DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
In the reply filed on 06 April 2026, the following changes have been made: amendments to claims 25-26.
Claims 1, 3-5, 7-8, 11, 13-15, 17-18, and 21-28 are currently pending and have been examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/047,372 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For claims 1 and 11 the prior-filed application does not provide support for “at least cognitive behavioral therapy content”, “a second efficacy value”, and “third set of one or more users.” Examiner cannot find disclosure that the digital therapy is at least cognitive behavioral content. Examiner cannot find disclosure of a second efficacy value that is determined, instead it seems only the first efficacy value is determined. Examiner also cannot find disclosure of a third set of users; it seems there is only disclosure of a treatment group and a placebo group.
Accordingly, claims 1 and 11 as well as their respective dependent claims are not entitled to the benefit of the prior application.
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, 3-5, 7-8, 11, 13-15, 17-18, and 21-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a machine (claims 1, 3-5, 7-8, 21, 23, 25, and 27) and a process (claims 11, 13-15, 17-18, 22, 24, 26, and 28).
INDEPENDENT CLAIMS
Step 2A Prong 1
Claim 1 recites steps of
data processing hardware; and
memory hardware in communication with the data processing
hardware, the memory hardware storing instructions that when executed on the
data processing hardware cause the data processing hardware to perform
operations comprising:
providing a first set of one or more access codes to a first set of
one or more users and a second set of one or more access codes to a second set of one or more users, wherein the access codes or users are randomized;
responsive to receiving at least one access code from a user of the
first set of one or more users, providing, to the user of the first set of one or
more users, the digital therapeutic by presenting a first user interface comprising
a first plurality of user interface elements, the digital therapeutic comprising at
least cognitive behavioral therapy content to address a disease or disorder
associated with the first set of one or more users;
responsive to receiving at least one access code from a user of the
second set of one or more users, providing, to the user of the second set of one
or more users, at least one of a sham or a placebo digital therapeutic by
presenting a second user interface comprising a second plurality of user interface
elements, wherein the at least one of the sham or the placebo digital therapeutic
does not comprise any cognitive behavioral therapy content to address the disease or disorder associated with the second set of one or more users;
determining a first efficacy value associated with the digital
therapeutic;
determining a second efficacy value associated with the at least one
of the sham or the placebo digital therapeutic;
modifying the first user interface based on a comparison between
the first efficacy value and the second efficacy value to generate a third user
interface comprising a modified first plurality of user interface elements;
and
providing, to a third set of one or more users, an updated digital
therapeutic by presenting the third user interface comprising the modified first
plurality of user interface elements.
Claim 11 recites similar limitations as claim 1 but for the recitation of generic computer components.
These steps for treating a disease or disorder using a digital therapeutic, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. That is, nothing in the claim element precludes the italicized portions from managing personal behavior or relationships or interactions between people through managing treatment of a disease or disorder for one or more users. This could be analogized to considering historical usage information while inputting data. If a claim limitation, under its broadest reasonable interpretation, covers performance as organizing human activity but for the recitation of generic computer components, then it falls within the “Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, the additional elements non-italicized portions identified above for claims 1 & 11, does not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as
recitation of data processing hardware; memory hardware in communication with the data processing hardware, the memory hardware storing instructions that when executed on the data processing hardware cause the data processing hardware; the digital therapeutic by presenting a first user interface comprising a first plurality of user interface elements, the digital therapeutic; at least one of a sham or a placebo digital therapeutic by presenting a second user interface comprising a second plurality of user interface elements, wherein the at least one of the sham or the placebo digital therapeutic; with the digital therapeutic; with the at least one of the sham or the placebo digital therapeutic; modifying the first user interface […] to generate a third user interface comprising a modified first plurality of user interface elements; an updated digital therapeutic by presenting the third user interface comprising the modified first plurality of user interface elements; and, via data processing hardware amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
Each of the above additional elements therefore only amounts to mere instructions to implement functions within the abstract idea using generic computer components or other machines within their ordinary capacity, and also add insignificant extra-solution activity to the abstract idea. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. These elements are therefore not sufficient to integrate the abstract idea into a practical application. Therefore, the above claims, as a whole, are directed to an abstract idea.
Step 2B
The claim(s) 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. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to mere instructions to apply an exception in particular fields such as recitation of data processing hardware; memory hardware in communication with the data processing hardware, the memory hardware storing instructions that when executed on the data processing hardware cause the data processing hardware; the digital therapeutic by presenting a first user interface comprising a first plurality of user interface elements, the digital therapeutic; at least one of a sham or a placebo digital therapeutic by presenting a second user interface comprising a second plurality of user interface elements, wherein the at least one of the sham or the placebo digital therapeutic; with the digital therapeutic; with the at least one of the sham or the placebo digital therapeutic; modifying the first user interface […] to generate a third user interface comprising a modified first plurality of user interface elements; an updated digital therapeutic by presenting the third user interface comprising the modified first plurality of user interface elements; and via data processing hardware, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f).
