DETAILED ACTION
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/29/2026 has been entered.
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Non-Final Office Action is in Reply to the amendment/request for continued examination (hereinafter “Response”) dated 07/29/2026. Claim(s) 1-4 and 8-13 are presently pending. Claim(s) 1 is/are amended. Claim(s) 5-7 is/have been cancelled.
Response to Amendment
The rejection of claim(s) 1-3, 5-6, and 10-13 under 35 U.S.C. 103 as being unpatentable over Dilanni (WO2006/104806A2) in view of Yang (CN108261585A), Guerrini (U.S. Pat. Pub. No. 20 16/0089494 A l), Grosman (U.S. Pat. Pub. No. 2019/0321553 Al), Bengtsson (U.S. Pat. Pub. No. 20 19/0228853 Al), and Haidar (U.S. Pat. Pub. No. 2020/01l97605 A l), of claim(s) 4 under 35 U.S.C. 103 as being unpatentable over Dilanni as modified by Yang, Guerrini, Grosman, Bengtsson, and Haidar according to claim 3, and in further view of Mahoney (U.S. Pat. Pub. No. 2003/0199824 Al), and of claim(s) 8-9 under 35 U.S.C. 103 as being unpatentable over Dilanni as modified by Yang, Guerrini, Grosman, Bengtsson, and Haidar according to claim 1, and in further view of Scherb (WO2013023014A) are each withdrawn in light of the applicant(s) amendments to claim 1, wherein applicant has incorporated newly claimed/narrowed subject matter.
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 “a manual input interface and an automatic detection sub-module” 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.
Claims 1-4 and 8-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, amended claim 1 now recites the limitation “wherein the insulin dose infused per day by users includes a bolus and basal data infused in different time periods, a temporary basal data and a correction bolus data, and an infusion data after different events”, this limitation being linked to the prior limitation “wherein the program module obtains an insulin dose infused per day by users, the insulin dose infused per day by users includes a total amount of daily infusion dose data.” The newly added limitation requires that the insulin dose infused per day by users, which is input to or detected by the program module of the claimed invention, must include each of these listed forms of insulin infusion data entry. Such 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention, since nowhere in the specification is it stated or suggested that the insulin dose infused per day by users may include all of the listed forms of insulin infusion data entry. Rather, Pg. 2, lines 22-24 and Pg. 6, lines 11-16 of the specification state that “the insulin dose infused per day by users includes the total amount of daily infusion dose data, or the bolus and basal data infused in different time periods, or the temporary basal data and the correction bolus data, or the infusion data after different events.” Here, the applicant(s) use of the term “or” between options and the lack of any statement within these passages or the remainder of the specification which suggests that all or multiple forms of insulin infusion data entry may be included in the insulin dose infused per day by users negates any potential interpretation of the specification as describing such a configuration as in now claimed. Appropriate correction or cancelation are required. Claims 2-4 and 8-13 present the same issue by virtue of dependence upon claim 1.
