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 Amendments
Claims 1-20 are currently pending in this case and have been examined and
addressed below. This communication is a Final Rejection in response to the
Amendment to the Claims and Remarks filed on 10/20/2025.
Claims 1 and 11- 18 are amended claims.
Claims 2-10 and 19-20 are original claims.
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 (i.e. an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 1-20 are drawn to a method and a system, which are statutory categories of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 1 recites a method for providing a first user [page] comprising a first plurality of user [page] elements to present first digital therapeutic content to a user, applicable to a plurality of conditions; identifying, a condition to be addressed in the user from the plurality of conditions, using data associated with the user; generating a second user [page] to include (i) at least one of the first plurality of user [page] elements of the first user [page] and (ii) a second plurality of user [page] elements to present second digital therapeutic content to address the condition identified for the user.
Independent claim 11 recites a system to provide a first user [page] comprising a first plurality of user [page] elements to present first digital therapeutic content to a user applicable to a plurality of conditions; identify a condition to be addressed in the user from the plurality of conditions, using data associated with the user; generate a second user [page] to include (i) at least one of the first plurality of user [page] elements of the first user [page] and (ii) a second plurality of user [page] elements to present second digital therapeutic content to address the condition identified for the user.
These steps amount to certain methods of organizing human activity which includes functions relating to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people – also note MPEP § 2106.04(a)(2)(II) stating certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping).
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
The claims recite the additional elements of one or more processors, a first user interface, a second user interface, and one or more processors coupled with memory.
These elements are recited at a high-level of generality such that it amounts to mere instructions to apply the exception because this is an example of applying the abstract idea by use of general-purpose computer which does not integrate the abstract idea into a practical application.
Claims 1 and 11 recite administering the second digital therapeutic content to the user to address the condition identified for the user via the second user interface comprising the second plurality of user interface elements. This step amounts
to insignificant extra solution activity. When determining if a particular treatment and
prophylaxis as a practical application under Step 2A Prong Two, Examiner considered
the factors presented in the MPEP 2106.04(d)(2).
Factor A: The Particularity Or Generality Of The Treatment Or Prophylaxis. The
generating a treatment plan the abstract idea is not "particular," i.e., specifically
identified so that it does not encompass all applications of the judicial exception(s).
Here, the administering of the digital therapeutic content to the user to address the condition is not specified to a specific condition of the user. The Specification recites that the claimed invention can be utilized to treat a plurality of conditions such substance use disorder, opioid use disorder, chronic insomnia, alcohol use disorder, schizophrenia, generalized anxiety disorder, major depressive disorder, bipolar, posttraumatic stress disorder, acute and chronic pain, migraine, multiple sclerosis, epilepsy, irritable bowel syndrome, specialty gastroenterology, cancer, or cardiovascular disease (Para. 0020). Therefore, the claims recite a high-level recitation of a treatment without explicitly providing a particular treatment for a particular disease or medical condition.
Factor B. Whether the Limitation(s) Have More Than a Nominal or Insignificant
Relationship to the Exception. The treatment limitation does not have a significant
relationship to the judicial exception – that is it does not integrate the law of nature into
a practical application. As stated above, because the specific treatment and the
particular disease or medical condition fails to be explicated recited, any possible
treatment combination could not reasonably be considered known in the art as a
treatment for any disease.
Factor C. Whether the Limitation(s) Are Merely Extra-Solution Activity or A Field
of Use. The treatment or prophylaxis limitation does not impose meaningful limits on the
judicial exception and is only extra-solution activity or a field-of-use (see MPEP §
2106.05(g))). The administering the second digital therapeutic content to the user to address the condition identified for the user is well known, and amounts to necessary data output similar to that of In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016). The step does not add a meaningful limitation to the process of determining treatment to be fabricated for a patient.
Therefore, the claims only recite the prophylactic step as a tool which only serves
to as insignificant post solution activity (MPEP § 2106.05(g) - insignificant pre/post-
solution activity) and is therefore not a practical application of the recited judicial
exception.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer.
As discussed above with respect to integration of the abstract idea into a
practical application, the claims recite the additional elements of one or more processors, a first user interface, a second user interface, and one or more processors coupled with memory.
The use of administering a digital therapeutic content to the user to address the condition identified for the user is well-understood, routine, and conventional. The position is supported by; (1) Abbadessa et al, Digital therapeutics in neurology (2022), teaching on cognitive rehabilitation via digital devices is increasingly regarded as a potentially effective rehabilitative option to enhance brain neuroplasticity that include Language TherAppy” is a tablet-based self-administered speech therapy and Cognitive Training Kit” (COGNI-TRAcK) is a customized application software for self-administered intensive and personalized cognitive training (Pgs. 4-5 Cognitive functions); (2) Riadi et al, Digital interventions for depression and anxiety in older adults: a systematic review of randomized controlled trials (2022), teaching on digitally-delivered cognitive behavioral therapy (CBT) can be considered as a low-intensity psychological intervention that can aid older adults with mild-to-moderate mental health problems (Pg. 1 Introduction); and (3) Boucher et al, Artificially intelligent chatbots in digital mental health interventions: a review (2021) the most common application of chatbots within digital mental health interventions (DMHIs) is to deliver content, which includes administering psychotherapeutic interventions and can simulate a therapeutic conversational style that implements and teaches users about various therapeutic techniques (Pg 3 4.2 Content delivery) (treated as a review under MPEP 2106.07(a)(III)(C) that describes the state of the art and discusses what is well-known and in common use in the relevant industry). Therefore, administering a digital therapeutic content to the user to address the condition identified for the user is not sufficient to amount to significantly more than the recited judicial exception.
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.
For the reasons stated, these claims fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. § 101.
