Prosecution Insights
Last updated: July 17, 2026
Application No. 18/693,319

SPIROHETEROCYCLE DERIVATIVE HAVING SEROTONIN RECEPTOR BINDING ACTIVITY

Non-Final OA §112
Filed
Mar 19, 2024
Priority
Sep 22, 2021 — JP 2021-153715 +1 more
Examiner
OH, TAYLOR V
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shionogi & Co., Ltd.
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allowance Rate
1428 granted / 1760 resolved
+21.1% vs TC avg
Strong +16% interview lift
Without
With
+15.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
43 currently pending
Career history
1788
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
61.6%
+21.6% vs TC avg
§102
15.6%
-24.4% vs TC avg
§112
16.8%
-23.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1760 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 . Non-Final Rejection . The Status of Claims: Claims 1-28 are pending. Claims 1-26 are rejected. Claims 27-28 are withdrawn from consideration. DETAILED ACTION 1. Claims 1-26 are under consideration in this Office Action. Priority 2. It is noted that this application is a 371 of PCT/JP2022/035044 09/21/2022 , which has a foreign priority document, JAPAN JP2021-153715 09/22/2021. Drawings 3. None. IDS 4. The IDS filed on 6/13/24 and 6/25/24 have been reviewed by the examiner. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. Election/Restriction Applicant’s election without traverse of Group I (claims 1-26) on 5/27/26 is acknowledged. Claims 27-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected group II, there being no allowable generic or linking claim. The elected compound I-080, PNG media_image1.png 191 286 media_image1.png Greyscale is allowable. 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 1-26 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 pre-AIA the applicant regards as the invention. In claim 23, the expression “compounds 1-067, 1-080, 1-104, 1-105, 1-113, 1-114, 1-115, 1-125, and 1-128 " is recited. This expression is vague and indefinite because the claim does not specify what types of the compounds are in the claim The examiner recommends to put the specific chemcal structures for the compounds or their corresponding chemical names in the claim Claims 1-14, and 23-26 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex Parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and /or a common use that flows from the substantial structural feature for the following reasons : In claim 1, a compound represented by Formula (I): PNG media_image2.png 225 360 media_image2.png Greyscale R1 is a hydrogen atom, substituted or unsubstituted alkyl, substituted or unsubstituted aromatic carbocyclyl, substituted or unsubstituted non-aromatic carbocyclyl, substituted or unsubstituted aromatic heterocyclyl, or substituted or unsubstituted non-aromatic heterocyclyl. Ring B is a ring represented by Formula : PNG media_image3.png 533 535 media_image3.png Greyscale R4 is a group represented by the formula : PNG media_image4.png 167 501 media_image4.png Greyscale R10 and R11 are each independently substituted or unsubstituted aromatic carbocyclyl, substituted or unsubstituted non-aromatic carbocyclyl, substituted or unsubstituted aromatic heterocyclyl, or substituted or unsubstituted non-aromatic heterocyclyl. According to the specification, it describes that the term "aromatic carbocyclyl" means a cyclic aromatic hydrocarbon group which is monocyclic or polycyclic having two or more rings. Examples include phenyl, naphthyl, anthryl, and phenanthryl. The term "non-aromatic carbocyclyl means PNG media_image5.png 169 516 media_image5.png Greyscale , cyclodecyl, cyclopropenyl, cyclobutenyl, cyclopentenyl, cyclohexenyl, cycloheptenyl, and cyclohexadienyl, indanyl, indenyl, acenaphthyl, tetrahydronaphthyl, and fluorenyl. The aromatic heterocyclyl includes pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, furyl, thienyl, isoxazolyl, oxazolyl, oxadiazolyl, isothiazolyl, thiazolyl, and thiadiazolyl. Examples of the 6-membered aromatic heterocyclyl include pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, triazinyl, indolyl, isoindolyl, indazolyl, indolizinyl, quinolinyl, isoquinolinyl, cinnolinyl, phthalazinyl, quinazolinyl, naphthyridinyl, quinoxalinyl, purinyl, pteridinyl, benzimidazolyl, benzisoxazolyl, benzoxazolyl, benzoxadiazolyl, benzisothiazolyl, benzothiazolyl, benzothiadiazolyl, benzofuryl, isobenzofuryl, benzothienyl, benzotriazolyl, imidazopyridyl, triazolopyridyl, imidazothiazolyl, pyrazinopyridazinyl, oxazolopyridyl, and thiazolopyridyI, carbazolyl, acridinyl, xanthenyl, phenothiazinyl, phenoxathiinyl, phenoxazinyl, and dibenzofuryl, pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, isoxazolyl, oxazolyl, oxadiazolyl, isothiazolyl, thiazolyl, and thiadiazolyl. Examples of the 6-membered aromatic nitrogen-containing heterocyclyl include pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, triazinyl, indolyl, isoindolyl, indazolyl, indolizinyl, quinolinyl, isoquinolinyl, cinnolinyl, phthalazinyl, quinazolinyl, naphthyridinyl, quinoxalinyl, purinyl, pteridinyl, carbazolyl, acridinyl, xanthenyl, phenothiazinyl, phenoxathiinyl, phenoxazinyl, and dibenzofuryl,pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, isoxazolyl, oxazolyl, oxadiazolyl, isothiazolyl, thiazolyl, thiadiazolyl, pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, triazinyl. indolyl, isoindolyl, indazolyl, indolizinyl, quinolinyl, isoquinolinyl, cinnolinyl, phthalazinyl, quinazolinyl, naphthyridinyl, quinoxalinyl, purinyl, pteridinyl, benzimidazolyl, benzisoxazolyl, benzoxazolyl, benzoxadiazolyl, benzisothiazolyl, benzothiazolyl, benzothiadiazolyl, benzotriazolyl, imidazopyridyl, triazolopyridyl, imidazothiazolyl, pyrazinopyridazinyl, oxazolopyridyl, and thiazolopyridyl, carbazolyl, acridinyl, and phenothiazinyl, [Chemical formula 34] PNG media_image6.png 165 417 media_image6.png Greyscale ,oxathiolanyl, thiazolidinyl, pyrrolidinyl, pyrrolinyl,imidazolidinyl, imidazolinyl, pyrazolidinyl, pyrazolinyl, tetrahydrofuryl, dihydrothiazolyl, tetrahydroisothiazolyl, dioxolanyl, dioxolyl, thiolanyl, dioxanyl, thianyl, piperidyl, piperazinyl, morpholinyl, morpholino, thiomorpholinyl, thiomorpholino, dihydropyridyl, tetrahydropyridyl, tetrahydropyranyl, dihydrooxazinyl,tetrahydropyridazinyl, hexahydropyrimidinyl, dioxazinyl, thiinyl, thiazinyl, hexahydroazepinyl,tetrahydrodiazepinyl, oxepanyl azocane, thiocane , oxocane,indolinyl, isoindolinyl, chromanyl, and isochromanyl, PNG media_image7.png 194 538 media_image7.png Greyscale and . PNG media_image8.png 200 933 media_image8.png Greyscale From the above, it is estimated that each of the variable R1, R10 and R11 contains at least 212 different compounds and the ring B with a subset of numerous with a subset of numerous substituents has 30 different compounds and R4 has 4 different formulas with a subset of numerous substituents and other variables with numerous substituents. The claims 1-14, 23-26 do read on an extremely high number of possible species due to all the permutations and combinations in terms of mathematically speaking. There is no substantial structural feature (for example a common core) shared by all species; furthermore, there is no indication that the species share a specific common on utility. In response to this rejection, Applicant should either amend the claims to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims in a fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. Claims 15-22 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex Parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and /or a common use that flows from the substantial structural feature for the following reasons : In claim 15, a compound represented by Formula (III) PNG media_image9.png 171 282 media_image9.png Greyscale wherein R31 is a hydrogen atom or Cl-C3 alkyl; R32 is each independently a hydrogen atom or substituted or unsubstituted alkyl; R33 is each independently a hydrogen atom or substituted or unsubstituted alkyl; R34 is each independently a hydrogen