Prosecution Insights
Last updated: October 02, 2026
Application No. 18/199,638

SWITCHING AND CUSTOMIZATION OF GLUCOSE PREDICTION MODELS IN MEDICAMENT DELIVERY DEVICES

Final Rejection §112
Filed
May 19, 2023
Priority
May 19, 2022 — provisional 63/343,739
Examiner
SHAH, NILAY J
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Insulet Corporation
OA Round
2 (Final)
76%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 76% — above average
76%
Career Allowance Rate
464 granted / 608 resolved
+6.3% vs TC avg
Strong +47% interview lift
Without
With
+46.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
54 currently pending
Career history
668
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
50.2%
+10.2% vs TC avg
§102
15.4%
-24.6% vs TC avg
§112
30.6%
-9.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 608 resolved cases

Office Action

§112
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 . Response to Amendment The Amendment filed 5/12/2026 has been entered. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 1/12/2026. Claim Rejections - 35 USC § 112 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-17 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. Regarding claim 1, lines 11-12, the recitation “glucose level history” renders the claim indefinite because the claim is unclear if “glucose level history” is same as “analyte level history” recited in claim 1, line 8 or additional. For examination purposes, examiner construes “glucose level history” same as “analyte level history”. Regarding claim 1, line 12, the recitation “medicament deliveries” renders the claim indefinite because the claim is unclear if “medicament deliveries” refer to “medicament delivery history” recited in claim 1, line 8 or additional. For examination purposes, examiner construes “medicament deliveries” as being referring to “medication delivery history”. Claims 2-9 being dependent on claim 1 are also rejected. Regarding claim 10, line 11, the recitation “past glucose level values and past medicament delivery doses” renders the claim indefinite because the claim is unclear if “past glucose level values and past medicament delivery doses” are part of “history of medicament delivery doses and glucose level values” recited in claim 10, line 7 or additional. For examination purposes, examiner construes “past glucose level values and past medicament delivery doses” are part of “history of medicament delivery doses and glucose level values”. Claims 11-17 being dependent on claim 10 are also rejected. Allowable Subject Matter Claims 18-20 are allowed. Claims 1-17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. The following is an examiner’s statement of reasons for allowance: The closest prior art of record, O’Connor et al. (US 2021/0313037 A1) discloses a medicament delivery system comprising: a non-transitory computer-readable storage medium storing computer programming instructions; create a first model of analyte-medicament interactions that is customized for the user based on analyte level history and medicament delivery history of the user but is silent regarding determine a standard impulse response for the first model; determine; from the standard impulse response, an indication of how much medicament is on board over time for the user after a specified amount of medicament is delivered to the user; use the indication in determining a basal dose in determining a basal dose of medicament for the user in combination with other claimed limitations of claim 1. Claims 2-9 being dependent on claim 1 are also allowed. The closest prior art of record, Doron (US 2020/0015738 A1) in view of O’Connor et al. (US 2021/0313037 A1) discloses a medicament delivery system comprising a non-transitory computer readable storage medium storing computer programming instructions; a processor configured for executing the computer programming instructions to cause the processor to: access a history of medicament delivery doses and glucose level values of the user but is silent regarding based on the history, determine an improved fit of parameters for a glucose prediction model that determines predicted future glucose level values for the user from the past glucose level values and past medicament delivery doses in the history, the improved fit being determined relative to current parameters of the glucose prediction model in combination with other claimed limitations of claim 10. Claims 11-17 being dependent on claim 10 are also allowed. The closest prior art of record, O’Connor et al. (US 2021/0313037 A1) discloses a medicament delivery system comprising a non-transitory computer-readable storage medium storing computer programming instructions; a processor configured for executing the computer programming instructions to cause the processor to: create a current model of analyte-medicament instructions that is customized for the user based on analyte level history and medicament delivery history the user; but is silent regarding determine a standard impulse response for the current model; determine, from the standard impulse response, an indication of how much medicament is on board over time for the user after a specified amount of medicament is delivered to the user; use the indication in determining a basal dose of medicament for the user in combination with other claimed limitations of claim 18. Claims 19 and 20 being dependent on claim 18 are also allowed. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” Response to Arguments Applicant’s arguments, see pages 10-14, filed 5/12/2026, with respect to claims 1-20 have been fully considered and are persuasive. The rejection/objection of claims 1-20 has been withdrawn. 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 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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached 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, CHELSEA STINSON can be reached at 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
Read full office action

Prosecution Timeline

May 19, 2023
Application Filed
Dec 05, 2025
Non-Final Rejection (signed) — §112
Jan 12, 2026
Non-Final Rejection mailed — §112
May 12, 2026
Response Filed
Aug 11, 2026
Final Rejection mailed — §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12746330
FLUID PATHS FOR ANGIOGRAPHY INJECTOR ASSEMBLY
4y 0m to grant Granted Sep 29, 2026
Patent 12746335
AUTO INJECTOR WITH CARTRIDGE LOCKING SYSTEM
3y 10m to grant Granted Sep 29, 2026
Patent 12741085
SKIN PATCH DRUG INFUSION DEVICE
3y 2m to grant Granted Sep 22, 2026
Patent 12734310
AN ACTIVATION ASSISTING ASSEMBLY FOR A MEDICAMENT DELIVERY DEVICE
3y 3m to grant Granted Sep 15, 2026
Patent 12728249
HIGH-PERFORMANCE MICRO-NEEDLE ARRAY
3y 9m to grant Granted Sep 08, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

3-4
Expected OA Rounds
76%
Grant Probability
99%
With Interview (+46.9%)
3y 1m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 608 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month