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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 5, 2025 has been entered.
Response to Amendment
Claims 1, 6, 9, 15, and 21 are currently amended. Claims 2-5, 8, 10-14, and 16-20 have not been modified. Claim 7 has been cancelled. Claims 1-6 and 8-21 are pending and are provided to be examined upon their merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 13, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to Remarks filed on November 5, 2025 have been considered but are not persuasive. Response has been provided below.
Applicant argues 35 U.S.C. §103 Rejection, starting pg. 8 of Remarks:
Applicant argues that Moturu in view of Roehr fail to teach amendments. Applicant argument is moot as new art is applied to teach the amended subject matter.
Regarding amendments to independent claims 6 and 15, the Examiner maintains the prior art rejection with respect to the newly applied art.
Applicant argues 35 U.S.C. §101 Rejection, starting pg. 11 of Remarks:
Applicant argues that the claims provides a specific improvement to existing treatment methodologies for patients exhibiting suicidal ideation and/or having attempted suicide, which is a technical improvement and provides a practical application. The Examiner respectfully disagrees. The improvements are instead to the abstract idea of providing treatment methodologies being instructions for patients to follow, which does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”). For an example of providing an practical application through prophylaxis, please see claim 2 of Example 49.
Regarding Priority
Examiner notes that claims 1-5 are given an effective filing date of June 19, 2020 as the provisional application to which the application depends on (62/864,348) does not provide support for crisis planning or exposure and/or imagined exposure relating to the suicidal ideation and/or suicide attempt.
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 1-6 and 8-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process and a machine (1-6 and 8-21). Accordingly, claims 1-6 and 8-21 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP §2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and /or c) mathematical concepts. MPEP §2106.04(a).
The Examiner has identified product Claim 1, product claim 6, and system claim 15 as the claims that represents the claimed invention for analysis.
Claim 1:
A non-transitory computer-readable storage medium having encoded thereon instructions that, when executed by at least one processor, cause the at least one processor to carry out a method, the method comprising:
generating an adapted list of suicide treatment activities that fits a duration of an inpatient stay of a patient who has exhibited suicidal ideation and/or attempted suicide, the generating comprising adapting a list of suicide treatment activities to fit the duration of the inpatient stay;
selecting at least one suicide treatment activity from the adapted list, the adapted list including:
instructions on crisis planning for a suicide attempt; and
instructions on exposure and/or imagined exposure relating to the suicidal ideation and/or attempted suicide; and
treating a risk of suicide of the suicidal patient, the treating comprising administering, to the suicidal patient, during the inpatient stay, the at least one suicide treatment activity selected from the adapted list.
These above limitations, not in bold, under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity. The claim elements are directed towards “adapting a list of suicide treatment activities”, “selecting at least one suicide treatment activity from a list”, and “treating a risk of suicide”. Adapting a list of treatment activities as fitting treatments for an inpatient stay based on suicidal ideation or a suicide attempt fall under managing the personal behavior or relationships or interactions between the suicidal patient and any electronic or human entities administering the treatment. It is akin to setting scheduled activities for a person to follow. Treating a patient condition also falls under the abstract concept of managing personal behaviors of people. It is important to note that the examples provided by the MPEP such as social activities, teaching, and following rules or instructions are provided as examples and not an exclusive listing and that MPEP 2106.04(a)(2)II states certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping.
These above limitations, under their broadest reasonable interpretation, also cover performance of the limitation as mental processes. The claims recite elements, underlined above, that can be performed in the mind of a person, with pen and paper, or using a generic computer. See also MPEP 2106.04(a)(2) III C that teaches generic computer performing an abstract idea can also fall under mental processes. These encompass adapting a list of treatment activities, selecting from a list and administering a treatment to a patient by supplying them with instructions to follow.
Accordingly, the claim recites an abstract idea.
Claim 6:
A non-transitory computer-readable storage medium having encoded thereon instructions that, when executed by at least one processor, cause the at least one processor to carry out a method, the method comprising:
obtaining patient data indicating exhibition of a suicidal ideation and/or suicide attempt of a patient, the patient data including a duration of an inpatient stay of the patient following the suicidal ideation and/or suicide attempt;
generating an adapted suicide treatment for the patient at least in part by adapting, based on the duration of the inpatient stay and based on patient response to a previously administered treatment following the suicidal ideation and/or suicidal attempt, a treatment that treats the suicidal ideation and/or attempt of the patient; and
administering, to the patient, during the inpatient stay, the adapted suicide treatment.
These above limitations, not in bold, under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity. The claim elements are directed towards adapting a treatment based on “duration of the patient's inpatient stay… following the suicidal ideation and/or suicide attempt”, and administering a suicide risk treatment. Adapting a list of treatment activities as fitting treatments for an inpatient stay fall under managing the personal behavior or relationships or interactions between the suicidal patient and any electronic or human entities administering the treatment. It is akin to setting scheduled activities for a person to follow. Treating a patient condition also falls under the abstract concept of managing personal behaviors of people.
These above limitations, under their broadest reasonable interpretation, also cover performance of the limitation as mental processes. The claims recite elements, underlined above, that can be performed in the mind of a person, with pen and paper, or using a generic computer. These encompass obtaining patient mental health data, adapting a treatment based on “duration of the patient's inpatient stay”, and administering a mental health treatment.
Accordingly, the claim recites an abstract idea.
Claim 15:
A system comprising at least one processor configured to:
obtaining patient data indicating exhibition of a suicidal ideation and/or suicide attempt of a patient;
generating an adapted suicide treatment for the patient at least in part by adapting, to fit a duration of an inpatient stay following the suicidal ideation and/or suicide attempt and a risk of suicide of the patient, a list of suicide treatment activities; and
send, over a communication network, to a device of the patient, during the inpatient stay, for administering during the inpatient stay, treatment activity data indicating the adapted list of suicide treatment activities.
These above limitations, not in bold, under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity. The claim elements are directed towards adapting a treatment based on “duration of an inpatient stay following the suicidal ideation and/or suicide attempt” and transmitting a list of suicide treatments to the patient. Adapting a list of treatment activities as fitting treatments for an inpatient stay fall under managing the personal behavior or relationships or interactions between the suicidal patient and any electronic or human entities administering the treatment. It is akin to setting scheduled activities for a person to follow. Treating a patient condition also falls under the abstract concept of managing personal behaviors of people.
These above limitations, under their broadest reasonable interpretation, also cover performance of the limitation as mental processes. The claims recite elements, underlined above, that can be performed in the mind of a person, with pen and paper, or using a generic computer. These encompass obtaining data, adapting or adapting a treatment based on “duration of the patient's inpatient stay”, and sending/communicating data.