Analysis of Dependent Claims
Dependent claims 2 and 12 recite receiving, by the one or more processors, input data identifying the interactions by the user with the second plurality of user interface elements of the second user interface, identifying, by the one or more processors, a second condition different from the first condition to be addressed in the user based on the input data; and generating, by the one or more processors, a third user [page] to include (i) the second user interface and (ii) a third plurality of user interface elements to provide third digital therapeutic content to address the second condition identified for the user.
Dependent claims 3 and 13 recite wherein identifying the condition further comprises identifying, from the plurality of conditions, at least a first condition and a second condition to be addressed in the user, and wherein generating the second user interface further comprises generating the second user interface to include (i) the second plurality of user interface elements for provision of the second digital therapeutic content to address the first condition and (ii) a third plurality of user interface elements for provision of third digital therapeutic content to address the second condition.
Dependent claims 4 and 14 recite receiving, by the one or more processors, input data identifying the interactions by the user with the first plurality of user interface elements of the first user interface, wherein identifying the condition further comprises determining a change in state associated with the user based on the input data on the first user interface, and wherein generating the second user interface further comprises generating the second user interface responsive to determining the change in state.
Dependent claims 5 and 15 recite selecting, by the one or more processors, from a plurality of user interface sets, a user interface set comprising at least a portion of the second plurality of user interface elements based on input data identifying the interactions by the user with the first plurality of user interface elements of the first user interface, and wherein generating the second user interface further comprises generating the second user interface to include at least the portion of the second plurality of user interface elements defined by the user interface set.
Dependent claims 7 and 17 recite receiving, by the one or more processors, input data identifying the interactions by the user with the second plurality of user interface elements of the second user interface, and identifying, by the one or more processors, a change in state associated with the user based on the input data on the second user interface, and determining, by the one or more processors, responsive to the change in state, to provide the first user interface comprising the first plurality of user interface elements to present the first digital therapeutic content to the user.
Dependent claims 8 and 18 recite wherein identifying the condition further comprises receiving an indication to provide a digital therapeutic associated with the second digital therapeutic content to the user to address the condition.
Dependent claims 9 and 19 recite wherein the plurality of conditions comprises at least one of: substance use disorder, opioid use disorder, chronic insomnia, alcohol use disorder, schizophrenia, generalized anxiety disorder, major depressive disorder, bipolar, posttraumatic stress disorder, acute and chronic pain, migraine, multiple sclerosis, epilepsy, irritable bowel syndrome, specialty gastroenterology, cancer, or cardiovascular disease.
Dependent claims 10 and 20 recite wherein the user is on a medication to address the condition, in partial concurrence with the presentation of at least one of the first digital therapeutic content or the second digital therapeutic content.
Each of these steps of the preceding dependent claims 2-5, 7-10, 12-15, 17-20 only serve to further limit or specify the features of independent claims 1 or 11 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
Dependent claims 2 and 12 recite a third user interface. Claim(s) 2 and 12 also includes the additional element of “third user interface” which is mere instructions to apply the exception and does not provide a practical application or significantly more for the same reasons.
Dependent claims 6 and 16 recite selecting the user interface set further comprises applying a machine learning model to the input data to select the user interface set from the plurality of user interface sets, wherein the machine learning model is establishing using a plurality of selections each identifying sample input data and a respective user interface set selected from the plurality of user interface sets. This limitation amounts to mere instructions to apply the exception because a mathematical algorithm applied on a general-purpose computer has been found by the courts to be mere instructions to apply as in MPEP 2106.05(f)(2).
Claim(s) 8 and 18 also includes the additional element of “remote computing system” which is mere instructions to apply the exception and does not provide a practical application or significantly more for the same reasons.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-9 and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaughn (US 20190019581 A1) in view of Mainwaring (US 20150379232 A1).
REGARDING CLAIM 1
Vaughn teaches a method of generating user interfaces based on conditions associated with users, comprising:
providing, by one or more processors, a first user interface comprising a first plurality of user interface elements to present first digital therapeutic content to a user applicable to a plurality of conditions; ([Para. 0033 and Para. 0174] The system comprises instructions to diagnose and treat one or more of cognitive or behavior development, neurodegenerative conditions, cognitive and behavioral disorders or conditions, including mood disorders. [Para. 0191] The diagnosis module communicates its diagnosis to the digital device 110, as well as to therapy module 134, which uses the diagnosis to suggest therapies to be performed to treat any diagnosed symptoms. The therapy module 134 sends its recommended therapies to the digital device 110, including instructions for the patient and caregivers to perform the therapies recommended over a given time frame. [Para. 0169] the digital personalized medicine system comprises digital devices with processors.)
identifying, by the one or more processors, a condition to be addressed in the user from the plurality of conditions, using data associated with the user; ([Para. 0191] The therapy module 134 can then indicate to the diagnosis module 132 that the latest round of therapy is finished, and that a new diagnosis is needed. The diagnostic module 132 can then provide new diagnostic tests and questions to the digital device 110, as well as take input from the therapy module of any data provided as part of therapy, such as recordings of learning sessions or browsing history of caregivers or patients related to the therapy or diagnosed condition. The diagnostic module 132 then provides an updated diagnosis to repeat the process and provide a next step of therapy. [Para. 0013] The digital diagnostic uses the data collected by the system about the patient, which may include complimentary diagnostic data captured outside the digital diagnostic, with analysis from tools such as machine learning, artificial intelligence, and statistical modeling to assess or diagnose the patient's condition. [Para. 0043] The behavioral, neurological or mental health disorder may be selected from the group consisting of autism, autistic spectrum, attention deficit disorder, depression, obsessive compulsive disorder, schizophrenia, Alzheimer's disease, dementia, attention deficit hyperactive disorder, and speech and learning disability. [Para. 0169] the digital personalized medicine system comprises digital devices with processors.)
