Prosecution Insights
Last updated: August 14, 2026
Application No. 18/715,609

METHOD FOR PREPARING DRUG-LINKER CONJUGATE

Non-Final OA §102§103§112
Filed
May 31, 2024
Priority
Dec 02, 2021 — CN 202111473108.9 +1 more
Examiner
AULAKH, CHARANJIT
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
66%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allowance Rate
1430 granted / 1769 resolved
+20.8% vs TC avg
Minimal -15% lift
Without
With
+-15.2%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 0m
Avg Prosecution
52 currently pending
Career history
1810
Total Applications
across all art units

Statute-Specific Performance

§101
3.4%
-36.6% vs TC avg
§103
14.9%
-25.1% vs TC avg
§102
20.5%
-19.5% vs TC avg
§112
43.5%
+3.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1769 resolved cases

Office Action

§102 §103 §112
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 . Claims 1-19 are pending in the application. Claim Objections Claim12 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in alternate only. See MPEP § 608.01(n). Claim Rejections - 35 USC § 112 4. 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. 5.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. 6.Claims 1-6, 9-10, 12-16, 18 and 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. In claims 1 and 6, the term- - - MMT - -- is not defined. In claim 6, it is not clear what is reacted with compound 1M2 to prepare compound 1M3? In claim 15, it is not clear what is reacted with compound 1M2 or 1M3 to prepare compound 1? A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 (I-3) recites the broad recitation 40 degree C, and the claim also recites preferably 30 degree C which is the narrower statement of the range/limitation. Claim 2 (I-4) recites the broad recitation 0.2-4.0, and the claim also recites preferably 0.5-2.0 which is the narrower statement of the range/limitation. Claim 2 (I-6) recites the broad recitation organic solvent, and the claim also recites preferably one or more of ethyl acetate, tetrahydrofuran, dichloromethane and chloroform which is the narrower statement of the range/limitation. Claim 3 (I-1) recites the broad recitation <1:1, and the claim also recites preferably (0.3-0.9):1, more preferably (0.4-0.7):1, for example 0.4:1 etc. which is the narrower statement of the range/limitation. Claim 3 (I-2) recites the broad recitation >3:1, and the claim also recites preferably (3.5-5.0):1, more preferably (3.5-4.5):1, such as etc. which is the narrower statement of the range/limitation. Claim 3 (I-3) recites the broad recitation 25 degree C, and the claim also recites 20, 15, 10, 5 degree C which is the narrower statement of the range/limitation. Claim 3 (I-4) recites the broad recitation 1: (1-2.0), and the claim also recites for example 1:1.1 etc. which is the narrower statement of the range/limitation. Claim 3 (I-5) recites the broad recitation 30 minutes-6 hr, and the claim also recites 30 min-5 hr etc. which is the narrower statement of the range/limitation. Claim 3 (I-7) recites the broad recitation inert gas, and the claim also recites e.g., nitrogen which is the narrower statement of the range/limitation. Claim 4 recites the broad recitation 25 degree C, and the claim also recites 20, 15, 10, 5 degree C which is the narrower statement of the range/limitation. Claim 4 recites the broad recitation 10-50 times, and the claim also recites =10-45 times etc. which is the narrower statement of the range/limitation. Claim 4 recites the broad recitation 1: (10-50), and the claim also recites 1: (10-40) etc. which is the narrower statement of the range/limitation. Claim 4 recites the broad recitation 5 min.-1.5 hr, and the claim also recites 1hr, 30 min. etc. which is the narrower statement of the range/limitation. Claim 5 recites the broad recitation 25 degree C, and the claim also recites 20, 15, 10, 5 degree C which is the narrower statement of the range/limitation. Claim 5 recites the broad recitation 10-50 times, and the claim also recites 10-45 times etc. which is the narrower statement of the range/limitation. Claim 5 recites the broad recitation 1: (10-50), and the claim also recites for example 1: (10-40) etc. which is the narrower statement of the range/limitation. Claim 5 recites the broad recitation 5 min.