Prosecution Insights
Last updated: May 29, 2026
Application No. 18/376,020

SUBSTITUTED AMIDE MACROCYCLIC COMPOUNDS WITH OREXIN-2 RECEPTOR AGONIST ACTIVITY

Non-Final OA §112
Filed
Oct 03, 2023
Priority
Apr 26, 2021 — provisional 63/179,616 +2 more
Examiner
VALLE, ERNESTO
Art Unit
1623
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Alkermes, Inc.
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
7m
Est. Remaining
93%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allowance Rate
12 granted / 20 resolved
At TC average
Strong +33% interview lift
Without
With
+33.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
38 currently pending
Career history
68
Total Applications
across all art units

Statute-Specific Performance

§103
62.7%
+22.7% vs TC avg
§102
12.7%
-27.3% vs TC avg
§112
9.1%
-30.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 20 resolved cases

Office Action

§112
DETAILED ACTION 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 . Priority This application is a CON of PCT/US22/26144, filed 04/25/2022, which claims the priority benefit of PRO Application No. 63/179,616, filed 04/26/2021. Information Disclosure Statement The information disclosure statements (IDS) submitted on 12/15/2023, 01/24/2024, 02/29/2024, 03/26/2025, 07/22/2025, 10/21/2025, and 03/09/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Election/Restrictions Applicant's election without traverse of Group I, claims 1, 2, 4, 6, 12, 14, 16-17, 22-23, 25-26, 28, 30-31, 33, 35, 36-37, 39, 41, 47, 49, 51-52, 57-58, 60-61, 63, 65-66, 68, 70-71, and 78, drawn to compound of Formula I and formula II or pharmaceutically acceptable salts thereof in the reply filed 03/09/2026 is acknowledged. Status of the application Claims 1, 2, 4, 6, 12, 14, 16, 17, 22, 23, 25, 26, 28, 30, 31, 33, 35-37, 39, 41, 47, 49, 51, 52, 57, 58, 60, 61, 63, 65, 66, 68, 70-73, and 78-80 are pending. Claims 3, 5, 7-11, 13, 15, 18-21, 24, 27, 29, 32, 34, 38, 40, 42-46, 48, 50, 53-56, 59, 62, 64, 67, 69, and 74-77 been cancelled without prejudice or disclaimer. Claims 72-73 and 79-80 have been withdrawn. Claims 1, 2, 4, 6, 12, 14, 16-17, 22-23, 25-26, 28, 30-31, 33, 35, 36-37, 39, 41, 47, 49, 51-52, 57-58, 60-61, 63, 65-66, 68, 70-71, and 78 are currently under examination. Specification The lengthy specification (107 pgs.) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. 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. Claim 12 is 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. The limitations of dependent claim 12 cite that T in formula I is CR1R2 or O which fails to further limit T of formula I in claim 1 which is state T is CR1R2 or O. 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. This rejection may be overcome by amending claim limitations to further limit T in claim 12. Claim 14 is 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. The limitations of dependent claim 14 cite W in formula I is CR4R5 or O which fails to further limit W of formula I in claim 1 which is state W is CR4R5 or O. 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. This rejection may be overcome by amending claim limitations to further limit W in claim 14. Claim 47 is 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. The limitations of dependent claim 47 cite that T in formula II is CR1R2 or O which fails to further limit T of formula II in independent claim 36 which is states T is CR1R2 or O. 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. This rejection may be overcome by amending claim limitations to further limit T in claim 47. Claim 49 is 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. The limitations of dependent claim 49 cites W in formula II is CR4R5 or O which fails to further limit W of formula II in claim 1 which is state W is CR4R5 or O. 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. This rejection may be overcome by amending claim limitations to further limit W in claim 49. Allowable Subject Matter The following is a statement of reasons for the indication of allowable subject matter: Applicants compound of formula I and II makes a contribution over the closest prior art of record of Pennington (WO2021/108628Al) which teaches the structure of compound 2 (table 1, pg. 38) and satisfies all of the structural limitations of formula I in instant claim 1 except for the MeSO2 attached to the amine group. Furthermore, Pennington does not fairly teach or suggest an attachment of MeSO2 to the amine group. PNG media_image1.png 170 436 media_image1.png Greyscale Pennington’s compound 2 Conclusion Claims 1, 2, 4, 6, 16-17, 22-23, 25-26, 28, 30-31, 33, 35, 36-37, 39, 41, 51-52, 57-58, 60-61, 63, 65-66, 68, 70-71, and 78 are allowable, claims 12, 14, 47, and 49 are rejected. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off. 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, Adam C Milligan can be reached at 571-270-7674. 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. /E.V./Examiner, Art Unit 1623 /SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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Prosecution Timeline

Oct 03, 2023
Application Filed
Apr 06, 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
60%
Grant Probability
93%
With Interview (+33.3%)
3y 3m (~7m remaining)
Median Time to Grant
Low
PTA Risk
Based on 20 resolved cases by this examiner. Grant probability derived from career allowance rate.

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