and administering providing, by the one or more processors, the second digital therapeutic content to the user to address the condition identified for the user via the second user interface comprising the second plurality of user interface elements. ([Para. 0169] The digital personalized medicine system comprises digital devices with processors. [Para. 0194] Therapy recommendation module 156 then generates a recommended therapy comprising one or more of the therapies identified as promising by the therapy matching module 154, and sends that recommendation to the subject with instructions for administration of the recommended therapies. [Para. 0201] A new therapy (i.e. second therapeutic) is recommended based on the assessment model, the degree of success of the previous therapy (i.e. first therapeutic), if any, and the scores assigned to a collection of candidate therapies based on previous uses of those therapies with the subject and other subjects with similar assessments. The recommended therapy is sent to the subject for administration, along with instructions of a particular span of time to apply it.)
Vaughn does not explicitly teach, however Mainwaring teaches
generating, by the one or more processors, a second user interface to include (i) at least one of the first plurality of user interface elements of the first user interface and (ii) a second plurality of user interface elements to present second digital therapeutic content to address the condition identified for the user; ([Para. 0010] Displaying, at a user interface, one or more user-selectable user interface elements for receiving an identity of at least one diagnosis of at least one medical condition, and receiving, at the user interface, user input identifying a particular diagnosis of a particular medical condition. Examiner interprets the user-selectable user interface elements to be indicative of at least one of the first plurality of user interface elements of the first user interface. [Para. 0057] The physician system 140 can present one or more diagnostic user interfaces that educate the patient about his condition using anatomical models, illustrations, text, etc. As such, physician system 140 can be configured to present one or more educational interfaces and/or one or more decision aid user interfaces configured to educate patients about conditions and treatment options, to ensure that the patients have reached an understanding of the risks and benefits of various treatment options (or no treatment), and to obtain informed consent from the patients. Examples of such user interfaces are presented hereinafter in FIGS. 4A-4J. [Para. 0093] The method 700 can also include an act 704 of presenting a selectable menu option for each content type. Act 704 can comprise presenting, at a user interface, a selectable menu option for each of the identified plurality of content types, each selectable menu option being configured to present medical content relevant to corresponding content type when selected. For example, the physician system 140 can present at the user interface a navigation area that enables selection of each of the identified categories. [Para. 0123] FIG. 11B illustrates an example care plan user interface. As depicted, the care plan user interface can include one or more interactive user interface elements that enable a physician to select one or more diagnoses (i.e. patient condition) and one or more treatment options (i.e. digital therapeutic content).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of digital diagnostics and digital therapeutics to patients as taught by Vaughn and incorporate diagnostic computer systems and diagnostic user interfaces as taught by Mainwaring, with the motivation of facilitating medical diagnosis, education, treatment, and recovery (Mainwaring Para. 0003).
REGARDING CLAIM 2
Vaughn/ Mainwaring teach the method of claim 1, Vaughn further teaches further comprising: receiving, by the one or more processors, input data identifying the interactions by the user with the second plurality of user interface elements of the second user interface, identifying, by the one or more processors, a second condition different from the first condition to be addressed in the user based on the input data; and generating, by the one or more processors, a third user interface to include (i) the second user interface and (ii) a third plurality of user interface elements to provide third digital therapeutic content to address the second condition identified for the user. ([Para. 0019] The diagnostic module may be configured to received updated subject data (i.e. interactions by the user with the second plurality of user interface elements) from the subject in response to the therapy of the subject and generate updated diagnostic data from the subject. The therapeutic module may be configured to receive the updated diagnostic data and output an updated personal treatment plan for the subject in response to the diagnostic data and the updated diagnostic data. [Para. 0126] The digital diagnostic further enables the assessment of a subject's change in state or performance, directly or indirectly via data and meta-data that can be analyzed by tools such as machine learning, artificial intelligence, and statistical modeling, to provide feedback into the system to improve or refine the diagnoses (i.e. a second condition) and potential therapeutic interventions. [Para. 0027] the data assessment and machine learning from the digital diagnostic and corresponding responses, or lack thereof, from the therapeutic interventions is configured to identify novel diagnoses for subjects and novel therapeutic regimens for both patents and caregivers. [Para. 0191] After performing the therapies over the given time frame, the caregivers or patient can indicate completion of the recommended therapies, and a report can be sent from the digital device 110 to the therapy module 134. The therapy module 134 can then indicate to the diagnosis module 132 that the latest round of therapy is finished, and that a new diagnosis is needed. The diagnostic module 132 can then provide new diagnostic tests and questions to the digital device 110, as well as take input from the therapy module of any data provided as part of therapy, such as recordings of learning sessions or browsing history of caregivers or patients related to the therapy or diagnosed condition. The diagnostic module 132 then provides an updated diagnosis to repeat the process and provide a next step of therapy.)