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 generic computer implementation.
DEPENDENT CLAIMS
Step 2A Prong 1
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 3-5, 7-8, 13-15, 17-18, and 21-28 reciting particular aspects of creating an urgent report for the one or more patients such as
[Claims 3 & 13] delivering one or more statements corresponding to general information related to at least one of an emotion, a disease, a disorder, or a condition associated with a user of the second set of one or more users;
[Claims 4 & 14] wherein the one or more statements are delivered in
response to the data processing hardware receiving an indication from a user of the second set of one or more users of an emotion, a disease, a disorder, or a condition that is associated with the user of the second set of one or more users;
[Claims 5 & 15] generating, for display on a display device, textual content, wherein the textual content is configured to simulate a conversation with a user of the second set of one or more users;
[Claims 7 & 17] generating, for display on a display device, graphical content, wherein the graphical content comprises a timer;
[Claims 8 & 18] generating, for display on a display device, one or more words, one or more objects, one or more auditory signals, or any combination thereof;
[Claims 21 & 22] determining an elapsed time since receiving the user input indicative of the current mood evaluation data, wherein determining whether to initiate the subsequent mood evaluation request is further based at least in part on the elapsed time;
[Claims 23 & 24] (i) a first path configured to a first subset of the first plurality of user interface elements to provide a first portion of the cognitive behavioral therapy content in response to a first user state and (ii) a second path configured to a second subset of the first plurality of user interface elements to provide a second portion of the cognitive behavioral therapy content in response to a second user state;
[Claims 25 & 26] comprises determining a first plurality of parameters
including at least one of an extent, duration, or frequency of a first interactions by the first set of one or more users, and
wherein determining the first efficacy value further comprises determining the first
efficacy value associated with the digital therapeutic relative to an effect of a drug to the first set of one or more users;
[Claims 27 & 28] wherein the disease or disorder comprises at least one of a substance use disorder, opioid use disorder, schizophrenia, post-traumatic stress disorder, general anxiety disorder, insomnia, traumatic brain injury, attention-deficit/hyperactivity disorder, multiple sclerosis, or major depressive disorder;
these italicized portions are methods of organizing human activity since they merely describe types of data and determinations that can be performed by humans.
Step 2A Prong 2
Dependent claims 4-5, 7-8, 14-15, 17-18, and 23-24 recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (the additional limitations in claims 4 & 14 (the data processing hardware); claims 5 & 15 (generating, for display on a display device, textual content); claims 7 & 17 (generating, for display on a display device, graphical content, wherein the graphical content comprises a timer); claims 8 & 18 (generating, for display on a display device, one or more words, one or more objects, one or more auditory signals, or any combination thereof); and, claims 23 & 24 (the first plurality of user interface elements) amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
Dependent claims 4-5, 7-8, 14-15, 17-18, and 23-24 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, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f). Also, see [0078], [0081], & [0086] which discloses off-the-shelf processors, [0084] & [0086] which provides examples of off-the-shelf memory types, and [0087] which provides examples of off-the-shelf display devices. There is no indication that these additional elements improve the functioning of a computer or improves any other technology. Their collective functions merely provide generic computer implementation.
Therefore, in consideration of all the facts, it is evident that the present invention is not a patent-eligible invention under USC 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35
U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-5, 8, 11, 13-15, 18, and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Espie et al. (A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application) in view of Alailima (US20200114115A1), and further in view of Ueno et al. (US20200388356A1).
Regarding claim 1, Espie discloses data processing hardware; and memory hardware in communication with the data processing hardware, the memory hardware storing instructions that when executed on the data processing hardware cause the data processing hardware to perform operations ([pg. 771-772] Espie makes it clear the invention executes on a computer, which has to have a processor and memory.)
providing, to the user of the first set of one or more users, the digital therapeutic by presenting a first user interface comprising a first plurality of user interface elements, the digital therapeutic comprising at least cognitive behavioral therapy content to address a disease or disorder associated with the first set of one or more users ([pg. 772] “Participants received 6 weekly sessions delivered by an animated “virtual therapist” (The Prof). The program comprised a fully automated media-rich web application, driven dynamically by baseline, adherence, performance, and progress data. […] CBT content was consistent with the literature […] engages with the participant to help them select the timing (onset/offset) of this window from a set of personalized options. An example of a cognitive technique, is where another animated character (with insomnia) presents to the Prof their concerns, dysfunctional beliefs, and associated emotions. The Prof then asks the participant to choose some solutions from a menu of options” [pg.773, Table 1 Col. 1] “Support/prompts/reminders by email and mobile SMS” [pg. 770] “Participants from the UK community (18+ years), who had completed the online Great British Sleep Survey (GBSS), and who met proposed DSM-5 criteria for persistent Insomnia Disorder were invited to take part.”)
