Prosecution Insights
Last updated: April 18, 2026
Application No. 18/343,732

2-AMINOPYRIMIDINE COMPOUND AND PHARMACEUTICAL COMPOSITION THEREOF AND APPLICATION THEREOF

Final Rejection §112
Filed
Jun 28, 2023
Examiner
NESTOR, DONNA MICHELLE
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Jinan University
OA Round
2 (Final)
57%
Grant Probability
Moderate
3-4
OA Rounds
3y 3m
To Grant
99%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allow Rate
35 granted / 61 resolved
-2.6% vs TC avg
Strong +50% interview lift
Without
With
+49.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
38 currently pending
Career history
99
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
33.9%
-6.1% vs TC avg
§102
16.1%
-23.9% vs TC avg
§112
25.9%
-14.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 61 resolved cases

Office Action

§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. Priority This application, filed 28 June, 2023, is a CON of a national stage application of PCT/CN2021/143765, filed 31 December, 2021, which claims foreign benefit of Application N° CN202110032031.5, filed 11 January, 2021. Information Disclosure Statement The information disclosure statement (IDS) submitted on 28 June, 2023 is acknowledged and has been considered. Status of the Application Receipt is acknowledged of Applicant’s claimed invention, filed 28 June, 2023 , in the matter of Application N° 18/ 343 , 732 . Said documents have been entered on the record. No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot. Thus, C laims 1- 20 represent all claims currently under consideration. Claim Objections Claims 1- 16 and 18- 20 are objected to because of the following informalities: unclear terminology, grammatical construction, or phrasing. These objections are made under 37 C.F.R. 1.75 and MPEP §§ 608.01 and 2173.05. as the claim language contains informal, unclear, or grammatically improper expressions that hinder precise interpretation but do not rise to the level of indefiniteness. Although understandable to a person skilled in the art, the language is objected to as informal and unclear. Claim 1 recites , Pg. 2, Lines 8-10, “ each R 10 is independently selected from: … one or more R11 substituted or unsubstituted C1-C3 alkyl groups, one or more R11 substituted or unsubstituted C1-C3 alkoxy groups ” which is syntactically improper when defining a single substituent and makes interpretation unnecessarily difficult. One suggested correction might be to replace with “ a C1-C3 alkyl group optionally substituted with one or more R11 groups” , and similarly with the alkoxy groups. Claim 1 recites, Pg. 1, Line 11, “formamide groups” is not standard nomenclature for a substituent and is objectionable for improper and unclear terminology. One suggested correction might be to replace the term with “formamido groups” and/or “(-NH-C(=O)H).” Claim 1 recites, Pg. 1, Lines 15-16, “ one or more R12 with ring atoms containing 0, 1, 2, or 3 heteroatoms ”, which is grammatically ambiguous as to whether the heteroatoms modify R12 or the substituted ring. One suggested correction is to replace with “a ring containing 0-3 heteroatoms and optionally substituted with one or more R12 groups.” Claim 1 recites, Pg. 2, Lines 3-4, “ one or more R11 substituted or unsubstituted C1-C6 alkyl groups ” is improper when defining a single R group. One suggested correction might be to replace with “a C1-C6 alkyl group optionally substituted with one or more R11 groups.” Claim 1 repeats the unclear grammatical construction in the alternative definition of R10 in the Ring A subsection, Pg. 2, Lines 9-11, “ one or more R 11 substituted or unsubstituted C1-C3 alkyl groups, one or more R11 substituted or unsubstituted C1-C3 alkoxy groups .” One suggested correction might be to replace with “a C1-C3 alkyl group optionally substituted with one or more R11 groups” and similarly for the alkoxy group. Claim s 2 -6 recite “…[Ring] A is selected from the following groups :” which does not clearly define the closed set. One suggested correction might be to replace with “ [Ring] A is selected from the group consisting of the following structures:”. Claims 2 - 16 , and 18-20 recite lis t(s) of selections, however, the lists are missing the final conjunction (e.g., “and” or “or”) before the last depicted component/ structure. Claim 11, and similarly Claim 12, recites “…each R3 and each R4 are independently selected from: H, one or more R12 substituted C1-C3 alkyl groups, or R3, R4, together with the attached N or C to form a 5-11 membered…” These two roles are not syntactically separated making it unclear whether the ring-forming clause applies only to some R3/R4 alternatives or to the entire list. One suggested correction might be to replace with : “…each R3 and each R4 are independently selected from: H, or one or more R12-substituted or unsubstituted