DETAILED ACTION
This action is in response to the Applicant Remarks received on June 30, 2026. Claims 1-30 are pending with claims 1-6 withdrawn, no claims canceled, and claims 11, 13, 23, and 25 currently amended.
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 .
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 § 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 (Iacoviello, [0008], “In particular embodiments, the affective disorder is MDD [ - major depressive disorder].”), the method comprising:
providing memory task exercises according to a first schedule (Iacoviello, [0014], “the therapy session is repeated on a recurring basis over the course of a number of weeks.”), 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 [0057], “the subject is queried at the completion of each respective expression image subset within the plurality of expression images as to whether the emotion of the first and last expression image in the respective image subset is the same (312)”); 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 (Iacoviello, [0068], “receiving 312 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”); 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], “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.
Response to Arguments
Applicant’s arguments, see page 9 of 20 of the Remarks, filed June 30, 2026, with respect to the objections of claims 11 and 23 have been fully considered and are persuasive. The objections of claims 11 and 23 have been withdrawn.
Applicant’s arguments, see pages 9-10 of 20 of the Remarks, filed June 30, 2026, with respect to the rejection of claims 11 and 23 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 11 and 23 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed June 30, 2026 regarding the rejections of claims 7-30 under 35 U.S.C. 101 and 35 U.S.C. 103 have been fully considered but they are not persuasive.
Specifically, the Applicant has not amended claims 19-30 to satisfy Step 1 of the Subject Matter Eligibility Test. As stated in the Non-Final Office Action filed March 31, 2026 and above, claims 19-30 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 specification further clarifies that a “computer-readable medium” is directed to ineligible subject matter in the recitation: “As used herein, the terms "machine-readable medium" "computer-readable medium" refers to any computer program product, apparatus and/or device … used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term "machine-readable signal" refers to any signal used to provide machine instructions and/or data to a programmable processor” (Specification, [0112]). This 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.
Regarding claims 7-30 – with claims 19-30 being examined as if they recited a “non-transitory computer readable medium” for the purposes of compact prosecution – the Applicant references Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018). However, the claims found eligible in Vanda are not analogous to the claims presented in the instant application. The claims found eligible in Vanda administered a specific compound at a specific dose, whereas the instant claims recite only display of information and receipt/scoring of inputs.
Furthermore, Vanda, in explaining the difference between the decision of Mayo and the decision of Vanda, states:
“Moreover, unlike the claim in Mayo, to the extent that preemption is a concern, the ’610 patent claims do not “tie up the doctor’s subsequent treatment decision.” Id. at 86. The claim in Mayo did not go beyond recognizing (i.e., “indicates”) a need to increase or decrease a dose. Id. at 75. In Mayo, “a doctor . . . could violate the patent even if he did not actually alter his treatment decision in the light of the test.” Id. The claim was not a treatment claim. It was “not limited to instances in which the doctor actually decreases (or increases) the dosage level where the test results suggest that such an adjustment is advisable.” Id. at 76.”
The claims of the instant application are similarly recited. The claims of the instant application merely recognize a need to increase or decrease an integer (claim 16) or an emotional intensity (claim 17) based on the patient’s response. No recitation requires the adjustment of a dosage level even if arguendo that the images are treated as a treatment and the emotional intensity as a dosage.
Regarding the Applicant’s argument that, “Vanda clarified that a claim recited eligible subject matter under Mayo Step 1 if it is directed to a specific method of treating a patient to achieve a therapeutic result … The court explained that the claims were directed to a practical application that improved treatment of a medical condition rather than an abstract idea.” (Remarks, p 11 of 20, para 3), the Examiner respectfully submits this is an improper summarization of the court’s findings in Vanda. In the court’s decision of Vanda, the court recites, “the claims here [analyzed in Vanda] are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” For the reasons provided in this Action, the claims analyzed in Vanda are not analogous to the claims within the instant application.