REGARDING CLAIM 3
Vaughn/ Mainwaring teach the method of claim 1, Vaughn further teaches wherein identifying the condition further comprises identifying, from the plurality of conditions, at least a first condition and a second condition to be addressed in the user, and wherein generating the second user interface further comprises generating the second user interface to include (i) the second plurality of user interface elements for provision of the second digital therapeutic content to address the first condition and (ii) a third plurality of user interface elements for provision of third digital therapeutic content to address the second condition. ([Para. 0279] The personalized medical system 130 can comprises a diagnosis module 132 to provide initial and updated diagnosis of a patient's developmental status, and a therapeutic module 134 to provide personalized therapy recommendations in response to the diagnoses of diagnosis module 132. [Para. 0282] The diagnosis module can communicate its initial diagnosis to the therapy module 134, which uses the initial diagnosis to suggest initial therapies to be performed to treat any diagnosed symptoms. The therapy module 134 sends its recommended therapies (i.e. the second plurality of user interface elements for provision of the second digital therapeutic content to address the first condition) to the digital device 110, including instructions for the patient and caregivers to perform the therapies recommended over a given time frame. The patient and caregivers can provide feedback to the diagnostic module 132, and the diagnostic module 132 can then instruct the data processing module to provide new diagnostic tests and questions to the digital device 110. The diagnostic module 132 then provides an updated diagnosis to the therapy module 134 which suggests updated therapies to be performed by the patient and caregivers as a next step of therapy. Therefore, a feedback loop between the patient and caregivers, the diagnostic module and the therapy module can be formed, and the patient can be diagnosed with fewer questions. The feedback can identify relative levels of efficacy, compliance and responses resulting from the therapeutic interventions, and allow corrective changes to improve treatment. Examiner interprets the use of the feedback loop to be indicative of determining the second and third plurality of user elements. [Para. 0283] The therapy module may rely on the diagnostic module in order to classify subjects as having different conditions or different severity levels of a condition. The therapy module can have its own independent prediction module or recommendation module in order to decide on next best therapy or treatment from a list of options. [Para. 0286] The user, such as the patient and caregivers, can for example download and install an App comprising software instructions on the digital device 110. The App can enable the user to receive instructions from the cloud-based server for the diagnostic tests, upload the answers to diagnostic tests, receive a treatment (for example, games or interactive content) from the cloud-based server, offer feedback, periodically receive new tests to determine how the treatment is progressing, and receive updated treatment. [Para. 0286] A feedback loop is thus created between the user and the cloud-based server (for example, the personalized medicine system 130), in which the evaluation of the subject subsequent to the initiation of therapy is used to adjust therapy to improve the response.)
REGARDING CLAIM 4
Vaughn/ Mainwaring teach the method of claim 1, Vaughn further teaches further comprising receiving, by the one or more processors, input data identifying the interactions by the user with the first plurality of user interface elements of the first user interface, wherein identifying the condition further comprises determining a change in state associated with the user based on the input data on the first user interface, and wherein generating the second user interface further comprises generating the second user interface responsive to determining the change in state. ([Para. 0184] The digital diagnostic can also provide assessment of a patient's change in state or performance, directly or indirectly via data and meta-data that can be analyzed by tools such as machine learning, artificial intelligence, and statistical modeling to provide feedback into the system to improve or refine the diagnoses and potential therapeutic interventions. [Para. 0191] The diagnosis module communicates its diagnosis to the digital device 110, as well as to therapy module 134, which uses the diagnosis to suggest therapies to be performed to treat any diagnosed symptoms. The therapy module 134 sends its recommended therapies to the digital device 110, including instructions for the patient and caregivers to perform the therapies recommended over a given time frame. After performing the therapies over the given time frame, the caregivers or patient can indicate completion of the recommended therapies, and a report can be sent from the digital device 110 to the therapy module 134. The therapy module 134 can then indicate to the diagnosis module 132 that the latest round of therapy is finished, and that a new diagnosis is needed. The diagnostic module 132 can then provide new diagnostic tests and questions to the digital device 110, as well as take input from the therapy module of any data provided as part of therapy, such as recordings of learning sessions or browsing history of caregivers or patients related to the therapy or diagnosed condition. The diagnostic module 132 then provides an updated diagnosis to repeat the process and provide a next step of therapy. [Para. 0262] The method 1100 may be performed with a user interface provided on a computing device, the computing device comprising a display and a user interface for receiving user input in response to the instructions provided on the display.)
REGARDING CLAIM 7
Vaughn/ Mainwaring teach the method of claim 1, Vaughn teaches further comprising: receiving, by the one or more processors, input data identifying the interactions by the user with the second plurality of user interface elements of the second user interface, and identifying, by the one or more processors, a change in state associated with the user based on the input data on the second user interface, and determining, by the one or more processors, responsive to the change in state, to provide the first user interface comprising the first plurality of user interface elements to present the first digital therapeutic content to the user. ([Para. 0013] The digital diagnostic can also provide assessment of a patient's change in state or performance, directly or indirectly via data and meta-data that can be analyzed by tools such as machine learning, artificial intelligence, and statistical modeling to provide feedback into the system to improve or refine the diagnoses and potential therapeutic interventions. [Para. 0019] The diagnostic module may be configured to received updated subject data from the subject in response to the therapy of the subject and generate updated diagnostic data from the subject. The therapeutic module may be configured to receive the updated diagnostic data and output an updated personal treatment plan for the subject in response to the diagnostic data and the updated diagnostic data. [Para. 0191] The therapy module 134 can then indicate to the diagnosis module 132 that the latest round of therapy is finished, and that a new diagnosis is needed. The diagnostic module 132 can then provide new diagnostic tests and questions to the digital device 110, as well as take input from the therapy module of any data provided as part of therapy, such as recordings of learning sessions or browsing history of caregivers or patients related to the therapy or diagnosed condition. The diagnostic module 132 then provides an updated diagnosis to repeat the process and provide a next step of therapy. [Para. 0262] The method 1100 may be performed with a user interface provided on a computing device, the computing device comprising a display and a user interface for receiving user input in response to the instructions provided on the display.)