providing, to the user of the second set of one or more users, at least one of a sham or a placebo digital therapeutic ([pg. 771] “(2) online imagery relief therapy (IRT: placebo)” [pg. 772] “The participant was trained to visualize neutral objects (e.g., a key) or shapes (e.g., a yellow square).”)
by presenting a second user interface comprising a second plurality of user interface elements, wherein the at least one of the sham or the placebo digital therapeutic does not comprise any cognitive behavioral therapy content to address the disease or disorder associated with the second set of one or more users ([pg. 772] “Imagery relief therapy was also delivered by The Prof, using the same application platform, and design and execution principles as for CBT, but with no known active therapeutic ingredient. IRT was based on a well-established and credible non-pharmacological placebo intervention used in several clinical trials.[…] IRT participants also received e-mail reminders from The Prof and had access to Wikipedia-style articles on sleep, its functions, and its disorders” also, see Table 1 Col. 2 Row 1 and Row 3 [pg.773, Table 1 Col. 2] “Support/prompts/reminders by email and mobile SMS” [pg. 770] “Participants from the UK community (18+ years), who had completed the online Great British Sleep Survey (GBSS), and who met proposed DSM-5 criteria for persistent Insomnia Disorder were invited to take part.”)
determining a first efficacy value associated with the digital therapeutic ([pg. 774] “CBT was associated with an absolute post-therapy increase of 19.5% (95%CI, 15.3 to 23.7) in SE (a 30.8% increase over baseline)”)
determining a second efficacy value associated with the at least one of the sham or the placebo digital therapeutic ([pg. 774] “an absolute post-therapy increase […] a 5.7% (95%CI, 2.79 to 8.52) gain following IRT”)
[…] a comparison between the first efficacy and the second efficacy […] value ([pg. 774] “CBT was associated with an absolute post-therapy increase of 19.5% (95%CI, 15.3 to 23.7) in SE (a 30.8% increase over baseline), compared with a 5.7% (95%CI, 2.79 to 8.52) gain following IRT) […] A near 20% level of improvement was sustained in the CBT group at follow-up (95%CI, 15.7 to 23.6), compared with 7% (95%CI, 4.53 to 10.1) IRT”)
Espie does not disclose however Alailima teaches modifying the first user interface based on (a comparison […]) to generate a third user interface comprising a modified first plurality of user interface elements ([0163] “In various implementations, the metric effort data 1012 a or 1012 b is continuously collected and one or more historical, current, or predicted states are analyzed from various instances/sessions of the application for quantifying performance, engagement, or adherence to tasks or therapy. In various implementations, the graphical element/output/ stimuli 1106 a or 1106 b is modified, preferably in a continuous mode, based on one or more said historical, current or predicted metric data […] whereby user engagement has a positive impact on treatment efficacy.” Also, see [0166] which narrowly discloses what the modification entails.”)
providing, to a third set of one or more users, an updated digital therapeutic by presenting the third user interface comprising the modified first plurality of user interface elements ([0167] “Method 1500 may be further configured to further modify, adapt, or deliver at least one user interface element or user prompt to the mobile electronic device in response to the measure of user engagement being below a specified threshold value, the at least one user interface element or user prompt comprising a task or instruction associated with the computerized therapeutic treatment regimen 1506.” [0102] “deliver a treatment that adapts CSIs to optimize the profile of a new user as confirmed by profiles from nData.”)
It would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Espie modifying the first user interface based on (a comparison […]) to generate a third user interface comprising a modified first plurality of user interface elements; and, providing, to a third set of one or more users, an updated digital therapeutic by presenting the third user interface comprising the modified first plurality of user interface elements as taught by Alailima since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Espie in view of Alailima does not disclose however Ueno teaches providing a first set of one or more access codes to a first set of one or more users and a second set of one or more access codes to a second set of one or more users, wherein the access codes or users are randomized ([0069] “The authentication information issuing unit 24 issues authentication information to be input when a subject uses the therapeutic application. Examples of the authentication information include a user ID and passwords.” [0070] “For example, timing at which the authentication information issuing unit 24 issues the authentication information can be set to timing at which assignment to the therapeutic group or the control group is performed with respect to a subject by the random assignment unit 22.”)
responsive to receiving at least one access code from a user of the first set of one or more users ([0060] “randomly assigns the subject to either the therapeutic group […]” [0077] “In addition, when the subject inputs the authentication information including the user ID and the passwords to the log-in screen, the authentication information is transmitted to the clinical trial management server 300, and authentication is executed.”)
responsive to receiving at least one access code from a user of the second set of one or more users ([0060] “randomly assigns the subject to either […] the control group” [0077] “In addition, when the subject inputs the authentication information including the user ID and the passwords to the log-in screen, the authentication information is transmitted to the clinical trial management server 300, and authentication is executed.”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Espie and Alailima, providing a first set of one or more access codes to a first set of one or more users and a second set of one or more access codes to a second set of one or more users, wherein the access codes or users are randomized; responsive to receiving at least one access code from a user of the first set of one or more users; and, responsive to receiving at least one access code from a user of the second set of one or more users as taught by Ueno since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 3, Espie discloses delivering one or more statements corresponding to general information related to at least one of an emotion, a disease, a disorder, or a condition associated with a user of the second set of one or more users ([pg. 773, Table 1] Table 1 discloses receiving interactive sessions, dynamic feedback against personal goals, a progress review, and praise/reinforcement contingent on progress as part of the IRT treatment group (i.e., sham treatment)).
