real-world usage and effectiveness of self-led digital mental health solutions, where one month retention rates are typically under 6%. The claimed invention addresses this technical problem through automated monitoring of both psychological condition and engagement, enabling the system to track patient progress and adherence in a manner that cannot practically be performed by a human mind or through mere human interaction”: First, Examiner respectfully submits that the problem of “poor real-world usage and effectiveness of self-led digital mental health solutions, where one month retention rates are typically under 6%” is not a problem caused by the technological environment of the claim, e.g., a general purpose computing system. While this may be a problem, it is not a “technical problem” as it is not caused by the computing system itself. Regarding how the claimed invention addresses the problem through “automated monitoring of both psychological condition and engagement, enabling the system to track patient progress and adherence in a manner that cannot practically be performed by a human mind or through mere human interaction”, Examiner respectfully disagrees with Applicant’s position. As stated earlier, automating a manual process (monitoring psychological condition and engagement) does not automatically confer subject matter eligibility. See MPEP 2106.05(a)(I), example (iii) under “Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality”. Examiner notes that the abstract idea was not classified as “mental processes”; as previously explained, the steps are all steps that could be performed by a person – providing therapy, receiving responses, determining scores. The recited computing components only amount to mere instructions to apply the abstract idea using general purpose computing components functioning in their ordinary capacities.
The above arguments are therefore unpersuasive.
Any Alleged Abstract Idea Recited in the Claimed Invention is Integrated into a Practical
Application (Step 2A Prong II)
Regarding (B), the Examiner respectfully disagrees that the abstract idea is integrated into a practical application.
Regarding remarks directed to Example 48, Examiner disagrees that the instant claims are analogous. The Examiner respectfully disagrees. MPEP 2106.04(d) states that one way in which a claimed abstract idea may be subject matter eligible under Prong 2A2 is if the claimed invention provides an improvement to the computer or an improvement another technology or technological field. Example 48, Claim 2 is an illustration of this. The Specification of Example 48 describes how prior speech separation techniques were unable to separate different conversations from one another such that unwanted utterances are identified and removed (emphasis Examiner). Examiner notes this is a technological problem caused by the technological environment of the claim. The additional elements of (f) and (g) of Example 48, Claim 2 provide a solution to this problem. As previously stated, the problem of “a recognized technical problem: "real-world usage, and in turn effectiveness, of many self-led digital solutions for mental health has been poor" with "one month retention rates ... typically under 6%" in the instant application is not a problem caused by the technological environment of the claim, e.g., the computer system.” For this reason alone, Examiner respectfully submits that the instant claims are not analogous to Example 48.
Regarding Example 48, Examiner further notes that steps (f) and (g) recite:
(f) synthesizing speech waveforms from the masked clusters, wherein each speech waveform corresponds to a different source sn;
(g) combining the speech waveforms to generate a mixed speech signal x' by stitching together the speech waveforms corresponding to the different sources sn, excluding the speech waveform from a target source ss such that the mixed speech signal x' includes speech waveforms from the different sources sn and excludes the speech waveform from the target source ss;
As stated in the USPTO July 2024 Subject Matter Eligibility Example 48, “steps (f) and (g) are directed to creating a new speech signal that no longer contains extraneous speech signals from unwanted sources. The claimed invention reflects this technical improvement by including these features.”
Applicant has not cited to, nor can Examiner find, any evidence of a similar technical improvement in the instant invention. Regarding remarks at pages 15-16, Examiner submits that this has already been addressed and the features to which applicant cites only amount to mere instructions to apply the abstract idea using a computer. Examiner submits that any purported improvements may be improvements to the abstract idea itself – e.g., an improved way of delivering therapy to a patient by tracking patient engagement and adherence. Please reference MPEP 2106.05(a) which states, “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” Applicant has not provided, nor can Examiner find evidence of, how any of the additional elements identified above in main 101 analysis section above are providing an improvement over prior art systems. The additional elements identified above are understood to be computing components functioning in their normal operating capacity, which is not sufficient to integrate the judicial exception into a practical application. Regarding remarks at top of page 16 pertaining to “usage metrics”, Examiner submits that this falls within the scope of the abstract idea, e.g., a therapist could observe a patient interacting with therapy materials, whether provided on paper or digitally via a device, and track how and where the users spend their time.
