Office Action Predictor
Last updated: April 15, 2026
Application No. 18/254,209

COMPOSITIONS AND METHODS FOR TREATING CNS DISORDERS

Non-Final OA §102§112
Filed
May 24, 2023
Examiner
YOO, SUN JAE
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Sage Therapeutics, INC.
OA Round
2 (Non-Final)
71%
Grant Probability
Favorable
2-3
OA Rounds
2y 8m
To Grant
72%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allow Rate
869 granted / 1225 resolved
+10.9% vs TC avg
Minimal +1% lift
Without
With
+1.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
43 currently pending
Career history
1268
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
14.5%
-25.5% vs TC avg
§102
29.8%
-10.2% vs TC avg
§112
32.6%
-7.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1225 resolved cases

Office Action

§102 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. 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 2. Applicant’s election without traverse of compound 1 ( PNG media_image1.png 140 258 media_image1.png Greyscale ) in the reply filed on November 18, 2025 is acknowledged. 3. Examination followed guidelines provided by MPEP 803.02. The elected species appeared to be allowable. Therefore, the search and examination was extended. Prior art was found that anticipates the claims with respect to a nonelected species. The Markush claims were rejected and claims to nonelected species were withdrawn from further consideration. The claims were searched to the extent of the elected species, the full scope of claims 21, 25, 48 and 52, and further to the extent of the nonelected species shown below in this office action. 4. Claims 19, 20, 22-24, 26-29, 35, 36, 46, 47, 49-51, 53-58, 60, 61, 64 67, 69, 70, 73-83, 85, 86, 89, 91-100, 103, 107, 110, 113, 116, 117, 120-128, 132, 133, 135, 137-147, 151, 152, 156, 160, 162, 163, 167, 168, 171, 175, 176, 179 and 181 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on November 18, 2025. Status of Claims 5. Claims 1-3, 5, 6, 10, 12, 13, 16-31, 34-36, 38, 39, 42, 44-58, 60, 61, 64, 67, 69, 70, 73-83, 85, 86, 89, 91-100, 103, 107, 110, 113, 116, 117, 120-128, 132, 133, 135, 137-147, 151, 152, 156, 160, 162, 163, 167, 168, 171,175, 176, 179, 181, 185 and 186 are pending. 6. Claims 1-3, 5, 6, 10, 12, 13, 16, 17, 18, 21, 25, 30, 31, 34, 38, 39, 42, 44, 45, 48, 52, 185 and 186 are elected. Claims 1 and 185 are independent. Information Disclosure Statement 7. The information disclosure statements (dated May 17, 2024 and November 18, 2025) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith. Claim Objections 8. Claims 21, 25, 48 and 52 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. 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. 9. Claim 1 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. Variable R20C is defined twice, once of page 2 line 8 and also on page 3 line 20. It is not possible to ascertain the structural limitations for this component as the two definitions provide different embodiments. Appropriate correction is required. For the purpose of examination, the first definition of variable R20C was used. 10. Claim 42 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. The claim depends from claim 40 which has been cancelled. Furthermore, the claim does not fully define the structure of the compounds. For this reason, the metes and bound of the claims cannot be ascertained. This claim was not further examined on the merits because the structural limitations could not be determined. Claim Rejections - 35 USC § 112 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. 11. Claims 3 and 10 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 3 refers to variable R3 = -H, C1-6 alkyl optionally substituted with R’, -N(R’)2, or -OR’. Claim 3 depends from claim 2 which defines R3=-LA-R30. The embodiment of C1-6 alkyl optionally substituted with R’ from claim 3 is not present in the definition of R3 in claim 2. Based on the definition of R3 in claim 2, if R3=optionally substituted C1-6 alkyl it can only optionally be substituted with 1-3 groups independently selected from halo, -OH, -CN, -NO2, -CF3, -CH3, -CH2OH or -C(CH3)3. Therefore, claim 3 is directed to an embodiment in addition to that present in claim 2 and thus does not further narrow. Similarly, claim 10 (which depends from claim 2) refers to R20a and R20b as having the embodiment of C1-6 alkyl optionally substituted with R’ whereas in claim 2 if R20a= and R20b=optionally substituted C1-6 alkyl they can only optionally be substituted with 1-3 groups independently selected from halo, -OH, -CN, -NO2, -CF3, -CH3, -CH2OH or -C(CH3)3. 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. 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. 12. Claim(s) 1-3, 5, 6, 10, 12, 17, 18, 30, 31, 34, 38, 39, 44, 186 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019154257. The reference has a publication date of August 15, 2019 which antedates the present claims having an effective filing date of November 22, 2021 and priority claim to provisional applications dated November 25, 2020. The reference teaches compounds such as PNG media_image2.png 94 128 media_image2.png Greyscale (page 16, compound 1) which corresponds to the present claims in the following manner: R1a=R1b=R2a=R2b=R4a=R4b=R6a=R6b=R7a=R7b=R11a=R11b=R12a=R12b= -LA(bond)-R30(=R’=H); n=1; R3=R13=-LA(bond)-R30(=R’=alkyl); R10=-H; D= PNG media_image3.png 122 112 media_image3.png Greyscale ; R21=-LA(bond)-R30(=R’=methyl); R20a and R20b from oxo; R31a=R31b=H; R5=Me. 13. Claim(s) 1-3, 5, 6, 10, 12, 13, 16, and 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 2369000-50-8 ( PNG media_image4.png 212 332 media_image4.png Greyscale ). The reference has a publication date of August 27, 2019 which antedates the present claims having an effective filing date of November 22, 2021 and priority claim to provisional applications dated November 25, 2020. The compound corresponds to the present claims in the following manner: R1a=R1b=R2a=R2b=R4a=R4b=R6a=R6b=R7a=R7b=R11a=R11b=R12a=R12b= -LA(bond)-R30(=R’=H); n=1; R3=R13=-LA(bond)-R30(=R’=alkyl); R10=-H; D= PNG media_image5.png 120 116 media_image5.png Greyscale ; R21=-LA(alkyl)-R30(=R’=heteroaryl); R20a and R20b from oxo; R31a=R31b=H. 14. Claim(s) 185 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 2368809 ( PNG media_image6.png 142 290 media_image6.png Greyscale ). The reference has a publication date of August 23, 2019 which antedates the present claims having an effective filing date of November 22, 2021 and priority claim to provisional applications dated November 25, 2020. The compound corresponds to claimed compound #9 on page 68. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN JAE YOO whose telephone number is (571)272-9074. The examiner can normally be reached Mon-Fri 8-5. 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. 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. /SUN JAE YOO/Primary Examiner, Art Unit 1621
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Prosecution Timeline

May 24, 2023
Application Filed
Dec 19, 2025
Non-Final Rejection — §102, §112
Mar 20, 2026
Response Filed
Apr 09, 2026
Final Rejection — §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

2-3
Expected OA Rounds
71%
Grant Probability
72%
With Interview (+1.0%)
2y 8m
Median Time to Grant
Moderate
PTA Risk
Based on 1225 resolved cases by this examiner. Grant probability derived from career allow rate.

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