Prosecution Insights
Last updated: April 19, 2026
Application No. 17/964,423

1H-PYRROLO[2,3-B]PYRIDINES AND PREPARATION AND USES THEREOF

Non-Final OA §103§112
Filed
Oct 12, 2022
Examiner
STOCKTON, LAURA LYNNE
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Biosplice Therapeutics Inc.
OA Round
5 (Non-Final)
75%
Grant Probability
Favorable
5-6
OA Rounds
2y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allow Rate
1009 granted / 1342 resolved
+15.2% vs TC avg
Strong +34% interview lift
Without
With
+33.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
26 currently pending
Career history
1368
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
21.1%
-18.9% vs TC avg
§102
22.1%
-17.9% vs TC avg
§112
34.6%
-5.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1342 resolved cases

Office Action

§103 §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 . DETAILED ACTION Claims 1-30 and 34-48 are pending in the instant application. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 20, 2026 has been entered. Election/Restrictions Applicant’s election without traverse of Group I, PNG media_image1.png 211 633 media_image1.png Greyscale , and the species of Compound 1194, disclosed on page 291 of the instant specification and in instant claim 22 (reproduced below), PNG media_image2.png 245 702 media_image2.png Greyscale , in the reply filed on November 14, 2023 was acknowledged in a previous Office Action. As a result of the current amendments to the claims filed January 20, 2026, the elected species of Compound 1194 is not embraced by the compound genus claimed in independent claim 15 or claimed in currently amended dependent claim 22 due to the amendment to the definition of variable R1 in claim 15. Applicant’s claimed compound genera in Formula I in independent claim 1, Formula Ia in independent claim 7, Formula Ib in independent claim 10 and Formula Ie in independent claim 15 have a number of variables and their permutations and combinations result in a vast number of compounds that are generically claimed. In an attempt to examine the full scope of compounds in elected Group I, over 22,400 Chemical Abstract Registry numbers were recovered in one database search alone. Therefore, the instant claimed compounds of elected Group I have been examined according to MPEP §803.02. The claims within elected Group I have been examined to the extent that they are readable on the elected species of Compound 1194. Since no prior art was found on the elected species, the examination was expanded within products of elected Group I until prior art was found, in which case, the examination stopped and prior art has been applied against the claims. Note, MPEP §803.02. As a result of the current amendments to the claims per the Amendment filed January 20, 2026, the search and examination has not been expanded beyond that which was indicated previously. The entire scope of compounds embraced by independent claims 15, 34, 39, 42, 44 and 48 has been searched and examined. Claims embraced by the elected species and the expanded search and examination are claims 15-18, 22, 26 and 31-48. The requirement was deemed proper and therefore made FINAL in a previous Office Action. Claims 31-33 have been cancelled per the Amendment filed January 20, 2026. Claims 1-14, 19-21, 23-25 and 27-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 14, 2023. Information Disclosure Statement The information disclosure statement (IDS) submitted on February 20, 2026 was filed after the mailing date of the final Office Action on October 20, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Rejections made in the previous Office Action that do not appear below have been overcome by either Applicant’s arguments or the amendments to the claims per the Amendment filed January 20, 2026. Therefore, arguments pertaining to these rejections will not be addressed. Claim Interpretation Upon reconsideration and based on Applicant’s arguments regarding the definition of “substituted” in paragraph [040] on pages 12-13 of the instant specification, the following interpretation has been revised. The interpretation for the R1 heteroaryl groups is that the hydrogen attached to ring nitrogens in the chemical structures can be replaced with a R group substituent (such as R6 or R6a or R6b) as defined in the claims. See the R1 heteroaryl groups PNG media_image3.png 110 120 media_image3.png Greyscale , PNG media_image4.png 96 84 media_image4.png Greyscale , PNG media_image5.png 92 92 media_image5.png Greyscale , etc. in claim 15 and the R1 heteroaryl ring in claim 34. Further, per the definition of “heteroaryl” in the instant specification in paragraph [033] on pages 10-11, only one ring in the heteroaryl system has to be aromatic and at least one ring in the system contains one or more heteroatoms. As a result of the amendments to the claims per the Amendment filed January 20, 2026, the following rejections apply. 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 15-18 and 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Currently amended independent claim 15 is unclear because there are two different definitions for variable n. See page 13, the 5th line of the page under the definition of variable R1; and the 5th line from the end of claim 15. Therefore, currently amended claim 15 is indefinite. Correction or Clarification is required. This rejection can be overcome by deleting the definition of variable n near the end of claim 15 which states “each n is independently 0 to 6;” since this definition of variable n is no longer needed in independent claim 15. Claims dependent on claim 15 which do not cure the problem cited above in claim 15 are also found indefinite. Response to Arguments Applicant's arguments filed January 20, 2026 have been fully considered. Applicant argues that claim 15 has been amended and requests that the rejection be reconsidered and withdrawn. In response, variable n is only used once in currently amended independent claim 15 and that one occurrence is found under the definition of variable R1 when R1 represents PNG media_image6.png 124 302 media_image6.png Greyscale (the 5th line on page 13). It does not appear that the definition of variable n near the end of independent claim 15 is needed and should be deleted. Claim Rejections - 35 USC § 103 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 (i.e., changing from AIA to pre-AIA ) 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. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 15 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bahceci et al. {US 2011/0201599}. Determination of the scope and content of the prior art (MPEP §2141.01) Applicant currently claims compounds of Formula Ie in independent claim 15, PNG media_image7.png 181 187 media_image7.png Greyscale wherein R1 can represent the heteroaryl group PNG media_image8.png 100 72 media_image8.png Greyscale , optionally substituted with 1 R6; R6 can represent halide; R3 can represent -OR10; and R10 can represent –(C1-9 alkyl). Bahceci et al. teach compounds of Formula IA in paragraphs [0034]-[0040] on pages 2-3, PNG media_image9.png 154 336 media_image9.png Greyscale wherein R1 can represent hydrogen; A can represent CR2; R2 can represent alkoxy; R3 can represent 5-9 membered heteroaryl, which is optionally substituted with 1 of 2 substituents such as halo; and B can represent CH. See especially the last compound on page 21 in Bahceci al., which is also disclosed in paragraph [0347] on page 17, PNG media_image10.png 280 220 media_image10.png Greyscale PNG media_image11.png 60 564 media_image11.png Greyscale . Bahceci et al. teach pharmaceutical compositions comprising his compounds together with a pharmaceutically acceptable excipient {paragraph [0441] on page 61 and paragraph [0522] on page 68}. Bahceci et al. {paragraph [0444] on page 61} teach that his compounds can be administered to a patient in the treatment of a disease or condition that involves CDK (cyclin-dependent kinase). Bahceci et al. teach that his compounds are useful for treating diseases such as cancer, inflammatory diseases, cardiac hypertrophy, etc. {paragraphs [0444]-[0445] on page 61-62}. Ascertainment of the difference between the prior art and the claimed invention (MPEP §2141.02) The difference between the compounds of Bahceci et al. and the compounds instantly claimed is that the instant claimed compounds are generically described in Bahceci et al. Additionally, the compound disclosed in paragraph [0347] on page 17 of Bahceci et al. is a positional isomer of the instant claimed compounds in that the methoxy group is attached at the 4-position of the pyrrolo[2,3-b]pyridine ring in the compound of Bahceci et al. instead of the 5-position of the pyrrolo[2,3-b]pyridine ring as found in the instant claims (see the position of the instant R3 variable in instant Formula Ie). Finding of prima facie obviousness--rational and motivation (MPEP §2142-2143) The indiscriminate selection of “some” among “many” is prima facie obvious, In re Lemin, 141 USPQ 814 (C.C.P.A. 1964). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (e.g., a modulator of CDK). Further, position isomers are a basic form of close “structural isomers.” MPEP §2144.09(II), first paragraph, states the following: II. HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). It is well established that position isomers are prima facie structurally obvious even in the absence of a teaching to modify. The isomer is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the position isomers. It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the instant claimed invention, to prepare products embraced by Bahceci et al. or positional isomers thereof. A person of ordinary skill in the art would have been motivated to prepare products embraced by Bahceci et al., or a positional isomer thereof, to arrive at the instant claimed products with the expectation of obtaining additional beneficial products which would be useful in treating, for example, breast cancer, rheumatoid arthritis, etc. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art. Allowable Subject Matter The elected species of Compound 1194, disclosed on page 291 of the instant specification and claimed in newly added claim 48 is allowable over the prior art of record. Claim 22 is 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. Claims 34-48 are allowed over the prior art of record. Reminder to Applicant As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I). Telephone Inquiry Any inquiry concerning this communication or earlier communications from the examiner should be directed to: Laura L. Stockton (571) 272-0710. The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time. 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 acting supervisor, James Alstrum-Acevedo can be reached on 571/272-5548. 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. /LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620 Technology Center 1600 March 23, 2026 Book XXVI, page 176
Read full office action

Prosecution Timeline

Oct 12, 2022
Application Filed
Feb 29, 2024
Non-Final Rejection — §103, §112
Jul 24, 2024
Examiner Interview Summary
Jul 24, 2024
Applicant Interview (Telephonic)
Sep 06, 2024
Response Filed
Sep 23, 2024
Final Rejection — §103, §112
Nov 25, 2024
Response after Non-Final Action
Dec 20, 2024
Request for Continued Examination
Jan 03, 2025
Response after Non-Final Action
Mar 14, 2025
Non-Final Rejection — §103, §112
Jul 25, 2025
Response Filed
Oct 15, 2025
Final Rejection — §103, §112
Jan 20, 2026
Response after Non-Final Action
Feb 20, 2026
Request for Continued Examination
Feb 25, 2026
Response after Non-Final Action
Mar 23, 2026
Non-Final Rejection — §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
75%
Grant Probability
99%
With Interview (+33.7%)
2y 6m
Median Time to Grant
High
PTA Risk
Based on 1342 resolved cases by this examiner. Grant probability derived from career allow rate.

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