DETAILED ACTION
This action is in response to the Response to Restriction received on February 9, 2026. Group II (Claims 7-30) have been elected by the Applicant for examination.
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 .
Election/Restrictions
Applicant's election with traverse of the elected Group II (Claims 7-30) in the reply filed on February 9, 2026 is acknowledged. The traversal is on the grounds that “both groups of claims recite a treatment schedule” and “searching both groups would not be an undue burden because the search results of one would likely yield relevant results for the other.”
This is not found persuasive because the, “analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis). See MPEP Chapter 1800, in particular MPEP § 1850, § 1875, and § 1893.03(d), for a detailed discussion of unity of invention under the Patent Cooperation Treaty (PCT)” (MPEP 823). According to PCT Rule 13, the international application (emphasis added), “shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”)” (PCT Rule 13.1). There is no search burden requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 11, 13, 23, and 25 are objected to because of the following terms lack antecedent basis:
Claims 11 and 23, lines 4-5: “The six-week treatment period”; and
Claims 13 and 25, line 2: “The first plurality of expression images”.
Appropriate correction is required.
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 7-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. As summarized in the 2019 Revised Patent Subject Matter Eligibility Guidance, examiners must perform a Two-Part Analysis for Judicial Exceptions.
Step 1
In Step 1, it must be determined whether the claimed invention is directed to a process, machine, manufacture, or composition of matter. The instant invention encompasses a method (i.e., process) in claims 7-18 and a computer-readable medium in claims 19-30 for treating psychological disorder(s) of a user. Claims 7-18 are directed to one of the four statutory categories and meet the requirements of Step 1.
Claims 19-30, however, are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because a “computer-readable medium”, as claimed in claims 19-30, does not fall within one of the four categories of patent eligible subject matter and thus is not patent eligible. A claim drawn to a computer-readable medium, under the broadest reasonable interpretation, typically covers forms of transitory, propagating signals per se. Signals per se do not fall within one of the four statutory categories of invention and are therefore not eligible for patent protection. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101, Aug. 24, 2009; p.2.
The rejection of claims 19-30 may be obviated by amending the claim to read on a “non-transitory” computer readable medium, or other appropriate language.
Step 2A
Prong One
The claimed invention, as disclosed within claims 7-30, is directed to an abstract idea without significantly more. Regarding the inclusion of claim 19-30 in the continued 101 analysis, claims 19-30 were previously identified as not being directed to statutory subject matter, which would typically result in the cessation of the 101 analysis, for the purpose of compact prosecution, claims 19-30 are being examined as if the Applicant amended the claims to cite a “non-transitory” computer readable medium. The instant invention is broadly directed to a device and method for “systems and methods for providing therapeutic content via a digital therapeutic ("DTx") for the treatment of mood disorders, such as depression and, in particular, major depressive disorder (MDD)” (Specification, [0004]).
Claim 7 recites the following (with emphasis added):
A method for treating depression, the method comprising:
providing memory task exercises according to a first schedule, wherein providing the memory task exercises comprises:
sequentially displaying a first plurality of expression images to a patient receiving treatment for depression,
wherein each of the first plurality of expression images is configured to convey a respective emotion;
prompting the patient to provide an input indicating whether the respective emotion of a first expression image of the first plurality of expression images matches the respective emotion of a second expression image of the first plurality of expression images; and
receiving a patient response indicating whether the respective emotions of the first and second expression images of the first plurality of expression images match one another; and
providing psychotherapy lessons according to a second schedule,
wherein providing the psychotherapy lessons includes displaying an animated video to the patient that is configured to provide therapeutic intervention through at least one of emotion regulation, behavioral activation and cognitive restructuring.
Claim 7 encompasses the abstract idea and had substantially similar features as claim 19, which is also encompassed by the dependent claims 8-18 and 20-30, respectively.