atom, halogen, or substituted or unsubstituted alkyl; R35 is each independently a hydrogen atom, halogen, or substituted or unsubstituted alkyl; R32 and R33 and R34 and R35 may be taken together with an identical carbon atom to which they are bonded to form a substituted or unsubstituted non-aromatic carbocycle or a substituted or unsubstituted non-aromatic heterocycle; ring B' is a group represented by Formula: PNG media_image10.png 154 788 media_image10.png Greyscale Wherein R6 is a group represented by Formula: PNG media_image11.png 200 400 media_image11.png Greyscale PNG media_image12.png 200 400 media_image12.png Greyscale PNG media_image13.png 200 400 media_image13.png Greyscale PNG media_image14.png 200 400 media_image14.png Greyscale PNG media_image15.png 200 400 media_image15.png Greyscale According to the specification, it describes that the term "aromatic carbocyclyl" means a cyclic aromatic hydrocarbon group which is monocyclic or polycyclic having two or more rings. Examples include phenyl, naphthyl, anthryl, and phenanthryl. The aromatic heterocyclyl includes pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, furyl, thienyl, isoxazolyl, oxazolyl, oxadiazolyl, isothiazolyl, thiazolyl, and thiadiazolyl. Examples of the 6-membered aromatic heterocyclyl include pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, triazinyl, indolyl, isoindolyl, indazolyl, indolizinyl, quinolinyl, isoquinolinyl, cinnolinyl, phthalazinyl, quinazolinyl, naphthyridinyl, quinoxalinyl, purinyl, pteridinyl, benzimidazolyl, benzisoxazolyl, benzoxazolyl, benzoxadiazolyl, benzisothiazolyl, benzothiazolyl, benzothiadiazolyl, benzofuryl, isobenzofuryl, benzothienyl, benzotriazolyl, imidazopyridyl, triazolopyridyl, imidazothiazolyl, pyrazinopyridazinyl, oxazolopyridyl, and thiazolopyridyI, carbazolyl, acridinyl, xanthenyl, phenothiazinyl, phenoxathiinyl, phenoxazinyl, and dibenzofuryl, pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, isoxazolyl, oxazolyl, oxadiazolyl, isothiazolyl, thiazolyl, and thiadiazolyl. Examples of the 6-membered aromatic nitrogen-containing heterocyclyl include pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, triazinyl, indolyl, isoindolyl, indazolyl, indolizinyl, quinolinyl, isoquinolinyl, cinnolinyl, phthalazinyl, quinazolinyl, naphthyridinyl, quinoxalinyl, purinyl, pteridinyl, carbazolyl, acridinyl, xanthenyl, phenothiazinyl, phenoxathiinyl, phenoxazinyl, and dibenzofuryl,pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, isoxazolyl, oxazolyl, oxadiazolyl, isothiazolyl, thiazolyl, thiadiazolyl, pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, triazinyl. indolyl, isoindolyl, indazolyl, indolizinyl, quinolinyl, isoquinolinyl, cinnolinyl, phthalazinyl, quinazolinyl, naphthyridinyl, quinoxalinyl, purinyl, pteridinyl, benzimidazolyl, benzisoxazolyl, benzoxazolyl, benzoxadiazolyl, benzisothiazolyl, benzothiazolyl, benzothiadiazolyl, benzotriazolyl, imidazopyridyl, triazolopyridyl, imidazothiazolyl, pyrazinopyridazinyl, oxazolopyridyl, and thiazolopyridyl, carbazolyl, acridinyl, and phenothiazinyl, The term "non-aromatic carbocyclyl means PNG media_image5.png 169 516 media_image5.png Greyscale , cyclodecyl, cyclopropenyl, cyclobutenyl, cyclopentenyl, cyclohexenyl, cycloheptenyl, and cyclohexadienyl, indanyl, indenyl, acenaphthyl, tetrahydronaphthyl, and fluorenyl. The aromatic heterocyclyl includes pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, furyl, thienyl, isoxazolyl, oxazolyl, oxadiazolyl, isothiazolyl, thiazolyl, and thiadiazolyl. Examples of the 6-membered aromatic heterocyclyl include pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, triazinyl, indolyl, isoindolyl, indazolyl, indolizinyl, quinolinyl, isoquinolinyl, cinnolinyl, phthalazinyl, quinazolinyl, naphthyridinyl, quinoxalinyl, purinyl, pteridinyl, benzimidazolyl, benzisoxazolyl, benzoxazolyl, benzoxadiazolyl, benzisothiazolyl, benzothiazolyl, benzothiadiazolyl, benzofuryl, isobenzofuryl, benzothienyl, benzotriazolyl, imidazopyridyl, triazolopyridyl, imidazothiazolyl, pyrazinopyridazinyl, oxazolopyridyl, and