Prosecution Insights
Last updated: May 29, 2026
Application No. 18/256,921

AUTOMATIC NEEDLE INSERTER FOR PEN INJECTION SYSTEM

Non-Final OA §102§112
Filed
Jun 12, 2023
Priority
Dec 10, 2020 — nonprovisional of PCTIB2020001075
Examiner
SCHMIDT, EMILY LOUISE
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
BIOCORP PRODUCTION S.A.
OA Round
2 (Non-Final)
59%
Grant Probability
Moderate
2-3
OA Rounds
5m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allowance Rate
585 granted / 997 resolved
-11.3% vs TC avg
Strong +36% interview lift
Without
With
+36.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
53 currently pending
Career history
1075
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
74.4%
+34.4% vs TC avg
§102
7.1%
-32.9% vs TC avg
§112
10.3%
-29.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 997 resolved cases

Office Action

§102 §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 . 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) 1-3 and 6-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deroo et al. (FR 3079422 A1). With regard to claim 1, Deroo et al. teach automatic needle inserter for a pen injection system comprising: an elongated inserter body having a proximal extremity and a distal extremity (Fig. 2 including at least 80 and 40), and a longitudinal bore extending through the elongate body from the proximal extremity to the distal extremity, the longitudinal bore having a central longitudinal axis (Fig. 3), wherein the elongated inserter body is dimensioned and configured to receive a pen injection system introduced into said bore via the proximal extremity of the inserter body, and is further configured and dimensioned to prevent the pen injection system from exiting the longitudinal bore via the distal extremity (Fig. 3 member 10); the elongated inserter body further comprising: a rotationally-activated locking means configured to lock the pen injection system in an axial position within the longitudinal bore through rotation of at least a part of the elongated inserter body about the central longitudinal axis from a first, non-locking position to at least one or more second, locking positions (Figs. 2 and 3 member 90 is locking through rotation of 80); wherein the rotationally-activated locking means includes a compression ring coaxially located with the longitudinal bore of the elongated inserter body, said compression ring defining a central bore having a varying inner diameter, said varying inner diameter is variable with respect to an inner circumference of said compression ring (Fig. 2, end portion with 93 forms a compression ring, members 93 hinge to compress around the instrument resulting in a gradual reduction in the internal diameter). With regard to claims 2 and 3, 40 and 80 can rotate with respect to each other. With regard to claims 6-8, members 93 hinge to compress around the instrument resulting in a gradual reduction in the internal diameter. With regard to claims 9-11, members 93 taper towards 94 resulting in a gradual reduction in thickness. With regard to claims 12-15 see Fig. 2 member 100. With regard to claims 16-30, see carriage member 30, the surface engagement means is the projecting contacts formed by the threads on 90 and 80, the runnel is formed on each by the insertion space before the start of the threads and the space between the threads which allows initial axial movement for the two components to attach before rotation, the slider arm is 34 which engages runnel 44, the releasable trigger arm is 32, and the release button is 60. See Figs. 2-7, generally pgs. 36 and 37 of the translation portion of the provided reference. With regard to claims 31-34 and 36, the selectively actionable member is formed by members 310 and 320 (Figs. 2 and 3). With regard to claims 31, 34, and 35, alternatively member 32 is taken as the selectively actionable member which articulates from a flush first position in Fig. 5 to a second abutting position extending into the longitudinal bore in Fig. 7. Response to Arguments Applicant's arguments filed April 7, 2026 have been fully considered but they are not persuasive regarding claim 1. Applicant argues Deroo refers to element 87 as a clamping ring. While this may be true the Examiner maintains other structures may also be considered as a clamping ring if they meet the claimed limitations to such structure despite the nomenclature. The end portion of 90 generally in the area of the threads forms a ring which includes members 93. These structures are arranged about a circumference. Definitions for the word ring from Merriam-Webster include “a circular line, figure, or object” and “an encircling arrangement.” Regarding the varying inner diameter, the claim does not recite structurally how the diameter is varied other than what it is varied in relation to. The Examiner maintains that as members 93 deform this changes the inner diameter with respect to the circumference. Applicant argues this change is with respect to the longitudinal axis, while that is also true, as members 93 flex about the circumference the diameter is changed relative to the circumference. Additionally, members 93 are tapered resulting in a varying inner diameter. The amendments to the specification and claims are sufficient to overcome the previous objections to the drawings, specification, and claims as well as the previous rejections under 35 U.S.C. 112. As the independent claim is amended any changes to dependent claims are necessitated as such. 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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM. 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, Kevin Sirmons can be reached at 571-272-4965. 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. /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Jun 12, 2023
Application Filed
Dec 19, 2025
Non-Final Rejection mailed — §102, §112
Apr 07, 2026
Response Filed
Apr 22, 2026
Final Rejection mailed — §102, §112 (current)

Precedent Cases

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

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Prosecution Projections

2-3
Expected OA Rounds
59%
Grant Probability
95%
With Interview (+36.4%)
3y 4m (~5m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 997 resolved cases by this examiner. Grant probability derived from career allowance rate.

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