Prosecution Insights
Last updated: October 04, 2026
Application No. 18/691,556

SOLID STATE FORMS OF RELUGOLIX

Final Rejection §112
Filed
Mar 13, 2024
Priority
Sep 15, 2021 — IN 202121041687 +1 more
Examiner
SZNAIDMAN, MARCOS L
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Cipla Limited
OA Round
2 (Final)
37%
Grant Probability
At Risk
3-4
OA Rounds
1y 0m
Est. Remaining
54%
With Interview

Examiner Intelligence

Grants only 37% of cases
37%
Career Allowance Rate
475 granted / 1273 resolved
-22.7% vs TC avg
Strong +16% interview lift
Without
With
+16.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
83 currently pending
Career history
1346
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
38.4%
-1.6% vs TC avg
§102
17.8%
-22.2% vs TC avg
§112
27.8%
-12.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1273 resolved cases

Office Action

§112
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 . DETAILED ACTION This office action is in response to Applicant’s reply filed on July 10, 2026. Status of Claims Amendment of claims 11 and 14, and addition of claims 16-21 is acknowledged. Claims 1-14 and 16-21 are currently pending and are the subject of this office action. Newly submitted claims 20-21 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 1-13 and 16-17 recite a composition and claims 14 and 18-19 recite a method of manufacturing a medicament, while claims 20-21 are related to a method of treatment. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 20-21 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Claims 1-14 and 16-19 are presently under examination. Priority The present application is a 371 of PCT/IN2022/050742 filed on 08/17/2022 and claims priority to foreign application INDIA IN2021041687 filed on 09/15/2021. Rejections and/or Objections and Response to Arguments Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application. Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn. Claim Rejections - 35 USC § 112 (Maintained Rejection). 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 14, and 18-19 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 14 recites: “A method comprising utilizing…….in the manufacture of a medicament” The claim is indefinite because it has no positive process steps associated with it. There are no steps indicating how to manufacture a medicament, further, how does the skill in the art “utilize” a compound in the manufacture of a medicament? Allowable Subject Matter Claims 1-13 and 16-17 are allowed as presently advised. Conclusion Claims 14 and 18-19 are rejected and claims 1-13 and 16-17 are allowed. Claims 20-21 are withdrawn. THIS ACTION IS MADE FINAL. 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 extension fee 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. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 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, Amy L. Clark can be reached on 571 272-1310. 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. /MARCOS L SZNAIDMAN/ Primary Examiner, Art Unit 1628 July 22, 2026.
Read full office action

Prosecution Timeline

Mar 13, 2024
Application Filed
May 13, 2026
Non-Final Rejection mailed — §112
Jul 10, 2026
Response Filed
Sep 11, 2026
Final Rejection mailed — §112 (current)

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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
37%
Grant Probability
54%
With Interview (+16.2%)
3y 6m (~1y 0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1273 resolved cases by this examiner. Grant probability derived from career allowance rate.

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