thiazolopyridyI, carbazolyl, acridinyl, xanthenyl, phenothiazinyl, phenoxathiinyl, phenoxazinyl, and dibenzofuryl, pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, isoxazolyl, oxazolyl, oxadiazolyl, isothiazolyl, thiazolyl, and thiadiazolyl. Examples of the 6-membered aromatic nitrogen-containing heterocyclyl include pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, triazinyl, indolyl, isoindolyl, indazolyl, indolizinyl, quinolinyl, isoquinolinyl, cinnolinyl, phthalazinyl, quinazolinyl, naphthyridinyl, quinoxalinyl, purinyl, pteridinyl, carbazolyl, acridinyl, xanthenyl, phenothiazinyl, phenoxathiinyl, phenoxazinyl, and dibenzofuryl,pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, isoxazolyl, oxazolyl, oxadiazolyl, isothiazolyl, thiazolyl, thiadiazolyl, pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, triazinyl. indolyl, isoindolyl, indazolyl, indolizinyl, quinolinyl, isoquinolinyl, cinnolinyl, phthalazinyl, quinazolinyl, naphthyridinyl, quinoxalinyl, purinyl, pteridinyl, benzimidazolyl, benzisoxazolyl, benzoxazolyl, benzoxadiazolyl, benzisothiazolyl, benzothiazolyl, benzothiadiazolyl, benzotriazolyl, imidazopyridyl, triazolopyridyl, imidazothiazolyl, pyrazinopyridazinyl, oxazolopyridyl, and thiazolopyridyl, carbazolyl, acridinyl, and phenothiazinyl, [Chemical formula 34] PNG media_image6.png 165 417 media_image6.png Greyscale ,oxathiolanyl, thiazolidinyl, pyrrolidinyl, pyrrolinyl,imidazolidinyl, imidazolinyl, pyrazolidinyl, pyrazolinyl, tetrahydrofuryl, dihydrothiazolyl, tetrahydroisothiazolyl, dioxolanyl, dioxolyl, thiolanyl, dioxanyl, thianyl, piperidyl, piperazinyl, morpholinyl, morpholino, thiomorpholinyl, thiomorpholino, dihydropyridyl, tetrahydropyridyl, tetrahydropyranyl, dihydrooxazinyl,tetrahydropyridazinyl, hexahydropyrimidinyl, dioxazinyl, thiinyl, thiazinyl, hexahydroazepinyl,tetrahydrodiazepinyl, oxepanyl azocane, thiocane , oxocane,indolinyl, isoindolinyl, chromanyl, and isochromanyl, and . PNG media_image8.png 200 933 media_image8.png Greyscale PNG media_image7.png 194 538 media_image7.png Greyscale From the above, it is estimated that R32 and R33 and R34 and R35 taken together with an identical carbon atom contain at least 65 different compounds and the ring B’ with a subset of numerous substituents has 4 different compounds of Formula and R6 has 2 different formulas with a subset of numerous substituents including the variable of R24 having at least 212 different compounds and R6’ has a formula with a subset of numerous substituents including the variable of R26 having at least 212 different compounds and R7 has a formula with a subset of numerous substituents including the variable of R23 having at least 212 different compounds and other variables with numerous substituents. The claims 15-22 do read on an extremely high number of possible species due to all the permutations and combinations in terms of mathematically speaking. There is no substantial structural feature (for example a common core) shared by all species; furthermore, there is no indication that the species share a specific common on utility. In response to this rejection, Applicant should either amend the claims to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims in a fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. Conclusion Claims 1-26 are rejected. Claims 27-28 are withdrawn from consideration. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00. 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. /TAYLOR V OH/Primary Examiner, Art Unit 1625 6/23/2026
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Prosecution Timeline

Mar 19, 2024
Application Filed
Jun 26, 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
81%
Grant Probability
97%
With Interview (+15.5%)
2y 3m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1760 resolved cases by this examiner. Grant probability derived from career allowance rate.

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