Claims 7-30 recite the steps for assessing and educating a patient on psychological material using a user interface. The device and method are directed to mental processes and certain methods of organizing human activity. A human – using pen and paper – is capable of creating a plurality of exercises/tasks/activities to provide to a patient based on a schedule in a set sequence, then assessing the patient based on the patient’s provided answers. These limitations, when given their broadest reasonable interpretation, recite collecting, analyzing, and sending data pertaining to assessing a user. Thus, the steps are directed to mental processes and certain methods of organizing human activity.
Prong Two
This judicial exception is not integrated into a practical application because mere instruction to implemented on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field is not considered integration into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the present claims include no additional elements other than the abstract idea which include a device. The conventional computer, as presented, are directed to the components of a system that amount to merely field of use type limitations and/or extra solution activity to implement the mental processes and certain methods of organizing human activity for assessing and educating a user.
Step 2B
Step 2B in the analysis requires us to determine whether the claims do significantly more than simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the claims to determine whether the claims contain an "inventive concept" to "transform" the claimed abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at 1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires ‘more than simply stat[ing] the [abstract idea] while adding the words ‘apply it.’’" Id. (quoting Mayo, 132 S. Ct. at 1294) (alterations in original). "A claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].’" Id. (quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The present claims do not include the additional elements that are sufficient to amount to significantly more than the judicial exception. Any potentially technical aspects of the claims are well-known, generic computational components performing conventional functions (e.g., “the user device may include a patient's mobile device programmed with the computer program instructions and/or other device” (Specification, [0018])). The present claims have been analyzed both individually and in combination and, the instant claims do not provide any improvement of the functioning of the computer or improvement to computer technology or any other technical field. There do not appear to be any meaningful limitations other than those that are well-understood, routine, and conventional in the field. Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims are not patent eligible.
The claims are generally linked to implement an abstract idea on a computer, server, or mobile device. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without "significantly more," and thus not patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11 and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 11 and 23, which depend upon claims 7 and 19, respectively, create ambiguity and confusion as to which limitations recited are required and which limitations are intended as optional and exemplary. Specifically, claims 11 and 23 recite limitations requiring therapeutic intervention to be conducted through all of the following methods: “emotion regulation”, “behavioral activation”, and “cognitive restructuring”. However, the claimed invention, as recited in claims 7 and 19, requires therapeutic intervention through only one of the aforementioned methods (Instant Application, Claims 7 and 19, emphasis added, “provide therapeutic intervention through at least one of emotion regulation, behavioral activation and cognitive restructuring.”).
For the purposes of examination, the Examiner assumes, by reciting “at least one” in claims 7 and 19, the Applicant’s limitations within claims 11 and 23 are only required to be present when the corresponding method is present within the prior art. For example, for the purposes of identifying prior art, if a reference recites method A and B but does not disclose method C (or any combination), then the reference must recite the limitations for method A and B but not be required to recite the limitations for method C. Specifically, if a reference recites emotion regulation and behavioral activation but does not disclose cognitive restructuring (or any combination), then the reference must recite the limitations for emotion regulation and behavioral activation but not be required to recite the limitations for cognitive restructuring.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 7-8, 10-20, and 22-30 are rejected under 35 U.S.C. 103 as being unpatentable over Iacoviello [US20170303851A1].
Regarding claim 7, Iacoviello discloses:
A method for treating depression, the method comprising:
providing memory task exercises according to a first schedule, wherein providing the memory task exercises comprises:
sequentially displaying a first plurality of expression images to a patient receiving treatment for depression, wherein each of the first plurality of expression images is configured to convey a respective emotion (Iacoviello, [0006], “The therapy session comprises sequentially displaying each respective expression image in a plurality of expression images for a predetermined amount of time.”);
prompting the patient to provide an input indicating whether the respective emotion of a first expression image of the first plurality of expression images matches the respective emotion of a second expression image of the first plurality of expression images (Iacoviello, [0007], “a response from the subject to a query as to whether the first and the last expression image in the respective expression image subset exhibits the same emotion is received.”); and
receiving a patient response indicating whether the respective emotions of the first and second expression images of the first plurality of expression images match one another (See citation directly above.); and
providing psychotherapy lessons according to a second schedule (Iacoviello, [0018], “the treatment regimen is characterized by a frequency by which the therapy session is conducted as well as an absolute number of times the therapy session is conducted and furthermore is characterized by the use of a psychotherapy for an affective disorder.”),
wherein providing the psychotherapy lessons includes displaying an animated video (Iacoviello, [0065], “In certain embodiments, the expression images are animated expression images.”) to the patient that is configured to provide therapeutic intervention through at least one of emotion regulation (Iacoviello, [0005], “Without being bound by any particular theory of operation or mechanism, it is believed that exercising the ability to manipulate emotional information in working memory by performing such cognitive emotional exercises enhances cognitive control for emotional material and emotion regulation, and has antidepressant effects.”), behavioral activation (Iacoviello, [0066], “In some embodiments are any image that induces amygdala activation (images that are emotionally salient or evocative).”) and cognitive restructuring.
