Prosecution Insights
Last updated: April 19, 2026
Application No. 18/276,831

A PROCESS FOR PREPARING NAVAFENTEROL AND INTERMEDIATES THEREOF

Non-Final OA §112
Filed
Aug 10, 2023
Examiner
CHENG, KAREN
Art Unit
1623
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Gbr Laboratories Private Limited
OA Round
1 (Non-Final)
76%
Grant Probability
Favorable
1-2
OA Rounds
2y 3m
To Grant
99%
With Interview

Examiner Intelligence

Grants 76% — above average
76%
Career Allow Rate
517 granted / 677 resolved
+16.4% vs TC avg
Strong +28% interview lift
Without
With
+27.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
34 currently pending
Career history
711
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
27.4%
-12.6% vs TC avg
§102
21.5%
-18.5% vs TC avg
§112
30.7%
-9.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 677 resolved cases

Office Action

§112
DETAILED ACTION Claims 1-11 are currently pending in the instant application. 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 PNG media_image1.png 66 384 media_image1.png Greyscale Information Disclosure Statement The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a). Claim Objections Claims 1-11 are objected to because of the following informalities: the use of parenthesis when referring to compounds of Formula (IV) is inconsistent. For example, in claim 1, step c it states “carbonylation of compound of formula IV rather than compound of formula (IV). Similarly, this issue occurs throughout the claims - some of the compounds of formula do not have parenthesis surrounding the roman numerals in the text of the claim. In claim 4, in the scheme under step b, the scheme shows (XI-a) but then the text of the claim refers to the compound as a formula XI(a). Appropriate correction is required. Claim 11 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 4. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 11 merely repeats that the compound of formula XIX is utilized in synthesis of a compound of formula I. However, this limitation is already found in claim 4 and thus claim 11 does not impart any additional limitations to claim 4, the claim upon which it depends. Claim 1 is objected to because of the following informalities: after step b) in the second line, it states “to make a reaction mixture; to obtain a compound of formula (IV)”. The “;” appears unnecessary. Appropriate correction is required. Claims 2-4 are objected to because of the following informalities: the period is not found at the end of the claim. The period is found following the end of the text of the claim rather than following the scheme below the text. Claim 5 is not in proper Markush format. See MPEP 2173.05 (h) which states that Markush type claim recites alternatives in a format such as “selected from the group consisting of A, B and C.” See Ex parte Markush, 1925 C.D. 126 (Comm' r Pat. 1925), MPEP 803.02. The claims do not contain the phrase “or” between the final two species, or recite “selected from the group” in the preamble. See for example claim 5, step b, under bromination with. Appropriate correction is required. 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 1-11 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. At the end of claim 1, it states three conditions: PNG media_image2.png 110 634 media_image2.png Greyscale . However, there is no compound of Formula (XVI), (XVIII), (XV), (XI-1) recited elsewhere in the claim. Thus, it is unknown what the structures of the compounds of said formulas are which renders the claim 1 unclear. As claims 2-11 do not fix this issue, they have also been rejected. Claim 4 states under step a) protection of compound of formula VIII with protecting agents. However, the scheme underneath shows a compound of formula VII rather than VIII. Thus it is unclear if it should be a compound of formula VII or formula VIII that is protected. PNG media_image3.png 238 678 media_image3.png Greyscale . Similarly under step b of claim 4, it states “treatment of a compound of fomrua VIII(a)” but the scheme shows a compound of formula (VIIII-a). As such, the scope of claim 4 is unclear. Claim 5 recites the limitation "in turn addition of N, N-dimethylformamide and tetrahydrofuran in the ratio of 1:1: to obtain compound of formula V" at the end of step c. However, it is unclear what the limitation “in turn addition” means. Further, it is unclear whether Claim 5 is referring to the compound of formula VIII(a) or VIIII(a) given inconsistency: PNG media_image4.png 58 682 media_image4.png Greyscale PNG media_image5.png 192 514 media_image5.png Greyscale Claim 8 states in the 4th line of the claim, “the condensation of compound of Formula XVIII in solvent toluene using base sodium methoxide is carried out”. However it is unclear what is being condensed with the compound of formula XVIII as claim 8 depends on claim 7 which depends on claim 2, which does not show a compound of formula XVIII. Claim 10 states in the 5th line from the end of the claim “isolation is carried out in toluene under cooling”. However it is unclear what is being isolated. Prior Art Not Otherwise Cited. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2013/068552 teaches compound of formula I PNG media_image6.png 140 384 media_image6.png Greyscale but does not teach a process of synthesizing said compound through a compound of formula XIII PNG media_image7.png 92 208 media_image7.png Greyscale . Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST. 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 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. /KAREN CHENG/Primary Examiner, Art Unit 1623 /ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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Prosecution Timeline

Aug 10, 2023
Application Filed
Nov 26, 2025
Non-Final Rejection — §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
76%
Grant Probability
99%
With Interview (+27.9%)
2y 3m
Median Time to Grant
Low
PTA Risk
Based on 677 resolved cases by this examiner. Grant probability derived from career allow rate.

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