Prosecution Insights
Last updated: April 19, 2026
Application No. 18/568,498

INTERMEDIATE FOR PREPARING FULVESTRANT AND PREPARATION METHOD THEREFOR

Non-Final OA §102§112
Filed
Dec 08, 2023
Examiner
BURKETT, DANIEL JOHN
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shanghai Best-Link Bioscience LLC
OA Round
1 (Non-Final)
68%
Grant Probability
Favorable
1-2
OA Rounds
3y 5m
To Grant
96%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allow Rate
51 granted / 75 resolved
+8.0% vs TC avg
Strong +28% interview lift
Without
With
+28.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
49 currently pending
Career history
124
Total Applications
across all art units

Statute-Specific Performance

§101
3.3%
-36.7% vs TC avg
§103
20.1%
-19.9% vs TC avg
§102
17.1%
-22.9% vs TC avg
§112
39.2%
-0.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 75 resolved cases

Office Action

§102 §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 . Status of Claims Claims 1-26 are pending in the instant application. Priority Acknowledgement 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. Specification The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification. Claim Objections Claims 1, 5, 13, 20 is objected to because of the following informalities: Claim 1 should be written in the singular alternative format. For example, the last line of Claim 1 should read “R1 is hydrogen or a hydroxyl protecting group.” 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 13 should be written in the singular alternative format. For example, the last line of Claim 13 should read “wherein R1 is hydrogen or a hydroxyl protecting group; R2 is a hydroxyl protecting group.” Claim 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 5-8, 10, 12 and 16-26 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. 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 do not provide clarification, and are therefore also rendered indefinite. Similarly, Claim 24 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 24 recites the limitation “The compound shown in formula Via and the compound shown in formula VIIa undergo addition reaction to obtain the compound shown in formula Va”. 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. Claim 26 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 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN102993259A (machine translation provided; cited on Applicant’s Information Disclosure Statement filed March 5th, 2024; hereinafter referred to as CN ‘259). At Page 3 of the provided machine translation of CN ‘259, CN ‘259 teaches a compound of the formula (III): PNG media_image1.png 218 341 media_image1.png Greyscale This compound reads on a compound of formula III as recited at instant claim 13 when R1 is defined as acetyl and R2 is defined as acetyl. Allowable Subject Matter Claims 2-4, 9 and 11 are allowed. Claim 25 is 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 5-8, 10, 12-24, and 26 are rejected. Claims 1 and 25 are objected to. Claims 2-4, 9, and 11 are 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
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Prosecution Timeline

Dec 08, 2023
Application Filed
Mar 04, 2026
Non-Final Rejection — §102, §112 (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

1-2
Expected OA Rounds
68%
Grant Probability
96%
With Interview (+28.2%)
3y 5m
Median Time to Grant
Low
PTA Risk
Based on 75 resolved cases by this examiner. Grant probability derived from career allow rate.

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