Prosecution Insights
Last updated: August 15, 2026
Application No. 18/696,960

PIKFYVE KINASE INHIBITOR

Non-Final OA §112
Filed
Oct 02, 2024
Priority
Sep 30, 2021 — RE 10-2021-0129839 +1 more
Examiner
SHIM, DAVID M.
Art Unit
Tech Center
Assignee
Hanmi Pharm. Co., Ltd.
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
1y 0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
52 granted / 90 resolved
-2.2% vs TC avg
Strong +56% interview lift
Without
With
+55.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
67 currently pending
Career history
128
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
37.4%
-2.6% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
35.8%
-4.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 90 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 1-7 are pending in the application. Claims 2 and 3 are rejected. Claims 1-3 and 5-7 are objected to. Claim 4 is allowable. Priority This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/KR2022/014781, filed on September 30, 2022, which claims priority to Korean Application No. KR10-2021-0129839, filed on September 30, 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 March 28, 2024 is 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 1-3 and 5-7 are objected to because of the following informalities: Claim 1 should be amended to recite, “A compound of Formula (1)” for clarity and consistency. Claim 1 should be amended to include the word “wherein” before the recited variable definition for ring B (i.e., after preamble) for proper Markush language. Claim 1 should be amended to recite, “n is an integer from [[of]] 0 to 4” for sake of clarity and consistency. Claim 1 should be amended to recite, “k is an integer from [[of]] 0 to 4” for sake of clarity and consistency. Claim 1 should be amended to recite, “p is an integer from [[of]] 0 to 4” for sake of clarity and consistency. Claim 1 should be amended to recite, “q is an integer from [[of]] 0 to 4” for sake of clarity and consistency. Claim 1 should be amended to include the word “and” before the recited variable definition for ring A for proper Markush language. Claim 2 should be amended to recite, “...is one selected from the group consisting of...” for sake of clarity and consistency. Claim 3 should be amended to recite, “...is one selected from the group consisting of...” for sake of clarity and consistency. Claim 5 should be amended to recite, “...is one selected from the group consisting of...” for sake of clarity and consistency. Claim 6 should be amended to recite, “...is one selected from the group consisting of...” for sake of clarity and consistency. Claim 7 should be amended to recite, “...consisting of the following compounds[[.]]:” for proper claim format. Claim 7 should be amended to correct for the typographical errors found in the nomenclatures for compound 30 and 31. 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. Claim 3 is 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 3 recites the following as alternative definitions for variable ring A and is rejected as indefinite: PNG media_image1.png 103 443 media_image1.png Greyscale . It is unclear where Applicant intended the point of attachment to be for the above moieties with respect to a compound of Formula (1). 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 2 and 3 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 2 recites PNG media_image2.png 102 119 media_image2.png Greyscale as an alternative for variable ring B. However, parent claim 1 does not provide for a 1,2-diazole moiety in the definition of ring B. Therefore, claim 2 fails to include all the limitations of parent claim 1. Claim 3 recites PNG media_image3.png 73 141 media_image3.png Greyscale as an alternative for variable ring A. However, parent claim 1 does not provide for variable Y6 being defined as an oxygen atom. At least for this reason, claim 3 fails to include all the limitations of parent claim 1. Claim 3 recites PNG media_image4.png 80 137 media_image4.png Greyscale as an alternative for variable ring A. However, parent claim 1 does not provide for variable Y6 being defined as a sulfur atom. At least for this reason, claim 3 fails to include all the limitations of parent claim 1. 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. Allowable Subject Matter Claims 1-7 are free of the prior art. Claim 4 is allowable. Claims 1-3 and 5-7 would also be allowable if amended to overcome the claim objection(s) and/or rejection(s) under 35 U.S.C. § 112 as indicated above. Closest Prior Art The closest prior art is Deng et al. (PCT Publication No. WO 2019/024908 A1; February 7, 2019) which teach the following compound VII-a-7 on e.g., page 78: PNG media_image5.png 136 227 media_image5.png Greyscale . The above prior art compound is encompassed by variable definitions of the instantly claimed compound of Formula (1), wherein ring A is PNG media_image6.png 105 129 media_image6.png Greyscale and Y1 and Y2 are each CH. The above prior art compound, however, does not correlate to the instantly claimed compound of formula (1) with respect to variable R4 (i.e., haloalkyl in prior art compound) and ring B (i.e., absent in prior art compound). Furthermore, the prior art does not provide any teaching, suggestion or motivation to modify the above prior art compound to arrive at the instantly claimed invention. Accordingly, instant claims 1-7 are not prima facie obvious over the prior art. Conclusion Claims 2 and 3 are rejected. Claims 1-3 and 5-7 are objected to. Claim 4 is allowable. 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
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Prosecution Timeline

Oct 02, 2024
Application Filed
Jul 21, 2026
Non-Final Rejection mailed — §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
58%
Grant Probability
99%
With Interview (+55.9%)
2y 11m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 90 resolved cases by this examiner. Grant probability derived from career allowance rate.

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