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 examiner acknowledges the reply filed on 04/30/2026 in which claims 1, 3, 11, 13, and 20, were amended. Currently, claims 1-20 are pending for examination in this application.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 04/30/2026, has been considered by the examiner.
Response to Arguments
Applicant's arguments, filed 04/30/2026, have been fully considered but they are not persuasive. Applicant’s representative asserts that the prior art of record does not disclose the invention as claimed.
The examiner has fully considered the applicant’s arguments but they are not persuasive. It is the examiner’s position that given a careful reading, the claims do not distinguish over the prior art of record.
With regards to the amended claim language of independent claims 1, 11, and 20, applicant’s representative asserts the prior art to Ginsburg fails to teach “monitoring the glucose data following the insulin delivery over a time period and analyzing a metabolic response of the host, and adaptively updating an insulin sensitivity of the host based, at least in part, on the metabolic response.” The examiner respectively disagrees. Specifically, applicant’s representative’s arguments rely on applying narrow definitions to terms (“monitoring,” “adaptively,” “metabolic response,” etc.) within the amended claim language which are not supported by the currently recited claim limitations. Although applicant’s specification contains many explicit definitions for various terms (paragraphs [0160]-[0183]), the terms/limitations relied upon within applicant’s representative’s arguments are not defined. Lacking any explicit definitions for terms within applicant’s specification or further limitations within the claim language, the examiner is required to provide the claims with the broadest reasonable interpretation in light of the specification.
As best understood by the examiner, applicant’s representative appears to be making the argument that the amended claim language of “monitoring the glucose data following the insulin delivery over a time period” requires a continuous collection of glucose data. This is simply not required by the currently recited claim limitations. As currently worded, even “monitoring” a single data point of glucose data following insulin delivery (“blood glucose at the end of the period”) would satisfy this limitation. Furthermore, applicant’s representative argues Ginsberg fails to teach “adaptively updating an insulin sensitivity of the host based, at least in part, on the metabolic response.” The examiner respectfully disagrees. Once again, applicant’s representative’s arguments rely on a narrowed definition for the term “adaptively.” Yet again, lacking any explicit definition within applicant’s specification or further limitations within the claim language, any change to the determined insulin sensitivity can be determined to be “adaptively” updated. Additionally, as the change insulin sensitivity, as taught by Ginsberg, is based on a change in glucose data, said change can be deemed to be based on a “metabolic response.” Given this, applicant’s representative’s arguments are unconvincing.
In light of the remarks and standing rejection above, the examiner asserts the prior art of record teaches all elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
Claim Objections
Claims 7 and 17 are objected to because of the following informalities: The claims recite the limitation of “the insulin pump.” There is a lack of antecedent basis for these limitations in the claims. The limitations should be amended to recite “an insulin pump.” Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Ginsberg (PGPub 2005/0192494).
[Claims 1, 10, 11, and 20] Ginsberg teaches a system and method (figure 2, item 50), comprising at least a memory (figure 2, item 54) and a processor (figure 2, item 52) (paragraphs [0032], [0033]) to perform operations comprising:
receiving, via one or more communication links, glucose data (“blood glucose readings”) of a host from a glucose monitor/continuous glucose monitor (figure 2, items 60/62/64) worn by a host (paragraphs [0013], [0034], [0037]-[0042]) and
insulin therapy data (“amount of insulin administered”) indicative of insulin delivered to the host (paragraphs [0013], [0034], [0037]-[0042]);
determining an updated insulin sensitivity (“insulin sensitivity factor”/”ISF”) of the host by analyzing the glucose data (“blood glucose readings”) and the insulin therapy data (“amount of insulin administered”), wherein determining the updated insulin sensitivity (“insulin sensitivity factor”/”ISF”) comprises monitoring the glucose data (“blood glucose readings”) following the insulin delivery over a time period and analyzing a metabolic response of the host, and adaptively updating an insulin sensitivity of the host based, at least in part, on the metabolic response; (paragraphs [0011], [0013], [0030], [0048], [0049]); and
adjusting a subsequent insulin dose (“insulin dosage recommendation”) for the host based at least in part on the updated insulin sensitivity of the host (paragraphs [0013], [0030], [0032], [0052], [0055]).
[Claims 2 and 12] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 2 and 12 depend. In addition, Ginsberg discloses wherein the determining the insulin sensitivity (“insulin sensitivity factor”/”ISF”) further comprises monitoring the glucose data to determine a metabolic response of the host to the insulin delivered to the host (Although Ginsberg discloses the ISF’s can be determined values which differ temporally, the examiner notes the term “monitoring” could be applied to the collection of a mere plurality of data points) (paragraph [0053]).
[Claims 3 and 13] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 3 and 13 depend. Ginsberg also discloses predicting glucose values (“target glucose values”) of the host based on the updated insulin sensitivity of the host, the glucose data, and the insulin therapy, wherein adjusting the subsequent insulin dose for the host is based, at least in part, on the predicted glucose values. (paragraphs [0007], [0009], [0030], [0064]).
[Claims 4-6 and 14-16] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 4-6 and 14-16 depend. Ginsberg also teaches
receiving meal information from the host, wherein the insulin dose for the host is adjusted based at least in part on the meal information (paragraphs [0013], [0039], [0042]);
wherein the meal information comprises an amount of carbohydrates consumed by the host (paragraphs [0039], [0042]); and
wherein the meal information is received via user input to a user interface displayed by a computing device (paragraph [0042]).
[Claims 7 and 17] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 7 and 17 depend. In addition, Ginsburg discloses causing the insulin pump to deliver the adjusted insulin dose to the host (“The insulin administration data can be provided automatically (e.g., the device 62 with sensor 64 is an insulin pump or medication delivery pen with automated output feature)”) (paragraphs [0030], [0034], [0042], [0055]).
[Claims 8, 9, 18, and 19] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 8, 9, 18, and 19, depend. Ginsburg also teaches wherein the adjusting comprises adjusting a bolus or basal insulin dose for the host based on the insulin sensitivity of the host (Ginsburg teaches the calculated insulin sensitivity values, and thus the determined adjusted insulin doses, can be determined for various temporal periods; as such, said adjustments could be termed as meeting a temporary (bolus) or continuous (basal) insulin requirement) (figure 3; paragraphs [0043], [0053]).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 07/06/2026
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