REGARDING CLAIM 8
Vaughn/ Mainwaring teach the method of claim 1, Vaughn further teaches wherein identifying the condition further comprises receiving, from a remote computing system, an indication to provide a digital therapeutic associated with the second digital therapeutic content to the user to address the condition. ([Para. 0188] FIG. 1A illustrates a system diagram for a digital personalized medicine platform 100 (i.e. remote computing system) for providing diagnosis and therapy related to behavioral, neurological or mental health disorders. The platform 100 can provide diagnosis and treatment of pediatric cognitive and behavioral conditions associated with developmental delays, for example. A user digital device 110—for example, a mobile device such as a smart phone, an activity monitors, or a wearable digital monitor—records data and metadata related to a patient. [Para. 0191] The diagnosis module communicates its diagnosis to the digital device 110, as well as to therapy module 134, which uses the diagnosis to suggest therapies to be performed to treat any diagnosed symptoms. [Para. 0201] A new therapy (i.e. second therapeutic) is recommended based on the assessment model, the degree of success of the previous therapy (i.e. first therapeutic), if any, and the scores assigned to a collection of candidate therapies based on previous uses of those therapies with the subject and other subjects with similar assessments. The recommended therapy is sent to the subject for administration, along with instructions of a particular span of time to apply it.)
REGARDING CLAIM 9
Vaughn/ Mainwaring teach the method of claim 1, Vaughn further teaches wherein the plurality of conditions comprises at least one of: substance use disorder, opioid use disorder, chronic insomnia, alcohol use disorder, schizophrenia, generalized anxiety disorder, major depressive disorder, bipolar, posttraumatic stress disorder, acute and chronic pain, migraine, multiple sclerosis, epilepsy, irritable bowel syndrome, specialty gastroenterology, cancer, or cardiovascular disease. ([Para. 0043] The behavioral, neurological or mental health disorder may be selected from the group consisting of autism, autistic spectrum, attention deficit disorder, depression, obsessive compulsive disorder, schizophrenia, Alzheimer's disease, dementia, attention deficit hyperactive disorder, and speech and learning disability. [Para. 0174] Examples of mood and mental illness disorders, which can effect children and adults, include behavioral disorders, mood disorders, depression, attention deficit hyperactivity disorder (“ADHD”), obsessive compulsive disorder (“OCD”), schizophrenia, and substance such as eating disorders and substance abuse.)
REGARDING CLAIM 11
Vaughn teaches a system for generating user interfaces based on conditions associated with users, comprising:
one or more processors coupled with memory, configured to: ([Para. 0265] The computer system 1201 includes a central processing unit (CPU, also “processor” and “computer processor” herein) 1205 and memory.)
provide a first user interface comprising a first plurality of user interface elements to present first digital therapeutic content to a user applicable to a plurality of conditions; ([Para. 0033 and Para. 0174] The system comprises instructions to diagnose and treat one or more of cognitive or behavior development, neurodegenerative conditions, cognitive and behavioral disorders or conditions, including mood disorders. [Para. 0191] The diagnosis module communicates its diagnosis to the digital device 110, as well as to therapy module 134, which uses the diagnosis to suggest therapies to be performed to treat any diagnosed symptoms. The therapy module 134 sends its recommended therapies to the digital device 110, including instructions for the patient and caregivers to perform the therapies recommended over a given time frame. [Para. 0169] the digital personalized medicine system comprises digital devices with processors.)
identify a condition to be addressed in the user from the plurality of conditions, using data associated with the user; ([Para. 0191] The therapy module 134 can then indicate to the diagnosis module 132 that the latest round of therapy is finished, and that a new diagnosis is needed. The diagnostic module 132 can then provide new diagnostic tests and questions to the digital device 110, as well as take input from the therapy module of any data provided as part of therapy, such as recordings of learning sessions or browsing history of caregivers or patients related to the therapy or diagnosed condition. The diagnostic module 132 then provides an updated diagnosis to repeat the process and provide a next step of therapy. [Para. 0013] The digital diagnostic uses the data collected by the system about the patient, which may include complimentary diagnostic data captured outside the digital diagnostic, with analysis from tools such as machine learning, artificial intelligence, and statistical modeling to assess or diagnose the patient's condition. [Para. 0043] The behavioral, neurological or mental health disorder may be selected from the group consisting of autism, autistic spectrum, attention deficit disorder, depression, obsessive compulsive disorder, schizophrenia, Alzheimer's disease, dementia, attention deficit hyperactive disorder, and speech and learning disability. [Para. 0169] the digital personalized medicine system comprises digital devices with processors.)
and administer the second digital therapeutic content to the user to address the condition identified for the user via the second user interface comprising the second plurality of user interface elements. ([Para. 0169] The digital personalized medicine system comprises digital devices with processors. [Para. 0194] Therapy recommendation module 156 then generates a recommended therapy comprising one or more of the therapies identified as promising by the therapy matching module 154, and sends that recommendation to the subject with instructions for administration of the recommended therapies. [Para. 0201] A new therapy (i.e. second therapeutic) is recommended based on the assessment model, the degree of success of the previous therapy (i.e. first therapeutic), if any, and the scores assigned to a collection of candidate therapies based on previous uses of those therapies with the subject and other subjects with similar assessments. The recommended therapy is sent to the subject for administration, along with instructions of a particular span of time to apply it.)