Regarding the Applicant’s argument that, “The specification also reinforces the treatment-oriented nature of the claimed invention through at least Example 1, which describes a multi-center clinical trial evaluating the effectiveness of the claimed digital therapeutic in patients diagnosed with major depressive disorder. Spec. ¶¶ 0112-0191. The specification describes therapeutic efficacy endpoints including MADRS scores, GAD-7 scores, remission rates, and other clinically recognized measures of depression severity. Spec. ¶¶ 0115-0119” (Remarks, p 12-13 of 20, para 9 and 1, respectively), the Examiner respectfully submits that the instant claims do not recite these measurements beyond extra-solution activity or a field of use. Specifically, these measurements are introduced in claims 12 and 24; however, the measurements do not impact the alleged treatment as currently claimed. See MPEP 2106.04(d)(2) for further details.
Regarding the Applicant’s arguments that the instant application does not recite mental processed or methods of organizing human activity (Remarks, p. 13-14 of 20, para 4-5 and 1, respectively), the Examiner respectfully disagrees and submits the explanation regarding how the claims recite the abstract ideas in the corresponding section above.
Regarding the Applicant’s argument that, “In McRO, the court explained that claims are not abstract where they recite a specific software implementation that achieves a technological result” (Remarks, p 14 of 20, para 3) and reliance on McRO, Inc. v. Bandai Namco Games
America Inc., 837 F.3d 1299 (Fed. Cir. 2016) and Diamond v. Diehr, 450 U.S. 175 (1981), the Examiner respectfully submits that this assertion is an oversimplification of the court’s findings. The court’s analysis in McRO does note, “The claimed process uses a combined order of specific rules that renders information into a specific format that is then used and applied to create desired results: a sequence of synchronized, animated characters.” However, the court continues their analysis by stating, “The concern underlying the exceptions to § 101 is not tangibility, but preemption.” The courts found the claims prevented preemption of all processes for achieving automated lip-synchronization of 3-D characters – a technological improvement to digital animation. Unlike McRO and Diehr, the instant application does not provide a technological improvement as claimed. The claims combine the functions of a media player, student test administration application, and calendar for the intended purpose of treating depression. In viewing the elements independently and in combination, no improvement to the functioning of a computer, technology, or technical field can be found as further discussed in the corresponding section above.
The Applicant also points to USPTO's July 2024 Guidance Update, Example 49, to assert the instant claims are patent eligible. In Example 49, claim 1 was found ineligible under 35 U.S.C. 101 and claim 2 was found eligible under 35 U.S.C. 101. Specifically, the Applicant asserts, “In USPTO Example 49, Claim 2, a diagnostic process was held patent-eligible because it was integrated with a specific therapeutic intervention.” However, this argument is an improper summarization of the analysis provided in the July 2024 Guidance Update. On p. 31 of the July 2024 Guidance Update, it is explicitly acknowledged that claim 1 was directed towards “administering a treatment to the patient at high risk of PI after microstent implant surgery” – yet remains ineligible.
Moreover, the claims do not recite a “specific therapeutic intervention” to an extent necessary to be considered patent eligible. As currently recited, the claims lack specificity. For example, the utmost specificity of the treatment from claim 7 is “expression images” conveying a “respective emotion” and “animated video” configured to “provide therapeutic intervention”. This lack of description can be equated to claim 1 in Example 49, which recites, “administering an appropriate treatment to the glaucoma patient at high risk of PI after microstent implant surgery.” Although these limitations indicate an image or video is to be administered, they do not provide any information as to how the patient is to be treated or what the treatment is but instead covers any possible treatment that a medical professional decides to administer to the patient via image or video.
As recited in MPEP 2106.04(d)(2), “the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. … 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, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.” As currently drafted, the claims do not affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. Instead, claim 7 (and similarly in claim 19) recites, “…providing psychotherapy lessons according to a second schedule, wherein providing the psychotherapy lessons includes displaying an animated video to the patient…”. The claims detail the content of the lessons, not a positive step of completion; therefore, the claims align with the prescribing fact pattern as determined in the MPEP as not a positive limitation that affirmatively recites an action that effects a particular treatment or prophylaxis.
