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 response dated January 22, 2026, Applicant amended claims 1-3, 5, 6, 8-11, and 13. Claims 4, 7, and 12 were canceled. Claims 14-17 were added. Claims 1-3, 5, 6, 8-11, and 13-17 are pending in the current application.
Response to Arguments
Claims 1-8 were interpreted under 35 U.S.C. 112(f). Examiner thanks Applicant for amending and canceling the claims. The claim interpretation under 35 U.S.C. 112(f) has been obviated.
Applicant's arguments with respect to the rejection under 35 U.S.C. 101 have been fully considered but they are not persuasive. First, Applicant asserts that the claims are analogous to Example 42 SME Guidelines because the claims solve the technical problem of insufficient linkage and data integration between various medical systems and the users when managing the disparate medical data. Examiner respectfully disagrees. To evaluate improvements, the specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. If the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement. In this case, Applicant’s specification discloses, “the use of the multimodal sensor may enable a more comprehensive assessment of the user's health status, and provision of information on environmental factors in addition to bio-signals. This provides healthcare professionals with a richer context to help develop patient-centered treatment approaches and ultimately improve patient health and well-being.” Applicant specification also discloses improved user experience, effectiveness of treatment maximized, improving the effectiveness of digital treatment through continuous monitoring and analysis and providing treatment optimized for the patient's health condition. These improvements are not technological in nature, rather they are improvements in patient care. Moreover, in example 42, the additional elements recited a specific improvement over prior art systems by allowing remote users to share information in real time in a standardized format regardless of the format in which the information was input by the user (i.e, converting the non-standardized updated information into the standardized format). In this case, the claims encompass a user (e.g., medical professional) collecting prescription information from a medical institution, evaluating said information (e.g., by reading or reviewing a document), and providing feedback information based on the evaluation. “Tracking effectiveness, side effects, and individual responses of the one or more digital therapeutics in real-time” can be achieved through observation and evaluation of the patient. Second, Applicant asserts that the claims are analogous to claim 3 of example 47 SME Guidelines because the claims recite using machine learning pattern recognition algorithm to analyze information. Examiner respectfully disagrees. The instant claims are analogous to Claim 2 of example 47, which is ineligible because the claimed discretizing, detecting, and analyzing steps encompass mental choices or evaluations, and the claimed discretizing and training using a backpropagation algorithm and gradient descent algorithm encompasses performing mathematical calculations. As stated above, the claims encompass a user (e.g., medical professional) collecting prescription information from a medical institution, evaluating said information (e.g., by reading or reviewing a document), and providing feedback information based on the evaluation or performing a mental process. Last, Applicant asserts that the claims are analogous to Vanda because they recite a specific application of judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. Examiner respectfully disagrees. As stated above, the claims are not directed to improvements nor do they recite specific machine learning algorithms. Therefore, the claims are not patent eligible.
Applicant’s arguments with respect to the rejection under 35 U.S.C. 102 have been fully considered and are persuasive. The prior art references do not teach or suggest “dynamically adjust and control a corresponding system environment according to the actual use of the one or more digital therapeutics to optimize treatment plans and effectiveness of the one or more digital therapeutics...using a multimodal sensor” and “update the received treatment result information in the EMR database, wherein the digital therapy management system is linked with the medical institution terminal and the user terminal through at least one of an application service and an IoT-enabled web service via a smart terminal or an IoT terminal equipped in the medical institution terminal and the user terminal” as recited in independent claims 1 and 9, and dependent claims 2 and 10. The closest prior art reference of record, Lee et al. (US 2022/0054081 A1) describes digital therapeutics for medication adherence. However, Lee does not teach or suggested the aforementioned limitations. The rejection has been withdrawn.
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, 6, 8-11, and 13-17 are rejected under 35 U.S.C. 101 because the claims are not directed to patent eligible subject matter.
Claims 1-3, 5, 6, 8-11, and 13-17 do fall within at least one of the four categories of patent eligible subject matter because the claims recite a machine (i.e., system) and process (i.e., a method).
Although claims 1-3, 5, 6, 8-11, and 13-17 fall under at least one of the four statutory categories, it should be determined whether the claim wholly embraces a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception (See MPEP 2106 I and II).
Claims 1-3, 5, 6, 8-11, and 13-17 are directed to a judicial exception (i.e., a law of nature, natural phenomenon, or abstract idea) without significantly more.
