Prosecution Insights
Last updated: July 17, 2026
Application No. 18/566,259

SUBSTITUTED INDOLE COMPOUNDS AND METHODS OF USE THEREOF

Non-Final OA §102
Filed
Dec 01, 2023
Priority
Jun 03, 2021 — provisional 63/196,339 +3 more
Examiner
CHONG, YONG SOO
Art Unit
1623
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Novartis AG
OA Round
1 (Non-Final)
44%
Grant Probability
Moderate
1-2
OA Rounds
1y 3m
Est. Remaining
85%
With Interview

Examiner Intelligence

Grants 44% of resolved cases
44%
Career Allowance Rate
383 granted / 878 resolved
-16.4% vs TC avg
Strong +41% interview lift
Without
With
+41.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
59 currently pending
Career history
944
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
71.3%
+31.3% vs TC avg
§102
17.3%
-22.7% vs TC avg
§112
5.0%
-35.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 878 resolved cases

Office Action

§102
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 . Status of the Application Applicant's election with traverse of Group I, drawn to a compound of formula I, as well as the species, example 54, in the reply filed on 3/27/26 is acknowledged. The traversal is on the grounds that there is unity of invention. This is not found persuasive because there is no unity of inventon as the special technical feature is not a contribution over the prior art in view of the prior art cited in the Restriction Requirement. The requirement is still deemed proper and is therefore made FINAL. Claims 1-32 are pending. Claims 29-32 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 2-3, 5, 8, 11-19 have been withdrawn from further consideration as being drawn to a non-elected species. Claims 1, 4, 6-7, 9-10, 20-28 are examined herein insofar as they read on the elected invention and species. A search has been performed on the elected species (example 54), which was found free of the prior art. The search will now be expanded and another species will be selected for examination. With regard to the expanded species selected by examiner for examination, claims 2-3, 5, 8-10, 12-28 have been withdrawn from further consideration as being drawn to a non-elected species. Claims 1, 4, 6-7, 11 are examined herein insofar as they read on the elected invention and the expanded species. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1, 4, 6-7, 9-11, 15, 20-26, 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-9 of U.S. Patent No. 12,617,774. Although the claims at issue are not identical, they are not patentably distinct from each other because the compound in referenced claim 1 anticipates the instant claims. 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. Claims 1, 4, 6-7, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams et al. (US Patent Application 2016/0152605, of record). Adams et al. teach compounds of formula I for treating diseases associated with complement alternative pathway activation, such as age-related macular degeneration, diabetic retinopathy, and related ophthalmic diseases (abstract and paragraph 0001). Pharmaceutical carriers are taught (paragraph 0014). A preferred compound is Example 17-18 below: PNG media_image1.png 240 256 media_image1.png Greyscale Adams et al. teach that R6 can be hydrogen and/or C1-alkoxy (paragraph 0032) and that at this R6 position, selective deuteration is preferred, for example OCD3 at the methoxy moiety above (paragraph 0358). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at (866)-217-9197 (toll-free). /Yong S. Chong/Primary Examiner, Art Unit 1623
Read full office action

Prosecution Timeline

Dec 01, 2023
Application Filed
Jun 09, 2026
Non-Final Rejection mailed — §102 (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
44%
Grant Probability
85%
With Interview (+41.4%)
3y 11m (~1y 3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 878 resolved cases by this examiner. Grant probability derived from career allowance rate.

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