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’s amendments dated 8/11/25 are hereby 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, 3, 6-20, and 25-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 3, 6-20, and 25-26 are directed to an abstract idea without significantly more. The claims recite a mental process that can be performed by human being and/or recite a method of organizing human activity and/or mathematical concepts.
In regard to Claims 1, 19, and 26, the following limitations can be performed as a mental process by a human being in terms of claiming collecting data, analyzing that data, and providing outputs based on that analysis which has been held by the CAFC to be an abstract idea in decisions such as, e.g., Electric Power Group, University of Florida Research Foundation, and Yousician v Ubisoft (non-precedential); and/or recite a method of organizing human activity in terms of claiming the teaching/training/evaluation of a human subject’s which has been identified by MPEP 2106.04(a)(2)(II) as being a method of organizing human activity; and/or claim mathematical concepts as outlined at MPEP 2106.04(a)(2)(I), in terms of the Applicant claiming in regard to Claims 1, 19, and 26:
[a] method for monitoring a therapeutic treatment, comprising:
receiving […] a selection of a program including a medication regimen indicating a dosage and a timing of ingestion of a medication by a user;
receiving [data regarding] a concentration of an analyte affected by the medication ingested by the user as a part of the program including the medication regimen; and
determining […] that the user has not complied with the medication regimen of the program […] based at least in part on
evaluating a continuous analyte curve to identify a plurality of curve features included in the continuous analyte curve, the plurality of curve features comprising an analyte curve rise, an analyte curve plateau, or an analyte curve fall, the continuous analyte curve corresponding to the signal and indicating the concentration of the analyte as a function of time; and
comparing the plurality of curve features to one or more curve features of a characteristic signature indicating a known decrease in a concentration of the analyte resulting from ingestion of the medication according to the dosage and the timing of the medication regimen;
receiving […] data about other users having a profile similar to the user;
modifying the program…having a profile similar to the user…medication; and
displaying an output responsive to the determining.
In regard to the dependent claims, they also claim an abstract idea to the extent that they merely claim further limitations that likewise could be performed as a mental process by a human being and/or recite a method of organizing human activity and/or mathematical concepts.
Furthermore, this judicial exception is not integrated into a practical application because to the extent that additional elements are claimed either alone or in combination such as, e.g., a software application, a monitoring device, employing software that executes in “real time”, employing a sensor or sensors to continuously monitor levels of chemicals and/or analytes in real-time, and/or employing cloud-based data, these are merely claimed to add insignificant extra-solution activity to the judicial exception (e.g., data gathering), to embody the abstract idea on a general purpose computer, and/or do no more than generally link the use of a judicial exception to a particular technological environment or field of use.
Furthermore, the claims do not include additional elements that taken individually, and also taken as an ordered combination, are sufficient to amount to significantly more than the judicial exception because to the extent that, e.g., a software application, a monitoring device, employing software that executes in “real time”, employing a sensor or sensors to continuously monitor levels of chemicals and/or analytes in real-time, and/or employing cloud-based data, these are generic, well-known, and conventional elements and are claimed for the generic, well-known, and conventional functions of collecting and processing data and/or providing an analysis/outputs based on that processing. To the extent that an apparatus is claimed as an additional element said apparatus fails to qualify as a “particular machine” to the extent that it is claimed generally, merely implements the steps of Applicant’s claimed method, and is claimed merely for purposes of extra-solution activity or field of use. See MPEP 2106.05(b). As evidence that these additional elements are generic, well-known, and conventional, Applicant’s specification discloses the support for these elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a). See, e.g., F2 in Applicant’s specification and text regarding same.
Response to Arguments
Applicant’s arguments are largely duplicative of the arguments made in its prior Remarks dated 4/2/25, which were addressed in the Office’s Response dated 5/14/25, which is herein incorporated by reference.
Applicant argues on page 9 of its Remarks in regard to the rejections made under 35 USC 101:
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Applicant’s arguments are not persuasive because efficiency gains made by embodying an otherwise abstract idea as a computer program do not render patent eligible subject matter. See the CAFC’s opinion in, e.g., Bancorp Service v Sun Life, slip. op., pages 20-21 in this regard (“As in Bilski, the claims do not effect a transformation, and the fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.”)
Applicant argues on page 12 of its Remarks in regard to the rejections made under 35 USC 101:
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Applicant argues that it has claimed a “practical application”. Applicant’s argument is not persuasive. “Practical application” is not part of the Mayo test but is, instead, a burden placed on examiners when they are making a 101 rejection employing the Mayo test. Simply invoking “practical application” but without citing specific legal authority in support of Applicant’s argument that it has claimed patent eligible subject matter under the two-part Mayo test, therefore, does not provide a proper basis or rationale as to why the 101 rejection being made is allegedly deficient. Furthermore, providing some differential visual output on a computer screen based on the analysis of collected sensor data has been held by the CAFC to be patent ineligible in decisions such as, e.g., Electric Power Group, University of Florida Research Foundation, and Yousician (non-precedential).
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 extension fee 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 Mike Grant whose telephone number is 571-270-1545. The Examiner can normally be reached on Monday through Friday between 8:00 a.m. and 5:00 p.m., except on the first Friday of each bi-week.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisory Primary Examiner, Peter Vasat can be reached at 571-270-7625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL C GRANT/Primary Examiner, Art Unit 3715
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