Prosecution Insights
Last updated: October 22, 2026
Application No. 18/564,805

DRUG DELIVERY DEVICES, FINGER-GRIP ELEMENTS, AND RELATED METHODS

Final Rejection §102
Filed
Nov 28, 2023
Priority
Jun 08, 2021 — provisional 63/208,322 +2 more
Examiner
DOUBRAVA, JOHN A
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Amgen Inc.
OA Round
2 (Final)
77%
Grant Probability
Favorable
3-4
OA Rounds
2m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allowance Rate
241 granted / 314 resolved
+6.8% vs TC avg
Strong +27% interview lift
Without
With
+26.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
30 currently pending
Career history
350
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
45.8%
+5.8% vs TC avg
§102
20.0%
-20.0% vs TC avg
§112
27.9%
-12.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 314 resolved cases

Office Action

§102
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 This office action is responsive to the amendment filed on July 21, 2026. As directed by the amendment: claims 28 and 31 have been amended, claims 1-27, 32, 39, 47, and 49-50 have been cancelled, and claims 51-52 have been added. Thus, claims 28-31, 33-38, 40-46, 48 and 51-52 are presently pending in this application, with claims 34-38, 40-46 and 48 withdrawn as being drawn to non-elected subject matter. Applicant’s amendments are sufficient to overcome the §112(b) rejections of the previous action. Response to Arguments Applicant’s arguments, see Remarks, filed July 21, 2026, with respect to the rejection of newly amended independent claim 1 under 35 U.S.C. §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Ohashi et al. (Ohashi) US 2018/0243509 A1. 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. Claims 28-31, 33 and 51-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohashi et al. (Ohashi) US 2018/0243509 A1. Regarding claim 28, Ohashi discloses a finger-grip element (grip 16, P0033 and shown in Figs. 1-5) for use with a syringe (syringe 12, P0033), the finger-grip element comprising: a proximal end (proximal end, see annotated Fig. 2 below) and a distal end (distal end, see annotated Fig. 2 below) disposed at respective axial positions along a longitudinal axis (a of Fig. 2); an opening (opening, see annotated Fig. 2 below) configured to receive at least portion of the syringe (Fig. 1); and a first distally facing surface (first distally facing surface, see annotated Fig. 3A below) comprising a first contour (concave shaped contour, see annotated Fig. 3A below) configured to:(a) inhibit or prevent at least a first finger of a user from moving in radially inward and outward directions with respect to the longitudinal axis during use of the syringe to deliver a drug (the concave shaped contour is fully capable of inhibiting or preventing at least a first finger of a user from moving in a radially inward and outward direction with the respect to the longitudinal axis during use of the syringe to deliver a drug because it is curved), and/or (b) exert a first reaction force on at least the first finger of the user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver the drug (the concave shaped first distally facing surface is fully capable of exerting a first reaction force on at least the first finger of the user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver the drug because it teaches the claimed structure). PNG media_image1.png 835 594 media_image1.png Greyscale PNG media_image2.png 858 592 media_image2.png Greyscale Regarding claim 29, Ohashi discloses the finger-grip element of claim 28, wherein the first distally facing surface comprises an outer portion (outer portion, see annotated Fig. 3A below) and an inner portion (inner portion, see annotated Fig. 3A below), the inner portion being closer than the outer portion to the longitudinal axis (see annotated Fig. 3A below), at least a portion of the outer portion being distal to at least a portion of the inner portion (because of the concave shape contour). PNG media_image3.png 858 592 media_image3.png Greyscale Regarding claim 30, Ohashi discloses the finger-grip element of claim 29, wherein the outer portion of the first distally facing surface of the finger-grip element is configured to inhibit or prevent at least the first finger of the user from moving in the radially outward direction with respect to the longitudinal axis during use of the syringe to deliver the drug (the first distally facing surface of the finger-grip element is fully capable of inhibiting or preventing at least the first finger of the user from moving in the radially outward direction with respect to the longitudinal axis during use of the syringe to deliver the drug due to the concave shaped contour). Regarding claim 31, Ohashi discloses the finger-grip element of claim 28, wherein the finger-grip element comprises a second distally facing surface (see annotated Fig. 3A below) having a second contour (concave shaped contour, see annotated Fig. 3A below) configured to: (a) inhibit or prevent at least a second finger of a user from moving in a radially outward direction with respect to the longitudinal axis during use of the syringe to deliver the drug (the second contour is the same as the first distally facing surface contour, and thus functions in the same way), and/or (b) exert a second reaction force on at least the second finger of the user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver the drug (the second contour is the same as the first distally facing surface contour, and thus functions in the same way), and wherein the first distally facing surface and the second distally facing surface are disposed on opposite sides of the longitudinal axis (Fig. 2). PNG media_image4.png 858 592 media_image4.png Greyscale Regarding claim 33, Ohashi discloses the finger-grip element of claim 31, wherein the first contour and the second contour are symmetric with each other across the longitudinal axis (Fig. 3A). Regarding claim 51, Ohashi discloses the finger-grip element of claim 28, comprising: a proximally facing interior surface (proximally facing interior surface, see annotated Fig. 2 below); a distally facing interior surface (distally facing interior surface, see annotated Fig. 2 below); a recess (groove portion 46, P0049) at least partially defined by the proximally facing interior surface and the distally facing interior surface; and wherein the opening is configured to permit lateral insertion of at least a portion of the syringe into the recess (Fig. 1). PNG media_image5.png 743 584 media_image5.png Greyscale Regarding claim 52, Ohashi discloses the finger-grip element of claim 28, wherein at least a portion of the first contour of the first distally facing surface has a concave curvature (see claim 28 and annotated Fig. 3A above showing the first distally facing surface having a concave curvature). 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 JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time. 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, Bhisma Mehta can be reached at 571-272-3383. 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. /J.A.D./Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Nov 28, 2023
Application Filed
Apr 21, 2026
Non-Final Rejection mailed — §102
Jul 21, 2026
Response Filed
Sep 29, 2026
Final Rejection mailed — §102 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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BALLOON CATHETER DEVICE FOR ATRAUMATIC EXPANSION OF HOLLOW ORGANS, AND A METHOD FOR PRODUCING SUCH A BALLOON CATHETER DEVICE
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Patent 12741088
CONTINUOUS SUBCUTANEOUS INSULIN INFUSION CATHETER
8y 6m to grant Granted Sep 22, 2026
Patent 12702757
MULTI-CHAMBER SYRINGE
3y 7m to grant Granted Aug 11, 2026
Patent 12697429
DEVICES AND METHODS FOR CLEANING CONTAMINATED BODY CAVITIES
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Patent 12685825
Sealed Multi Chamber Syringe for Storage, Mixing and Delivery of Multi Part Substances
4y 0m to grant Granted Jul 21, 2026
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
77%
Grant Probability
99%
With Interview (+26.6%)
3y 1m (~2m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 314 resolved cases by this examiner. Grant probability derived from career allowance rate.

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