Accordingly, the claim recites an abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the idea into a practical application. As noted at MPEP §2106.04 (ID)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
Additional Elements Cited in the claims:
A non-transitory computer-readable storage medium (1-14,21); at least one processor (1,6,15-20); communication network (3,10,11,15,17); one or more sensors (9)
Any computing devices that would be able to perform the method are taught at a high level of generality such that the claim elements amount's to no more than mere instructions to apply the exception using any generic component capable of performing the claim limitations. The Examiner cites [0051] of Applicant specification: “For example, a patient's device (e.g., mobile phone, tablet, computer, etc.) may be configured to select and administer one or more treatment activities to reduce the patient's risk of suicide.” The Examiner also cites [0062] of Applicant’s specification: “For example, devices 120 may include mobile phones belonging to various patients. Alternatively or additionally, devices 120 may include multiple devices for each patient, such as a mobile phone and tablet computer, laptop computer, desktop computer, or other such devices.” No specific, technical improvements are being made to the technology of computing devices.
The Examiner further notes that any and all sensors that are claimed are also taught at a high level of generality such that the claim elements amounts to no more than mere instructions to apply the exception using any generic component capable of performing the claim limitations. The Examiner cites [0067] of Applicant specification: “In some embodiments, sensors 128a and/or 128b may be configured to capture patient input and/or feedback in connection with administered treatment activities. In some embodiments, sensor 128a may include a camera and/or microphone, and sensor 128b may include an accelerometer and/or a gyroscope.” [0044] further recites: “The sensory data may indicate the patient's readiness for a particular treatment activity, and/or the patient's response to previously administered treatment, such as the patient's level of fatigue and/or attentiveness to the previously administered treatment.” No specific, technical improvements are being made to sensor technologies as they are simply being applied to perform the abstract idea of monitoring a patient.
The Examiner further notes that the communication network is also taught at a high level of generality such that the claim elements amounts to no more than mere instructions to apply the exception using any generic component capable of performing the claim limitations. The Examiner cites [0074] of Applicant specification: “In some embodiments, communication network 102 may include the Internet. In some embodiments, communication network 102 may include a local area network (LAN), a wireless local area network (WLAN) such as Wi-Fi, a Bluetooth network, or other suitable networks.” No specific, technical improvements are being made to the technology of communication networks.
Looking at the additional elements as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID)(A)(2).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claim 2: This claim recites wherein: selecting the at least one suicide treatment activity comprises selecting a cognitive behavioral therapy (CBT) step from the adapted list; and treating the risk of suicide of the suicidal patient comprises administering the CBT step to the suicidal patient; which is an abstract idea of diagnosing a patient and mental processes, such as an observation. The claim serves to limit the type of treatment that is administered.
Claim 3: This claim recites wherein the method further comprises receiving, over a communication network, the adapted list; which teaches the network at a high level of generality, such that it is only applied to perform an insignificant extra-solution activity of transmitting data for reception.
Claim 4: This claim recites wherein the method further comprises sending, to a healthcare provider of the suicidal patient, a message; which is an abstract idea of communicating messages with a healthcare provider.
Claim 5: This claim recites wherein the message notifies the healthcare provider that the suicidal patient is at risk of suicide; which only serves to further the limit the message.
Claim 8: This claim recites wherein obtaining the patient data further comprises asking the patient whether the patient is ready for a treatment activity; and adapting the treatment further comprises selecting the treatment activity from a list of treatment activities; which falls under an abstract concept of managing personal behaviors through obtaining consent and devising a treatment plan and mental processes, such as an observation.
Claim 9: This claim recites wherein obtaining the patient data further comprises obtaining sensory data from one or more sensors of a device of the patient; and the patient data indicates a response of the patient to the previously administered treatment; which teaches sensors of a device at a high level of generality, such that it is only applied to perform an insignificant extra-solution activity of receiving and selecting a data type.
Claim 10: This claim recites wherein obtaining the patient data further comprises obtaining, over a communication network, instructions for selecting a treatment activity from a list of treatment activities; and adapting the treatment further comprises selecting the treatment activity; which is an abstract concept of managing personal behaviors through devising a treatment plan and mental processes, such as an observation. This claim further teaches the communication network at a high level of generality, such that it is only applied to perform an insignificant extra-solution activity of transmitting data for reception.
Claim 11: This claim recites wherein the method further comprises: transmitting, over the communication network to a healthcare provider, an indication of a response of the patient to the treatment activity; which is an abstract idea of communicating information about the patient with a healthcare provider. This claim further teaches the communication network at a high level of generality, such that it is only applied to perform an insignificant extra-solution activity of transmitting data for reception.
Claim 12: This claim recites wherein adapting the treatment further comprises: selecting, from an ordered list of treatment activities, at least one first treatment activity, rather than selecting at least one second treatment activity listed before the at least one first treatment activity in the ordered list; and selecting, at a later time, the at least one second treatment activity; which is an abstract concept of mental processes, such as an observation.
Claim 13: This claim recites wherein obtaining the patient data further comprises: accessing an application on a device of the patient; and determining a risk of suicide of the patient based on one or more of: words spoken by the patient; and/or a message sent by the patient; which is an abstract concept of managing personal behaviors, such as diagnosing a patient based on data obtained by monitoring said patient.
Claim 14: This claim recites wherein accessing the application comprises determining a contact of the patient; and the method further comprises sending, to the contact, a message; which is an abstract concept of managing personal behaviors, such as reaching out to a contact.
Claim 16: This claim recites wherein the at least one processor is configured to adapt the list of suicide treatment activities to fit the duration of the inpatient stay; which is an abstract concept of managing personal behaviors, such as refining a treatment plan based on a duration of time.
Claim 17: This claim recites wherein the at least one processor is further configured: to obtain, over the communication network, from the device, patient data indicative of a response of the patient to at least one suicide treatment activity of the list of suicide treatment activities; adapt, based on the patient data, the list of treatment activities; and send, over the communication network, to the device, an update to the treatment activity data; which is an abstract concept of managing personal behaviors, such as devising a treatment plan. This claim further teaches the communication network at a high level of generality, such that it is only applied to perform an insignificant extra-solution activity of transmitting data for reception.
Claim 18: This claim recites wherein the at least one processor is further configured to: access electronic health records of the patient; and adapt the list of suicide treatment activities based on the electronic health records; which is an abstract concept of managing personal behaviors, such as devising a treatment plan. This claim further teaches the communication network at a high level of generality, such that it is only applied to perform an insignificant extra-solution activity of transmitting data for reception.
Claim 19: This claim recites wherein the at least one processor is further configured to: send, to a healthcare provider of the patient, a message relating to the patient; which is an abstract idea of communicating messages with a healthcare provider.
Claim 20: This claim recites wherein the at least one processor is further configured to: send, to a contact of the patient, a message relating to the patient; which is an abstract idea of communicating messages with a healthcare provider.