Amended claim 1 also comprises the limitation “wherein data automatically detected and manually input are combined and compared to make the program module adjust the total daily dose algorithm in real time.” While the phrasing of this limitation is recited more or less verbatim within the specification, the concept expressed by the phrasing was not explained 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. First, it is unclear what exactly is meant by the phrase “combined and compared” within the context of automatically detected and manually input sources of the same types of data (see below rejection under 35 U.S.C. 112(b) for deeper discussion). Second, the applicant does not sufficiently identify how this claimed function (data combination/comparison and algorithm update) is performed by identifying any elements/steps necessary to achieve the claimed function. For example, description of the manner in which manually collected and automatically collected data are combined (merged into a single data set, or merely collated along a joint timeline) or compared (compared against each other, compared against an expected or prior known injection schedule, etc.), as well as details of how the total daily dose algorithm is updated (back-filling of data, frequency of update, handling of potential outlier/noise data entries, etc.) are all lacking in the present specification. Thus, the applicant has failed to provide any evidence beyond the mere statement of concept (which is itself unclear) to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, that they had possession of the claimed invention. Appropriate correction or cancelation are required. Claims 2-4 and 8-13 present the same issue by virtue of dependence upon claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-4 and 8-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 comprises the limitation “wherein data automatically detected and manually input are combined and compared to make the program module adjust the total daily dose algorithm in real time.” This limitation renders the claim indefinite, since it is unclear how insulin dose infusion data from two different sources (manual input and automatic detection) can be both combined and compared, and it is further unclear what the term “compared” refers to in this context. The term “combined” is commonly understood to mean “to bring into such close relationship as to obscure individual characters: merge” or “to unite into a single number or expression” (Merriam-Webster). The definition of the term as used in the field of data handling and algorithmic logic is similar – to merge/adjoin data sets into a single data set. Once a data set has been merged with another data set, however, it is unclear how the originally separate data sets may then be compared against each other. Thus, if the phrase “combined and compared” refers to the two data sets of manually entered and automatically detected data being joined and compared against each other, a contradiction exists within the limitation that renders the scope of the claim impossible to determine. If the phrase “combined and compared” is intended to refer to the data sets being combined (adjoined/merged) and compared against some other standard of comparison (such as the previously collected insulin infusion historical data, previously calculated total daily dose, or an expected theoretical trend), the claim limitation is likewise unclear, since no explanation is given within the claim as to what the combined data set is being compared against. The specification provides no additional insight to either of these identified issues, stating merely that “the data automatically detected and manually input can be combined and compared to make the program module adjust the algorithm in real time, helping to make the calculation result more accurate.” Thus, in either case, the scope of the claim is rendered indefinite and impossible to interpret due to contradictory phrasing or incomplete identification of the standard of comparison invoked by the term “compared.” Appropriate clarification or correction is required. Claims 2-4 and 8-13 are also rendered indefinite due to their dependence upon claim 1. Because the scope of these claims are also rendered indefinite and uninterpretable due to the above described issues, the claims are not presently examined in view of the prior art. Such should not, however, be taken as an indication of allowability.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. This art includes
Haidar (U.S. Pat. Pub. No. 2020/0197605 A1) exhibits a closed-loop artificial pancreas of the type claimed, which may comprise a manual input interface (input devices 36 of UI 20) allowing users to input dosing information manually for purposes such as initializing the insulin infusion algorithm ([0028-0030]), as well an automatic detection sub-module for automatically detecting insulin infusion data during operation (evidenced by the fact that the controller stores such data in memory, and that the algorithm compares the present proposed insulin dose against limits on insulin delivery by calculating a total daily dose (TDD) and total basal insulin dose (TDB) based on automatically detected infusion data – see [0029] and [0097]).
Schaible (U.S. Pat. Pub. No. 2016/0082187 A1) exhibits a closed-loop artificial pancreas of the type claimed, which may comprise a manual input interface (230) allowing users to input dosing information manually, allowing users to establish an initial basal profile for the control algorithm, to input/distinguish bolus events in addition to basal rate, and to designate certain bolus infusion events as pre-meal bolus (Abstract, [0048] and [0073-0075]). The algorithm then automatically measures and stores historical data of insulin delivery to the patient, compares this information against the user-supplied profile and bolus data, and makes appropriate adjustments to the basal profile (see Abstract, [0008-0022], [0048-0055] and [0073-0077]).
Mazlish (U.S. Pat. Pub. No. 2018/0200435 A1) exhibits a method of adjusting the insulin dose administered by an automated (closed-loop) artificial pancreas of the type claimed, wherein a user may input one or more dosage parameters via a user interface 220, whereupon the closed-loop insulin infusion algorithm may be updated in view of the user supplied dosage parameters ([0060-0061], [0133], and [0196]), and wherein the control circuitry of the artificial pancreas may automatically detect and store insulin infusion/pump usage data as historical data [0061], ln 12-24).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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