Regarding claim 4, Espie discloses wherein the one or more statements are delivered in response to the data processing hardware receiving an indication from a user of the second set of one or more users of an emotion, a disease, a disorder, or a condition that is associated with the user of the second set of one or more users ([pg. 773, Table 1] Table 1 discloses interactive sessions, dynamic feedback against personal goals, a progress review, and praise/reinforcement contingent on progress as part of the IRT treatment group (i.e., sham treatment), wherein the personal goal/progress is of the user and pertains to insomnia (i.e., a disease, a disorder, or a condition of the user)).
Regarding claim 5, Espie discloses generating, for display on a display device, textual content, wherein the textual content is configured to simulate a conversation with a user of the second set of one or more users ([pg. 772] “An example of a cognitive technique, is where another animated character (with insomnia) presents to the Prof their concerns, dysfunctional beliefs, and associated emotions. The Prof then asks the participant to choose some solutions from a menu of options and delivers this as advice to the character, who is seen to revise his thinking.”)
Regarding claim 8, Espie discloses wherein providing the placebo digital therapeutic comprises: generating, for display on a display device, one or more words, one or more objects, one or more auditory signals, or any combination thereof ([pg. 772] “The participant was trained to visualize neutral objects (e.g., a key) or shapes (e.g., a yellow square).”)
Regarding claim 11, Espie discloses providing, via data processing hardware, to the user of the first set of one or more users, the digital therapeutic by presenting a first user interface comprising a first plurality of user interface elements, the digital therapeutic comprising at least cognitive behavioral therapy content to address a disease or disorder associated with the first set of one or more users ([pg. 772] “Participants received 6 weekly sessions delivered by an animated “virtual therapist” (The Prof). The program comprised a fully automated media-rich web application, driven dynamically by baseline, adherence, performance, and progress data. […] CBT content was consistent with the literature […] engages with the participant to help them select the timing (onset/offset) of this window from a set of personalized options. An example of a cognitive technique, is where another animated character (with insomnia) presents to the Prof their concerns, dysfunctional beliefs, and associated emotions. The Prof then asks the participant to choose some solutions from a menu of options” [pg.773, Table 1 Col. 1] “Support/prompts/reminders by email and mobile SMS” [pg. 770] “Participants from the UK community (18+ years), who had completed the online Great British Sleep Survey (GBSS), and who met proposed DSM-5 criteria for persistent Insomnia Disorder were invited to take part.” Note, Espie makes it clear the invention executes on a computer.)
providing, to the user of the second set of one or more users, at least one of a sham or a placebo digital therapeutic ([pg. 771] “(2) online imagery relief therapy (IRT: placebo)” [pg. 772] “The participant was trained to visualize neutral objects (e.g., a key) or shapes (e.g., a yellow square).”)
by presenting a second user interface comprising a second plurality of user interface elements, wherein the at least one of the sham or the placebo digital therapeutic does not comprise any cognitive behavioral therapy content to address the disease or disorder associated with the second set of one or more users ([pg. 772] “Imagery relief therapy was also delivered by The Prof, using the same application platform, and design and execution principles as for CBT, but with no known active therapeutic ingredient. IRT was based on a well-established and credible non-pharmacological placebo intervention used in several clinical trials.[…] IRT participants also received e-mail reminders from The Prof and had access to Wikipedia-style articles on sleep, its functions, and its disorders” also, see Table 1 Col. 2 Row 1 and Row 3 [pg.773, Table 1 Col. 2] “Support/prompts/reminders by email and mobile SMS” [pg. 770] “Participants from the UK community (18+ years), who had completed the online Great British Sleep Survey (GBSS), and who met proposed DSM-5 criteria for persistent Insomnia Disorder were invited to take part.”)
determining, via the data processing hardware, a first efficacy value associated with the digital therapeutic ([pg. 774] “CBT was associated with an absolute post-therapy increase of 19.5% (95%CI, 15.3 to 23.7) in SE (a 30.8% increase over baseline)” Note, Espie makes it clear the invention executes on a computer.)
determining, via the data processing hardware, a second efficacy value associated with the at least one of the sham or the placebo digital therapeutic ([pg. 774] “an absolute post-therapy increase […] a 5.7% (95%CI, 2.79 to 8.52) gain following IRT.” Note, Espie makes it clear the invention executes on a computer.)