Claim 21: This claim recites wherein the method further comprises: adapting the treatment based on the response of the patient to the previously administered treatment; and after adapting the treatment based on the response to the previously administered treatment, administering further treatment to the patient; which teaches an abstract idea of certain methods of organizing human activity, such as setting scheduled activities for a person to follow. This claim also teaches an insignificant extra-solution activity of administering the treatment, as administering the treatment is simply providing instruction on a display.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
These claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
Amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as determining the wellness categories of a person based on tested blood, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv); providing a credit offset for the deductible, e.g., performing repetitive calculations, Flook, MPEP §2106.05(d)(II)(ii).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-5, 8-14, and 16-21, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 2-5, 8-14, and 16-21, e.g., performing repetitive calculations, Flook, MPEP §2106.05(d)(II)(ii); claims 2-5, 8-14, and 16-21, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv). 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.
Therefore, whether taken individually or as an ordered combination, claims 1-6 and 8-21 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ghahramanlou-Holloway (Ghahramanlou-Holloway; Marjan, Post-Admission Cognitive Therapy: A Brief Intervention for Psychiatric Inpatients Admitted After a Suicide Attempt, May 2012, Cognitive and Behavioral Practice, Volume 19, Issue 2, pgs. 233-244) in view of Moturu (US 20150370993).
Regarding claim 1, Ghahramanlou-Holloway teaches method comprising:
generating an adapted list of suicide treatment activities that fits a duration of an inpatient stay of a patient who has exhibited suicidal ideation and/or attempted suicide, the generating comprising adapting a list of suicide treatment activities to fit the duration of the inpatient stay (Table 1, pg. 233, “We present an overview of a novel psychotherapeutic approach, Post-Admission Cognitive Therapy (PACT), currently under development and empirical testing for inpatients who have been admitted for a recent suicide attempt.” Pg. 238, “The first PACT session will begin by socializing the patient to the treatment format, structure, delivery, and content... Thus, the therapist will be knowledgeable about the patient's history and familiar to the patient, facilitating a strong therapeutic relationship. Psychoeducation on suicide attempt risk and protective factors, typical cognitive and emotional reactions to post suicide attempt psychiatric hospitalization, and the targeted treatment aim of reducing the recurrence of another suicide attempt will be provided to the patient.” pg. 237, “PACT has been modified from Brown et al.'s (2005) original protocol (ten 45-minute sessions; total 7.5 hours) to consist of approximately six 60- to 90-minute sessions (total 6 to 9 hours). PACT is administered through individual therapy sessions preferably offered to the patient over the course of 3 consecutive days during inpatient psychiatric hospitalization… Decisions about the length and duration of treatment have been partially based on consultation with inpatient psychiatric staff and a review of the average length of inpatient stay.”). Please see Table 1, below, which comprises a list of suicide treatment activities intended to fit the duration of the inpatient stay (“Goals and Activities”).
PNG
media_image1.png
577
665
media_image1.png
Greyscale
selecting at least one suicide treatment activity from the adapted list, the adapted list including: instructions on crisis planning for a suicide attempt; and instructions on exposure and/or imagined exposure relating to the suicidal ideation and/or attempted suicide (pg. 238, “The primary objective of the second session is to collaboratively generate a cognitive conceptualization of the recent suicide attempt... More simply stated, the patient is asked to provide a suicide attempt story with a beginning, middle, and an end. Similar to what happens in a prolonged exposure session for traumatized patients, the PACT therapist guides the patient through the process of sharing his/her experiences on the day of the suicide attempt.” Pg. 240, “The construction of a safety plan relates directly to preventing relapse, and these activities complement each other. Hence, the final PACT session is focused on generating a collaborative, feasible, and detailed written safety plan with the patient… Before a safety plan is constructed, the therapist inquires about the patient's prior experiences and challenges in maintaining safety. Then, the patient is guided to develop an individualized hierarchically arranged written list of coping strategies to implement in future distressing circumstances.”). Examiner notes that providing a treatment to a patient encompasses a selection of said treatment.
and treating a risk of suicide of the suicidal patient, the treating comprising administering, to the suicidal patient, during the inpatient stay, the at least one suicide treatment activity selected from the adapted list (pg. 238, “The primary objective of the second session is to collaboratively generate a cognitive conceptualization of the recent suicide attempt... More simply stated, the patient is asked to provide a suicide attempt story with a beginning, middle, and an end. Similar to what happens in a prolonged exposure session for traumatized patients, the PACT therapist guides the patient through the process of sharing his/her experiences on the day of the suicide attempt.” pg. 240 ,“ The construction of a safety plan relates directly to preventing relapse,… the patient is guided to develop an individualized hierarchically arranged written list of coping strategies to implement in future distressing circumstances.”).
Ghahramanlou-Holloway does not teach a non-transitory computer-readable storage medium having encoded thereon instructions that, when executed by at least one processor, cause the at least one processor to carry out the method.
However, Moturu does teach a non-transitory computer-readable storage medium having encoded thereon instructions that, when executed by at least one processor, cause the at least one processor to carry out the method ([0070], “The method 100 and/or system 200 of the embodiments can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions can be executed by computer-executable components integrated with the application, applet, host, server, network, website, communication service, communication interface, hardware/firmware/software elements of a patient computer or mobile device, or any suitable combination thereof.”).
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of “automatically initiating provision of a therapeutic intervention for the individual by way of at least one of the computing system and the mobile communication device” (Moturu; [0014]).
Regarding claim 2, Ghahramanlou-Holloway in view Moturu teaches the product of claim 1. Ghahramanlou-Holloway further teaches wherein:
selecting the at least one suicide treatment activity comprises selecting a cognitive behavioral therapy (CBT) step from the adapted list (pg. 237, “The cognitive behavioral components of PACT, as described here, are based on evidence-informed practices aimed at improving the quality of care provided to inpatients following a suicide attempt.” Pg. 238, “In this phase, the therapist is given flexibility to make informed decisions about how to best accomplish these objectives with the use of various evidence-based cognitive and behavioral strategies.”); and
treating the risk of suicide of the suicidal patient comprises administering the CBT step to the suicidal patient (pg. 238, “The primary objective of the second session is to collaboratively generate a cognitive conceptualization of the recent suicide attempt... More simply stated, the patient is asked to provide a suicide attempt story with a beginning, middle, and an end. Similar to what happens in a prolonged exposure session for traumatized patients, the PACT therapist guides the patient through the process of sharing his/her experiences on the day of the suicide attempt.” pg. 240 ,“ The construction of a safety plan relates directly to preventing relapse,… the patient is guided to develop an individualized hierarchically arranged written list of coping strategies to implement in future distressing circumstances.”).
Regarding claim 4, Ghahramanlou-Holloway in view Moturu teaches the product of claim 1. Ghahramanlou-Holloway does not explicitly teach wherein the method further comprises sending, to a healthcare provider of the suicidal patient, a message.
