Prosecution Insights
Last updated: October 25, 2026
Application No. 18/744,303

COMPOUNDS HAVING S1P5 RECEPTOR AGONISTIC ACTIVITY

Non-Final OA §102§112
Filed
Jun 14, 2024
Priority
Feb 22, 2018 — JP 2018-029549 +3 more
Examiner
HUTTER, GILLIAN A
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Ono Pharmaceutical Co., Ltd.
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
6m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allowance Rate
67 granted / 123 resolved
-5.5% vs TC avg
Strong +46% interview lift
Without
With
+46.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
55 currently pending
Career history
185
Total Applications
across all art units

Statute-Specific Performance

§101
3.1%
-36.9% vs TC avg
§103
40.8%
+0.8% vs TC avg
§102
21.7%
-18.3% vs TC avg
§112
21.4%
-18.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 123 resolved cases

Office Action

§102 §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 . Election/Restrictions Applicant’s election without traverse of Group I in the reply filed on 08/13/2026 is acknowledged. Applicants elected the compound PNG media_image1.png 66 506 media_image1.png Greyscale , which is depicted below. PNG media_image2.png 457 618 media_image2.png Greyscale This compound was indexed into STN September 3, 2019 (after the effective filing date). The Markush group was extended to PNG media_image3.png 227 500 media_image3.png Greyscale . This compound maps to formula (V) wherein L is selected to be a linear chain group composed of carbon, oxygen, and sulfur atoms, wherein one of the carbon atoms is substituted with 3 halogen atoms, Y is selected to be N ring 2, R3 and R4 are H, the ring 2 is a 4-memebered nitrogen-containing heterocycle, n is 0, Z is selected to be a carboxyl group, R1 is methyl, and m is 1. Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/13/2026. Current Status of 18/744,303 This Office Action is responsive to the original claims of 06/14/2024. Claims 1-14 are examined on the merits. Priority This Application is a continuation of US patent 12049445, which also is a divisional of US patent 11198672. The application also claims foreign priority to JP2018/029549. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. A review of the file wrapper indicates a Japanese language foreign priority document. However, since it is not in English, a judgement cannot be made as to whether it supports the instant claims, which is required to perfect foreign priority. The conditions of 35 U.S.C. § 119(a)-(d) or (f) are not met. Therefore, the effective filing date for the instant claims is the international filing date of 02/21/2019. Information Disclosure Statement The information disclosure statement (IDS) submitted on 06/14/2024, and 05/20/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claim 1 is objected to because of the following informalities: Linear (“liner”) is spelt wrong in the third line of L’s limitation. Claim 1 is objected to for containing illustrations that lack a squiggle mark which denotes the point of attachment to the genus formula. Currently in use is an arrow pointing from A to Z (in Y’s limitation). Examiner highly recommends using squiggle marks. Claim 1 is objected to because in the drawing of formula (V) ring 2 looks like it is written like “ring2” while in the claims it is referred to as “ring 2”. To avoid confusion that they could be referring to different rings, choose a constant name. Also see Claim 7 which does the same for “ring2-1”. Claim 8 recites “same meaning as describe in claim 1”. Describe should be described. 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 1-14 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 the limitation “wherein the carbon atom in L is optionally substituted with 1 to 13 halogen atoms”. This limitation is physically impossible since one carbon atom can have 4 single bonds maximum. Therefore, the metes and bounds of claim 1 are unclear and thus indefinite. Dependent claims 2-14 are similarly rejected for not resolving the rationale underpinning this rejection. Claim 1 recites the limitation “and the branched or liner chain group optionally contains 1 to 3 heteroatoms”. Examiner in unsure if the 3 to 8 atoms is the total number of atoms allowed by L OR if the “optionally contains 1 to 3 heteroatoms” is an additional 1 to 3 atoms (i.e. the total atoms allowed in L is 4 to 11). Therefore, the metes and bounds of claim 1 are unclear and thus indefinite. Dependent claims 2-14 are similarly rejected for not resolving the rationale underpinning this rejection. Claim 1 recites the limitation "the compound" in the last two lines of the claim. Claim 1 recites earlier “a compound of the following formula (V)”. There is insufficient antecedent basis for this limitation in the claim. Changing “the compound” to “the compound of formula (V)” would resolve this rejection. Dependent claims 2-14 are similarly rejected for not resolving the rationale underpinning this rejection. Claim 1 recites the limitation “represents” for limitations Y, A, R1-5, Z, Ring 2, m, and n. This is not physically possible. Compounds of formula (V) cannot be represented. Examiner suggests “selected to be”, or “is”. Therefore, the metes and bounds of claim 1 are unclear and thus indefinite. Dependent claims 2-14 are similarly rejected for not resolving the rationale underpinning this rejection. Claim Rejections - 35 USC § 102 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. Claim(s) 1-4, 6-8, 10-11, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KUSUMI (WO 2016/088834 Al). KUSUMI anticipates the compound depicted below PNG media_image3.png 227 500 media_image3.png Greyscale (example 12 on page 47). This compound maps to formula (V) wherein L is selected to be a linear chain group composed of carbon, oxygen, and sulfur atoms, wherein one of the carbon atoms is substituted with 3 halogen atoms, Y is selected to be N ring 2, R3 and R4 are H, the ring 2 is a 4-memebered nitrogen-containing heterocycle, n is 0, Z is selected to be a carboxyl group, R1 is methyl, and m is 1. This compound is also not the compound in claim 1’s proviso. This anticipates claims 1-4, 6-8, 10-11. KUSUMI anticipates a pharmaceutical composition comprising a compound (such as the one above) (ref claim 9). This anticipates claims 13-14. Conclusion No claims are allowed as currently written. There are two patents in the patent family. They are not double patents because at the end of instant claim 1, there is a proviso disclaiming out that compound used in both patents. Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5. 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. /G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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Prosecution Timeline

Jun 14, 2024
Application Filed
Sep 30, 2026
Non-Final Rejection mailed — §102, §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
54%
Grant Probability
99%
With Interview (+46.0%)
2y 11m (~6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 123 resolved cases by this examiner. Grant probability derived from career allowance rate.

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