[…] a comparison between the first efficacy and the second efficacy […] value ([pg. 774] “CBT was associated with an absolute post-therapy increase of 19.5% (95%CI, 15.3 to 23.7) in SE (a 30.8% increase over baseline), compared with a 5.7% (95%CI, 2.79 to 8.52) gain following IRT) […] A near 20% level of improvement was sustained in the CBT group at follow-up (95%CI, 15.7 to 23.6), compared with 7% (95%CI, 4.53 to 10.1) IRT”)
Espie does not disclose however Alailima teaches modifying, via the data processing hardware, the first user interface based on (a comparison […]) to generate a third user interface comprising a modified first plurality of user interface elements ([0006] “an integral or remote processor” [0163] “In various implementations, the metric effort data 1012 a or 1012 b is continuously collected and one or more historical, current, or predicted states are analyzed from various instances/sessions of the application for quantifying performance, engagement, or adherence to tasks or therapy. In various implementations, the graphical element/output/ stimuli 1106 a or 1106 b is modified, preferably in a continuous mode, based on one or more said historical, current or predicted metric data […] whereby user engagement has a positive impact on treatment efficacy.” Also, see [0166] which narrowly discloses what the modification entails.”)
providing, via the data processing hardware, to a third set of one or more users, an updated digital therapeutic by presenting the third user interface comprising the modified first plurality of user interface elements ([0006] “an integral or remote processor” [0167] “Method 1500 may be further configured to further modify, adapt, or deliver at least one user interface element or user prompt to the mobile electronic device in response to the measure of user engagement being below a specified threshold value, the at least one user interface element or user prompt comprising a task or instruction associated with the computerized therapeutic treatment regimen 1506.” [0102] “deliver a treatment that adapts CSIs to optimize the profile of a new user as confirmed by profiles from nData.”)
It would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Espie modifying the first user interface based on (a comparison […]) to generate a third user interface comprising a modified first plurality of user interface elements; and, providing, to a third set of one or more users, an updated digital therapeutic by presenting the third user interface comprising the modified first plurality of user interface elements as taught by Alailima since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Espie in view of Alailima does not disclose however Ueno teaches providing a first set of one or more access codes to a first set of one or more users and a second set of one or more access codes to a second set of one or more users, wherein the access codes or users are randomized ([0069] “The authentication information issuing unit 24 issues authentication information to be input when a subject uses the therapeutic application. Examples of the authentication information include a user ID and passwords.” [0070] “For example, timing at which the authentication information issuing unit 24 issues the authentication information can be set to timing at which assignment to the therapeutic group or the control group is performed with respect to a subject by the random assignment unit 22.”)
responsive to receiving at least one access code from a user of the first set of one or more users ([0060] “randomly assigns the subject to either the therapeutic group […]” [0077] “In addition, when the subject inputs the authentication information including the user ID and the passwords to the log-in screen, the authentication information is transmitted to the clinical trial management server 300, and authentication is executed.”)
responsive to receiving at least one access code from a user of the second set of one or more users ([0060] “randomly assigns the subject to either […] the control group” [0077] “In addition, when the subject inputs the authentication information including the user ID and the passwords to the log-in screen, the authentication information is transmitted to the clinical trial management server 300, and authentication is executed.”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Espie and Alailima, providing a first set of one or more access codes to a first set of one or more users and a second set of one or more access codes to a second set of one or more users, wherein the access codes or users are randomized; responsive to receiving at least one access code from a user of the first set of one or more users; and, responsive to receiving at least one access code from a user of the second set of one or more users as taught by Ueno since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 13, the limitations are rejected for the same reasons as stated above for claim 3.
Regarding claim 14, the limitations are rejected for the same reasons as stated above for claim 4.
Regarding claim 15, the limitations are rejected for the same reasons as stated above for claim 5.
Regarding claim 18, the limitations are rejected for the same reasons as stated above for claim 8.
Regarding claim 21, Espie does not disclose however Alailima teaches wherein at least one of the modified first plurality of user interface elements of the third user interface comprises a type of content different from at least one of the first plurality of user interface elements of the first user interface ([0164] “In accordance with certain embodiments, the computing device may be configured to present the different types of interference as CSIs or other interactive elements that divert the user's attention from a primary task.” [0167] “Method 1500 may be further configured to further modify, adapt, or deliver at least one user interface element or user prompt to the mobile electronic device in response to the measure of user engagement being below a specified threshold value, the at least one user interface element or user prompt comprising a task or instruction associated with the computerized therapeutic treatment regimen 1506.”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Espie at least one of the modified first plurality of user interface elements of the third user interface comprises a type of content different from at least one of the first plurality of user interface elements of the first user interface as taught by Alailima since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 22, the limitations are rejected for the same reasons as stated above for claim 21.