However, Moturu does teach wherein the method further comprises sending, to a healthcare provider of the suicidal patient, a message ([0015], “provide an alert to a caretaker associated with the patient and/or to the patient upon detection that the individual has entered or is at risk of entering a critical state of depression (e.g., suicidal state)” [0060], “Block S152, which recites: transmitting an alert based upon the analysis. Block S152 functions to alert at least one of an entity associated with the individual and/or the individual regarding a critical state of depression that the patient has or will enter... In relation to an entity associated with the patient(s), the entity can include any one or more of: a caretaker, a healthcare provider, a relative (e.g., parent, significant other, etc.), and any other suitable entity associated with the patient.” ). The Examiner interprets the alert notifying that a patient has entered or is at risk of entering a critical state of depression to encompass a message.
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of “provid[ing] an alert to a caretaker associated with the patient… upon detection that the individual has entered or is at risk of entering a critical state of depression (e.g., suicidal state)” (Moturu; [0015]).
Regarding claim 5, Ghahramanlou-Holloway in view Moturu teaches the product of claims 1 and 4. Ghahramanlou-Holloway does not teach wherein the message notifies the healthcare provider that the suicidal patient is at risk of suicide.
However, Moturu does teach wherein the message notifies the healthcare provider that the suicidal patient is at risk of suicide ([0015], “provide an alert to a caretaker associated with the patient and/or to the patient upon detection that the individual has entered or is at risk of entering a critical state of depression (e.g., suicidal state)” [0060], “Block S152, which recites: transmitting an alert based upon the analysis. Block S152 functions to alert at least one of an entity associated with the individual and/or the individual regarding a critical state of depression that the patient has or will enter... In relation to an entity associated with the patient(s), the entity can include any one or more of: a caretaker, a healthcare provider, a relative (e.g., parent, significant other, etc.), and any other suitable entity associated with the patient.” ). The Examiner interprets the alert notifying that a patient has entered or is at risk of entering a critical state of depression to encompass a message.
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of “provid[ing] an alert to a caretaker associated with the patient… upon detection that the individual has entered or is at risk of entering a critical state of depression (e.g., suicidal state)” (Moturu; [0015]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ghahramanlou-Holloway (Ghahramanlou-Holloway; Marjan, Post-Admission Cognitive Therapy: A Brief Intervention for Psychiatric Inpatients Admitted After a Suicide Attempt, May 2012, Cognitive and Behavioral Practice, Volume 19, Issue 2, pgs. 233-244) in view of Moturu (US 20150370993) further in view of deCharms (US 20160267809).
Regarding claim 3, Ghahramanlou-Holloway in view Moturu teaches the product of claim 1. Ghahramanlou-Holloway in view Moturu does not teach wherein the method further comprises receiving, over a communication network, the adapted list.
However, deCharms does teach wherein the method further comprises receiving, over a communication network, the adapted list ([0226], “The device/software 1300 may interact with the user 1100 as well as one or more guides or providers 1500. This interaction may take place by communication network or in-person, and may use a variety of communication technologies available, including text messaging, audio or videochat, screen sharing, or use of UI elements to make selections or receive information.” [0256], “The software may include a stored list of medications, with corresponding settings and/or stimuli, based on the individual medication, the therapeutic area, the indication, or other factors designed to match the medication or treatment with the software's stimuli or instructions.” [0258], “The software may provide stimuli, exercises, training or instruction for individuals receiving any of these medications or treatments.”). The Examiner interprets modifying the treatment plan by creating additional, personalized elements after it has been pre-selected to encompass the above claim element.
Ghahramanlou-Holloway in view Moturu further in view of deCharms are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway in view Moturu with deCharms for the advantage of “teach[ing] a user to engage in specific mental exercises designed to engage the antinociceptive system in the brain, and thereby produce decreases in pain over time” (deCharms; [0028]).
Claims 6, 9, 12-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ghahramanlou-Holloway (Ghahramanlou-Holloway; Marjan, Post-Admission Cognitive Therapy: A Brief Intervention for Psychiatric Inpatients Admitted After a Suicide Attempt, May 2012, Cognitive and Behavioral Practice, Volume 19, Issue 2, pgs. 233-244) in view of Moturu (US 20150370993) in view of Roehr (US 20070282630).
Regarding claim 6, Ghahramanlou-Holloway teaches a method comprising:
obtaining patient data indicating exhibition of a suicidal ideation and/or suicide attempt of a patient (pg. 238, “during the first session, the therapist gauges the patient's readiness for change, assesses for emotional and cognitive responses to the recent suicide attempt (e.g., automotive thought, “I regret that I did not succeed.”), and pays close attention to motivational factors (i.e., reasons for living) that may best move the patient toward engagement in and compliance with treatment.”);
generating an adapted suicide treatment for the patient at least in part by adapting, based on the duration of the inpatient stay and based on patient response to a previously administered treatment following the suicidal ideation and/or suicidal attempt, a treatment that treats the suicidal ideation and/or attempt of the patient (Table 1, pg. 237, “PACT has been modified from Brown et al.'s (2005) original protocol (ten 45-minute sessions; total 7.5 hours) to consist of approximately six 60- to 90-minute sessions (total 6 to 9 hours). PACT is administered through individual therapy sessions preferably offered to the patient over the course of 3 consecutive days during inpatient psychiatric hospitalization… Decisions about the length and duration of treatment have been partially based on consultation with inpatient psychiatric staff and a review of the average length of inpatient stay.” Pg. 238, “ Past experiences with therapy, perceived obstacles to success and strategies to address these obstacles will be discussed.”). Please see Table 1, below, which comprises a list of suicide treatment activities intended to fit the duration of the inpatient stay.
PNG
media_image1.png
577
665
media_image1.png
Greyscale
And administering, to the patient, the adapted suicide treatment (pg. 238, “The primary objective of the second session is to collaboratively generate a cognitive conceptualization of the recent suicide attempt... More simply stated, the patient is asked to provide a suicide attempt story with a beginning, middle, and an end. Similar to what happens in a prolonged exposure session for traumatized patients, the PACT therapist guides the patient through the process of sharing his/her experiences on the day of the suicide attempt.” pg. 240 ,“ The construction of a safety plan relates directly to preventing relapse,… the patient is guided to develop an individualized hierarchically arranged written list of coping strategies to implement in future distressing circumstances.”).
Ghahramanlou-Holloway does not teach a non-transitory computer-readable storage medium having encoded thereon instructions that, when executed by at least one processor, cause the at least one processor to carry out the method; and wherein the patient data including a duration of an inpatient stay of the patient following the suicidal ideation and/or suicide attempt.
However, Moturu does teach a non-transitory computer-readable storage medium having encoded thereon instructions that, when executed by at least one processor, cause the at least one processor to carry out the method ([0070], “The method 100 and/or system 200 of the embodiments can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions can be executed by computer-executable components integrated with the application, applet, host, server, network, website, communication service, communication interface, hardware/firmware/software elements of a patient computer or mobile device, or any suitable combination thereof.”).
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of “automatically initiating provision of a therapeutic intervention for the individual by way of at least one of the computing system and the mobile communication device” (Moturu; [0014]).
