Prosecution Insights
Last updated: April 19, 2026
Application No. 18/371,995

DELIVERY SYSTEM DEVICE AND METHOD FOR PHARMACEUTICAL IMPLANTATION FOR TIMED RELEASE

Final Rejection §112§DP
Filed
Sep 22, 2023
Examiner
AZPURU, CARLOS A
Art Unit
1617
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Cemstar LLC
OA Round
2 (Final)
84%
Grant Probability
Favorable
3-4
OA Rounds
2y 9m
To Grant
94%
With Interview

Examiner Intelligence

Grants 84% — above average
84%
Career Allow Rate
1067 granted / 1276 resolved
+23.6% vs TC avg
Moderate +10% lift
Without
With
+10.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
23 currently pending
Career history
1299
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
23.0%
-17.0% vs TC avg
§102
18.4%
-21.6% vs TC avg
§112
29.8%
-10.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1276 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 . Receipt is acknowledged of the amendment and terminal disclaimer filed 01/29/2026. Withdrawn Rejection(s) The rejections under 35 USC 112, first and second paragraphs, and the judicially created doctrine of obviousness-type double patenting are withdrawn in view of the amendment and terminal disclaimer filed 01/29/2026. New Rejection(s) 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 applicant regards as his invention. Claim 49, 52, 54, 66, 69, 70, 71,72, 73, 87, 91, and 93 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 49 is indefinite in designating the Markush Group of the bioabsorbable sleeve with asterisks since it is not pointed out what they designate. The claim is also indefinite in setting out “composites’ of the polymer since this could potentially include any number of other components which make the metes and bounds of the claim indefinite. Regarding claim 52, the claim is indefinite with reference to “structural reinforcement materials’ which are not specifically enumerated, and whose metes and bounds are indefinite. Similarly with regard to claim 54, the claim is indefinite in reference to “other binding materials” because the metes and bounds of this term are not particularly pointed out. Claim 66 is indefinite in the use of the term “time-released implantable compound” which is not particularly pointed out. This is particularly indefinite since the two other members of the Markush Group are set out definitively. Claim 69 is indefinite in referencing “drugs to reduce gastroparesis” without setting out which drugs these entail. Claim 70 sets out “drugs to reduce gastroparesis” including…This calls into question the metes and bounds of the drugs this entails. Also, the claim includes the tradename Reglan™. Claim 71 contains the phrase “including disulfran” , which makes the metes and bounds of the claim indefinite. Claim 72 also uses the phrase “including”, which as explained above makes the metes and bounds of the claim indefinite. Claim 73 claim wording is indefinite and difficult to follow. Claim 87 is indefinite in setting out “synthetic bio-absorbable polymer’ without setting out the metes and bounds of this term. Claim 88 again uses asterisks in listing polymers, and attempts to include “composites” of unknown composition. Claim 91 sets out a Markush Group which entails “structural reinforcement materials” without particularly pointing out what they entail. Claim 93 sets out a Markush Group comprising “stearic acid or other binding chemicals”. The other binding chemicals are not particularly set out . 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. Claims 36-48, 50, 51, 55-65, 67-68, 70, 74-86, 90, and 94-113 are allowed. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm. 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, Sue X Liu can be reached at 571-272-5539. 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. /CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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Prosecution Timeline

Sep 22, 2023
Application Filed
Sep 25, 2025
Non-Final Rejection — §112, §DP
Jan 29, 2026
Response Filed
Feb 18, 2026
Examiner Interview (Telephonic)
Feb 25, 2026
Final Rejection — §112, §DP (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

3-4
Expected OA Rounds
84%
Grant Probability
94%
With Interview (+10.3%)
2y 9m
Median Time to Grant
Moderate
PTA Risk
Based on 1276 resolved cases by this examiner. Grant probability derived from career allow rate.

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