Regarding claim 23, Espie does not disclose however Alailima teaches wherein the first user interface comprises: (i) a first path configured to a first subset of the first plurality of user interface elements to provide a first portion of the cognitive behavioral therapy content in response to a first user state and (ii) a second path configured to a second subset of the first plurality of user interface elements to provide a second portion of the cognitive behavioral therapy content in response to a second user state ([0066] “The quantifier of amount/degree of effort can indicate the user is giving little to no effort to the stimuli to perform the task(s) (e.g., paying little attention), or is giving a moderate amount of effort to the stimuli to perform the task(s) (e.g., paying a moderate amount of attention), or is giving best effort to the stimuli to perform the task(s) (e.g., paying great amount of attention).” [0163] “In various implementations, the computerized graphical element or output rendered on graphical user interface 1008 is based on feedback using effort metric data and said non-linear computational framework to write, send, adjust, or modify a user interface element, user prompt, notification, message, visual element of varying shape, color, sizes, rendering of a graphical output, visual stimuli, computerized stimuli, or the like. In various implementations, the computerized graphical element or output rendered on graphical user interface 1008 is continuously modified or adaptively changed as to optimize a subjective degree of user engagement in a computerized therapeutic treatment regimen.”)
Note: the various states of attentiveness or inattentiveness causes the system to optimize delivery of computerized, stimuli, or interaction paths (i.e., cognitive behavior therapy path).
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Espie the first user interface comprising: (i) a first path configured to a first subset of the first plurality of user interface elements to provide a first portion of the cognitive behavioral therapy content in response to a first user state and (ii) a second path configured to a second subset of the first plurality of user interface elements to provide a second portion of the cognitive behavioral therapy content in response to a second user state as taught by Alailima since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 24, the limitations are rejected for the same reasons as stated above for claim 23.
Regarding claim 25, Espie discloses wherein determining the first plurality of parameters comprises determining the first plurality of parameters including at least one of an extent, duration, or frequency of first interactions by the first set of one or more users (pg. 773, Table 1] Table 1 Column 1, Row 2 discloses the analysis of the CBT for 6 sessions over minimum of 6 weeks.)
Espie does not disclose however Alailima teaches and wherein determining the first efficacy value further comprises determining the first efficacy value associated with the digital therapeutic relative to an effect of a drug to the first set of one or more users ([0125] “The example analysis (and associated computation) can be performed by comparing each variable using any example model described herein for the nData corresponding to the drug group along with a covariate set. The example analysis (and associated computation) also can be performed by comparing effects of group classification (such as but not limited to grouping based on differences in cognition between individuals (including children) […] where the cData (from performance of single-tasking tasks and/or multi-tasking tasks) are compared to determine the efficacy of the drug on the individual's performance.” [0105] “As a non-limiting example, the example system, method and apparatus configured to provide a provide a quantitative measure of the degree of efficacy of a cognitive treatment (including the degree of efficacy in conjunction with use of a biologic, a drug or other pharmaceutical agent) for a given individual or certain individuals of the population”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Espie determining the first efficacy value associated with the digital therapeutic relative to an effect of a drug to the first set of one or more users as taught by Alailima since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 26, the limitations are rejected for the same reasons as stated above for claim 25.
Regarding claim 27, Espie does not disclose however Alailima teaches wherein the disease or disorder comprises at least one of a substance use disorder, opioid use disorder, schizophrenia, post-traumatic stress disorder, general anxiety disorder, insomnia, traumatic brain injury, attention-deficit/ hyperactivity disorder, multiple sclerosis, or major depressive disorder ([0033] “The example platform products and cognitive platforms according to the principles described herein can be applicable to many different types of neuropsychological conditions, such as but not limited to dementia, Parkinson's disease, cerebral amyloid angiopathy, familial amyloid neuropathy, Huntington's disease, or other neurodegenerative condition, autism spectrum disorder (ASD), presence of the 16p11.2 duplication, and/or an executive function disorder (such as but not limited to attention deficit hyperactivity disorder (ADHD), sensory-processing disorder (SPD), mild cognitive impairment (MCI), Alzheimer's disease, multiple-sclerosis, schizophrenia, depression, or anxiety).”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Espie the disease or disorder comprising at least one of a substance use disorder, opioid use disorder, schizophrenia, post-traumatic stress disorder, general anxiety disorder, insomnia, traumatic brain injury, attention-deficit/ hyperactivity disorder, multiple sclerosis, or major depressive disorder as taught by Alailima since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 28, the limitations are rejected for the same reasons as stated above for claim 27.
Claim(s) 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Espie et al. (A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application) in view of Alailima (US20200114115A1), Ueno et al. (US20200388356A1), and further in view of Barry et al. (US20180174677A1).
Regarding claim 7, Espie in view of Alailima and Ueno does not disclose however Barry teaches generating, for display on a display device, graphical content, wherein the graphical content comprises a timer ([0103] “This display also includes timer set boxes 2540 which can be used to select a time to be counted down, and a start switch 2550 which can start or stop a countdown timer 2560.”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Espie, Alailima and Ueno generating, for display on a display device, graphical content, wherein the graphical content comprises a timer as taught by Barry since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 17, the limitations are rejected for the same reasons as stated above for claim 7.