Ghahramanlou-Holloway in view of Moturu does not teach wherein the patient data including a duration of an inpatient stay of the patient following the suicidal ideation and/or suicide attempt.
However, the combination of Ghahramanlou-Holloway in view of Roehr does teach the patient data including a duration of the patient's inpatient stay (Roehr, [0004], “The owner-member then enters the medical retreat program for a predetermined period of time, such as three to six weeks, to follow a design wellness program custom designed for the owner-member.” Ghahramanlou-Holloway, Pg. 235, “Each patient was offered 10 individual therapy sessions over 3 weeks. Problem-solving abilities improved most for those in the problem-solving condition, followed by those who received cognitive restructuring. Levels of hopelessness, suicide ideation, and intent improved for all participants regardless of treatment condition.”).
Ghahramanlou-Holloway in view Moturu further in view of Roehr are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway in view Moturu with Roehr for the advantage of “providing a regimen which is then put into effect for a period of time” (Roehr; [0003]).
Regarding claim 9, Ghahramanlou-Holloway in view Moturu further in view of Roehr teaches the product of claim 6. Ghahramanlou-Holloway further teaches wherein the patient data indicates a response of the patient to a previously administered portion of the treatment (pg. 238, “Furthermore, during the first session, the therapist gauges the patient's readiness for change, assesses for emotional and cognitive responses to the recent suicide attempt (e.g., automotive thought, “I regret that I did not succeed.”), and pays close attention to motivational factors (i.e., reasons for living) that may best move the patient toward engagement in and compliance with treatment.”),
Ghahramanlou-Holloway does not teach wherein: obtaining the patient data further comprises obtaining sensory data from one or more sensors of a device of the patient.
However, Moturu does teach:
obtaining the patient data further comprises obtaining sensory data from one or more sensors of a device of the patient ([0015], “the method 100 can monitor and analyze communication behavior, mobility behavior, and/or other behavior detected from any other suitable sensor(s) associated with an individual with depression over time” [0025], “Block S120 can additionally or alternatively include receiving one or more of: physical activity- or physical action-related data (e.g., accelerometer data, gyroscope data, data from an M7 or M8 chip) of the individual, …, biometric data (e.g., data recorded through sensors within the individual's mobile communication device, data recorded through a wearable or other peripheral device in communication with the individual's mobile communication device) of the individual, and any other suitable data. In examples, one or more of: a wireless-enabled scale, a blood pressure sensor, and a pulse-oximeter sensor can transmit the individual's weight, blood pressure, and blood oxygen level to a mobile communication device of the individual”).
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of making determinations “based upon data from sensors associated with the individual” (Moturu; [0029]).
Regarding claim 12, Ghahramanlou-Holloway in view Moturu further in view of Roehr teaches the product of claim 6. Ghahramanlou-Holloway further teaches wherein adapting the treatment further comprises:
selecting, from an ordered list of treatment activities, at least one first treatment activity, rather than selecting at least one second treatment activity listed before the at least one first treatment activity in the ordered list; and selecting, at a later time, the at least one second treatment activity (Table 1). Please see Table 1, below, which lists the treatment activities in order. Thus, a first treatment activity is performed prior to a second activity in the ordered list.
PNG
media_image2.png
580
662
media_image2.png
Greyscale
Regarding claim 13, Ghahramanlou-Holloway in view Moturu further in view of Roehr teaches the product of claim 6. Ghahramanlou-Holloway does not teach wherein obtaining the patient data further comprises: accessing an application on a device of the patient; and determining a risk of suicide of the patient based on one or more of: words spoken by the patient; and/or a message sent by the patient.
However, Moturu does teach wherein obtaining the patient data further comprises:
accessing an application on a device of the patient ([0020], “accessing a log of use of a communication application (e.g., native communication application) executing on a mobile communication device by the patient within a time period, which functions to unobtrusively collect and/or retrieve communication-related data from a patient's mobile communication device.”); and
determining a risk of suicide of the patient based on one or more of: words spoken by the patient; and/or a message sent by the patient ([0021], “in accessing the log of use of the native communication application, Block S110, preferably enables collection of one or more of: phone call-related data (e.g., number of sent and/or received calls, call duration, call start and/or end time, location of patient before, during, and/or after a call, and number of and time points of missed or ignored calls); text messaging (e.g., SMS test messaging) data (e.g., number of messages sent and/or received, message length associated with a contact of the individual, message entry speed, delay between message completion time point and sending time point, message efficiency, message accuracy, time of sent and/or received messages, location of the patient when receiving and/or sending a message); data on textual messages sent through other communication venues (e.g., public and/or private textual messages sent to contacts of the patient through an online social networking system, reviews of products, services, or businesses through an online ranking and/or review service, status updates, “likes” of content provided through an online social networking system), vocal and textual content (e.g., text and/or voice data that can be used to derive features indicative of negative or positive sentiments) and any other suitable type of data.” [0036], “for at least a time point of the set of time points, transforming data from the log of use, the supplementary dataset, and the survey dataset into an analysis of a depression-risk state of the individual associated with at least a portion of the time period” [0043], “positive correlations between daily mood survey score and call count/SMS count during peak hours, positive correlations between daily mood survey score and communication diversity, negative correlations between daily mood survey score and incoming call count during off-peak hours, negative correlations between daily mood survey score and SMS message length to a primary contact during peak hours”).
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of considering “vocal and textual content (e.g., text and/or voice data that can be used to derive features indicative of negative or positive sentiments)” (Moturu; [0021]).
Regarding claim 14, Ghahramanlou-Holloway in view Moturu further in view of Roehr teaches the product of claims 6 and 13. Ghahramanlou-Holloway does not teach wherein: accessing the application comprises determining a contact of the patient; and the method further comprises sending, to the contact, a message.
However, Moturu does teach wherein:
accessing the application comprises determining a contact of the patient ([0026], “Blocks S120 and/or Silo can additionally or alternatively include receiving data pertaining to individuals in contact with the individual during the period of time… aggregates communication behavior data and contextual data of two sides of a communication involving the individual who experiences states of depression. In examples, such data can include one or more of: a second party's location during a phone call with the individual, the second party's phone number, the second party's length of acquaintance with the individual, and the second party's relationship to the individual (e.g., top contact, spouse, family member, friend, coworker, business associate, etc.)”); and
the method further comprises sending, to the contact, a message ([0060], “transmitting an alert based upon the analysis. Block S152 functions to alert at least one of an entity associated with the individual and/or the individual regarding a critical state of depression that the patient has or will enter... The alert can be a visual alert (e.g., text-based alert, graphic alert), audio alert, haptic alert, and/or any other suitable type of alert. In relation to an entity associated with the patient(s), the entity can include any one or more of: a caretaker, a healthcare provider, a relative (e.g., parent, significant other, etc.), and any other suitable entity associated with the patient.”).
