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 the Application
This communication is in response to remarks and amendments filed on August 18, 2025.
Claims 1-6 are pending and addressed below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.
Claim 1 contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites:
a method of monitoring a user-specific-health-and-activity data and developing a therapy solution through a modular digital therapy framework, the method comprising:
(a) causing a user to be monitored by at least one digital therapy application of a user terminal for the user-specific-health-and-activity data;
(b) for the user, obtaining, by a digital therapy module library, the user-specific-health- and-activity data from the at least one digital therapy application of the user terminal, the user- specific-health-and-activity data comprising a sleep time, a dietary habit and a heartbeat;
(c) analyzing, by a processor, the user-specific-health-and-activity data from step (b);
(d) automatically operating a digital therapy solution generator, by the processor sending a control signal to the digital therapy solution generator to generate a digital therapy solution personalized for the user on the basis of the user-specific-health-and-activity data; and
(e) repeating steps (b) through (d) for the user,
wherein
the digital therapy module library comprises a plurality of digital therapy modules, and as steps (b) through (d) being repeated, the plurality of digital therapy modules are dynamically updated for the digital therapy solution personalized for the user.
The italicized language above lacks support in the original disclosure.
Regarding (a) and (b), the only discussion regarding logging health and activity data appears in the “2. Discussion of Related Art” section ([0002]-[0005]) and not in the description of the invention. In addition, the original disclosure does not mention a user terminal with an application that monitors a user’s health and activity data. The application mentioned in the original disclosure is developed by a person and is not used to monitor health and activity data of a user as claimed ([0036] “For example, it may be assumed that a user, who is a developer, develops a digital therapy application for insonmia therapy.”). Further, it appears the original disclosure uses the word application as an alternative word for solution (emphasis added [0032] “A new digital therapy solution may be developed…” [0033] “The digital therapy solution tester 140 may be implemented to test the generated digital therapy solution. When a specific digital therapy application is developed…”).
Regarding (c) and (d) and claim 2, the word processor does not appear in the original disclosure, Applicant provided paragraph [0085] for support, which describes computer parts at a high level. However, neither this paragraph nor the original disclosure provides support for a computer or the like performing the claimed functions. The original disclosure also lacks support for generating personalized solutions as claimed. In fact, the word personalized (or synonyms) do not appear in the original disclosure.
Regarding (e), the word repeat or any similar term does not appear in the original disclosure.
The last limitation “as steps (b) through (d) being repeated, the plurality of digital therapy modules are dynamically updated for the digital therapy solution personalized for the user.” lacks support as well. The only portion in the original disclosure mentioning updates was found in paragraph [0046], however, this paragraph, if a module in the library is updated, then its related solution is updated. This is unlike the limitation above.
Applicant provided paragraphs [0026], [0045]-[0046] and [0085] as support for the amended claims. However, according to [0026], the digital therapy application is developed using e.g., “a sleep time check module, a dietary habit check module, a heartbeat check module, and the like.” Which is different from the claim which requires the digital therapy application to monitor a user’s sleep, diet and heartbeat. Paragraph [0045] describes combining new and existing modules “such that a new digital therapy solution may be developed.”. Paragraphs [0046] and [0085] have been discussed above.
None of the provided paragraphs or the original disclosure provide support for the language as claimed.
In addition, claim 1 is rejected for lack written description because it defines the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. Specifically, claim 1 recites “generate a digital therapy solution personalized for the user on the basis of the user-specific-health-and-activity data” and “as steps (b) through (d) being repeated, the plurality of digital therapy modules are dynamically updated for the digital therapy solution personalized for the user.”
MPEP 2161.01 recites in part:
“…original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02and 2181, subsection IV.”
The present Specification states in multiple parts that a digital therapy solution is generated. However, the original disclosure does not recite any algorithms or steps/procedures taken to perform the claimed function with sufficient detail. Merely reproducing a claim limitation in the specification or pointing to an original claim does not satisfy the written description requirement, unless the claim itself conveys enough information to show that the inventor had possession of the claimed invention at the time of filing; and it is not necessarily sufficient to merely repeat the claimed function in the written description. Thus, one of ordinary skill in the art would not understand how the inventor intended the functions to be performed. As mentioned above, there is no support for the last limitation in claim 1, therefore there is also lack of support for any algorithm describing how the updating function is performed.
Claims 2-3 depend from claim 1 and do not cure the deficiencies above.
Claims 4-5 recite substantially similar language as claims 1-3 are rejected for the same reasons above.