Response to Arguments
The arguments filed on 06 April 2026 have been considered, but are not fully persuasive.
Regarding the USC 101 rejection, applicant argues that under Step 2A Prong 1the claims do not recite methods of organizing human activity. That the claim limitations describe how a technique determines efficacy values and modifies user interfaces in the digital therapeutic in response to those values. Under Step 2A Prong 2, the applicant argues that the claim covers a technical solution to a technical problem, and thus, as a whole, integrates the recited judicial exception into a practical application of the exception. Citing the 2019 PEG and the 2024 USPTO AI Guidance, the applicant points to the problem being solved in [0006] of the specification which is the inability of conventional systems to evaluate a digital therapeutic against a comparable digital product. Applicant, citing multiple portions of the specification, asserts that claim 1 incorporates the technical solution to a technical problem recited in the specification. Applicant cites USPTO Example 37 and argues that claim 1 is directly analogous since just as Example 37 the result of claim 1 is a specific, computer-implemented technique in which efficacy data drives modification of a user interface. Applicant asserts that claim 1 integrates the alleged judicial exception into a practical application because it recites elements that reflect an improvement to a technology or technical field, and specifically, an improvement in how digital therapeutics is evaluated and improved through comparison against digital placebos/shams and modification of user interface elements. Applicant requests withdrawal of the USC 101 rejection.
Examiner disagrees with the applicant’s arguments. Examiner asserts the claims under Step 2A Prong 1still recite organizing human activity as it involves managing personal behavior and relationships or interactions between people; specifically, fundamental, age-old clinical research techniques which have historically been performed by clerical/medical staff. The applicant attempts to stretch the claim limitations to argue that the claims are not abstract. Examiner is not persuaded and points to the USPTO October 2019 Guidance (also incorporated in MPEP 2106) which states that claims can recite an abstract idea even if they are claimed as being performed on a computer. The USPTO October 2019 Guidance is clear in that the courts have found claims requiring a generic computer or nominally reciting a generic computer may still recite an abstract idea even though the limitations may not be entirely performed by humans. The computers in the claims are not used in a specific, inventive way. The claims are very outcome-focused and do not detail how each of the outcomes are reached. There is no clarity on the actual computer processing or how the computer is programmed to achieve the results in a non-abstract way different from how humans analyze/process data. One of ordinary skill in the art would understand that applicant’s invention is directed to judicial exception, as also confirmed by multiple subject matter experts at the USPTO. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1984 (2014). See also OIP Techs. v. Amazon.com, 788 F.3d 1359, 1364, 115 USPQ2d 1090, 1093-94 (Fed. Cir. 2015) ("Just as Diehr could not save the claims in Alice, which were directed to ‘implement[ing] the abstract idea of intermediated settlement on a generic computer’, it cannot save OIP's claims directed to implementing the abstract idea of price optimization on a generic computer.") (citations omitted).
Examiner also asserts, under Step 2A Prong 2, that the present specification provides a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art. The MPEP provides that improvements to the functioning of a computer or to any other technology or technical field can signal eligibility, see MPEP 2106.05(a), and provides examples of improvements to computer functionality, MPEP 2106.05(a)(I), and improvements to any other technology of technical field, MPEP 2106.05(a)(I). “In computer-related technologies, the examiner should determine whether the claim purports to improve computer capabilities or, instead, invokes computers merely as a tool”. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). In Enfish, the court evaluated the patent eligibility of claims related to a self-referential database. Id. The court concluded the claims were not directed to an abstract idea, but rather to an improvement to computer functionality. Id. It was the specification' s discussion of the prior art and how the invention improved the way the computer stores and retrieves data in memory in combination with the specific data structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, 118 USPQ2d at 1691. The claim was not simply the addition of general-purpose computers added post-hoc to an abstract idea, but a specific implementation of a solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at 1691. Unlike Enfish, the instant claimed invention appears to improve upon a judicial exception rather than a problem in the software arts. Rather than improving a computer's algorithm (i.e., solving a technically based problem), the claimed invention purports to solve the non-technological problem of the lack of effectiveness for comparing treatment options for evaluating the performance of a digital therapeutic relative to another digital product ([0006] of specification) by using computers to automate the comparison using computer(s) as a tool. In other words, one of the main/glaring issues with the present invention is that the problem solved by the applicant is not a technological problem. All the applicant is doing is applying known technology for their intended benefit(s) to a new data environment and calling it an improvement (see Customedia Techs., LLC v. Dish Network Corp., Case No.18-2239 (Fed. Cir. Mar. 6, 2020).
