Prosecution Insights
Last updated: April 19, 2026
Application No. 18/047,071

ESTABLISHING AND MAINTAINING VACUUM IN THE RESERVOIR OF A DRUG DELIVERY DEVICE

Final Rejection §102§112
Filed
Oct 17, 2022
Examiner
STIGELL, THEODORE J
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Insulet Corporation
OA Round
2 (Final)
78%
Grant Probability
Favorable
3-4
OA Rounds
3y 4m
To Grant
93%
With Interview

Examiner Intelligence

Grants 78% — above average
78%
Career Allow Rate
975 granted / 1245 resolved
+8.3% vs TC avg
Moderate +15% lift
Without
With
+14.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
45 currently pending
Career history
1290
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
31.3%
-8.7% vs TC avg
§102
31.7%
-8.3% vs TC avg
§112
21.1%
-18.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1245 resolved cases

Office Action

§102 §112
DETAILED ACTION Response to Amendment Drawings The drawings were received on 12/18/2025. These drawings are accepted. Specification The specification amendments were received on 12/18/2025. These amendments are accepted. Claim Objections The claim objections are withdrawn in light of the claim amendments filed on 12/18/2025. Claim Rejections - 35 USC § 112 The 112 rejections are withdrawn in light of the claim amendments filed on 12/18/2025. Claim Rejections - 35 USC § 102 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kreisel (US 5,741,242). In regard to claim 1, Kriesel discloses a reservoir (see at least Figs. 5-8) comprising: a rigid shell (62, 74); a foil lining (66) disposed on an interior surface of the rigid shell; an inlet port (at 112 or 81) in fluid communication with a space between the foil lining and the rigid shell (see Fig. 7); and a fill structure (port structure defining 112 or 84) in fluid communication with the inlet port (see Fig. 7a). In regard to claim 5, Kriesel discloses further comprising: a sealing barrier film (114 or 90) covering the rigid shell and the fill structure. Allowable Subject Matter Claims 2-4 and 21-23 are allowed. The following is an examiner’s statement of reasons for allowance: Kriesel fails to disclose or suggest the septum, first and second spaces, and barrier film as recited in combination with the other limitations of claim 2. 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 filed 12/18/2025 have been fully considered but they are not persuasive. In response to the applicant’s argument that Kreisel fails to disclose a foil lining disposed on an interior surface of the rigid shell, the examiner respectfully disagrees. The applicant argues that the thin elastomeric layer 66 of Kreisel is not a foil lining. In the last paragraph of page 8 of the Remarks (continuing to top of page 9), the applicant discusses that the foil of the instant application can be punctured, is air impermeable, and can maintain a vacuum and therefore is different from the elastomer layer of Kreisel. This argument is not persuasive because the claim does not recite any of these capabilities in the claim. The applicant appears to be reading limitations from the specification into the claim. Furthermore, the applicant switches between discussing the “foil lining” (the recited limitation) and a “foil” in the paragraph discussed above. The examiner’s position is that “foil lining” is a broader limitation in that the interpretation can be a lining for a foil. The elastomer layer 66 appears to be able to provide such an ability. For these reasons, the rejection has been maintained. 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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 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, Michael Tsai can be reached at 571-270-5246. 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. THEODORE J. STIGELL Primary Examiner Art Unit 3783 /THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Oct 17, 2022
Application Filed
Sep 15, 2025
Non-Final Rejection — §102, §112
Dec 18, 2025
Response Filed
Jan 23, 2026
Final Rejection — §102, §112 (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

3-4
Expected OA Rounds
78%
Grant Probability
93%
With Interview (+14.6%)
3y 4m
Median Time to Grant
Moderate
PTA Risk
Based on 1245 resolved cases by this examiner. Grant probability derived from career allow rate.

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