Prosecution Insights
Last updated: July 17, 2026
Application No. 18/568,498

INTERMEDIATE FOR PREPARING FULVESTRANT AND PREPARATION METHOD THEREFOR

Non-Final OA §112
Filed
Dec 08, 2023
Priority
Jun 09, 2021 — CN 202110644317.9 +1 more
Examiner
BURKETT, DANIEL JOHN
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shanghai Best-Link Bioscience LLC
OA Round
2 (Non-Final)
64%
Grant Probability
Moderate
2-3
OA Rounds
9m
Est. Remaining
92%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
58 granted / 90 resolved
+4.4% vs TC avg
Strong +28% interview lift
Without
With
+28.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
48 currently pending
Career history
132
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
25.8%
-14.2% vs TC avg
§102
21.5%
-18.5% vs TC avg
§112
28.8%
-11.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 90 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 sent in replacement of the non-final rejection mailed March 6th, 2026. Status of Claims Claims 1, 5-13, 16-23, and 25-26 are pending in the instant application. Claims 2-4, 14-15, and 24 have been canceled. Priority Acknowledgment is made of Applicant’s claim for foreign priority based on the CN202110644317.9 application filed in the People’s Republic of China on June 9th, 2021. Information Disclosure Statement The Information Disclosure Statement received March 5th, 2024 has been fully considered by the examiner, except where marked with a strikethrough. Claim Objections Claims 5 and 20 are objected to because of the following informalities: Claim 5 should be written in the singular alternative format. For example, the sixth line of Claim 5 should read “R1 is hydrogen or a hydroxyl protecting group” Claim 5 erroneously places a period at the end of both the sixth and seventh lines. Per MPEP 608.01(m), “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.” Claims 15 and 20 should be written in the singular alternative format. For example, the 15th line of Claim 20 should read, “wherein R1 is hydrogen or a hydroxyl protecting group: R2 is a hydroxyl protecting group;”, Appropriate correction is required. 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. Claims 1, 5-8, 10, 12-13, 16, 20-23, and 25-26 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. Regarding claims 1 and 13, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 5 is rendered indefinite because no active steps delimiting how the preparation method is practiced have been positively recited. Dependent Claims 6-8 do not clarify the method with recitation of any positively recited active steps and therefore are also rendered indefinite. Per MPEP 2173.05(q), “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” Further, “Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims.” Claim 10 is rendered indefinite because no active steps delimiting how the preparation method is practiced have been positively recited. Per MPEP 2173.05(q), “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” Further, “Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims.” Claim 12 is rendered indefinite because no active steps delimiting how the preparation method is practiced have been positively recited. Per MPEP 2173.05(q), “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” Further, “Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims.” Claim 16 is rendered indefinite because no active steps delimiting how the preparation method is practiced have been positively recited. Dependent Claims 17-19 do not clarify the method with recitation of any positively recited active steps and therefore are also rendered indefinite. Per MPEP 2173.05(q), “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” Further, “Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims.” Claim 20 is rendered indefinite. Though active steps are recited, insufficient limitations are recited for a person having ordinary skill in the art to readily understand how to practice these steps. For example, step 1, as recited at Claim 20 recites the limitation, “The compound shown in formula VI and the compound shown in formula VII undergo addition reaction to obtain the compound shown in formula V.” In the absence of reaction conditions, an “addition reaction” is a broad term, and a person having ordinary skill in the art would not readily understand the metes and bounds of this limitation to be able to practice the addition reaction as recited. Appropriate clarification is required. Dependent Claims 21-23 and 25-26 do not provide clarification, and are therefore also rendered indefinite. Allowable Subject Matter Claims 9 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion Claims 1, 5-8, 10, 12-13, 16-23, and 25-26 are rejected. Claims 9 and 11 are objected to. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday. 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, Jeffrey Murray can be reached at (571) 272-9023. 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. /D.J.B./Examiner, Art Unit 1624 /JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

Dec 08, 2023
Application Filed
Mar 06, 2026
Non-Final Rejection mailed — §112
May 20, 2026
Non-Final Rejection mailed — §112 (current)

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Prosecution Projections

2-3
Expected OA Rounds
64%
Grant Probability
92%
With Interview (+28.0%)
3y 4m (~9m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 90 resolved cases by this examiner. Grant probability derived from career allowance rate.

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