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 .
Applicant filed a response dated 9/17/2025 in which claims 1, 3, 5, 7, 9-10, 11, and 18-19 have been amended, claims 16 and 20 have been canceled. Thus, the claims 1-15 and 17-19 are pending in the application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/17/2025 has been entered.
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 1-15 and 17-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of monitoring an opioid tapering treatment for a patient without significantly more.
Examiner has identified claim 1 as the representative claim that represent the invention described in independent claims 1, 10, and 19.
Claim 1 is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 recites a series of steps, e.g., a method for identifying tapering points in an opioid tapering treatment, using a mobile application, comprising the steps of: storing in a nonvolatile memory of a mobile device an application program configured to manage opioid tapering treatment; accessing the nonvolatile memory to upload application program into a processor of the mobile device and run the application; and programming the processor with the uploaded application program for: collecting data of at least one patient corresponding at least in part with the medication; de-identifying the collected data by removing or modifying at least one element regarded as protected health information associated with the patient and adding a unique encrypted user token to the de-identified data; generating an initial treatment plan for the patient based on processing of the tokenized de-identified data, wherein generating the initial treatment plan comprises merging the tokenized de-identified data with previously de-identified and tokenized healthcare data sets having the same unique encrypted user token; identifying tapering points based on opioid information of the patient on the treatment plan, wherein the tapering points include at least one physiological or psychological parameter associated with the patient; minimizing opioid dosage by adjusting the treatment plan based on the identified tapering points; generating a report comprising information associated with at least a set of probabilistic outcomes of the adjusted treatment plan; transmitting the generated report to a mobile device associated with a user; and generating an automatic call for alerting the user when the at least one physiological or psychological parameter associated with the patient deviates from a normal range. These limitations (with the exception of italicized limitations) describe the abstract idea of monitoring an opioid tapering treatment for a patient which corresponds to a certain method of organizing human activity and hence are abstract in nature. The additional elements of a mobile application, a nonvolatile memory of a mobile device, an application program, a mobile device (user’s), and automatic feature do not necessarily restrict the claim from reciting an abstract idea. Thus, the claim 1 recites an abstract idea (Step 2A, Prong 1: YES).
This judicial exception is not integrated into a practical application because the additional elements of a mobile application, a nonvolatile memory of a mobile device, an application program, a mobile device (user’s), and automatic feature result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a mobile application, a nonvolatile memory of a mobile device, an application program, a mobile device (user’s), and automatic feature are all recited at a high level of generality and under their broadest reasonable interpretation comprise a generic computer arrangement. The presence of a generic computer arrangement is nothing more than to implement the claimed invention (MPEP 2106.05(f)). Therefore, the recitations of additional elements do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 1 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of a mobile application, a nonvolatile memory of a mobile device, an application program, a mobile device (user’s), and automatic feature result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a mobile application, a nonvolatile memory of a mobile device, an application program, a mobile device (user’s), and automatic feature are all recited at a high level of generality in that it results in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these limitations provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 1 is not patent eligible.
Similar arguments can be extended to other independent claims 10 and 19 and hence the claims 8 and 15 are rejected on similar grounds as claim 1.
Dependent claims 2-9, 11-15, and 17-18 further define the abstract idea that is present in the independent claims 1, 10, and 19, thus correspond to a Certain Methods of Organizing Human Activity and hence are abstract in nature. Dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 2-9, 11-15, and 17-18 are directed to an abstract idea. Thus, the claims 1-15 and 17-19 are not patent eligible.
Response to Arguments
Examiner has withdrawn 35 U.S.C. 103 rejection of claims 1-20 in view of the argument/amendment.
Applicant's arguments filed dated 9/17/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-20 under 35 U.S.C. 101, Applicant states that under Step 2A: Prong One, the amended claim 1 is not directed to an abstract idea. Applicant states that the claimed method for monitoring an opioid tapering treatment for a patient does not fall under “Certain methods of organizing human activity” grouping of abstract ideas.
Examiner respectfully disagrees and notes that monitoring an opioid tapering treatment for a patient is clearly an abstract ideas as it is nothing more than an observation which can be done by an individual or health care professional treating the patient. The additional elements present in the claim do not restrict the claim from reciting an abstract idea. Thus, the claim recites an abstract idea.
With respect to Step 2A: Prong Two, Applicant states that there exists a technical problem in the field of opioid tapering monitoring, as existing systems fail to provide an automated solution for generating individualized and flexible treatment plans. The existing systems require a medically supervised inpatient or outpatient setting. Moreover, existing systems lack real-time monitoring of patient conditions, which is critical for ensuring effective and optimized treatment plans being provided to the patients.
Examiner respectfully disagrees and notes that the additional elements are simply applying the abstract idea without providing any technical improvements. If there is an improvement, it is to the abstract idea and not to technology. The improvement claimed are to the monitoring/supervising of a patient and providing an optimized treatment plans, which are abstract in nature. There is no technical solution to a technical problem. In fact, the specification does not define a technical problem to which a technical solution is needed. The specification discusses a need for an opioid tapering monitoring and the claimed invention provides a solution to the monitoring process by using additional elements (technology). However, in doing so, the additional elements provide an improvement to an abstract concept without offering any technical solution. Examiner interprets automated solution to be a mere automating a manual process which is not sufficient to integrate the abstract idea into a practical application.
With respect to Step 2B, Applicant states that the amended claim 1 describes de-identification and tokenization of patient data, wherein protected health information is removed or modified, and a unique encrypted user token is added to each record. Thus token is not merely a generic identifier; rather, it is cryptographically secure and allows the method to merge previously de-identified and tokenized healthcare data across sources while maintaining patient anonymity. This privacy-preserving architecture is not routine or conventional in typical mobile health systems, which often rely on direct patient identifiers or static tokens. The implementation of a secure, token-based, cross-dataset merging process solves a specific technical challenge- how to safely reuse patient data in compliance with privacy standards-thereby providing significantly more than a mere abstract concept.
Examiner respectfully disagrees and notes that under Step 2B, the claim does not present an inventive concept as limitations are abstract in nature and the additional elements are recited at a high level of generality in that it amounts to simply applying the abstract idea without amounting to add significantly more. The privacy-preserving architecture is not an inventive concept as the claim simply makes use of existing technology and applies it to the claimed invention. By doing so, the claims remain abstract and the additional elements do not amount to add significantly more. Thus, these arguments are not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684