Prosecution Insights
Last updated: April 19, 2026
Application No. 18/527,877

SINGLE DOSE MEDICAMENT DELIVERY DEVICE

Non-Final OA §112§DP
Filed
Dec 04, 2023
Examiner
FARRAR, LAUREN PENG
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Shl Medical AG
OA Round
1 (Non-Final)
79%
Grant Probability
Favorable
1-2
OA Rounds
3y 8m
To Grant
94%
With Interview

Examiner Intelligence

Grants 79% — above average
79%
Career Allow Rate
593 granted / 753 resolved
+8.8% vs TC avg
Strong +15% interview lift
Without
With
+15.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
60 currently pending
Career history
813
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
51.9%
+11.9% vs TC avg
§102
25.4%
-14.6% vs TC avg
§112
13.7%
-26.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 753 resolved cases

Office Action

§112 §DP
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 § 112 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 appl icant regards as his invention. Claims 11 and 13 and all dependents thereof 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 11 recites “a delivery member cover” in line 2. However, a delivery member cover is already introduced in claim 1 from which claim 11 depends. Therefore, it is unclear if a delivery member cover in claim 11 is the same as the one introduced in claim 1. For purposes of examination they are being interested as the same structure. Claim 13 recites “a delivery member shield link” in line 2. However, a delivery member shield link is already introduced in claim 1 from which claim 13 depends. Therefore, it is unclear if a delivery member shield link in claim 13 is the same as the one introduced in claim 1. For purposes of examination they are being interested as the same structure. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 18/062,726 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the present invention recites similar limitations as Claim 15 (including claim 1) of the co-pending application including a medicament delivery device having a main body, a syringe, a delivery member shield unit, a removable cap, a dose stop, a plunger rod, a tubular member coupled to the plunger wherein removal of the cap a rotation of the tubular member releases the plunger rod thereby allowing the plunger rod to travel a predetermined distance (claim 15) . Further the dependent claims of the present invention also recite similar limitations to the dependent claims of the co-pending application as outlined in the cart below: Present Invention Co-Pending Application 2 1 3 1 4 4 5 5 6 6 7 7 8 8 9 9 10 10 11 11 12 12 13 13 14 14 15 15 16 16 17 17 18 18 19 19 20 20 This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-20 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-20 of U.S. Patent No. 11,872,378 . Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the present invention recites similar limitations as claim 1 of U.S. Patent No. 11,872,378 including a medicament delivery device having a main body, a syringe, a delivery member shield unit, a removable cap, a dose stop, a plunger rod, a tubular member coupled to the plunger wherein removal of the cap a rotation of the tubular member releases the plunger rod thereby allowing the plunger rod to travel a predetermined distance . Further the dependent claims of the present invention also recite similar limitations to the dependent claims of the co-pending application as outlined in the cart below: Present Invention U.S. Patent No. 11,872,378 2 10 3 10 4 16 5 17 6 18 7 19 8 20 11 11 12 12 13 13 15 1 16 2 17 4 18 5 19 6 20 7 Claims 1-20 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-13 of U.S. Patent No. 10,857,300 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the present invention recites similar limitations as claim 1 of U.S. Patent No. 11,872,378 including a medicament delivery device having a main body, a syringe, a delivery member shield unit, a removable cap, a dose stop, a plunger rod, a tubular member coupled to the plunger wherein removal of the cap a rotation of the tubular member releases the plunger rod thereby allowing the plunger rod to travel a predetermined distance . Further the dependent claims of the present invention also recite similar limitations to the dependent claims of the co-pending application as outlined in the cart below: Present Invention U.S. Patent No. 10,857,300 B2 2 8 3 8 4 10 5 11 6 12 7 13 10 1 11 9 13 9 15 1 16 2 17 4 18 5 19 6 20 7 Allowable Subject Matter Claims 1-20 would be allowed if they were to overcome the 112(b) and Double Patenting Rejections. Claim 1 recites the limitation “a tubular member inside the delivery shield link and connected to the plunger rod such that wherein during removal of the cap rotation of the tubular member releases the plunger rod there by allowing the plunger rod to travel a predetermined distance so as to automatically prime the medicament delivery device” which was indicated as allowable subject matter in the parent applications. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LAUREN P FARRAR whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1496 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 9am - 5pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kevin Sirmons can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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. /Lauren P Farrar/ Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Dec 04, 2023
Application Filed
Mar 25, 2026
Non-Final Rejection — §112, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12594410
DEVICE FOR DELIVERING AN ANTIMICROBIAL COMPOSITION INTO A MEDICAL DEVICE
2y 5m to grant Granted Apr 07, 2026
Patent 12575966
SYSTEM AND METHOD FOR ULTRASOUND-ENHANCED DELIVERY OF DRUGS
2y 5m to grant Granted Mar 17, 2026
Patent 12569662
MEDICAL CONNECTOR
2y 5m to grant Granted Mar 10, 2026
Patent 12564681
PEN-LIKE SYRINGE SYSTEM
2y 5m to grant Granted Mar 03, 2026
Patent 12558484
Autoinjector
2y 5m to grant Granted Feb 24, 2026
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
79%
Grant Probability
94%
With Interview (+15.1%)
3y 8m
Median Time to Grant
Low
PTA Risk
Based on 753 resolved cases by this examiner. Grant probability derived from career allow rate.

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