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 .
DETAILED ACTION
Status of the Application
Claims 1, 4-7, 9-10, 13-14, and 41-51 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendments to the Claims and the Remarks filed on 09/19/2025.
Claims 1, 41-42, and 51 have been amended.
Claims 2-3, 8, 11-12, and 15-40 are canceled and not considered at this time.
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, 4-7, 9-10, 13-14, and 41-51 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1, 4-7, 9-10, 13-14, and 41 fall within the statutory category of a process. Claims 42-51 fall within the statutory category of a system.
Step 2A, Prong One
As per Claims 1 and 42, the limitations of collecting data values in response to interactions by the user with the one or more interactive GUI elements, determining an intervention engagement metric for achieving improvement in a cardiometabolic disorder in a timeline based on comparing the data values collected from the user device with one or more pre-stored parameters or one or more pre-stored data values corresponding to the improvement in the cardiometabolic disorder, determining the user not satisfied a medication adjustment threshold for achieving the improvement in the cardiometabolic disorder in the timeline based on the intervention engagement metric, identifying a treatment regime for a digital therapeutic for achieving the improvement in the cardiometabolic disorder in the user in need thereof, wherein the treatment regimen comprises a recommendation or explanation of behavioral actions that are predictive of success in achieving the improvement in the cardiometabolic disorder in response to determining the user has not satisfied the medication adjustment threshold, and administering the digital therapeutic according to the identified treatment regime by presenting the digital therapeutic administered to the patient, under its broadest reasonable interpretation, covers managing personal interactions or personal behaviors as an interaction of treating a patient with a disorder. The steps are those taken by a care provider in the treatment of a patient of giving a patient a task, analyzing the patient data from the task, determine the patient has reached a goal level, identifying a treatment regime which a recommendation or explanation of behavioral actions to achieve improvement in the disorder in response to the user not having satisfied a threshold, and administering the digital therapeutic according to the treatment regime. If a claim limitation, under its broadest reasonable interpretation, covers management of personal interactions or personal behavior but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claims recite the additional element – processors coupled with memory for implementing the method. The processors in these steps is 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. The claims also recite a graphical user interface for presenting interactive graphical user interface elements to implement the abstract idea including prompting a user to perform tasks. Presenting elements on a graphical user interface is use of the interface for its ordinary capacity, which as per MPEP 2106.05(f)(2) amounts to mere instructions to apply the exception. 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. Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional element of processors coupled to a memory to perform the method of the invention and a graphical user interface for presenting interactive graphical user interface elements amounts to no more than mere instructions to apply the exception using a generic computing component. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims
Dependent Claims 4-7, 9-10, 13-14, 41, and 43-51 add further limitations which are also directed to an abstract idea. Claims 4-5, 7, 43-44, and 46 further limit or specify the data of Claims 1 and 42 and therefore merely further limit the same abstract idea and are directed to certain methods of organizing human activity for the same reasons as the independent claims. Claims 6 and 45 include a multi-factorial weighted analysis or machine learning performed by an operations server. The use of either a weighted analysis or machine learning is use of a mathematical algorithm to execute the abstract idea, which amounts to mere instructions to apply the exception, as per MPEP 2106.05(f)(2). Claims 9-10 and 47-48 include receiving patient data, storing the patient data in a record, and transmitting the data to a patient which is merely data exchange which falls into the category of certain methods of organizing human activity, similar to the independent claims. Claims 13-14 and 49-50 include communicating user data which falls into the grouping of certain methods of organizing human activity. The claims also include the use of an EMR server, networks, consumer devices, and retrieving data from a database which are all mere instructions to apply the exception for using general purpose computing components to carry out the abstract idea. Claims 41 and 51 include a description of the GUI elements and the tasks to be performed by the user which only serves to further limit the abstract idea and is therefore directed to the same abstract idea as the independent claims. The digital therapy is not recited as a particular therapy because it claims one or more tasks related to a diet routine or an exercise routine, which does not specify a particular treatment for the user. Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
Response to Arguments
Applicant’s arguments, see Pages 8-11, “Claim Rejections - 35 U.S.C. §101”, filed 09/19/2025 with respect to claims 1, 4-7, 9-10, 13-14, and 41-51 have been fully considered but they are not persuasive.
Applicant argues that the claims of the present application are not directed to a judicial exception. Applicant argues that the claims do not recite a mental process because it contains limitations which could not be performed in the human mind. Specifically, Applicant argues that collecting data values in response to interactions by a user with one or more interactive graphical user interface elements and administering the digital therapeutic according to the identified treatment regime by causing the user device to present one or more other interactive GUI elements of the digital therapeutic administered to the user are not activities that are able to be performed in the human mind. Examiner notes that the claims are rejected as being directed to certain methods of organizing human activity and not categorized as a mental process. Therefore, the arguments with regard to the claims being directed to a mental process are moot. Applicant argues that the claims are not directed to any method of organizing human activity because the claim is directed to specific technical features including interactive GUI elements, identifying treatment regime for achieving improvement in a cardiometabolic disorder, and administering the digital therapeutic according to the identified regime. Examiner respectfully disagrees. The GUI elements are additional elements which are mere instructions to apply the exception and not directed to the abstract idea itself. The step of identifying treatment regime for achieving improvement in a cardiometabolic disorder is activity which is performed as a routine part of a physician treating a patient and therefore is managing personal behavior or personal interactions and falls into the abstract grouping of certain methods of organizing human activity. The step of administering the digital therapeutic according to the identified treatment regime, where the identified treatment regime comprises a recommendation or explanation of behavioral actions of behavioral actions that are predictive of success in achieving the improvement, is the act of giving a digital therapeutic to a patient based on a recommendation which is also a routine part of a physician treating a patient and therefore is managing personal behavior or personal interactions and falls into the abstract grouping of certain methods of organizing human activity. Therefore, the claims are directed to an abstract idea.
Applicant argues that the claims apply or use a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Examiner notes that although the claims use the words administering a digital therapeutic are recited in the claims, whether or not this limitation constitutes administration of a particular treatment is based on more than stating administration of a therapy. As per MPEP 2106.04(d)(2), determining a claim applies or uses a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition considers the particularity of the treatment or prophylaxis. The treatment must be specifically identified so that it does not encompass all applications of the judicial exception. The present claim merely recites “the digital therapeutic according to the identified treatment regime”. The treatment regime is a recommendation or explanation of behavioral actions, which does not specifically identify the digital therapeutic. The digital therapeutic can be any therapy provided to the user which is based on a recommendation or explanation of behavioral actions. This could be any of a multitude of specific treatments and therefore is not particular. Therefore, the rejection is maintained.
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 Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682