- 1.5 hr, and the claim also recites 1 hr etc. which is the narrower statement of the range/limitation. Claim 9 (II-1) recites the broad recitation (2-8):1, and the claim also recites preferably (3-7):1 which is the narrower statement of the range/limitation. Claim 9 (II-2) recites the broad recitation 1: (1-15), and the claim also recites preferably 1: (1-12) which is the narrower statement of the range/limitation. Claim 9 (II-3)) recites the broad recitation 1: (0.2-4), and the claim also recites preferably 1: (0.5-2) which is the narrower statement of the range/limitation. Claim 9 (II-5) recites the broad recitation 15 min.-4 hr, and the claim also recites such as 0.5-3 hr. which is the narrower statement of the range/limitation. Claim 10 (II-1)) recites the broad recitation (4-6):1, and the claim also recites preferably (4.5-6):1 such as 4.5:1 etc. which is the narrower statement of the range/limitation. Claim 10 (II-2) recites the broad recitation 1: (2-10), and the claim also recites for example 1: (2-9) etc. which is the narrower statement of the range/limitation. Claim 10 (II-3)) recites the broad recitation 1: (1-2), and the claim also recites for example 1:1 etc. which is the narrower statement of the range/limitation. Claim 10 (II-6) recites the broad recitation 30 min.-2 hr, and the claim also recites such as 1-1.5 hr which is the narrower statement of the range/limitation. Claim 10 (II-7) recites the broad recitation inert gas and the claim also recites e.g., nitrogen which is the narrower statement of the range/limitation. Claim 13 (III-1) recites the broad recitation 10-50 times, and the claim also recites for example 10, 20 times etc. which is the narrower statement of the range/limitation. Claim 13 (III-2) recites the broad recitation 10-50, and the claim also recites for example 10, 20 etc. which is the narrower statement of the range/limitation. Claim 13 (III-3)) recites the broad recitation 5.5-8.0, and the claim also recites 5.5-6.0 etc. which is the narrower statement of the range/limitation. Claim 13 (III-3)) recites the broad recitation 3-8 %, and the claim also recites preferably 4% which is the narrower statement of the range/limitation. Claim 13 (III-5)) recites the broad recitation 1-2 times, and the claim also recites e.g., 1 time which is the narrower statement of the range/limitation. Claim 13 (III-5)) recites the broad recitation aqueous EDTA-2 Na solution, and the claim also recites preferably 4% aqueous EDTA-2 Na solution which is the narrower statement of the range/limitation. Claim 13 (III-5)) recites the broad recitation 1-2 times, and the claim also recites e.g., 2 time which is the narrower statement of the range/limitation. Claim 13 (III-5)) recites the broad recitation aqueous NaCl, and the claim also recites preferably 10% aqueous NaCl which is the narrower statement of the range/limitation. Claim 13 (III-5) recites the broad recitation 10-50 times, and the claim also recites for example 10, 20 etc. which is the narrower statement of the range/limitation. Claim13 (III-6) recites the broad recitation organic solvent, and the claim also recites preferably one or more of ethyl acetate, tetrahydrofuran, dichloromethane and chloroform, further preferably dichloromethane which is the narrower statement of the range/limitation. Claim 13 (III-7) recites the broad recitation 5-25 degree C, and the claim also recites for example 5-20degree C. preferably 5-15 degree C which is the narrower statement of the range/li1itation. Claim 14 (III-1) recites the broad recitation 10-50 times, and the claim also recites for example 10, 20 etc. which is the narrower statement of the range/limitation. Claim 14 (III-2) recites the broad recitation 10-50 times, and the claim also recites for example 10, 20 etc. which is the narrower statement of the range/limitation. Claim 14 (III-3)) recites the broad recitation 5.5-8.0, and the claim also recites 5.5-6.0 etc. which is the narrower statement of the range/limitation. Claim 14 (III-5)) recites the broad recitation 1-2 times, and the claim also recites e.g., 1 time which is the narrower statement of the range/limitation. Claim 14 (III-5)) recites the broad recitation aqueous NaCl solution, and the claim also recites preferably 10% aqueous NaCl solution which is the narrower statement of the range/limitation. Claim 14 (III-5)) recites the broad recitation 10-50 times, and the claim also recites 10, 20 times etc. which is the narrower statement of the range/limitation. Claim 14 (III-5)) recites the broad recitation 1-2 times, and the claim also recites e.g., 2 time which is the narrower statement of the range/limitation. Claim 14 (III-6)) recites the broad recitation 10-20 times, and the claim also recites 10, 12 times