Prosecution Insights
Last updated: July 31, 2026
Application No. 18/000,102

PREPARATION METHOD FOR (S)-2-AMINO-3-(4-(2,3-DIMETHYLPYRIDIN-4-YL)PHENYL)METHYL PROPIONATE DIACID SALT

Non-Final OA §112
Filed
Jul 17, 2023
Priority
May 28, 2020 — CN 202010481657.X +1 more
Examiner
ANDERSON, REBECCA L
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd.
OA Round
1 (Non-Final)
73%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
759 granted / 1034 resolved
+13.4% vs TC avg
Strong +24% interview lift
Without
With
+23.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
47 currently pending
Career history
1087
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
29.1%
-10.9% vs TC avg
§102
32.7%
-7.3% vs TC avg
§112
21.9%
-18.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1034 resolved cases

Office Action

§112
DETAILED ACTION Claims 1-8 are currently pending in the instant application. Claims 1-8 are rejected. Claims 1-3 and 6 are objected. 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 . Election/Restrictions Applicant’s election without traverse of Group I in the reply filed on 21 January 2026 is acknowledged. Specification The disclosure is objected to because of the following informalities: The pages of the specification do not have page numbers. As there are no paragraph numbers or page numbers provided, it is difficult to point to refer to a portion of the specification as one cannot refer to page number, line number, or paragraph number. Please see 37 CFR 1.52(b)(5): Other than in a reissue application or a reexamination or supplemental examination proceeding, the pages of the specification including claims and abstract must be numbered consecutively, starting with 1, the numbers being centrally located above or preferably, below, the text. Appropriate correction is required. Claim Objections Claims 1-3 and 6 are objected to because of the following informalities: Claim 1, last three lines, there should be an “of” after the word “consisting” and an “and” before “hydrobromide” for clarity. Claim 2, 5th to last line, there should be an “and” before “PPh3” for clarity. Claim 3, 5th line, there should be an “and” before “sodium maleate” for clarity. Claim 6, 2nd to last line, the “or” should be replaced with “and” before “2-methyltetrahydrofuran” for clarity. 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 1-8 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, 5, and 8 (and claims 2, 3, 6, and 7, dependent upon claim 1) the phrases which have "preferably" render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For claim 1, the phrase “preferably oxalate and phosphate,” renders the claim 1 and its dependent claims 2, 3, 6, and 7 indefinite as it is unclear if the salt group is selected from the group consisting of oxalate, L-tartrate, malate, succinate, maleate, citrate, phosphate, sulfate, and hydrobromide, or if the salt group is limited to only oxalate and phosphate. For claim 5, the phrase “preferably 1:2,” renders the claim indefinite as it is unclear if the molar ratio can be in the range of 1:1.5 to 1:2.5 or if the molar ratio is limited to 1:2. For claim 8, the phrase “preferably oxalic acid or phosphoric acid,” renders the claim indefinite as it is unclear if the organic acid or inorganic acid is selected from the group consisting of oxalic acid, L-tartaric acid, malic acid, succinic acid, maleic acid, citric acid, phosphoric acid, sulfuric acid, and hydrobromic acid, or if the organic acid or inorganic acid I only oxalic acid or phosphoric acid. It is suggested that the phrases which have “preferably” be deleted from claims 1, 5, and 8. Claim 3 recites the limitation "after the adjustment of pH" in reference to step (b) in claim 1 along with “the solvent used in step (b)” in reference to step (b) in claim 1. There is insufficient antecedent basis for these limitation in the claim 3 as claim 1 step (b) is: PNG media_image1.png 26 660 media_image1.png Greyscale which does not have “a pH adjustment” or “a solvent”. Claim 6 recites the limitation “and/or the extraction solvent” in regards to claim 1 or the initial limitation in claim 6. When the “or” is utilized, there is insufficient antecedent basis for this limitation in the claim 6 as there is not “an extraction solvent” anywhere in claim 1. There is only antecedent basis if it is “and the extraction solvent” as “extracted with solvent” is only found in the first option of claim 6. Closest Prior Art The closest prior art is CN102378574B (IDS 12/20/2022, cite no. 005 Foreign Patent Documents) which is discussed in the background of the invention in the instant specification. CN102378574B discloses the process PNG media_image2.png 222 728 media_image2.png Greyscale see paragraph [1411]-[1415] which differs from the claimed process: PNG media_image3.png 272 776 media_image3.png Greyscale , for example, as formula I is not utilized in the prior art process to prepare formula IV which is utilized to prepare formula V of the instant claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm. 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, Andrew Kosar can be reached at 571-272-0913. 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. /REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 14 April 2026 Rebecca Anderson Primary Examiner Art Unit 1626, Group 1620 Technology Center 1600
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Prosecution Timeline

Jul 17, 2023
Application Filed
Apr 24, 2026
Non-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

1-2
Expected OA Rounds
73%
Grant Probability
97%
With Interview (+23.7%)
2y 3m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1034 resolved cases by this examiner. Grant probability derived from career allowance rate.

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