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of providing “text-based alerts including a type of alert (e.g., related to active data, related to passive data), a value of a depression-risk parameter associated with the alert, and a graphic that displays values of one or more scores of a survey (e.g., a daily mood survey) and/or a depression-risk parameter over time” (Moturu; [0060]).
Regarding claim 15, Ghahramanlou-Holloway teaches a system configured to:
obtaining patient data indicating exhibition of a suicidal ideation and/or suicide attempt of a patient (pg. 238, “during the first session, the therapist gauges the patient's readiness for change, assesses for emotional and cognitive responses to the recent suicide attempt (e.g., automotive thought, “I regret that I did not succeed.”), and pays close attention to motivational factors (i.e., reasons for living) that may best move the patient toward engagement in and compliance with treatment.”);
generating an adapted suicide treatment for the patient at least in part by adapting, to fit a duration of an inpatient stay following the suicidal ideation and/or suicide attempt and a risk of suicide of the patient, a list of suicide treatment activities(Table 1, pg. 237, “PACT has been modified from Brown et al.'s (2005) original protocol (ten 45-minute sessions; total 7.5 hours) to consist of approximately six 60- to 90-minute sessions (total 6 to 9 hours). PACT is administered through individual therapy sessions preferably offered to the patient over the course of 3 consecutive days during inpatient psychiatric hospitalization… Decisions about the length and duration of treatment have been partially based on consultation with inpatient psychiatric staff and a review of the average length of inpatient stay.” Pg. 238, “ Past experiences with therapy, perceived obstacles to success and strategies to address these obstacles will be discussed.”). Please see Table 1, below, which comprises a list of suicide treatment activities intended to fit the duration of the inpatient stay.
PNG
media_image1.png
577
665
media_image1.png
Greyscale
Ghahramanlou-Holloway does not teach wherein the system comprises a processor; and sending, over a communication network, to a device of the patient, during the inpatient stay, for administering during the inpatient stay, treatment activity data indicating the adapted list of suicide treatment activities.
However, Moturu does teach wherein the system comprises a processor ([0070], “The method 100 and/or system 200 of the embodiments can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions can be executed by computer-executable components integrated with the application, applet, host, server, network, website, communication service, communication interface, hardware/firmware/software elements of a patient computer or mobile device, or any suitable combination thereof.”); and
sending, over a communication network, to a device of the patient, treatment activity data indicating the adapted list of suicide treatment activities ([0014], “providing a notification to the individual, at the mobile communication device, in response to the analysis S160; and automatically initiating provision of a therapeutic intervention for the individual by way of at least one of the computing system and the mobile communication device S170.” [0063], “The notification can include one or more health improving tips and/or any other suitable therapeutic invention characterized by a therapy orientation (…) and a category (…) configured to address a variety of factors contributing to depression.”).
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of “automatically initiating provision of a therapeutic intervention for the individual by way of at least one of the computing system and the mobile communication device” (Moturu; [0014]).
Ghahramanlou-Holloway in view of Moturu does not teach wherein the treatment activity data indicating the adapted list of treatment activities is for administering during the inpatient stay.
However, the combination of Ghahramanlou-Holloway in view of Roehr does teach wherein the treatment activity data indicating the adapted list of treatment activities is for administering during the inpatient stay (Roehr, [0004], “The diagnostic testing and the doctor's examination information are processed in a central computer for designing an owner-member wellness program for entering the medical retreat program using diagnostic test results and a doctor's examination and including designing custom nutrition activities and therapy plans for the owner-member during his tenure in the medical retreat.” Ghahramanlou-Holloway, Pg. 235, “Each patient was offered 10 individual therapy sessions over 3 weeks. Problem-solving abilities improved most for those in the problem-solving condition, followed by those who received cognitive restructuring. Levels of hopelessness, suicide ideation, and intent improved for all participants regardless of treatment condition.”).
Ghahramanlou-Holloway in view Moturu further in view of Roehr are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway in view Moturu with Roehr for the advantage of “providing a regimen which is then put into effect for a period of time” (Roehr; [0003]).
Regarding claim 16, Ghahramanlou-Holloway in view Moturu further in view of Roehr teaches the system of claim 15. Ghahramanlou-Holloway further teaches adapting the list of suicide treatment activities to fit the duration of the inpatient stay (Table 1, pg. 237, “PACT has been modified from Brown et al.'s (2005) original protocol (ten 45-minute sessions; total 7.5 hours) to consist of approximately six 60- to 90-minute sessions (total 6 to 9 hours). PACT is administered through individual therapy sessions preferably offered to the patient over the course of 3 consecutive days during inpatient psychiatric hospitalization… Decisions about the length and duration of treatment have been partially based on consultation with inpatient psychiatric staff and a review of the average length of inpatient stay.”). Please see Table 1, below, which comprises a list of suicide treatment activities intended to fit the duration of the inpatient stay.
PNG
media_image1.png
577
665
media_image1.png
Greyscale
Ghahramanlou-Holloway does not teach wherein a processor is used to perform the method.
However, Moturu does teach wherein a processor is used to perform the method ([0070], “The method 100 and/or system 200 of the embodiments can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions can be executed by computer-executable components integrated with the application, applet, host, server, network, website, communication service, communication interface, hardware/firmware/software elements of a patient computer or mobile device, or any suitable combination thereof.”).
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of “automatically initiating provision of a therapeutic intervention for the individual by way of at least one of the computing system and the mobile communication device” (Moturu; [0014]).
Regarding claim 17, Ghahramanlou-Holloway in view Moturu further in view of Roehr further teaches the system of claim 15. Ghahramanlou-Holloway further teaches adapting, based on the patient data, the list of suicide treatment activities (Table 1, pg. 238, “during the first session, the therapist gauges the patient's readiness for change, assesses for emotional and cognitive responses to the recent suicide attempt (e.g., automotive thought, “I regret that I did not succeed.”), and pays close attention to motivational factors (i.e., reasons for living) that may best move the patient toward engagement in and compliance with treatment.” Pg. 241, “A psychiatric hospital is a multidisciplinary setting and, given the heterogeneity of inpatient milieus,2 we expect that PACT may require slight adaptations once disseminated.”).
Ghahramanlou-Holloway does not teach wherein the at least one processor is further configured to: obtain, over the communication network, from the device, patient data indicative of a response of the patient to at least one suicide treatment activity of the list of suicide treatment activities; and send, over the communication network, to the device, an update to the treatment activity data.
