DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment to the claims filed 18 May 2026 has been entered. Claim(s) 61 and 70 is/are currently amended. Claim(s) 1-60, 67-69 and 76-78 has/have been canceled. Claim(s) 61-66 and 70-75 is/are pending.
Rejections Withdrawn
Rejections 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Objections
Claim(s) 61 and 70 is/are objected to because of the following informalities: abbreviations (e.g., "HCP") should be defined in the claim.
Appropriate correction is required.
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.
Claim(s) 61-66 and 70-75 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 61-66 and 70-75 recite the steps of identifying potential rate-of-change episodes extending between a start point and an end point and having a rate of change in analyte value over time above a threshold rate of change for a duration threshold; determining if the time between episodes is less than a time/distance threshold; merging episodes that are sufficiently close together in time; redefining merged episodes if a minimum and/or maximum value occurs before the start point of the merged episode and/or occurs after the end point of the merged episode; comparing the redefined episode to the rate of change and duration thresholds; and determining recommended medication adjustments based on redefined merged episodes.
These limitations, as drafted, are a process that, under their BRI, covers performance of the limitations in the mind but for the recitation of generic computer components. That is nothing in the claim elements preclude the steps from practically being performed in the mind. For example, identifying potential episodes can be mentally and/or manually performed by a user upon visual inspection of an analyte data (e.g., graph, trace, etc.), i.e., judging the start and end point of periods of rapidly changing analyte levels. Merging episodes encompasses the user deciding that adjacent periods/episodes should be combined if they are sufficiently close in time, i.e., within a threshold amount of time. Redefining a merged episode encompasses the user again mentally re-evaluating the episode to ensure the correct start and end points are assigned as the start and end points. Comparing the redefined episode encompasses the user mentally assessing whether the redefined episode still meets his/her rate-of-change episode criteria, such as a minimum rate of change and duration. Lastly, determining a recommended medication adjustment based on the redefined merged single rate-of-change episode encompasses the user mentally considering the episode, or aspect thereof, to form a judgment about future treatment/medication. If claim limitations, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer components (where present), then they fall within the "mental processes" grouping of abstract ideas. Accordingly, claims 61-66 and 70-75 recite an abstract idea.
This judicial exception is not integrated into a practical application. The claims recite the additional elements of establishing a communication link with a generic analyte monitoring device, such as a partially-implanted continuous glucose monitor; receiving analyte measurement data via the communication link, storing the identified episodes in memory, limiting the type of analyte data to glucose or ketone body data, and a generic input (e.g., communication unit) for said receiving and a generic computer component (computer, processor(s)) configured to perform the steps of the abstract idea.
The steps of establishing a communication link with a generic analyte monitoring device, such as a CGM having a sensor at least partially implanted and receiving analyte measurement data via the communication link amount to mere data gathering necessary to perform the abstract idea, and is comparable to concepts identified by the courts as insignificant extra-solution activity (see MPEP 2106.05(g), performing clinical tests on individuals to obtain input for an equation, determining the level of a biomarker in blood, etc.). The steps of storing identified episodes in memory and generically displaying a recommended medication adjustment on a user interface amount to an insignificant application and/or necessary outputting of the results of performing the abstract idea, and is comparable to concepts identified by the courts as insignificant extra-solution activity (see MPEP 2106.05(g), printing or downloading generated menus, etc.). Limiting the abstract idea to glucose and/or ketone body data is comparable to limitations described by the courts as merely indicating a field of use or technological environment in which to apply a judicial exception (see MPEP 2106.05(h), example vi). The processor, communication unit and user interface are recited at a high-level of generality (i.e., as a generic means for a computer to receive data, process said data (e.g., comparing a change in glucose to a threshold(s), accessing and reading a look-up table with medication recommendations, etc.), and generically output results), such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, claims 61-66 and 70-75 are directed to an abstract idea.
The pending claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a communication unit, a processor and a user interface to perform receiving the analyte data and remaining steps of the abstract amounts to no more than mere instructions to apply the exception using a generic computer component(s). Additionally, the steps of establishing a communication link, receiving data over said link, and storing data analysis results are comparable to concepts recognized by the courts as well‐understood, routine, and conventional computer functions when they are claimed in a merely generic manner (e.g., at a high level of generality) (see, MPEP 2106.05(d)(II), receiving or transmitting data over a network, storing and retrieving information in memory, etc.). Further, there is sufficient evidence that receiving analyte measurement data of a sensor representing analyte measurement data collected continuously over a time period wherein the sensor is partially implanted is well-understood, routine and/or conventional in the field. For example, Olczuk et al. ("A history of continuous glucose monitors (CGMs) in self-monitoring of diabetes mellitus") discloses CGMs having subcutaneous sensors and the ability to report real-time glucose values and trends were commercially available before the effective filing date of the present application (pg. 184, wherein at least one CGM system from Medtronic, Dexcom, etc. were released or commercially available in 1999, 2006, etc.).
Even when considered in combination, the limitations of the pending claims merely require the use of software to tailor analyte (e.g., glucose or ketone body) information to a user (e.g., patient), provide the tailored information to a user (e.g., HCP) and store it using a generic computer, similar to concepts identified by the courts as mere instructions to apply an exception. See MPEP 2106.05(f) (e.g., "Requiring the use of software to tailor information and provide it to the user on a generic computer"). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept; simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception; adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with an abstract idea so that the information can be analyzed by an abstract mental process; and/or generally linking the use of the judicial exception to a particular technological environment or field of use cannot provide an inventive concept. See MPEP 2106.05(A). Therefore, claims 61-66 and 70-75 are not patent eligible.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to eligibility under 35 U.S.C. 101, Applicant contends, "As discussed with the Examiner, Applicants respectfully assert that the claims as amended recite causing display of a recommended medication treatment that does not encompass all applications of the judicial exception. […] Thus, because the claims are tied to a practical application and not an abstract idea, the claims are patentable subject matter under prong II of Step 2A," with Applicant comparing the above-noted display of a recommended medication adjustment to limitations that effect a particular treatment in MPEP 2106.04(d)(2)(a) (Remarks, pg. 7).
The examiner respectfully disagrees. Unlike the limitation(s) that was found to integrate a mental analysis step into a practical application cited by Applicant in MPEP 2106.04(d)(2), the displaying limitation of the pending claims does not effect a particular treatment. As noted MPEP 2106.04(d)(2), "the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition." In the present case, it does not. Merely displaying a recommendation does not effect a treatment. This is expressly acknowledged by Applicant (e.g., ¶ [0004] recommendations are optional and not required to be implemented by a user). Further, assuming arguendo that the limitation does effect a treatment, which the examiner does not concede, said treatment is not "particular." Rather, the recommendation is instead merely instructions and/or a suggestion to apply the exception in a generic way comparable to the example limitation "administering a suitable medication to a patient" in MPEP 2106.04(d)(2)(a). Thus, the displaying step does not integrate the mental analysis step into a practical application.
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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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