Office Action Predictor
Last updated: April 15, 2026
Application No. 18/279,732

BENZO[C][2,6]NAPHTHYRIDINE DERIVATIVES, COMPOSITIONS AND THERAPEUTIC USES THEREOF

Non-Final OA §112§DP
Filed
Aug 31, 2023
Examiner
AULAKH, CHARANJIT
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Cambridge Enterprise Limited
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
2y 0m
To Grant
71%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allow Rate
1407 granted / 1741 resolved
+20.8% vs TC avg
Minimal -9% lift
Without
With
+-9.4%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 0m
Avg Prosecution
54 currently pending
Career history
1795
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
15.2%
-24.8% vs TC avg
§102
21.0%
-19.0% vs TC avg
§112
42.7%
+2.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1741 resolved cases

Office Action

§112 §DP
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. According to a preliminary amendment filed on March 29, 2024, the applicants have canceled claims 6, 9, 11, 16, 19 and 25; amended claims 4-5, 7-8, 10, 12-15, 17-18 and 20-24 and furthermore, have added a new claim 26. Claims 1-5, 7-8, 10, 12-15, 17-18, 20-24 and 26 are pending in the application. Claim Rejections - 35 USC § 112 4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-5, 7-8, 10, 12-15, 17-18, 20-24 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for preparing compounds and salts, does not reasonably provide enablement for preparing hydrates and solvates of compounds of formula I. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed: Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as quantity of experimentation necessary, the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims. In regard to lack of enablement issue of instant claims for hydrates or solvates of instant compounds of formula I, there is no teaching or guidance present in the specification for preparing any specific hydrates (mono, di, tri or tetra) or solvates. Preparation of specific hydrates or solvates of any compound is a very specialized field and involves their characterization using different techniques such as infrared spectrum, XRD powder diffraction etc. There is no teaching or guidance present in the specification regarding any specific solvents used for preparing specific hydrates or solvates and their characterization using any techniques such as XRD powder diffraction or infrared spectrum etc. There is not even a single example present for preparing any specific hydrate or solvate of instant compounds of formula I . Healy (Adv. Drug Deliv. Rev.) teaches that differences in solid forms (hydrates, solvates or polymorphic forms) often leads to differences in thermodynamic parameters and physiochemical properties such as solubility, dissolution rate, stability and mechanical properties (see abstract and table 1 on page 28). Therefore, in absence of such teachings, guidance, presence of working examples and unpredictability, it would require undue experimentation to select specific hydrates or solvates of instant compounds with enhanced stability properties. Claim 26 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The instant compounds are inhibitors of CK2 alpha kinase activity as shown on pages 254-261 of the specification. However, there is no written description in the background section of the specification for well established utility of C2k alpha kinase inhibitors for treating every known viral infection, diabetes, neurodegenerative disorders, vascular and ischemic disorders or irregular cardiac rhythm. The only written description is for treating cancer as also shown by Pierre (J. Med. Chem. Cited on applicant’s form 1449) for treating various cancers (see table 7 on page 643). Furthermore, there is no written description showing efficacy of instant compounds in animal models of every known viral infection, diabetes, neurodegenerative disorders, vascular and ischemic disorders or irregular cardiac rhythm. 8. 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 appl icant regards as his invention. Claim 26 is 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 26 recites the broad recitation proliferative disorders, and the claim also recites e.g, cancer, viral infection, diabetes etc. which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. 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 1-5, 7-8, 10, 12-14, 18, 20-21 and 23-24 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-2 of U.S. Patent No. 11,866,436, cited on applicant’s form 1449 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the cited patent anticipate the instant claims when variable Q represents formula Ia in the instant compounds of formula I . Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT CHARANJIT AULAKH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0678 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 7:00-3:30 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Clinton A Brooks can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-7682 . 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. /CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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Prosecution Timeline

Aug 31, 2023
Application Filed
Dec 16, 2025
Non-Final Rejection — §112, §DP
Mar 23, 2026
Response Filed

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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
81%
Grant Probability
71%
With Interview (-9.4%)
2y 0m
Median Time to Grant
Low
PTA Risk
Based on 1741 resolved cases by this examiner. Grant probability derived from career allow rate.

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