etc. which is the narrower statement of the range/limitation. Claim 14 (III-7)) recites the broad recitation 5-25 degree C, and the claim also recites e.g., 5-20 degree C, preferably 5-15 degree C which is the narrower statement of the range/limitation. Claim 16 recites the broad recitation acids, and the claim also recites preferably trifluoroacetic acid which is the narrower statement of the range/limitation. Claim 18 (IV-1) recites the broad recitation 30-100 times, and the claim also recites for example 40-60 times etc. which is the narrower statement of the range/limitation. Claim18 (IV-1) recites the broad recitation organic solvent, and the claim also recites preferably one or more of ethyl acetate, tetrahydrofuran, dichloromethane and chloroform which is the narrower statement of the range/limitation. Claim 18 (IV-2) recites the broad recitation 1: (5-20), and the claim also recites for example 1: (5-16) etc. which is the narrower statement of the range/limitation. Claim 18 (IV-3) recites the broad recitation 0-25 degree C, and the claim also recites for example 5-10 degree C which is the narrower statement of the range/limitation. Claim 18 (IV-4) recites the broad recitation inert gas, and the claim also recites for example nitrogen which is the narrower statement of the range/limitation. Claim 18 (IV-5) recites the broad recitation 30 min.-24 hr, and the claim also recites such as 4-5 hr which is the narrower statement of the range/limitation. Claim19 (IV-1) recites the broad recitation 50-100 times, and the claim also recites for example 50-60 times etc.which is the narrower statement of the range/limitation. Claim 19 (IV-2) recites the broad recitation 1: (5-20), and the claim also recites for example 1: (5-10) etc. which is the narrower statement of the range/limitation. Claim 18 (IV-3) recites the broad recitation 0-25 degree C, and the claim also recites for example 5-10 degree C which is the narrower statement of the range/limitation. Claim 19 (IV-4) recites the broad recitation inert gas, and the claim also recites for example nitrogen which is the narrower statement of the range/limitation. Claim 19 (IV-5) recites the broad recitation 30 min.-24 hr and the claim also recites such as 4-5 hr which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim Rejections - 35 USC § 102 7. 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. 8. Claims 1, 6-8, 11-12 and 15-17 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Cai (CA 3080236 A1). Cai discloses Bioactive conjugate, preparation method thereof and use thereof. The method of preparing compounds 33-1, 33-2 and TL 033 disclosed in example 14 (see steps 2, 3 and 4) on pages 135-137 by Cai anticipate the instant claims when the organic solvent represents dichloromethane. Claim Rejections - 35 USC § 103 9. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 10. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 11. Claims 2-5, 9, 13-14 and 18-19 are rejected under 35 U.S.C. 103 as being obvious over Cai (CA 3080236 A1). Cai discloses Bioactive conjugate, preparation method thereof and use thereof. The method of preparing compounds 33-1, 33-2 and TL 033 disclosed in example 14 (see steps 2, 3 and 4) on pages 135-137 by Cai meets all the limitations of instant claims when the organic solvent represents dichloromethane except that Cai is silent about feed-ratios, weight ratios and molar ratios of various reactants. However, the reactants used as well as the final products are identical in Cai and the instant method. Therefore, unless applicants provide unexpected results of superior yield etc. of the instant method over the method of Cai, it will be within the routine skill of an artesian to select feed-ratios, weight ratios and molar ratios of various reactants with reasonable expectation of success. 12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30. 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, Clinton A Brooks can be reached at 571-270-7682. 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. /CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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Prosecution Timeline

May 31, 2024
Application Filed
Jun 25, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
81%
Grant Probability
66%
With Interview (-15.2%)
2y 0m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1769 resolved cases by this examiner. Grant probability derived from career allowance rate.

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