Within Iacoviello, the nomenclature of the disclosure is similar to the instant application, but does not distinguish the terms for psychotherapy lessons and the memory tasks as performed in the instant application.
The Examiner makes this note to record the various reasonable interpretations throughout the field and to detail where Iacoviello teaches the activities (i.e., memory tasks and psychotherapy lessons) separately as in the instant application. Similar to the memory tasks of the instant application, Iacoviello discloses the Emotional Faces Memory Task (EFMT) (Iacoviello, [0137], “Subjects in the training condition complete the EFMT task for the purposes of increasing their ability to accurately identify and remember facial emotions.”). Within Iacoviello, the cognitive-emotional training exercises are a subset of the psychotherapy lessons. Similar to the psychotherapy lessons of the instant application, Iacoviello discloses varied methods of the memory tasks (Iacoviello, [0065], “In certain embodiments, the expression images are animated expression images.”), therapy sessions (Iacoviello, [0016], “In some embodiments, the treatment regimen is characterized by a frequency by which the therapy session is conducted as well as an absolute number of times the therapy sessions are conducted and furthermore is characterized by the use of a pharmaceutical composition.”), and cognitive emotional training/exercises (Iacoviello, [0091], “Cognitive-Emotional Training as an Intervention for Major Depressive Disorder”).
Regarding claims 7-8, 11, 14-15, 18, 20, and 30, the claims disclose various forms of a schedule for the instant application that are merely design choice limitations. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice) (See MPEP 2144.04). As such, as long as the prior art teaches the limitation of various alternative scheduling implementations (Iacoviello, See [0082]-[0083] for the in-depth scheduling implementations disclosed.), the prior art fits the claims as this is the limitation that structurally modifies the disclosed invention. Iacoviello discloses various examinations, sessions, and activities at varied frequencies.
Regarding claim 10, Iacoviello discloses:
The method of claim 7, wherein one or more of the psychotherapy lessons include an activity or task to be completed by the patient (Iacoviello, [0139], “At the mid-study assessment session, to take place at the end of the participants' third week of training, participants complete the RRS, eStroop, EFRT and AGNG to monitor changes in cognitive and affective processing that might precede changes in mood symptoms.”).
Regarding claim 11, Iacoviello discloses a six week treatment period (Iacoviello, [0126], “They are then randomly assigned to either a training group or control group, and required to make 18 three-times-weekly appointments over 6 weeks.”), rendering animated videos, and performing the tasks/activities for the intended use of emotion regulation and behavioral activation (Citations regarding the disclosure of animated videos, emotion regulation, and behavioral activation can be found in claim 7 above.). Regarding performing the specific tasks/activities in the given weekly schedule as details in claim 11 of the instant application, see the Examiner’s note above regarding design choice limitations.
Regarding claim 12, Iacoviello discloses:
The method of claim 7, wherein at least one of the psychotherapy lessons is configured to reduce a severity of depression as measured by the Montgomery-Asberg Depression Rating Scale or the Hamilton Depression Rating Scale (Iacoviello, [0147], “In addition to the weekly depression and suicidality symptom assessment conducted by the study investigators (including standardized rating scales: Columbia Suicide Severity Rating Scale (CSSRS) and Hamilton Depression Rating Scale (Ham-D))…”).
