Prosecution Insights
Last updated: October 02, 2026
Application No. 18/159,445

DRUG DELIVERY DEVICE SAFETY SYSTEM

Non-Final OA §103
Filed
Jan 25, 2023
Priority
Jan 25, 2022 — provisional 63/302,989 +2 more
Examiner
TRINH, HONG-VAN N
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Regeneron Pharmaceuticals Inc.
OA Round
1 (Non-Final)
63%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
169 granted / 269 resolved
-7.2% vs TC avg
Strong +57% interview lift
Without
With
+57.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
21 currently pending
Career history
296
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
42.7%
+2.7% vs TC avg
§102
25.5%
-14.5% vs TC avg
§112
27.8%
-12.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 269 resolved cases

Office Action

§103
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 . Election/Restrictions Applicant’s election without traverse of Group II and Species F in the reply filed on 5/15/2026 is acknowledged. Claims 1-16, 29-33, and 37-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/15/2026. Examiner notes that claims 18-28 and 34-36 are also being withdrawn from further consideration because they are drawn to a nonelected species. Claim 18 recites “… a first state in which a proximal end of the needle cover abuts the deflectable arm…”. This feature is disclosed in Species B-C, a nonelected embodiment. Claims 21-23, dependent on claim 18, are being withdrawn for the same reasons above. Claim 19 recites “wherein the second indent has a smaller diameter than the first indent”. This feature is disclosed in Species B-C, a nonelected embodiment. Claim 20 recites “wherein the housing includes a ledge for abutting a portion of the needle cover to prevent proximal movement of the needle cover into the housing”. This feature is disclosed in Species B-C, a nonelected embodiment. Claim 24 recites “an internal rod configured to be secured within the plunger rod”. This feature is disclosed in Species M-N and P, a nonelected embodiment. Claims 25-27, dependent on claim 24, are being withdrawn for the same reasons above. Claim 28 recites “a button mechanism, wherein the button mechanism is configured to abut a portion of the plunger rod in a first state and deflect away from the plunger rod in a second state”. This feature is disclosed in Species M-N and P, a nonelected embodiment. Claim 34 recites “a housing comprising a deflectable tab” and “a ring comprising a ledge”. These features are disclosed in Species E: Figs. 11-13, a nonelected embodiment. Claims 35-36, dependent on claim 34, are being withdrawn for the same reasons above. Claim Rejections - 35 USC § 103 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Perot et al. (US 20210093787 A1) in view of Peach (US 2799272 A). Regarding claim 17, Perot discloses a drug delivery device (1), the device comprising: a housing (11); a product container (3) disposed in the housing (Fig. 1), and a needle (4) extending from a distal end of the product container (Fig. 1); a plunger rod (6) for dispensing a product from the product container, the plunger rod including a first indent (41) at a distal portion of the plunger rod (Fig. 1) and a second indent (42) at a proximal portion of the plunger rod (Fig. 1); a blocking component (30) at a proximal end of the housing (Fig.4), wherein the plunger rod is slidably received within the blocking component (Figs. 1-4), and wherein the blocking component includes a deflectable arm (33). Perot is silent regarding a needle cover at least partially disposed in the housing. In analogous art, Peach teaches a needle cover (26) covering a needle (11/12). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the drug delivery device of Perot to incorporate the teachings of Peach to incorporate a needle cover in order to protect the cutting edges of the needle (Col 2, lines 12-13). The modification of Perot in view of Peach would teach a needle cover at least partially disposed in the housing because Perot shows the needle (4) disposed in the housing (11, Fig. 1), therefore the needle cover (26) of Peach would also be disposed in the housing. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG-VAN N TRINH whose telephone number is (571)272-8039. The examiner can normally be reached Thursday-Thursday 12-8 ET. 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. /HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Jan 25, 2023
Application Filed
Sep 15, 2026
Non-Final Rejection mailed — §103 (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

1-2
Expected OA Rounds
63%
Grant Probability
99%
With Interview (+57.0%)
3y 5m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 269 resolved cases by this examiner. Grant probability derived from career allowance rate.

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