Prosecution Insights
Last updated: April 19, 2026
Application No. 18/319,895

AROMATIC SPIRO RING AMIDE DERIVATIVES FOR THE TREATMENT AND PROPHYLAXIS OF HEPATITIS B VIRUS INFECTION

Non-Final OA §112
Filed
May 18, 2023
Examiner
COLEMAN, BRENDA LIBBY
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hoffmann-La Roche, Inc.
OA Round
1 (Non-Final)
75%
Grant Probability
Favorable
1-2
OA Rounds
2y 7m
To Grant
90%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allow Rate
1201 granted / 1604 resolved
+14.9% vs TC avg
Strong +15% interview lift
Without
With
+15.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
46 currently pending
Career history
1650
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
5.8%
-34.2% vs TC avg
§102
16.9%
-23.1% vs TC avg
§112
52.3%
+12.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1604 resolved cases

Office Action

§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 1-26 are pending in this application. 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 2, 3, 9, 15, 17, 18 and 20-25 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. The following reasons apply: Claim 2 is vague and indefinite in that it is not known what is meant by “1-oxo-1lambda6-thia-2-azacyclohexen-1-yl” in the definition of R1. Claim 2 is vague and indefinite in that it is not known what is meant by “1-oxo-1-lambda6-thia-2-azacyclohexen-1-yl” in the definition of R1. Claim 9 is vague and indefinite in that it is not known what is meant by “m H” in the definition of R6. Claim 15 is vague and indefinite in that it is not known what is meant by “1-oxo-1lambda6-thia-2-azacyclohexen-1-yl” in the nomenclature of the 62 species, lines 29-30 on page 149. Claim 17 is vague and indefinite in that it is not known what is meant by the capital letter which appears in the throughout the claim, i.e., the beginning of each section (a), (b), (c), (d), (e), (f), (g), (h) and (i). 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 17 is vague and indefinite in that it is not known what is meant by “A1 to A4” in line 8 on page 158, which is a range which does not particularly point out and distinctly claim the subject matter which applicants regard as the invention, i.e., it fails to indicate that which is embraced by the range. The definitions of each individual variable must be clearly set forth herein. Claim 17 is vague and indefinite in that it is not known what is meant by the definition of Rx and Ry where there is not variable Rx and Ry. Claims 18 and 25 are substantial duplicates of claim 1, as the only difference is a statement of intended use, which does not limit the scope of the claim under the broadest reasonable interpretation and therefore is not given material weight. Note In re Tuominen 671 F.2d 1359, 1360, 213 USPQ 89, 90 (C.C.P.A. 1982). Claims 20-24 provide for the use of the compound of claim 1, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Claim Objections Claim 17 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim must be stated in the alternative. See MPEP § 608.01(n). Allowable Subject Matter Claims 1, 4-8, 10-14, 16, 19 and 26 are allowed. None of the prior art of record nor a search in the pertinent art area teaches the compounds, compositions and method of use of the compounds of formula (I) as claimed herein. 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 on 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

May 18, 2023
Application Filed
Oct 02, 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
75%
Grant Probability
90%
With Interview (+15.4%)
2y 7m
Median Time to Grant
Low
PTA Risk
Based on 1604 resolved cases by this examiner. Grant probability derived from career allow rate.

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