Vaughn does not explicitly teach, however Mainwaring teaches
generate a second user interface to include (i) at least one of the first plurality of user interface elements of the first user interface and (ii) a second plurality of user interface elements to present second digital therapeutic content to address the condition identified for the user; ([Para. 0010] Displaying, at a user interface, one or more user-selectable user interface elements for receiving an identity of at least one diagnosis of at least one medical condition, and receiving, at the user interface, user input identifying a particular diagnosis of a particular medical condition. Examiner interprets the user-selectable user interface elements to be indicative of at least one of the first plurality of user interface elements of the first user interface. [Para. 0057] The physician system 140 can present one or more diagnostic user interfaces that educate the patient about his condition using anatomical models, illustrations, text, etc. As such, physician system 140 can be configured to present one or more educational interfaces and/or one or more decision aid user interfaces configured to educate patients about conditions and treatment options, to ensure that the patients have reached an understanding of the risks and benefits of various treatment options (or no treatment), and to obtain informed consent from the patients. Examples of such user interfaces are presented hereinafter in FIGS. 4A-4J. [Para. 0093] The method 700 can also include an act 704 of presenting a selectable menu option for each content type. Act 704 can comprise presenting, at a user interface, a selectable menu option for each of the identified plurality of content types, each selectable menu option being configured to present medical content relevant to corresponding content type when selected. For example, the physician system 140 can present at the user interface a navigation area that enables selection of each of the identified categories. [Para. 0123] FIG. 11B illustrates an example care plan user interface. As depicted, the care plan user interface can include one or more interactive user interface elements that enable a physician to select one or more diagnoses (i.e. patient condition) and one or more treatment options (i.e. digital therapeutic content).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of digital diagnostics and digital therapeutics to patients as taught by Vaughn and incorporate diagnostic computer systems and diagnostic user interfaces as taught by Mainwaring, with the motivation of facilitating medical diagnosis, education, treatment, and recovery (Mainwaring Para. 0003).
REGARDING CLAIM 12
Claim(s) 12 is/are analogous to Claim(s) 2, thus Claim(s) 12 is/are similarly analyzed
and rejected in a manner consistent with the rejection of Claim(s) 2.
REGARDING CLAIM 13
Claim(s) 13 is/are analogous to Claim(s) 3, thus Claim(s) 13 is/are similarly analyzed
and rejected in a manner consistent with the rejection of Claim(s) 3.
REGARDING CLAIM 14
Claim(s) 14 is/are analogous to Claim(s) 4, thus Claim(s) 14 is/are similarly analyzed
and rejected in a manner consistent with the rejection of Claim(s) 4.
REGARDING CLAIM 17
Claim(s) 17 is/are analogous to Claim(s) 7, thus Claim(s) 17 is/are similarly analyzed
and rejected in a manner consistent with the rejection of Claim(s) 7.
REGARDING CLAIM 18
Claim(s) 18 is/are analogous to Claim(s) 8, thus Claim(s) 18 is/are similarly analyzed
and rejected in a manner consistent with the rejection of Claim(s) 8.
REGARDING CLAIM 19
Claim(s) 19 is/are analogous to Claim(s) 9, thus Claim(s) 19 is/are similarly analyzed
and rejected in a manner consistent with the rejection of Claim(s) 9.
Claim(s) 5-6 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaughn (US 20190019581 A1) in view of Mainwaring (US 20150379232 A1) in view of Saigal (US 20140081898 A1) .
REGARDING CLAIM 5
Vaughn/ Mainwaring teach the method of claim 1, however Saigal teaches further comprising selecting, by the one or more processors, from a plurality of user interface sets, a user interface set comprising at least a portion of the second plurality of user interface elements based on input data identifying the interactions by the user with the first plurality of user interface elements of the first user interface, and wherein generating the second user interface further comprises generating the second user interface to include at least the portion of the second plurality of user interface elements defined by the user interface set. ([Para. 0255] distinct medical-condition-specific graphic user interfaces (i.e. plurality of user interface sets) and each distinct medical-condition-specific graphic user interface would interact with a particular conjoint analysis software module/nucleus. [Para. 0258] a user selection, e.g., by clicking, of a particular exemplary medical condition tab (2010, 2020, 2030 or 2040), would cause the exemplary embodiment to navigate to a corresponding medical-condition-specific graphic user interface module and associated set of interactive graphic user interface screens corresponding to the selected medical condition. For example, a user selection of the exemplary prostate cancer tab 2010 would cause the exemplary system to navigate to an exemplary prostate cancer graphic user interface module, depicted as element 1910 in FIG. 19. In the exemplary embodiment system 1900 depicted in FIG. 19, exemplary prostate cancer graphic user interface module 1910 would interface and interact with an exemplary ASEMAP-adapted conjoint analysis-based software module nucleus 1901.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of digital diagnostics and digital therapeutics to patients as taught by Vaughn and incorporate medical care treatment decision support system, with the motivation of analyzing medical care treatment alternatives that are available to them and to select a treatment option that suits their individual preferences (Saigal Para. 0002).
REGARDING CLAIM 6
Vaughn/ Mainwaring/ Saigal teach the method of claim 5, Vaughn further teaches wherein selecting the user interface set further comprises applying a machine learning model to the input data to select the user interface set from the plurality of user interface sets, wherein the machine learning model is establishing using a plurality of selections each identifying sample input data and a respective user interface set selected from the plurality of user interface sets. ([Para. 0141] The therapeutic process is performed by a process selected from the group consisting of machine learning, a classifier, artificial intelligence, and statistical modeling based on at least a portion the subject population to determine the personal therapeutic treatment plan of the subject. [Para. 0173] The data used in the diagnosis and treatment can come from a plurality of sources, and may comprise a combination of passive and active data collection gathered from one device such as a mobile device with which the user interacts. [Para. 0175] The digital diagnosis and treatment as described herein is well suited for behavioral intervention coupled with biological or chemical therapeutic treatment. By gathering user interaction data as described herein, feedback effective therapies can be provided for combinations of behavioral intervention data pharmaceutical and biological treatments. [Para. 0219] If the digital personalized medicine system predicts that the user is likely to have a diagnosable condition (e.g. Autism Spectrum Disorder), then a therapy module can provide a behavioral treatment (530) which can comprise behavioral interventions; prescribed activities or trainings; interventions with medical devices or other therapeutics for specific durations or, at specific times or instances. As the subject undergoes the therapy, data (e.g. passive data and diagnostic question data) can continue to be collected to perform follow-up assessments, to determine for example, whether the therapy is working. Collected data can undergo data analysis (540) (e.g. analysis using machine learning, statistical modeling, classification tasks, predictive algorithms) to make determinations about the suitability of a given subject.)
