Prosecution Insights
Last updated: April 19, 2026
Application No. 18/319,860

SPIRO[3.3]HEPTANE DERIVATIVES FOR THE TREATMENT AND PROPHYLAXIS OF HEPATITIS B VIRUS INFECTION

Non-Final OA §112§DP
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 §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 . Claims 1-20 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 1-20 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: Claims 1, 2 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the proviso where “R1 and R2 are not H or halogen simultaneously”. R1 and R2 are only H or halogen when they are not together with the phenyl ring they are attached to form a PNG media_image1.png 67 92 media_image1.png Greyscale . Claim 2 recites the limitation "halogen" in the proviso at the end of the claim for R1 and R2. There is insufficient antecedent basis for this limitation in the claim. Claim 10 recites the limitation "2-amino-thiazole" in the nomenclature of the species 19 in the on page 66, line 21 with respect to R3. There is insufficient antecedent basis for this limitation in the claim. Claim 10 is vague and indefinite in that it is not known what is meant by “carboxamid” in the last species at the bottom of page 67. Claim 10 is vague and indefinite in that it is not known what is meant by the capital letter which appears in the last line of the claim at the bottom of page 68, i.e., “Or”. 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 11 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) and (d). Claim 11 is vague and indefinite in that it is not known what is meant by “isselected” in line 6 of the claim. Regarding claim 11, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 12 and 19 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 14-18 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. 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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-10, 13 and 16-23 of copending Application No. 18/454,315 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compounds of formula (I) where L is spiro[3.3]heptan-2-yl as set forth in the examples on page 73, column 2, lines 34-36 and page 74, column 1, lines 51-52. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 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, §DP (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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