Regarding remarks pertaining to “ordered combination”, Applicant has not cited to, nor can Examiner find in original disclosure, any evidence of how the ordered combination of additional elements provide a technological improvement. Regarding “improvement to the functioning of digital mental health intervention systems”, please see above remarks pertaining to MPEP 2106.05(a). Examiner is unable to find any evidence of an improvement to the computer system itself and maintains the position that any purported improvements are only improvements to the abstract idea, which is not sufficient to integrate the judicial exception into a practical application.
Therefore, the above arguments are not persuasive
The Claimed Invention Recites "Significantly More" Than Any Alleged Abstract Idea (Step 2B)
Regarding (C), the Examiner respectfully disagrees. Applicant remarks, “that the arrangement of all of the claim features provides an improvement to the technology of the claimed invention. That is, the claimed invention is directed to, and specifically recites, a method and a system that are fundamentally different from generic computing functions or conventional human processes. The claimed steps amount to more than the sum of their parts, resulting in unique technical benefits”. Examiner respectfully disagrees and submits that all of these arguments have previously been addressed in preceding remarks. Applicant has not provided any evidence, nor can Examiner find evidence, how of the additional elements provide significantly more than the judicial exception.
Therefore, the above arguments are not persuasive
For all of the above reasons, Applicant’s remarks with respect to the rejections of Claims 1-20 under 35 USC 101 are not persuasive.
The rejections of Claims 1-20 under 35 USC 101 are maintained.
35 USC 103 Rejections
Applicant’s remarks have been fully considered but are not persuasive.
Applicant argues:
The combination of Darcy, Saliman, and Bulaj constitutes impermissible hindsight.
Regarding (A), the Examiner respectfully disagrees. Applicant appears to be arguing one particular embodiment of Saliman (“surgical outcome database”). Examiner notes that Saliman has multiple embodiments and may be addressed to cover mental health issues (Saliman at [0108] As used herein, the term “treatment” is broadly defined to cover medical interventions to address physical and/or mental health – as cited by Examiner in non-final action and above in 103 section). Examiner further submits that Darcy teaches on the majority of limitations in Claim 1. Darcy teaches on determining a final psychological condition and final patient score after a patient has completed a digital care program. Saliman was introduced to teach on the concept of collecting intermediate patient condition and patient score data during a treatment program. The only difference is the timing of when the condition and score are determined. As such, Examiner submits that it would have been obvious to a POSITA to look to Saliman to modify Darcy so that the patient condition and score are monitored and determined at an intermediate time point in a treatment. Examiner submits that 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 teachings of Darcy with these teachings of Saliman, to monitor the patient’s intermediate condition during the care program of Darcy and determine an intermediate score for the intermediate patient condition, with the motivation of tracking progress over time so that a healthcare provider can see how the patient’s condition has improved or deteriorated in response to the treatment and determine the overall effectiveness of the selected treatment on the patient’s medical condition/symptoms (Saliman [0414]).
Regarding Bulaj, Examiner respectfully disagrees with Applicant’s position and submits that Balaj is indeed analogous art. Applicant appears to be focusing on one particular aspect of Bulaj (treating epilepsy with music therapy). Examiner respectfully notes that the Abstract of Bulaj discloses, “The present disclosure describes computer systems and computer-implemented methods for treating epilepsy. An interactive user interface is configured to deliver self-care and cognitive behavioral therapy to a user, and also to deliver antiseizure music to the user, as the user engages with the interactive content”. While the condition treated may be different, Examiner submits that Bulaj is very much analogous as it pertains to using a computer system to deliver “self care and cognitive behavioral therapy to a user”, e.g., a person engaging with interactive content for delivering self-care and CBT.
These arguments are not persuasive.
Saliman is not analogous art and there is no motivation to combine its teachings with Darcy
Regarding (B), the Examiner disagrees. Examiner further submits that Darcy teaches on the majority of limitations in Claim 1. Darcy teaches on determining a final psychological condition and final patient score after a patient has completed a digital care program. Saliman was introduced to teach on the concept of collecting intermediate patient condition and patient score data during a treatment program. The only difference is the timing of when the condition and score are determined. As such, Examiner submits that it would have been obvious to a POSITA to look to Saliman to modify Darcy so that the patient condition and score are monitored and determined at an intermediate time point in a treatment. Examiner notes that Saliman has multiple embodiments and may be used in conjunction with treating mental health issues (Saliman at [0108] As used herein, the term “treatment” is broadly defined to cover medical interventions to address physical and/or mental health – as cited by Examiner in non-final action and above in 103 section). Applicant remarks “A skilled person seeking to improve Darcy would look to art related to conversational AI, user engagement in mobile applications, or digital therapeutics, not to a system for tracking post-surgical recovery metrics”. Examiner submits that both the instant invention and system of Saliman include aspects of monitoring/tracking a patient’s progress over time in relation to receiving a treatment, and as such, 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 teachings of Darcy with these teachings of Saliman to collect intermediate data and intermediate scores, as it is just collecting data at a different time point.