REGARDING CLAIM 15
Claim(s) 15 is/are analogous to Claim(s) 5, thus Claim(s) 15 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 5.
REGARDING CLAIM 16
Claim(s) 16 is/are analogous to Claim(s) 6, thus Claim(s) 16 is/are similarly analyzed
and rejected in a manner consistent with the rejection of Claim(s) 6.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaughn (US 20190019581 A1) in view of Mainwaring (US 20150379232 A1) in view of Rajput (US 20230395235 A1).
REGARDING CLAIM 10
Vaughn/ Mainwaring teach the method of claim 1, however Rajput teaches wherein the user is on a medication to address the condition, in partial concurrence with the presentation of at least one of the first digital therapeutic content or the second digital therapeutic content. ([Para. 0027-0030] The digital cognitive therapy delivery module provides a user interface on a computing device comprising: a reminder and calendar module configured to allow patients to record reminders and to notify the patient of a scheduled therapy, and monitors therapy compliance; a note module configured to track goals and record electronic information to assist with daily living activities; a medication schedule module configured to record a medication schedule and track compliance)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of digital diagnostics and digital therapeutics to patients as taught by Vaughn and incorporate diagnostic computer systems and diagnostic user interfaces as taught by Mainwaring, and incorporate a computational personalized cognitive therapeutic system for treating patients, with the motivation of assist clinicians to determine improved treatments for patients including combinations of pharmacological and non-pharmacological interventions that best alleviate symptoms and reduce side effects (Rajput Para. 0004).
REGARDING CLAIM 20
Claim(s) 20 is/are analogous to Claim(s) 10, thus Claim(s) 20 is/are similarly analyzed
and rejected in a manner consistent with the rejection of Claim(s) 10.
Response to Arguments
Applicant's arguments, see pgs. 8-11 “Claim Rejections – 35 U.S.C. 101” filed 10/20/2025have been fully considered but they are not persuasive.
Applicant argues that the amended Claim 1 is not directed to any of the enumerated groupings of abstract ideas. Examiner respectfully disagrees. Claim 1 recites a method for providing a first user [page] comprising a first plurality of user [page] elements to present first digital therapeutic content to a user, applicable to a plurality of conditions; identifying, a condition to be addressed in the user from the plurality of conditions, using data associated with the user; generating a second user [page] to include (i) at least one of the first plurality of user [page] elements of the first user [page] and (ii) a second plurality of user [page] elements to present second digital therapeutic content to address the condition identified for the user; and administering the second digital therapeutic content to the user to address the condition identified for the user via the second user [page] comprising the second plurality of user [page] elements, which are part of the abstract idea. The claim also recites the additional elements of one or more processors, a first user interface, a second user interface, and one or more processors coupled with memory. Claim 1 recites administering the second digital therapeutic content to the user to address the condition identified for the user via the second user interface comprising the second plurality of user interface elements. amounts to insignificant extra solution activity, because the administering of the digital therapeutic is not specified for treating a specific disease or condition, does not disclose the specific therapeutic that is administered, and is considered well-understood, routine, and conventional.
Applicant argues that the claims integrate the judicial exception into a practical application. Applicant argues that it recites a specifically identified treatment regime which amounts to reciting an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Examiner respectfully disagrees.
MPEP 2106.04(d)(2) sets out the requirements for whether a particular treatment and prophylaxis is sufficient to integrate a judicial exception into a practical application under Step 2A Prong 2, stating initially that “[o]ne way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.” (emphasis added).
MPEP 2106.04(d)(2) further sets out that “in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition.” “If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient…”. Id.
The specific considerations for whether a claim integrates a recited abstract idea into a practical application by effecting a particular treatment or prophylaxis for a disease or medical condition are:
a) the particularity or generality of the treatment or prophylaxis;
b) whether the limitations have more than a nominal or insignificant relationship to the exception; and
c) whether the limitations are merely extra-solution activity or a field of use.
Initially, the treatment or prophylaxis must be “particular,” i.e. specifically identified. MPEP 2106.04(d)(2) provides the example of a claim reciting mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications, wherein the additional element of “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype” was considered to be “particular.” Conversely, MPEP 2106.04(d)(2) states that the recitation of “administering a suitable medication to a patient” would not constitute a “particular” treatment or prophylaxis in conjunction with the same abstract idea.
The present claims do not recite a particular treatment or prophylaxis given that they only recite administering a digital therapeutic content to the user to address the condition identified for the user. The claim limitations nor the specification specify the specific treatment that is to be administered or the specific disease or condition of the user that is to be treated by said treatment. Furthermore, administering a digital therapeutic content to the user to address the condition identified for the user is activity that is well-understood, routine, and conventional in the art.
Applicant argues that the claims integrate the judicial exception into a practical application. Applicant argues amended claim 1 imposes meaningful limits on the alleged judicial exception and integrates the alleged judicial exception into a practical application, such that the claim is "more than a drafting effort designed to monopolize the exception." Examiner respectfully disagrees. Claim 1 recites a method for providing a first user [page] comprising a first plurality of user [page] elements to present first digital therapeutic content to a user, applicable to a plurality of conditions; identifying, a condition to be addressed in the user from the plurality of conditions, using data associated with the user; generating a second user [page] to include (i) at least one of the first plurality of user [page] elements of the first user [page] and (ii) a second plurality of user [page] elements to present second digital therapeutic content to address the condition identified for the user; and administering the second digital therapeutic content to the user to address the condition identified for the user via the second user [page] comprising the second plurality of user [page] elements, which are part of the abstract idea. The claim also recites the additional elements of one or more processors, a first user interface, a second user interface, and one or more processors coupled with memory. Claim 1 recites administering the second digital therapeutic content to the user to address the condition identified for the user via the second user interface comprising the second plurality of user interface elements. amounts to insignificant extra solution activity, because the administering of the digital therapeutic is not specified for treating a specific disease or condition, does not disclose the specific therapeutic that is administered, and is considered well-understood, routine, and conventional.
