Prosecution Insights
Last updated: April 19, 2026
Application No. 18/546,087

BICYCLIC TETRAHYDROAZEPINE DERIVATIVES FOR THE TREATMENT OF CANCER

Non-Final OA §101§112
Filed
Aug 10, 2023
Examiner
HABTE, KAHSAY
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hoffmann-La Roche, Inc.
OA Round
1 (Non-Final)
85%
Grant Probability
Favorable
1-2
OA Rounds
1y 11m
To Grant
93%
With Interview

Examiner Intelligence

Grants 85% — above average
85%
Career Allow Rate
1348 granted / 1589 resolved
+24.8% vs TC avg
Moderate +8% lift
Without
With
+8.1%
Interview Lift
resolved cases with interview
Fast prosecutor
1y 11m
Avg Prosecution
45 currently pending
Career history
1634
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
6.9%
-33.1% vs TC avg
§102
18.9%
-21.1% vs TC avg
§112
47.0%
+7.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1589 resolved cases

Office Action

§101 §112
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, 4-6, 8-10, 15, 17-18, 22-24, 26, 31, 33, 36-38, 41, 43, 45-47, 53 and 55 are pending in this application. Election/Restrictions Applicant’s election without traverse of Group I and a species (Y = S, S(O), or S(O)2) in the reply filed on 12/18/2025 is acknowledged. The claims are drawn to multiple inventions for reasons set forth in the restriction requirement. The claims are examined only to the extent that they read on the elected invention. Cancellation of the non-elected subject matter is recommended in response to this Office Action. Applicants have to delete Y = S(O)N(Ry) from claim 1. Specification 4. The abstract of the disclosure is objected to because the abstract is on two pages and also the abstract is at the bottom of a WIPO document that contains publication date, inventor name, etc. that is not relevant to an abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Claim Rejections - 35 USC § 112 5. 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. 6. Claims 37 and 45 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: a. In claim 37, the chemical structures recited for variable R4 are not clear. The compounds appear to be drawn as triplets and also overlap with each other as shown below. PNG media_image1.png 200 1068 media_image1.png Greyscale The first three phenyl appears to be the same, the second three appears to be a 2-pyridyl moieties. It is recommended that applicants redraw the compounds. The examiner also recommends that applicants redraw the chemical structures of R1 that appears to be faded. PNG media_image2.png 317 1005 media_image2.png Greyscale b. In claim 45, the phrase, “for use” is indefinite. Literally, it simply states an intention, which is a mental state, not a patentable limitation. Hence the claim is improperly dependent, as it does not further limit the claim on which it depends. That is how the claim has been examined. Alternatively, this may be intended as a method of use claim, in which case, the claim would be garbled, as it begins as a compound claim, and ends as a method claim. Moreover, as it does not contain any actual step, it would not be a proper process claim. Alternatively, applicants may have intended the compound “in the form in which it is used”, i.e. what is intended is a composition claim. That, however, would require a second ingredient (the carrier) to become a proper composition claim. The intended scope of the claim is thus unclear. Claim Rejections - 35 USC § 101 7. 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claim 45 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). Allowable Subject Matter 8. Claims 1, 4-6, 8-10, 15, 17-18, 22-24, 26, 31, 33, 36, 38, 41, 43 and 46-47 are allowed. Information Disclosure Statement 9. Applicant’s Information Disclosure Statement, filed on 11/13/2025, 09/04/2025, 06/13/2025, 03/13/2025 and 12/15/2023 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith. To expedite prosecution after rejoinder, the examiner recommends that applicants delete “prevention” from claim 53 and also recite specific cancers. Conclusion 10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM. 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 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Kahsay Habte/ Primary Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

Aug 10, 2023
Application Filed
Jan 03, 2026
Non-Final Rejection — §101, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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NOVEL PROCESS FOR THE PREPARATION OF MACROCYCLIC CHELANT 2,2',2''-(10-(2-HYDROXYPROPYL)-1,4,7,10-TETRA AZACYCLODODECANE-1,4,7-TRIYL) TRIACETIC ACID AND IT'S COMPLEXES WITH PARAMAGNETIC METAL IONS
2y 5m to grant Granted Mar 31, 2026
Patent 12590067
HERBICIDAL CYCLOHEXANEDIONE DERIVATIVES
2y 5m to grant Granted Mar 31, 2026
Patent 12583866
PYRIDO[2,3-B][1,4]OXAZINES OR TETRAHYDROPYRIDO[2,3-B][1,4]OXAZEPINES AS IAP ANTAGONISTS
2y 5m to grant Granted Mar 24, 2026
Patent 12576040
IONIZABLE LIPIDS AND METHODS OF MANUFACTURE AND USE THEREOF
2y 5m to grant Granted Mar 17, 2026
Patent 12577253
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2y 5m to grant Granted Mar 17, 2026
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
85%
Grant Probability
93%
With Interview (+8.1%)
1y 11m
Median Time to Grant
Low
PTA Risk
Based on 1589 resolved cases by this examiner. Grant probability derived from career allow rate.

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