Regarding remarks at page 11 at which Applicant argues “no motivation to combine”, Examiner notes that Applicant appears to be paraphrasing a portion of the motivation presented in non-final action. Examiner submits that a proper motivation to combine Darcy/Saliman was provided, e.g., “the motivation of tracking progress over time so that a healthcare provider can see how the patient’s condition has improved or deteriorated in response to the treatment and determine the overall effectiveness of the selected treatment on the patient’s medical condition/symptoms” (Saliman [0414]). Examiner submits that the intended use of the monitoring of Saliman argued by Applicant is irrelevant; Saliman has been introduced to teach on the time point of collecting intermediate patient condition and an intermediate patient score during a treatment. Regarding Applicant’s remark to “triggering escalation” in the dependent claims, Applicant has not provided any specific arguments so this is not persuasive; however, Examiner asserts that the references applied in dependent claims teach on using the engagement score to trigger escalation.
These arguments are not persuasive.
There is no motivation to modify Darcy/Saliman with the teachings of Bulaj
Regarding (C), the Examiner respectfully disagrees with Applicant’s position and submits that Balaj is indeed analogous art. Applicant appears to be focusing on one particular aspect of Bulaj (treating epilepsy with music therapy). Examiner respectfully notes that the Abstract discloses, “The present disclosure describes computer systems and computer-implemented methods for treating epilepsy. An interactive user interface is configured to deliver self-care and cognitive behavioral therapy to a user, and also to deliver antiseizure music to the user, as the user engages with the interactive content”. While the underlying condition treated may be different, Examiner submits that Bulaj is very much analogous as it pertains to using a computer system to deliver “self care and cognitive behavioral therapy to a user”. Examiner further submits that Darcy already teaches on determining engagement of the user with a therapeutic application (see paras. [0104] and [0153] as cited in 103 section above) but does not specifically label it an “engagement score”, and asserts that it would have been obvious to a POSITA to incorporate the teachings of Bulaj (an engagement score, e.g., a 95/100) as the engagement metrics of Darcy with the motivation of quantifying the patient’s engagement to motivate the patient to stay engaged with the application, as presented in 103 section above and in non-final action.
Examiner submits that Applicant appears to be arguing a particular, narrow interpretation and/or intended use of the engagement score (Applicant remarks, “In Applicant's invention, the engagement score is an active, functional element used by the system to make decisions. It is a measurement that is monitored and can trigger system actions, such as for instance prompting the patient to re-engage ( as recited in dependent claim 11). Bulaj does not teach or suggest using an engagement score as a dynamic input to control the behavior of the therapeutic system itself It is merely a static display)”. However, Examiner submits that Claim 1 does not actually require the engagement score to be used for anything; it is merely determined and relates to measurements of the patient’s interactions with the application.
These arguments are not persuasive.
The claimed invention as a whole is a synergistic system not taught by the art.
Regarding (D), the Examiner respectfully disagrees and submits that Applicant appears to be arguing the individual references rather than the combination of references. Examiner further submits that the arguments in (D) have already been addressed above with respect to (A), (B), and (C). Please see above.
These arguments are not persuasive.
For all of the above reasons, Applicant’s remarks are not persuasive and the rejections of Claims 1-20 under 35 USC 103 are maintained.
Conclusion
Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20220028528 A1, teaching on systems and methods for treating health conditions using prescription digital therapeutics
WIPO Publication WO2022174161A1, teaching on systems and methods for psychotherapy using artificial intelligence
WIPO Publication WO 2024090712A1, teaching on an artificial intelligence chatbot system capable of providing sentences and encouragement, using a psychotherapy method that induces a sense of empathy and positively effects a user's psychological condition
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE-MARIE K ALDERSON whose telephone number is (571)272-3370. The examiner can normally be reached on Mon-Fri 9:00am-5:00pm EST, and generally schedules interviews in the timeframe of 2:00-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long, can be reached on 571-270-5096. 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.
/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682
Prosecution Insights