DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
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paid, the finality of the previous Office action (mailed 24 September 2025, hereinafter "3rd Final Rejection") has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 March 2026 has been entered.
Status of Claims
Claim(s) 1, 11 and 21 is/are currently amended. Claim(s) 6-10, 16-20, 22-23 and 25-26 has/have been canceled. New claim(s) 27-28 has/have been added. Claim(s) 1-5, 11-15, 21, 24 and 27-28 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) presented in the 3rd Final Rejection, but not reproduced below, have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the claimed method of/means for causing a request for confirmation of the potential external event to be displayed to the user must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as "amended." If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet" pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 28 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 28 and claims dependent thereon, the limitation "wherein the input comprises adjusting event information of the potential external event, adjusting the time period of the potential external event, or both" lacks sufficient support in the application as filed. Applicant discloses:
[0071] Whenever historical glucose data is available to the system, and when the event estimator previously described estimates the presence of an event, a status icon (e.g. a question mark icon, or icons that represent the most likely event as estimated by the estimator) may appear in the main menu in the handheld display. Alternatively, an LED or the strip port could light up in a special color to attract the user's attention or the device could present an auditory and/or vibratory alert to the user that a potential event has been detected. The event estimator could be designed to present estimates to the user for review when requested by the user (e.g., when the feature is selected by the patient from the device UI) or the event estimator could be part of, and run from, a separate PC-based data management system. Should the user choose to respond by tapping on the on-screen icon or an alternate softkey, then a brief question could be provided, in which the user can confirm by choosing yes or no. For example, a query "Tap if you had breakfast around 8: 15am" accompanied by a historical glucose graph, could appear on screen. Tapping the screen confirms the event; sliding the screen allows for adjustment; ignoring the menu item after a pre-determined time removes the query.
Applicant broadly discloses sliding the screen in response to a displayed query "allows for adjustment." However, there is no disclosure as to what is being adjusted, or more particularly that said adjustment comprises and/or encompasses "adjusting event information of the potential external event" and/or "adjusting the time period of the potential external event" as required by claim 28. Accordingly, the above-noted limitation encompasses new matter.
Allowable Subject Matter
Claim(s) 1-5, 11-15, 21, 24 and 27 is/are allowed.
Mault (previously cited, US 2003/0208113 A1) discloses, "If blood glucose levels deviate from that predicted by models, then the person can be prompted by the PDA to enter any meals perhaps accidentally omitted" (¶ [0142]). Mault does not disclose the method/means by which the user is prompted. In particular, Mault does not disclose/suggest displaying, on a display device, a status icon indicative of the potential external event, and upon selection of the status icon, presenting a query on the display device requesting an input to confirm that the potential external event occurred during a time period.
Kamen (previously cited, US 2010/0185175 A1) similarly discloses, "In some embodiments, where there is an unexpected result, the user may have the opportunity to explain the aberration/unexpected result. For example, if a patient intended to eat a meal, and input this information into the system, but failed to eat, e.g., changed their mind or forgot, the system, in reviewing the blood glucose readings, may see that the patient's blood glucose levels have not risen, as would be expected, thus, this may qualify as an aberration from the expected. The system may alert the patient of an aberration, and the patient may input (thru a menu or other) that the intended meal did not take place" (¶ [0152]); and further discloses, "where the user fails to input the event into the system, the system itself may recognize the pattern and prompt the user with a question, e.g., 'are you eating?'" (¶ [0147]). Accordingly, while Kamen discloses presenting a query on a display device requesting an input to confirm that a potential external event (e.g., eating, a meal, etc.) has occurred and/or is occurring, Kamen does not disclose displaying, on a display device, a status icon indicative of the potential external event, and upon selection of the status icon, presenting a query on the display device requesting an input to confirm that the potential external event occurred during a time period.
Stephens (US 2010/0041084 A1) discloses querying a user to select one of a predetermined plurality of flags in response to an analyte measurement being outside a predetermined range (e.g., ¶ [0046]), wherein the querying comprises displaying a selectable icon (e.g., ¶ [0019]). Stephens does not disclose displaying, on a display device, a status icon indicative of a potential external event, and upon selection of the status icon, presenting a query on the display device requesting an input to confirm that the potential external event occurred during a time period.
In view of the above, the prior art of record fails to disclose and/or suggest a method (or processor configured by instructions to perform said method) comprising, in combination with the remaining recited steps, causing, by a processor, a request for confirmation of the potential external event to be displayed to the user, wherein the causing the request for confirmation comprises displaying, on a display device, a status icon indicative of the potential external event, and upon selection of the status icon, presenting a query on the display device requesting an input to confirm that the potential external event occurred during a time period.
Response to Arguments
Applicant's arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791