The examiner asserts the following facts which the applicant will not be able to dispute:
1) the invention does NOT involve a novel algorithm or data structure that significantly improves the computer's functionality,
2) the invention does NOT involve a new hardware component or configuration that works with the computer to achieve a specific technical benefit, and
3) the computer is NOT used in a completely new way demonstrating a significant technical advancement.
The present claims are absolutely not providing an improved user interface like Core Wireless Licensing S.A.R.L., v. LG Electronics, Inc., 880 F.3d 1356, 1362-63, 125 USPQ2d 1436, 1440-41 (Fed. Cir. 2018). The courts held that the claims in the Core Wireless Licensing S.A.R.L. case were directed to an improvement in the functioning of computers, particularly those with small screens. On the other hand, in this present application, applicant is improving upon the abstract idea; applicant’s specification does not describe a problem with existing user interfaces. In regards to USPTO Example 37, examiner points out that the claim was found not to be abstract not just because it required a processor accessing a computer memory, but specifically because the “the claimed step of determining the amount of use of each icon by tracking how much memory has been allocated to each application associated with each icon over a predetermined period of time is not practically performed in the human mind” (i.e., beyond what humans can do). Even with the recitation of the Interface in the present claim, examiner points that it’s more generic than the USPTO Example 37 since it is disconnected from any user involvement. An improvement to the abstract idea is not an improvement to computer technology. Thus, examiner does not see how the present claims improve the functioning of a computer or provide improvements to any other technology or technical field. The claimed invention appears similar to the example of improvements that are insufficient to show an improvement in computer-functionality such as arranging transactional information on a graphical user interface in a manner that assists traders in processing information more quickly, Trading Technologies v. IBG LLC, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019). See MPEP 2106.05(a)(I)(viii). The broad claims are lacking concrete limitations to integrate the abstract idea into a practical application. Examiner points out that the claimed limitations have no indication in the specification that the operations recited invoke any inventive programming, require any specialized computer hardware or other inventive computer components, i.e., a particular machine, or that the claimed invention is implemented using other than generic computer components to perform generic computer functions. See DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256 (fed Cir. 2014) (“[A]fter Alice, there can remain no doubt: recitation of generic computer limitations does not make an otherwise ineligible claim patent-eligible.”). Most importantly, in DDR Holdings & unlike the present claims, the claims at issue specified how interactions with the Internet were manipulated to yield a desired result—a result that overrode the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink. 773 F.3d at 1258; 113 USPQ2d at 1106. The examiner also points out that there is no indication in the specification that the claimed invention affects a transformation or reduction of a particular article to a different state or thing. To show an involvement of a computer assists in improving technology, the claims must recite details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology (MPEP 2106.05(a)(II)). In Finjan, Inc. v. Blue Coat Systems the courts found that the claims were “directed to a non-abstract improvement in computer functionality…” (MPEP 2106.04(d)). The present invention clearly does not meet the condition set forth by the courts and thus is not integrated into a practical application. The applicant has not demonstrated that their invention is inventive; thus, the present invention is not patent-eligible under USC 101. Additionally, it is evident that the present claims monopolize the concept of delivering randomized, adaptive digital therapy via user interfaces, restricting further innovation in this area without offering a specific, technical improvement to how the computer actually operates; “monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.” Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (quoting Myriad, 569 U.S. at 589, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). Therefore, the USC 101 rejection is strongly maintained.
Regarding the USC 103 rejection, applicant argues that none of the cited references teach a third set of one or more users, let alone providing an updated interface. Applicant states that Alailima is providing updates for a given user and not a third set of one or more users as recited in claim 1. Applicant requests withdrawal of the USC 103 rejection.
Examiner disagrees with the applicant’s arguments. Examiner asserts that the applicant seems to argue a non-functional descriptive material that describes one or more users is non-obvious. MPEP 2141 is clear that non-functional descriptive material does not generally impart patentable weight to a claim under 35 U.S.C. 103 if they do not interact with the other elements of the claim to create a new, unexpected function or technical result. It is also not clear what is involved in the providing step such that it is different from Alailima. Hence, Alailima does still teach the argued limitations. Therefore, the USC 103 rejection is maintained.
Regarding the priority, applicant does not acquiesce to the examiner's comments in this regard.
Examiner acknowledges the applicant’s position. Therefore, applicant is still not entitled to the priority date of 63/047,372.
Prior Art Cited but Not Relied Upon
The following document was found relevant to the disclosure but not applied:
Maricich, Y. A., Xiong, X., Gerwien, R., Kuo, A., Velez, F., Imbert, B., ... & Williams, K. (2021). Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. Current Medical Research and Opinion, 37(2), 175-183.
This reference is relevant since it discloses the applicant’s mobile application called reSET-O.
US20200335191A1.
This reference is relevant since it discloses substantially similar specification, but different assignee.
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 WINSTON FURTADO whose telephone number is (571)272-5349. The examiner can normally be reached Monday-Friday 8:00 AM to 4:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WINSTON R FURTADO/Examiner, Art Unit 3687
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