Regarding claim 13, Iacoviello discloses:
The method of claim 7, wherein:
the first plurality of expression images comprise facial expressions (Iacoviello, [0033], “In some embodiments at least one expression image in the plurality of expression images is a facial expression.”), and
each of the respective emotions of the first plurality of expression images are configured to represent at least one of: happiness, worry, anger, sadness, surprise, or disgust (Iacoviello, [0013], “the set of expressions include happy, worried, angry and sad.”).
Regarding claim 14, Iacoviello discloses:
The method of claim 7, wherein providing the memory task exercises according to the first schedule further comprises:
determining a score based at least in part on whether the patient response is correct (Iacoviello, [0023], “the plurality of scores is determined as the total number of correct responses from the subject to the query as to whether the first and last expression in a respective expression image subset is the same.”).
Regarding claim 15, Iacoviello discloses:
The method of claim 14, wherein providing the memory task exercises according to the first schedule further comprises:
sequentially displaying a second plurality of expression images to the patient,
wherein each of the second plurality of expression images is configured to convey a respective emotion (See claim 7 for citations from the prior art.); and
prompting the patient to provide an input indicating whether the respective emotion of a first expression image of the second plurality of expression images matches the respective emotion of a second expression image of the second plurality of expression images (See claim 7 for citations from the prior art.),
wherein the second expression image of the second plurality of expression images is N-images back from the first expression image of the second plurality of expression images (Iacoviello, [0007], “Each respective expression image subset within the plurality of expression images consists of N sequentially displayed expression images.”).
Regarding claim 16, Iacoviello discloses:
The method of claim 15, wherein a value of N is an integer configured to be adjusted based at least in part on whether the patient response with respect to the first plurality of expression images was correct (Iacoviello, [0023], “the resetting of N is based at least in part on the percentage of correct responses from the subject to the query as compared to the total number of responses.”).
Regarding claim 17, Iacoviello discloses:
The method of claim 15, wherein the first and second expression images of the second plurality of expression images each include a respective emotional intensity (Iacoviello, [0006], “Each expression image in the plurality of expression images is images is … engineered to display a predetermined intensity of the respective expression on an intensity scale that ranges from low intensity to high intensity of the respective expression.”) configured to be adjusted based at least in part on whether the patient response with respect to the first plurality of expression images was correct (Iacoviello, [0006], “[The emotional intensity scale] contributes to the difficulty of the task across levels. This is purposeful to increase engagement and learning throughout the session.” In other words, the emotional intensity is adjusted throughout the session to ensure the difficulty of the task remains at a level that ensures the user remains engaged and continues to learn.).
Regarding claim 18, Iacoviello discloses:
The method of claim 7, wherein the first and second schedules define a six-week treatment period (See claim 11 regarding the six-week treatment period.).
Claims 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Iacoviello as applied to claims 7-8, 10-20, and 22-30 above, and further in view of Hall [US20020168620A1].
Regarding claim 9, Iacoviello discloses:
The method of claim 7, wherein the psychotherapy lessons comprise
cognitive behavioral therapy lessons (Iacoviello, [0018], “In certain embodiments, the psychotherapy is a cognitive behavioral psychotherapy.”),
Although Iacoviello discloses psychotherapy lessons that comprise cognitive behavioral therapy lessons, Iacoviello does not explicitly disclose lessons with a duration approximately 3-5 minutes.
Hall, however, discloses:
lessons each having a duration of approximately 3-5 minutes (Hall, [0024], “Each learning activity or task is limited in duration to approximately 5 minutes or less, depending on content requirement.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to maintain user’s attention for individual lessons by including information at short durations for lessons (approximately 3-5 minutes each) provided to users as in the improvement discussed in Hall in the system executing the method of Iacoviello. As in Hall, it is within the capabilities and understanding of one of ordinary skill in the art to provide information in manageable portions to Iacoviello’s therapy regimen with the predicted result of increasing user’s comprehension as needed in Iacoviello.
Regarding claims 19-30, the claims share similar limitations to claims 7-18. For citations on rejection, see the rejection of claims 7-18 above.
Conclusion
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/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
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