Prosecution Insights
Last updated: April 19, 2026
Application No. 17/784,098

TWO-STEP AUTO-INJECTION APPARATUS

Non-Final OA §112
Filed
Jun 09, 2022
Examiner
SCHMIDT, EMILY LOUISE
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.
OA Round
3 (Non-Final)
59%
Grant Probability
Moderate
3-4
OA Rounds
3y 5m
To Grant
95%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allow Rate
581 granted / 992 resolved
-11.4% vs TC avg
Strong +36% interview lift
Without
With
+36.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
77 currently pending
Career history
1069
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
48.9%
+8.9% vs TC avg
§102
25.8%
-14.2% vs TC avg
§112
18.7%
-21.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 992 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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 10, 2025 has been entered. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 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 39-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 39 recites “a second lock catch member disposed on the pushing rod and positioned to engaged only after the pushing rod completes its full axial injection stroke.” The specification at the time of filing does not appear to recite the second lock catch disposed on the pushing rod only after the pushing rod completes its full injection stroke. The second lock catch appears to be disposed on the pushing rod before the completion of the full axial injection stroke as well as after. Claims 39-41 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. Claim 39 recites “a second lock catch member disposed on the pushing rod and positioned to engaged only after the pushing rod completes its full axial injection stroke.” It is not clear what the second lock catch member is positioned to engage. It is also not clear if the claim is intended to recite that the second lock catch member is both disposed on the pushing rod and positioned to engage only after the injection stroke or if it is intended to separately recite the second lock catch member is disposed on the pushing rod and only positioned to engage and the injection stroke. For purposes of interpretation of the claim for Examination the former interpretation is considered. Allowable Subject Matter Claims 25-38 are allowed. The following is an examiner’s statement of reasons for allowance: With regard to claim 25, the prior art of record does not teach or otherwise render obvious in combination with all claimed limitations a two-step auto-injection apparatus, comprising a housing, a protective sleeve cylinder disposed in the housing, an injection assembly and a drive feedback apparatus, wherein the drive feedback apparatus comprises an ejection mechanism, a release mechanism and a feedback mechanism, the release mechanism is used to release the ejection mechanism, wherein the ejection mechanism comprises a guide tube and a pushing rod co-axially disposed in the guide tube, and a first energy storage member axially storing energy is disposed between the pushing rod and the guide tube, a first limiting structure is disposed between the pushing rod and the guide tube, wherein the release mechanism comprises a release sleeve cylinder co-axially sleeved on an outer side of the guide tube, and the release sleeve cylinder is provided with a second limiting structure, when the ejection mechanism is not released, the second limiting structure cooperates with the first limiting structure to position the pushing rod in the guide tube, when the protective sleeve cylinder axially moves to drive the release sleeve cylinder to axially move, the first limiting structure is separated from the second limiting structure, wherein the feedback mechanism comprises a feedback ring co-axially sleeved around an outer side of the pushing rod and is in contact with an outer circumferential surface of the pushing rod at a position between a distal end of the pushing rod and the first limiting structure, an inner wall of the guide tube is provided axially with a first guide groove, and the feedback mechanism is configured such that the feedback ring strikes a side wall of the first guide groove to generate the sound signal and/or the haptic signal. With regard to claim 33, the prior art of record does not teach or otherwise render obvious in combination with all claimed limitations a two-step auto-injection apparatus, comprising a housing, a protective sleeve cylinder disposed in the housing, an injection assembly and a drive feedback apparatus; wherein the drive feedback apparatus comprises an ejection mechanism, a release mechanism and a feedback mechanism, the release mechanism is used to release the ejection mechanism; wherein the ejection mechanism comprises a guide tube and a pushing rod co-axially disposed in the guide tube, the feedback mechanism comprises a feedback ring co-axially sleeved around an outer side of the pushing rod and is in contact with an outer circumferential surface of the pushing rod at a position between a distal end of the pushing rod and the first limiting structure, and a second energy storage member for storing energy is disposed circumferentially around a circumference of the pushing rod and is disposed between the feedback ring and an end of the pushing rod at the distal end, an outer wall of the feedback ring is provided with a first convex portion, and an inner wall of the guide tube is provided axially with a first guide groove for the first convex portion to slide, the first guide groove is provided internally and the second energy storage member drives the first convex portion to strike a side wall of the first guide groove to generate a sound signal and/or a haptic signal. 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 with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion 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 09, 2022
Application Filed
May 13, 2025
Non-Final Rejection — §112
Aug 18, 2025
Response Filed
Sep 08, 2025
Final Rejection — §112
Nov 11, 2025
Response after Non-Final Action
Dec 10, 2025
Request for Continued Examination
Dec 19, 2025
Response after Non-Final Action
Mar 20, 2026
Non-Final Rejection — §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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BUTTON AND BUTTON ASSEMBLY FOR A DRUG DELIVERY DEVICE
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Patent 12569625
RIGID NEEDLE SHIELD REMOVER WITH DROP TEST FEATURE FOR AUTOINJECTOR
2y 5m to grant Granted Mar 10, 2026
Patent 12544516
Ultra-Low Waste Disposable Syringe with Self-Adjusting Integrated Safety Features
2y 5m to grant Granted Feb 10, 2026
Patent 12502482
COLLAR CAM LOCK FOR INJECTION DEVICES
2y 5m to grant Granted Dec 23, 2025
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
59%
Grant Probability
95%
With Interview (+36.0%)
3y 5m
Median Time to Grant
High
PTA Risk
Based on 992 resolved cases by this examiner. Grant probability derived from career allow rate.

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