Prosecution Insights
Last updated: July 17, 2026
Application No. 18/516,710

SPIRO COMPOUND AND USE THEREOF

Non-Final OA §112
Filed
Nov 21, 2023
Priority
May 21, 2021 — CN 202110557549.0 +2 more
Examiner
SHIM, DAVID M.
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Cspc Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
3m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
51 granted / 88 resolved
-2.0% vs TC avg
Strong +56% interview lift
Without
With
+55.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
63 currently pending
Career history
126
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
59.1%
+19.1% vs TC avg
§102
13.1%
-26.9% vs TC avg
§112
19.7%
-20.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 88 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 Claims 39-58 are pending in the application. Claims 39, 46-50, 52 and 53 are rejected. Claim 48 is objected to. Claims 40-45, 51 and 54-58 are withdrawn. Restriction/Election of Species Applicant’s election without traverse of Group I, presently canceled claims 28-36, and further elected species of Compound 56, having the structure below, in the reply filed on March 19, 2026 is acknowledged: PNG media_image1.png 185 340 media_image1.png Greyscale . Previously pending claims 28-38 are canceled by Applicant. Newly added claims 39, 46-50, 52 and 53 read on Group I and Applicant’s elected species. Newly added claims 40-45, 51 and 54-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (i.e., Group II) or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 19, 2026. As per MPEP § 803.02(III), the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears to be free of the prior art. Therefore, according to MPEP § 803.02(III): should the elected species be found allowable over the prior art, the examination of the Markush claim will be extended. The prior art search will be extended to cover non-elected species or group of species that fall within the scope of a proper Markush grouping which includes the elected species. The prior art search will not be extended unnecessarily to cover all nonelected species, and need not be extended beyond a proper Markush grouping. However, if prior art is found that anticipates or renders obvious the Markush claims with respect to a nonelected species, the Markush claims shall be rejected and claims to the nonelected species held withdrawn from further consideration. Consequently, the prior art search was extended to include the full scope of a compound represented by formula (I), as recited in instant claim 39, but did not result in prior art being found. Priority This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2022/094255, filed on May 20, 2022, which claims priority to Chinese Application No. CN202111000088.3, filed on August 27, 2021, which claims priority to Chinese Application No. CN202110557549.0, filed on May 21, 2021. Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The Information Disclosure Statement(s) (IDS) filed on December 18, 2023 and July 14, 2025 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached. Claim Objections Claim 48 is objected to because of the following informalities: Claim 48 should be amended to replace “or 3-6 membered” with “and 3-6 membered” for proper Markush language and consistency. Claim 48 should further be amended to include the word “and” between the two recited alternatives for variable “R2” for sake of clarity. Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 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 39, 46-50, 52 and 53 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 39 recites the limitation “the heteroatoms in the heterocycloalkyl and heteroaryl are independently selected from O, N, and S, and the number of heteroatoms is 1 or 2” in the last two lines of the claim and is rejected as indefinite. It is unclear if the “heteroaryl” in this expression is in reference to the “5-6 membered heteroaryl” as recited for variable “R3.” If this was Applicant’s intent, then the above expression, with respect to heteroaryl, would be considered redundant as the heteroatoms in the previously recited “5-6 membered heteroaryl” already require the same further limitation. It is suggested Applicant revise the above expression to be limited to “the heterocycloalkyl” for sake of clarity and consistency. Dependent claims 46-52 and 53 do not correct this issue of indefiniteness and are hence rejected as indefinite. Claim 50 is rejected as indefinite because the full chemical structure is not shown for Compound Nos. 5, 10 and 21. Claim Rejections - 35 USC § 112(d) The following is a quotation of 35 U.S.C. § 112(d): (d) REFERENCE IN DEPENDENT FORMS — Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. § 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 48 and 50 are rejected under 35 U.S.C. § 112(d) or pre-AIA 35 U.S.C. § 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 48 recites the limitation “R2 is...3-6 membered heterocycloalkyl.” However, with respect to variable “R2,” parent claim 39 provides for “an unsubstituted 3-6 membered heterocycloalkyl” (emphasis added). Therefore, claim 48 is broader in scope than and, consequently, fails to include all the limitations of parent claim 39. Applicant should include the word “unsubstituted” before “3-6 membered heterocycloalkyl” in the above limitation for sake of consistency. Claim 50 recites the following structures that are not encompassed by variable definitions of the compound represented by formula (I) as recited in parent claim 39: PNG media_image2.png 177 403 media_image2.png Greyscale PNG media_image3.png 319 416 media_image3.png Greyscale . Therefore, claim 50 fails to include all the limitations of parent claim 39. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST. 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, RENEE CLAYTOR can be reached at (571)272-8394. 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.S./Examiner, Art Unit 1626 /KAMAL A SAEED/Primary Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Nov 21, 2023
Application Filed
May 28, 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
58%
Grant Probability
99%
With Interview (+55.9%)
2y 11m (~3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 88 resolved cases by this examiner. Grant probability derived from career allowance rate.

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