C1-C3 alkyl groups; and R3 and R4, together with the attached N or C, may form a 5-11 membered single ring, fused ring, bridge ring, or spiral ring substituted by one or more R12 groups.” Claim 1 4 recites the molecule “formamide”, which should be corrected to “ formamido group ” or “ (-C(=O)NH2). ” Additionally “halogenated C1-C6 alkoxy group” is unclear, whether the alkoxy oxygen is halogenated or the alkyl portion. One suggested correction might be to replace with “C1-C6 haloalkoxy group.” Claim 18 recites a list of species which is presented as consecutive structures without punctuation, inconsistent structural labels, and no final conjunction clearly identifying a closed set. Claim 20 presents mixed terminology: “hematomas” vs. “hematomas and solid tumors” vs. “the hematomas are multiple myeloma, B-lymphoma…” Multiple myelomas and lymphomas are not hematomas (a bruise or collection of blood). One suggested correction might be to replace “hematomas” with “hematologic malignancies.” Additionally, “psoriasis” is duplicated in the list. Appropriate correction is required. As an administrative note, Claims 19-20 are drawn to pharmaceutical compositions. The recited disease lists are interpreted as non-limiting intended-use language, because no method steps are recited and the preamble defines the claims as compositions. See MPEP §§ 2111.02 and 2114. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim s 1 -20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim s 1 - 19 recite “… compound or their pharmaceutically acceptable salts, isotope derivatives , solvates, or their stereoisomers, geometric isomers, tautomers, or prodrug molecules or metabolites .” Although the specification includes extensive synthetic examples for compounds of Formula s I and II and their salts, the disclosure does not describe any isotopically labeled derivatives, any specific prodrug structures or prodrug-forming functional groups, or any metabolites or metabolic pathways associated with the claimed compounds. The specification merely states that metabolites and prodrugs “fall within the scope” of the invention, but does not identify structural features that would enable or predict such derivatives. A generic, functional reference to prodrugs, metabolites, or isotope variants – without structural examples, representative species, or guidance on their preparation – is insufficient to demonstrate possession of the full claimed scope. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) ( en banc ) ; MPEP § 2163.03. Claim 20 is dependent from Claim 1 9 , and fail s to cure the deficiencies as stated above. 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 appl icant regards as his invention. Claim s 1 - 20 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 1 recites, Pg. 2, Lines 7-8: “ [Ring] A is a 8-10 membered saturated or p art ially saturated fused double r ing substituted with one or more R 10 with ring atoms containing 1, 2, or 3 oxygen atoms … ” The phrase “ with ring atoms containing 1, 2, or 3 oxygen atoms ” is grammatically positioned to modify R10, which is defined to include substituents such as hydrogen, halogen, alkyl, or alkoxy groups that do not contain ring atoms. This grammatical structure creates two reasonable but conflicting interpretations: the grammatical interpretation - that each R10 substituent contains ring atoms with 1-3 oxygen atoms, or the chemical interpretation - that the fused double ring A contains 1-3 oxygen atoms. Because these interpretations lead to different claim scopes, and the grammatical relationship does not make clear which meaning is intended, a person of ordinary skill in the art cannot determine the metes and bounds of the claim with reasonable certainty. Claim s 2- 20 are dependent from , or rely upon, Claim 1, and fail to cure the deficiencies as stated above. Communication Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Donna M. Nestor whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-5316 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT generally (w/flex): 5:30a-5p EST M-Th . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kortney Klinkel can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5239 . 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.M.N./ Examiner, Art Unit 1627 /Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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Prosecution Timeline

Jun 28, 2023
Application Filed
Dec 02, 2025
Non-Final Rejection — §112
Mar 13, 2026
Response Filed
Apr 09, 2026
Final Rejection — §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
57%
Grant Probability
99%
With Interview (+49.7%)
3y 3m
Median Time to Grant
Moderate
PTA Risk
Based on 61 resolved cases by this examiner. Grant probability derived from career allow rate.

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