Therefore, claims 1-6 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
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 (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.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (US 2023/0223127 Al, hereinafter Cho), in view of Paull et al. (US 2022/0028528 Al, hereinafter Paull)
As per claim 1, Cho discloses a method of monitoring a user-specific-health-and-activity data and developing a therapy solution through a modular digital therapy framework, the method comprising:
(a) causing a user to be monitored by at least one digital therapy application of a user terminal for the user-specific-health-and-activity data ([0090] “Referring to FIG. 8, in operation 801, the processor 110 of the electronic device 100 may acquire biometric information about the user of the electronic device 100. According to an embodiment of the disclosure, the processor 110 may acquire the biometric information through the sensor module 150 of the electronic device 100. According to another embodiment of the disclosure, the processor 110 may acquire the biometric information by receiving the biometric information about the user from at least one external device through the communication circuit 130.” [0153] “According to an embodiment of the disclosure, the at least one external device may include at least one of a wearable device, a body weight scale, a blood glucose meter, and a pedometer.”);
(b) for the user, obtaining, by a digital therapy module library, the user-specific-health- and-activity data from the at least one digital therapy application of the user terminal, the user- specific-health-and-activity data comprising a sleep time, a dietary habit and a heartbeat
(Figure 4, 420 includes multiple modules [0153] “… the at least one external device may include at least one of a wearable device, a body weight scale, a blood glucose meter, and a pedometer.” [0156] “…biometric information may include at least one of … a diet, …sleep information, a heart rate, …”);
(c) analyzing, by a processor, the user-specific-health-and-activity data from step (b) (Figure 4, BIOMETRIC INFORMATION ANALYSIS MODULE (220));
(d) automatically operating a digital therapy solution generator, by the processor sending a control signal to the digital therapy solution generator to generate a digital therapy solution personalized for the user on the basis of the user-specific-health-and-activity data ([0007] “Even if the digital therapeutic agent is a therapeutic agent for the same disease, it is necessary to be personalized for each user of the electronic device”); and
(e) repeating steps (b) through (d) for the user ([0137] “According to various embodiments, operations performed by the module, the program, or another component may be carried out sequentially, in parallel, repeatedly, or heuristically…”),
wherein the digital therapy module library comprises a plurality of digital therapy modules (Figure 4, 420 comprises multiple modules).
Cho does not explicitly disclose
as steps (b) through (d) being repeated, the plurality of digital therapy modules are dynamically updated for the digital therapy solution personalized for the user.
However, Cho discloses repeating steps and dynamically updating the digital therapy solution personalized for the user ([0137] and [0099] According to an embodiment of the disclosure, when the biorhythm information is changed, the processor 110 may, in operation 909, update the dose information, based on the changed biorhythm information and prescription information.), and Paull’s invention titled METHODS AND SYSTEMS FOR TREATING HEALTH CONDITIONS USING PRESCRIPTION DIGITAL THERAPEUTICS teaches in [0260] “…dynamically updating the patients' personalized intervention regimen includes one or more of: adjusting the order of administration of the interactive therapy modules; adjusting the frequency of administration of the interactive therapy modules; adjusting the mode of administration of the interactive therapy modules; adjusting the content of the interactive therapy modules; adjusting the content size of the interactive therapy modules; adjusting the presentation of the interactive therapy modules; adjusting the layout of the interactive therapy modules; updating the patient's electronic health records; updating the patient's personal health records; updating the patient's open medical records; and increasing personalization of the intervention regimen. In one embodiment, the patient's personalized intervention regimen is updated in near-real time based on the patient's interactions with the content of the interactive therapy modules.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the teachings of Paull in the system and methods of Cho, in order to provide the patient with relevant and useful digital therapy solutions, and 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.
As per claim 2, Cho further discloses wherein the processor further receives data regarding the plurality of digital therapy modules, a therapy algorithm, or an artificial intelligence (AI) model (Figure 4, 420 includes multiple modules).
Please note that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” (MPEP 2111.04). Although all optional elements have been addressed, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that the recitations further limit the claimed structure.
As per claim 3, Cho further discloses wherein the digital therapy solution is generated based on a combination the plurality of digital therapy modules, the therapy algorithm, or the AI model (Figure 4, 420 includes a combination of multiple modules).
In addition, please note that claim 3 depends from claim 2 and claim 2 only requires one of: digital therapy module, a therapy algorithm, or an artificial intelligence (AI) model. As noted above, “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed”. Although all three elements have been addressed in claim 3, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that the recitations further limit the claimed structure.
Claims 4-6 recite substantially similar limitations as claims 1-3 and are rejected using the same art and rationale.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to the applicant' s disclosure has been cited in Non-Final dated 5/29/2025.
Response to Arguments
Applicant’s arguments are fully considered but are moot in view of the new grounds of rejection.
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 HAJIME ROJAS whose telephone number is (571)270-5491. The examiner can normally be reached Th-Fr, M-T 8AM - 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAJIME ROJAS/Primary Patent Examiner, Art Unit 3682
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