Prosecution Insights
Last updated: April 19, 2026
Application No. 18/289,294

INSULIN ON BOARD FOR GLUCOSE SENSITIVE INSULIN

Non-Final OA §102
Filed
Nov 02, 2023
Examiner
SHAH, NILAY J
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Novo Nordisk A/S
OA Round
1 (Non-Final)
77%
Grant Probability
Favorable
1-2
OA Rounds
3y 3m
To Grant
99%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allow Rate
439 granted / 571 resolved
+6.9% vs TC avg
Strong +47% interview lift
Without
With
+47.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
76 currently pending
Career history
647
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
45.5%
+5.5% vs TC avg
§102
20.3%
-19.7% vs TC avg
§112
27.5%
-12.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 571 resolved cases

Office Action

§102
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. Claim Objections Claims 2, 3 and 5-7 are objected to because of the following informalities: Regarding claims 2 and 3, line 1, the recitation “A method” appears to be amended to recite “The method” in order to refer to “A method” recited in claim 1. Regarding claims 5-7, line 1, the recitation “A computer system” appears to be amended to recite “The computer system” in order to refer to “A computer system” recited in claim 4. 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 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 – (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1 -7 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Chen et al. (US 2020/0342974 A1) . Regarding claim 1, Chen teaches a method of estimating insulin on board (IOB) for a given glucose sensitive insulin (GSI) in a subject, comprising: for the given GSI, providing at least one rate constant ( r c ) ( K 1 in equation 1, paragraph 0096, paragraph 0120 and δ I in equation 1, paragraph 0125 ) as function of glucose concentration ( r c (G)), providing for a period of time (paragraph 01 17, lines 1-5 ) a continuous blood glucose log G(t) from the subject, providing for the period of time (paragraph 0093, “meal boluses”) an insulin dose log I(t) form the subject, based on r c (G) and G(t), calculating for each r c a rate constant as a function of time ( r c (t)) (paragraph 0096, equation 1) , and based on the at least one r c (t) and I(t) and using an estimating algorithm, calculating an estimated IOB (paragraph 0096, equation 1, paragraph 0165) for the subject. Regarding claim 2, Chen teaches wherein the estimating algorithm is based on a compartment model (paragraph 0096, equation 1, paragraph 0165). Regarding claim 3, Chen teaches wherein the compartment model comprises at least 2 compartments, at least one transfer rate constant ( one of two K I in figure 5, examiner construes K 1 representing K I in figure 5 ) between compartments, 240, 245, 210, 215, and at least one clearance rate constant (other of two K I , paragraph 0090, “absorption time constant”) , at least one of the rate constants being a function of glucose concentration (paragraphs 0096, 0120) . Regarding claim 4, Chen teaches a computer system 24 (figure 1) for estimating insulin on board (IOB) for a given glucose sensitive insulin (GSI) in a subject, wherein the system 24 comprises one or more processors and a memory (paragraph 0067, lines 6-11), the memory comprising: instructions that, when executed by the one or more processors, perform a method responsive to receiving a request for calculation of an IOB value, the method comprising: for the given GSI, providing at least one rate constant ( r c ) ( K 1 in equation 1, paragraph 0096, paragraph 0120 and δ I in equation 1, paragraph 0125) as function of glucose concentration ( r c (G)), providing for a period of time (paragraph 0117, lines 1-5) a continuous blood glucose log G(t) from the subject, providing for the period of time (paragraph 0093, “meal boluses”) an insulin dose log I(t) form the subject, based on r c (G) and G(t), calculating for each r c a rate constant as a function of time ( r c (t)) (paragraph 0096, equation 1), and based on the at least one r c (t) and I(t) and using an estimating algorithm, calculating an estimated IOB (paragraph 0096, equation 1, paragraph 0165) for the subject. Regarding claim 5, Chen teaches wherein the estimating algorithm is based on a compartment model (paragraph 0096, equation 1, paragraph 0165). Regarding claim 6, Chen teaches wherein the compartment model comprises at least 2 compartments, at least one transfer rate constant (one of two K I in figure 5, examiner construes K 1 representing K I in figure 5) between compartments, 240, 245, 210, 215, and at least one clearance rate constant (other of two K I , paragraph 0090, “absorption time constant”), at least one of the rate constants being a function of glucose concentration (paragraphs 0096, 0120). Regarding claim 7, Chen teaches adapted to provide a long-acting or ultra-long-acting insulin dose recommendation for a subject to treat diabetes mellitus, the memory further comprising: instructions (paragraph 0074) that, when executed by the one or more processors, perform a method responsive to receiving a dose guidance request, the method further comprising providing the long-acting or ultra-long-acting insulin ADR, the recommendation (figure 4, paragraph 0077) being calculated based on the estimated IOB. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NILAY J SHAH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9689 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Thursday 8:00 AM-4:30 PM EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT CHELSEA STINSON can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-1744 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NILAY J SHAH/ Primary Examiner, Art Unit 3783
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Prosecution Timeline

Nov 02, 2023
Application Filed
Feb 27, 2026
Non-Final Rejection — §102 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
77%
Grant Probability
99%
With Interview (+47.4%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 571 resolved cases by this examiner. Grant probability derived from career allow rate.

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