Prosecution Insights
Last updated: April 19, 2026
Application No. 18/499,940

BICYCLIC HETEROCYCLE COMPOUNDS AND THEIR USES IN THERAPY

Final Rejection §DP
Filed
Nov 01, 2023
Examiner
BORI, IBRAHIM D
Art Unit
1629
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Astex Therapeutics Limited
OA Round
2 (Final)
43%
Grant Probability
Moderate
3-4
OA Rounds
3y 4m
To Grant
81%
With Interview

Examiner Intelligence

Grants 43% of resolved cases
43%
Career Allow Rate
255 granted / 590 resolved
-16.8% vs TC avg
Strong +38% interview lift
Without
With
+38.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
44 currently pending
Career history
634
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
36.6%
-3.4% vs TC avg
§102
17.1%
-22.9% vs TC avg
§112
25.0%
-15.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 590 resolved cases

Office Action

§DP
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Reassignment of Application Please note that this application has been reassigned to Examiner Ibrahim Bori, in Art Unit 1629. In order to expedite accurate processing of the application papers, all future correspondence with the office should reflect this change. Information Disclosure Statement The information disclosure statement (IDS) submitted on 02/16/2026, have been received and entered into the instant application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98, and MPEP §609. Withdrawn Claim Objections The objection to claim 1 is overcome by the cancellation of claim 1, and is hereby withdrawn. Withdrawn Rejections The rejection of claims 1-17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is overcome by the cancellation of claims 1-17, and is hereby withdrawn. The rejection of claims 1-23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is overcome by the cancellation of claims 1-23, and is hereby withdrawn. Status of the claims Claims 24-30 are pending. Applicants’ arguments, filed 02/16/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application. Applicants’ amendments, filed on 02/16/2026, have each been entered into the record. Applicants have cancelled claims 1-23. Applicants have newly added claims 24-30. Therefore, claims 24-30 are subject of the Office action below. Non-Statutory Obviousness-Type Double Patenting New Grounds of Rejection Necessitated by Applicants’ Amendments 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. Preliminary matter: Although the Office have cited some of applications and/or patents for the nonstatutory double patenting rejections (see rejections below), it is noted that the instant application is from an enormous family of applications and patents, which are commonly owned, such that it is burdensome for the Office to identify all potential applications and/or patents that can invoke the issue of nonstatutory double patenting. Therefore, applicants are requested to assist the Office in identifying all potential applications and/or patents that raises the issue of nonstatutory double patenting with regard to the claims of the instant application, specifically for instant claims 24-30. Claims 24-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims U.S. Patent Nos: 1) 9,676,768; 2) 9,617,283; 3) 9,617,248; 4) 9,018,214; 5) 11,866,428; and 6) 9,663,512. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and claims of the reference U.S. patents are similarly drawn to bicyclic heterocycle compounds. For example, the claims of the instant invention are drawn to bicyclic heterocycle compounds recited in instant claim 24, whereas, the claims of the U.S. Patent No. 9,676,768 (‘768 patent) are drawn to bicyclic heterocycle compounds recited in ‘768 patent claims 1-16. Although the ‘768 patent is not explicit in claiming bicyclic heterocycle compounds recited in the instant invention, the claimed invention would have been obvious over the ‘768 patent. This is because the ‘768 patent (see, e.g., columns 190-191 and 197), discloses bicyclic heterocycle compounds of the instant claims. A patent’s "disclosure may be used…to answer the question whether claims merely define an obvious variation of what is earlier disclosed and claimed." AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 112 USPQ2d 1001, 1012 (Fed. Cir. 2014) (quoting In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). In the instant case, since the ‘768 patent (see discussions above), discloses bicyclic heterocycle compounds of the instant application, these aspects of the instant claims are, therefore, obvious over the ‘768 patent. The AbbVie court explicitly noted that the Federal Circuit has “repeatedly approved examination of the disclosed utility of the invention claimed in an earlier patent to address the question of obviousness” and that “a later expiring patent is not patentably distinct from an earlier expiring patent if it merely claims a disclosed utility of the earlier claimed invention." Id. For example, when the claims in a later-expiring patent "merely recite methods of administering" the compositions claimed in the earlier patent, they are not patentably distinct over the claims of the earlier expiring patent." Id. (quoting Pfizer, Inc. v. Teva Pharms. USA, Inc., 86 USPQ2d 1001, 1008 (Fed. Cir. 2008)). Furthermore, for double patenting of previously disclosed, but newly claimed utility, please see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter. Conclusion No claim is allowable. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. 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 Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /IBRAHIM D BORI/ Examiner, Art Unit 1629 /JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Read full office action

Prosecution Timeline

Nov 01, 2023
Application Filed
Oct 10, 2025
Non-Final Rejection — §DP
Feb 16, 2026
Response Filed
Mar 18, 2026
Final Rejection — §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
43%
Grant Probability
81%
With Interview (+38.0%)
3y 4m
Median Time to Grant
Moderate
PTA Risk
Based on 590 resolved cases by this examiner. Grant probability derived from career allow rate.

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