Part I: Step 2A, Prong One: Identify the Abstract Idea
Under step 2A, Prong One of the Alice framework, the claims are analyzed to determine if the claims are directed to a judicial exception. MPEP §2106.04(a). The determination consists of a) identifying the specific limitations in the claim that recite an abstract idea; and b) determining whether the identified limitations fall within at least one of the three subject matter groupings of abstract ideas (i.e., mathematical concepts, mental processes, and certain methods of organizing human activity).
The identified limitations of independent claim 9 (representative of independent claim 1) recite
providing prescription information generated by a medical institution terminal to a user terminal;
collecting, from the user terminal, implementation result information generated according to actual use of one or more digital therapeutics based on the prescription information, the implementation result information including a user input data and bio-signal data of a user that is continuously monitored through a multimodal sensor of the user terminal;
tracking effectiveness, side effects, and individual responses of the one or more digital therapeutics in real-time;
providing the implementation result information to the medical institution terminal, and transmitting the tracked effectiveness, side effects, and individual responses to the medical institution terminal;
analyzing and evaluating the collected implementation result information by:
identifying data patterns, trends, and statistical indicators by using machine learning and pattern recognition algorithm to track performance of the one or more digital therapeutics, and
using the identified data patterns, trends, and statistical indicators to train predictive models configured to predict effective combination of the one or more digital therapeutics and potential side effects for a specific user or a group of users to optimize effective treatment plan for the specific user or the group of users;
generating feedback information based on the analyzed and evaluated result; and
providing the generated feedback information to an input-side system environment required to generate the one or more digital therapeutics or an output-side system environment providing a physical hospital service or a virtual hospital service that supports the actual use of the one or more digital therapeutics;
dynamically adjusting and controlling a corresponding system environment according to the actual use of the one or more digital therapeutics to optimize treatment plans and effectiveness of the one or more digital therapeutics;
receiving treatment result information corresponding to the implementation result information from the medical institution terminal; and
updating the received treatment result information in electronic medical record (EMR) database,
wherein the EMR database is configured to:
collect and manage EMR data of a plurality of medical institutions,
collect personal health record (PHR) data of the user, and
provide remote access to the EMR data and the PHR data in real-time, allowing the plurality of medical institutions and the user terminal to simultaneously view and share necessary data and information, and
wherein the digital therapy management system is linked with the medical institution terminal and the user terminal through at least one of an application service and an IoT-enabled web service via a smart terminal or an IoT terminal equipped in the medical institution terminal and the user terminal.
The identified limitations, under their broadest reasonable interpretation, cover performance of the limitations in the mind (including observation, evaluation, judgement or opinion) but for the recitation of generic computer components. That is, other than the terminal and database, nothing in the claim elements precludes the steps form practically being performed in the mind. For example, the identified limitations encompass a user (e.g., medical professional) collecting prescription information from a medical institution, evaluating said information (e.g., by reading or reviewing a document), and providing feedback information based on the evaluation. The claim limitations fall within the Mental Processes groupings of abstract ideas. Thus, the claimed invention recites a judicial exception.
Part I: Step 2A, prong two: additional elements that integrate the judicial exception into a practical application
Under step 2A, Prong Two of the Alice framework, the claims are analyzed to determine whether the claims recite additional elements that integrate the judicial exception into a practical application. In particular, the claims are evaluated to determine if there are additional elements or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claims are more than a drafting effort designed to monopolize the judicial exception.
This judicial exception is not integrated into a practical application. The terminal and database are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Dependent claims 2, 3, 5, 6, 8, 10,11, and 13-17, when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed to an abstract idea. For example, the dependent claims recites providing feedback information to adjust setting for a device, type of feedback information processing, such as questionnaire data, collecting data using the implementation manager.
Since these claims are directed to an abstract idea, the Office must determine whether the remaining limitations “do significantly more” than describe the abstract idea.
Part II. Determine whether any Element, or Combination, Amounts to“Significantly More” than the Abstract Idea itself
Under Part II, the steps of the claim, when considered individually and as an ordered combination, do not improve another technology or technical field, do not improve the functioning of the computer itself, and are not enough to qualify as "significantly more". For example, the steps require no more than a conventional computer to perform generic computer functions. As stated above, the terminal and database are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Therefore, based on the two-part Mayo analysis, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself. Claims 1-3, 5, 6, 8-11, and 13-17, when considered individually and as an ordered combination, are rejected as ineligible subject matter under 35 U.S.C. 101.
Dependent claims 2, 3, 5, 6, 8, 10,11, and 13-17, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional claims do no recite significantly more than an abstract idea.
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.
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/CHINYERE MPAMUGO/Primary Examiner, Art Unit 3685
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