However, Moturu does teach wherein the at least one processor is further configured to:
obtain, over the communication network, from the device, patient data indicative of a response of the patient to at least one suicide treatment activity of the list of suicide treatment activities ([0062], “In variations wherein the notifications are personalized to the individual, Block S160 can utilize a machine learning technique to identify the types of notifications that the patient responds positively to and/or negatively to, as assessed by patient outcomes in relation to depressive state (e.g., indicated in values of the depression-risk parameter).” [0032], “the survey dataset comprises biweekly responses (e.g., for a period of 6 months) to the PHQ-9 survey, biweekly responses (e.g., for a period of 6 months) to the WHO-5 survey in alternation with the PHQ-9 survey, responses to the PAM assessment at an initial time point, at an intermediate time point (e.g., 1-month time point), and at a termination time point, responses to the HAM-D assessment at an initial time point and a termination time point, biweekly response to a recent care survey, daily responses to a mood survey, and twice-per-week responses to a medication adherence survey.” [0033], “responses to one or more of the set of depression-assessment surveys can be provided by user input at an electronic device (e.g., a mobile communication device of the patient), or automatically detected from user activity (e.g., using suitable sensors).”);
send, over the communication network, to the device, an update to the treatment activity data ([0062], “The notifications can be personalized to the individual, or can be provided in the same manner to each of a population of individuals. In variations wherein the notifications are personalized to the individual, Block S160 can utilize a machine learning technique to identify the types of notifications that the patient responds positively to and/or negatively to, as assessed by patient outcomes in relation to depressive state (e.g., indicated in values of the depression-risk parameter).”).
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of utilizing a system wherein “notifications can be personalized to the individual” (Moturu; [0062]).
Regarding claim 19, Moturu in view of Roehr teaches the system of claim 15. Moturu further teaches wherein the at least one processor is further configured to send, to a healthcare provider of the patient, a message relating to the patient ([0015], “provide an alert to a caretaker associated with the patient and/or to the patient upon detection that the individual has entered or is at risk of entering a critical state of depression (e.g., suicidal state)” [0060], “Block S152, which recites: transmitting an alert based upon the analysis. Block S152 functions to alert at least one of an entity associated with the individual and/or the individual regarding a critical state of depression that the patient has or will enter... In relation to an entity associated with the patient(s), the entity can include any one or more of: a caretaker, a healthcare provider, a relative (e.g., parent, significant other, etc.), and any other suitable entity associated with the patient.” ). The Examiner interprets the alert notifying that a patient has entered or is at risk of entering a critical state of depression to encompass a message.
Regarding claim 20, Ghahramanlou-Holloway in view Moturu further in view of Roehr teaches the system of claim 15. Ghahramanlou-Holloway does not teach wherein the at least one processor is further configured to send, to a contact of the patient, a message relating to the patient.
Moturu further teaches wherein the at least one processor is further configured to send, to a contact of the patient, a message relating to the patient ([0060], “transmitting an alert based upon the analysis. Block S152 functions to alert at least one of an entity associated with the individual and/or the individual regarding a critical state of depression that the patient has or will enter... The alert can be a visual alert (e.g., text-based alert, graphic alert), audio alert, haptic alert, and/or any other suitable type of alert. In relation to an entity associated with the patient(s), the entity can include any one or more of: a caretaker, a healthcare provider, a relative (e.g., parent, significant other, etc.), and any other suitable entity associated with the patient.”).
Ghahramanlou-Holloway in view Moturu are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway with Moturu for the advantage of providing “text-based alerts including a type of alert (e.g., related to active data, related to passive data), a value of a depression-risk parameter associated with the alert, and a graphic that displays values of one or more scores of a survey (e.g., a daily mood survey) and/or a depression-risk parameter over time” (Moturu; [0060]).
Claims 8, 10-11, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ghahramanlou-Holloway (Ghahramanlou-Holloway; Marjan, Post-Admission Cognitive Therapy: A Brief Intervention for Psychiatric Inpatients Admitted After a Suicide Attempt, May 2012, Cognitive and Behavioral Practice, Volume 19, Issue 2, pgs. 233-244) in view of Moturu (US 20150370993) further in view of Roehr (US 20070282630) and deCharms (US 20160267809).
Regarding claim 8, Ghahramanlou-Holloway in view Moturu further in view of Roehr further teaches the product of claim 6. Ghahramanlou-Holloway further teaches wherein:
adapting the treatment further comprises selecting the treatment activity from a list of treatment activities (pg. 238, “The primary objective of the second session is to collaboratively generate a cognitive conceptualization of the recent suicide attempt... More simply stated, the patient is asked to provide a suicide attempt story with a beginning, middle, and an end. Similar to what happens in a prolonged exposure session for traumatized patients, the PACT therapist guides the patient through the process of sharing his/her experiences on the day of the suicide attempt.” pg. 240 ,“ The construction of a safety plan relates directly to preventing relapse,… the patient is guided to develop an individualized hierarchically arranged written list of coping strategies to implement in future distressing circumstances.”). Examiner interprets providing the therapy (exposure treatment or development of a safety/crisis plan to encompass a selection from the list of treatment activities.
Although Ghahramanlou-Holloway suggests assessing patient readiness (pg. 238, “during the first session, the therapist gauges the patient's readiness for change”), Ghahramanlou-Holloway in view Moturu further in view of Roehr does not explicitly teach obtaining the patient data further comprises asking the patient whether the patient is ready for a treatment activity.
However, deCharms does teach obtaining the patient data further comprises asking the patient whether the patient is ready for a treatment activity ([0055], “The timing of the sequence of the instructions may be provided by the software, or may be controlled by the user, for example by clicking the UI to receive each additional sequence step, using a sound or voice control or other input. This input may indicate when the user has completed each sequence step, or when they are ready to go to the next step.”).
Ghahramanlou-Holloway in view Moturu further in view of Roehr and deCharms are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway in view Moturu further in view of Roehr with deCharms for the advantage of understanding when the patient is “ready to go to the next step” (deCharms; [0028]).
Regarding claim 10, Ghahramanlou-Holloway in view Moturu further in view of Roehr teaches the product of claim 6. Ghahramanlou-Holloway further teaches wherein:
adapting the treatment further comprises selecting the treatment activity (pg. 238, “The primary objective of the second session is to collaboratively generate a cognitive conceptualization of the recent suicide attempt... More simply stated, the patient is asked to provide a suicide attempt story with a beginning, middle, and an end. Similar to what happens in a prolonged exposure session for traumatized patients, the PACT therapist guides the patient through the process of sharing his/her experiences on the day of the suicide attempt.” pg. 240 ,“ The construction of a safety plan relates directly to preventing relapse,… the patient is guided to develop an individualized hierarchically arranged written list of coping strategies to implement in future distressing circumstances.”). Examiner interprets providing the therapy (exposure treatment or development of a safety/crisis plan to encompass a selection from the list of treatment activities.
Ghahramanlou-Holloway in view Moturu further in view of Roehr does not teach wherein obtaining the patient data further comprises obtaining, over a communication network, instructions for selecting a treatment activity from a list of treatment activities.
However, deCharms does teach wherein obtaining the patient data further comprises obtaining, over a communication network, instructions for selecting a treatment activity from a list of treatment activities ([0344], “The software may provide a common platform for a guide and/or a user (and/or the user's support system or follow-up providers where appropriate) to create a patient treatment plan based upon the recommendations made by the software, and based upon individual-appropriate choices. After patient assessment and treatment plan recommendations are provided by the software, the guide and patient may select, adjust and discuss the treatment plan recommendations provided by the software.”). The Examiner interpret a guide and a user using a common platform to select a treatment plan based on a list of recommendations made by a software to encompass a user obtaining, over a communication network, instructions for selecting a treatment activity from a list of treatment activities.