Applicant's arguments, see pgs. 11 “Claim Rejections – 35 U.S.C. 103” filed 10/20/2025 have been fully considered but they are not persuasive.
Applicant argues that Claims 1 and 11 are amended, thereby rendering the rejection moot. Examiner respectfully disagrees. Vaughan and Mainwaring teach the limitations of the amended claim.
Vaughan, with Claim 1 being representative, teaches at Para. 0033 that the system comprises instructions to diagnose and treat one or more of cognitive or behavior development, neurodegenerative conditions, cognitive and behavioral disorders or conditions, including mood disorders. Para. 0191 teaches the diagnosis module communicates its diagnosis to the digital device 110, as well as to therapy module 134, which uses the diagnosis to suggest therapies to be performed to treat any diagnosed symptoms. The therapy module 134 sends its recommended therapies to the digital device 110, including instructions for the patient and caregivers to perform the therapies recommended over a given time frame. Para. 0169 further teaches the digital personalized medicine system comprises digital devices with processors. This is indicative of providing, by one or more processors, a first user interface comprising a first plurality of user interface elements to present first digital therapeutic content to a user applicable to a plurality of conditions.
Vaughan teaches at Para. 0191 that the therapy module 134 can then indicate to the diagnosis module 132 that the latest round of therapy is finished, and that a new diagnosis is needed. The diagnostic module 132 can then provide new diagnostic tests and questions to the digital device 110, as well as take input from the therapy module of any data provided as part of therapy, such as recordings of learning sessions or browsing history of caregivers or patients related to the therapy or diagnosed condition. The diagnostic module 132 then provides an updated diagnosis to repeat the process and provide a next step of therapy. Para. 0013 teaches that the digital diagnostic uses the data collected by the system about the patient, which may include complimentary diagnostic data captured outside the digital diagnostic, with analysis from tools such as machine learning, artificial intelligence, and statistical modeling to assess or diagnose the patient's condition. Para. 0043 teaches the behavioral, neurological or mental health disorder may be selected from the group consisting of autism, autistic spectrum, attention deficit disorder, depression, obsessive compulsive disorder, schizophrenia, Alzheimer's disease, dementia, attention deficit hyperactive disorder, and speech and learning disability. Para. 0169 teaches the digital personalized medicine system comprises digital devices with processors. This is indicative of identifying, by the one or more processors, a condition to be addressed in the user from the plurality of conditions, using data associated with the user.
Vaughan teaches at Para. 0169 that the digital personalized medicine system comprises digital devices with processors. Para. 0194 teaches therapy recommendation module 156 then generates a recommended therapy comprising one or more of the therapies identified as promising by the therapy matching module 154, and sends that recommendation to the subject with instructions for administration of the recommended therapies. Para. 0201 further teaches a new therapy (i.e. second therapeutic) is recommended based on the assessment model, the degree of success of the previous therapy (i.e. first therapeutic), if any, and the scores assigned to a collection of candidate therapies based on previous uses of those therapies with the subject and other subjects with similar assessments. The recommended therapy is sent to the subject for administration, along with instructions of a particular span of time to apply it. This is indicative of administering providing, by the one or more processors, the second digital therapeutic content to the user to address the condition identified for the user via the second user interface comprising the second plurality of user interface elements.
Mainwaring teaches Para. 0010 teaches displaying, at a user interface, one or more user-selectable user interface elements for receiving an identity of at least one diagnosis of at least one medical condition, and receiving, at the user interface, user input identifying a particular diagnosis of a particular medical condition. Examiner interprets the user-selectable user interface elements to be indicative of at least one of the first plurality of user interface elements of the first user interface. Para. 0057 teaches the physician system 140 can present one or more diagnostic user interfaces that educate the patient about his condition using anatomical models, illustrations, text, etc. As such, physician system 140 can be configured to present one or more educational interfaces and/or one or more decision aid user interfaces configured to educate patients about conditions and treatment options, to ensure that the patients have reached an understanding of the risks and benefits of various treatment options (or no treatment), and to obtain informed consent from the patients. Examples of such user interfaces are presented hereinafter in FIGS. 4A-4J. Para. 0093 further teaches the method 700 can also include an act 704 of presenting a selectable menu option for each content type. Act 704 can comprise presenting, at a user interface, a selectable menu option for each of the identified plurality of content types, each selectable menu option being configured to present medical content relevant to corresponding content type when selected. For example, the physician system 140 can present at the user interface a navigation area that enables selection of each of the identified categories. Para. 0123 taches at FIG. 11B illustrates an example care plan user interface. As depicted, the care plan user interface can include one or more interactive user interface elements that enable a physician to select one or more diagnoses (i.e. patient condition) and one or more treatment options (i.e. digital therapeutic content). This is indicative of generating, by the one or more processors, a second user interface to include (i) at least one of the first plurality of user interface elements of the first user interface and (ii) a second plurality of user interface elements to present second digital therapeutic content to address the condition identified for the user.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia K Edouard whose telephone number is (571)272-6084. The examiner can normally be reached Monday - Friday 7:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya M Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.K.E./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682