When determining whether a claim applies or uses a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, the same MPEP section states the treatment or prophylaxis must be particular and must be more than merely extra-solution activity or field-of-use.
When reviewing the particularity or generality of the treatment or prophylaxis of the instant claims, the treatment must be specifically identified so that it does not encompass all applications of the judicial exception(s). The instant claims have been identified as being directed to mental processes and certain methods of organizing human activity. Further, the administration step is not particular as the treatment lacks specificity. As currently claimed, the instant application merely requires the treatment to be “expression images” or “animated video”. The surrounding limitations lack sufficient structure to objectively bind the treatment beyond what the prescribing physician finds to be “suitable” treatment.
When reviewing whether the limitations are merely extra-solution activity or a field-of-use, the limitations must impose meaningful limits on the judicial exception and cannot be extra-solution activity or a field-of-use. The steps recited in claim 7, and similarly recited in claim 19, are either one or more judicial exception, extra-solution activity, field-of-use, additional elements, or a combination.
Regarding the Applicant’s argument that, “The Office Action provides no evidence demonstrating that the claimed combination of coordinated memory-task exercises and psychotherapy lessons was well-understood, routine, and conventional” (Remarks, p 15 of 20, para 6), the Examiner respectfully submits the claims as currently presented do not demonstrate coordinated memory-task exercises and psychotherapy lessons. Claims 7 and 19 recite memory-task exercises and psychotherapy lessons separately with no coordinating elements between the two features. The only interaction between memory-task exercises and psychotherapy lessons appears in claims 8 and 20; however, no coordination is recited in the claims – the exercises and lessons are merely recited as occurring on different days from each other. Due to the lack of presence of coordinated memory-task exercises and psychotherapy lessons, no evidence is required to prove the features are well-understood, routine, and conventional.
As outlined above, the claims are not recited in such a way as to be patent eligible under 35 U.S.C. 101.
Regarding the Applicant’s arguments pertaining to the rejection of claims 7-30 under 35 U.S.C. 103, the Examiner submits the following arguments.
Regarding the Applicant’s argument that, “Applicant traverses the rejection for at least the reason that the Office Action relies upon an unreasonable interpretation of the claim language that improperly conflates the separately recited "memory task exercises" and "psychotherapy lessons" into the same disclosure” (Remarks, p 16 of 20, para 3), the Examiner respectfully submits this is not the case. The Applicant’s reliance on Applied Medical and CAE Screenplates is misplaced. Those decisions construe terms within a patentee’s claims, holding that different claim terms are presumed to connote different meanings absent evidence to the contrary. They do not address, and impose no requirement on, how a prior art reference describes its own embodiments. The rejection gives “memory task exercises” and “psychotherapy lessons” different meanings and different prior-art support: the former is met by Iacoviello’s therapy session of sequential display, query, response, scoring, and N-reset ([0006], [0007], [0057]); the latter by the psychotherapy Iacoviello recites as a further component of the treatment regimen ([0018]). No claim term has been read on the same disclosure twice.
Applicant’s premise that Iacoviello presents the two as “interchangeable” is not supported by the reference. Iacoviello describes them as additive, not alternative: [0018] and [0082] characterize the regiment by the therapy session and the psychotherapy. A reference is prior art for all it teaches, including combinations it describes as optional (MPEP 2123).
Furthermore, under broadest reasonable interpretation (MPEP 2111), “providing memory task exercises” and “providing psychotherapy lessons” require two content types; the references provide both. Applicant’s own specification states the components “may be rendered and processed individually or in combination” ([0024]) – the same flexibility Applicant attributes to Iacoviello – so the argument, if accepted, would equally undermine Applicant’s disclosure.
Regarding the Applicant’s arguments disputing specific features not existing within specific references, the Examiner submits the corresponding section above with citations provided for each limitation to demonstrate the disclosure of the limitation within the reference.
Conclusion
THIS ACTION IS MADE FINAL. 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 ZACHARY JOSEPH POLLOCK whose telephone number is (703)756-5952. The examiner can normally be reached Monday-Friday 10:00am-8:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, XUAN THAI can be reached at (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
Prosecution Insights