Ghahramanlou-Holloway in view Moturu further in view of Roehr and deCharms are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway in view Moturu further in view of Roehr with deCharms for the advantage of “teach[ing] a user to engage in specific mental exercises designed to engage the antinociceptive system in the brain, and thereby produce decreases in pain over time” (deCharms; [0028]).
Regarding claim 11, Ghahramanlou-Holloway in view Moturu further in view of Roehr and deCharms teaches the product of claims 6 and 10. Ghahramanlou-Holloway in view Moturu further in view of Roehr does not teach wherein the method further comprises: transmitting, over the communication network to the healthcare provider, an indication of a response of the patient to the treatment activity.
However, deCharms does teach wherein the method further comprises:
transmitting, over the communication network to a healthcare provider, an indication of a response of the patient to the treatment activity ([0258], “The user may indicate use of medication or treatment compliance 12170 and input this information into the software 12370. This information may also be communicated by the software to the guide or provider 12570, or integrated into an EMR system.” [0357], “The software platform may be linked to API hooks of EMR/EHR systems, providing the ability to import data into personal health records (PHRs) that provide standards-compliant APIs. The software may integrate with EMR/EHRs to exchange information, providing patient data to the EHR, or accessing patient information from an EHR. This may allow guides/providers and patients to view and track their software-generated data in the context of their other health information, using any features provided by the PHR, and providing greater linkage between healthcare providers in the context of treatment.”).
Ghahramanlou-Holloway in view Moturu further in view of Roehr and deCharms are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway in view Moturu further in view of Roehr with deCharms for the advantage of utilizing a provider “to make selections or recommendations on behalf of the user” (deCharms; [0223]).
Regarding claim 18, Ghahramanlou-Holloway in view Moturu further in view of Roehr teaches the system of claim 15. Although Ghahramanlou-Holloway teaches suicide treatment activities (pg. 234, “The primary aims of PACT are to reduce the likelihood of suicide attempt recurrence as well as decrease the severity of established psychological risk factors for suicide.”), Ghahramanlou-Holloway in view Moturu further in view of Roehr does not teach wherein the at least one processor is further configured to access electronic health records of the patient; and adapt the list of treatment activities based on the electronic health records.
However, deCharms does teach wherein the at least one processor is further configured to access electronic health records of the patient ([0357], “The software platform may be linked to API hooks of EMR/EHR systems, providing the ability to import data into personal health records (PHRs) that provide standards-compliant APIs. The software may integrate with EMR/EHRs to exchange information, providing patient data to the EHR, or accessing patient information from an EHR. This may allow guides/providers and patients to view and track their software-generated data in the context of their other health information, using any features provided by the PHR, and providing greater linkage between healthcare providers in the context of treatment.”); and
adapt the list of treatment activities based on the electronic health records ([0262], “The software may use a variety of types of data for the characterization of users, and for grouping of users to compute responses to any form of treatment, alone or in combination with the provision of stimuli, instructions or training provided by this software. Examples of the types of data that may be used to characterize individuals include genetic data, disease risk data, family history of a condition, brain imaging data, neurophysiological data, questionnaire data, performance data, medication data.” [0309], “The software may provide for interaction with a guide or provider, who may guide or make recommendations for the user, and receive corresponding information. For example, the guide may indicate or recommend what stimuli, exercises, training or content a user should receive. This recommendation may be based upon the characterization of the user provided by the software”).
Ghahramanlou-Holloway in view Moturu further in view of Roehr and deCharms are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway in view Moturu further in view of Roehr with deCharms for the advantage of “teach[ing] a user to engage in specific mental exercises designed to engage the antinociceptive system in the brain, and thereby produce decreases in pain over time” (deCharms; [0028]).
Regarding claim 21, Ghahramanlou-Holloway in view Moturu further in view of Roehr teaches the non-transitory computer-readable storage medium of claims 6 and 9. Ghahramanlou-Holloway in view Moturu further in view of Roehr does not explicitly teach wherein the method further comprises: adapting the treatment based on the response of the patient to the previously administered portion of the treatment; and after adapting the treatment based on the response to the previously administered portion, administering a further portion of the treatment to the patient.
However, deCharms does teach adapting the treatment based on the response of the patient to the previously administered portion of the treatment ([0217], “Within an exercise, selection of content presented to the user by the software may be determined in real-time based on user-inputs and software algorithms. For example, the user's input may lead to a substantially immediate change in sound level, sound selection, sound quality or parameters, image selection, image opacity, image brightness, image timing or rhythm. Stimuli that are altered in real time by the software may be intended to represent the input being provided by the user, for example representing intensity, quality, or quantity. For example, if a user selects a position along a left-right or up-down continuum on a user interface to indicate the level of pain sensation that they are experiencing, the software may determine a corresponding sound volume or sound pitch to present to the user, and may update the sound presented to the user in substantially real time.” [0233], “1. User self-optimizes the training; a. Software changes length of pause, preferred music, preferred nature sound, preferred video that are played during training based on user choices; 2. Selecting audio based on history of user's responses; a. Software may select different audio tracks, e.g. different spoken instructions, based on which tracks have been most successful in decreasing users pain or other experience ratings in previous trials; b. Software may select different posture sequences, e.g. different sequences of spoken instructions, based on which sequences have been most successful in decreasing users pain or other experience ratings in previous trials; 3. Software may customize the content provided to subject, including sequences and instruction tracks, based on inputs of the subject; a. Location of painful area; b. Mood; c. Extensive surveys (e.g. neurotype); 4. Automatically modulating focus period length based on subject's performance; a. e.g. making it shorter if users indicate “I spaced out”;”); and
after adapting the treatment based on the response to the previously administered portion, administering a further portion of the treatment to the patient. ([0217], “Within an exercise, selection of content presented to the user by the software may be determined in real-time based on user-inputs and software algorithms.” [0235], “Content may be presented to the user 1340, for example via a presentation device or display 140, 160, 170, which may include a computer, mobile device, or other device.”). It would be obvious to administer a further portion of the treatment after adapting the treatment in real time within an exercise.
Ghahramanlou-Holloway in view Moturu further in view of Roehr and deCharms are considered analogous to the claimed invention because they are in the field of mental health treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ghahramanlou-Holloway in view Moturu further in view of Roehr with deCharms for the advantage of the functionality wherein “the difficulty of steps, levels, exercises may be adjusted to fit the user's abilities or performance” (deCharms; [0298]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID CHOI whose telephone number is (571)272-3931. The examiner can normally be reached M-Th:8:30-5:30 ET.
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, Shahid Merchant can be reached on (571)270-1360. 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.
/D.C./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684