Prosecution Insights
Last updated: October 04, 2026
Application No. 18/262,234

PROCESSES FOR PURIFICATION OF BICTEGRAVIR INTERMEDIATES

Non-Final OA §103§112
Filed
Jul 20, 2023
Priority
Jan 22, 2021 — IN 202141003141 +2 more
Examiner
COLEMAN, BRENDA LIBBY
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Laurus Labs Limited
OA Round
3 (Non-Final)
75%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allowance Rate
1230 granted / 1643 resolved
+14.9% vs TC avg
Strong +16% interview lift
Without
With
+15.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
52 currently pending
Career history
1670
Total Applications
across all art units

Statute-Specific Performance

§101
3.4%
-36.6% vs TC avg
§103
8.5%
-31.5% vs TC avg
§102
15.8%
-24.2% vs TC avg
§112
52.8%
+12.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1643 resolved cases

Office Action

§103 §112
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 . Claims 32 and 34-47 are pending in this application. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. 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. Claim 38 and 39 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 pre-AIA the applicant regards as the invention. The following reasons apply: Claims 38 and 39 are vague and indefinite in that it is not known what is meant by “tert-butanol solvate” does not clarify whether the claim is limited to a compound, composition, or even complex composition. Claim 38 is vague and indefinite in that it is not known what is meant by the lack of a capital letter at the beginning of the claim. 608.01(m) Form of Claims [R - 3] The claim or claims must commence on a separate sheet and should appear after the detailed description of the invention.< While there is no set statutory form for claims, the present Office practice is to insist that each claim must be the object of a sentence starting with "I (or we) claim", "The invention claimed is" (or the equivalent). If, at the time of allowance, the quoted terminology is not present, it is inserted by the clerk. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, >36 USPQ2d 1211< (D.D.C. 1995). ** >Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). Claim Rejections - 35 USC § 103 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. Claims 32, 37 and 43-47 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chiu et al., WO 2015/195656. The process of preparing the compound of Formula II is as set forth in Chiu (see Formula G-I, page 66) as claimed herein. Example on page 115 differs only in the purification method. Page 66, paragraph [0236] defines the extraction and purification method a solvent extraction, silica gel chromatography and crystallization. Paragraph [0237] defines those solvents which would be appropriate to obtain the purified compounds of G-I as a non-protic polar organic solvent, such as, but not limited to, tetrahydrofuran, acetonitrile, diisopropyl ether, methyl tert-butyl ether, N,N-dimethylformamide, N,N-dimethylacetamide, 1,4-dioxane, or N-methyl-2-pyrrolidinone, or mixtures thereof. The compounds of the instant invention are by the applicants own specification prepared as set forth in WO 2015/195656 (see specification page 24) and thus would be expected to possibly contain the impurities as set forth in claim 32 and in view of the disclosure of Chiu one of ordinary skill in the art would have been motivated to select for example tetrahydrofuran of the reference as well as other possibilities from the generically disclosed alternatives of the reference and in so doing obtain the instant compounds in view of the equivalency teachings outlined above. Claim Objections Claims 32, 38, 40, 43 and 45 are objected to because of the following informalities: the structures are not clear. Appropriate correction is required. Claims 34-36, 41 and 42 are 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex). 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, Jeffrey H. Murray can be reached at 571-272-9023. 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. /BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

Jul 20, 2023
Application Filed
Oct 02, 2025
Non-Final Rejection mailed — §103, §112
Apr 01, 2026
Response Filed
May 05, 2026
Final Rejection mailed — §103, §112
Jul 06, 2026
Response after Non-Final Action
Jul 16, 2026
Request for Continued Examination
Jul 17, 2026
Response after Non-Final Action
Aug 06, 2026
Non-Final Rejection mailed — §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12740961
USE OF AN ORGANOMETALLIC COMPOUND AS A DNA-DEMETHYLATING AGENT
5y 4m to grant Granted Sep 22, 2026
Patent 12723055
PHOSPHOANTIGEN PRODRUG COMPOUNDS
5y 8m to grant Granted Sep 01, 2026
Patent 12723038
ALPHA1A-ADRENERGIC RECEPTOR AGONISTS AND METHODS OF USE
3y 6m to grant Granted Sep 01, 2026
Patent 12708629
METHODS AND COMPOSITIONS FOR REDUCING PARATHYROID LEVELS
3y 3m to grant Granted Aug 18, 2026
Patent 12709621
TYK2 INHIBITORS
3y 1m to grant Granted Aug 18, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

3-4
Expected OA Rounds
75%
Grant Probability
90%
With Interview (+15.5%)
2y 5m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 1643 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month