Prosecution Insights
Last updated: April 19, 2026
Application No. 18/319,920

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

Non-Final OA §101§112§Other
Filed
May 18, 2023
Examiner
SAEED, KAMAL A
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hoffmann-La Roche, Inc.
OA Round
1 (Non-Final)
84%
Grant Probability
Favorable
1-2
OA Rounds
2y 3m
To Grant
93%
With Interview

Examiner Intelligence

Grants 84% — above average
84%
Career Allow Rate
1007 granted / 1194 resolved
+24.3% vs TC avg
Moderate +9% lift
Without
With
+9.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
16 currently pending
Career history
1210
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
11.5%
-28.5% vs TC avg
§102
9.4%
-30.6% vs TC avg
§112
19.3%
-20.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1194 resolved cases

Office Action

§101 §112 §Other
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 1-25 are currently pending in this Application. Priority CONTINUING DATA This application is a CON of PCT/EP2021/082590 11/23/2021 FOREIGN APPLICATIONS PCTCN2020131372 11/25/2020 Information Disclosure Statement Applicant’s Information Disclosure Statement, filed on May 22, 2024 has been considered. Please refer to Applicant’s copies of the 1449 submitted herewith. Compact Prosecution In the interest of compact prosecution, the examiner attempted to reach out to applicants to suggest some Examiner’s Amendment to advance the prosecution of the case. Claim Objections Claims 2-15, 17 and 24 are objected to over the following informal issues, appropriate correction is required. In claims 2-15, 17 and 24, each claim begins by reciting ” A compound …”, since this claims depend directly or indirectly from claim 1, for the purpose of clarity, it is suggested to change the beginning of each claim to recite “The compound….” Claim 17 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. 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 § 706.03(k). Both claims 1 and 17 are directed to a compound of Formula I, despite the difference in wording. It is suggested to delete claim 17. 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. The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173). Claims 19-23 is 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. Claims 19-23 recite “ The use of compound of claim 1 …” but, since the claims do not set forth any steps involved in the "use,” method, or 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. It is suggested to change the claims to method claims. For example “ A method for the treatment of …” Claim Rejections - 35 USC § 101 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. Claims 19-23 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific or substantial asserted utility or a well-known established utility. Claims 19-23 claim a purpose of using the compound of claim 1 ( i.e. “ The use of compound of claim 1 …..) but does not set any steps related to this application. Since the claim does not set forth any steps involved in the "use,” method, or process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a purpose or application without any active, positive steps delimiting how this application is actually practiced. The recitation of an application or 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), Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986), and also MPEP § 2173.05(q). Allowable Subject Matter Claims 2-15, 17 and 24 would be allowable once objection outlined above have been overcome. Claims 19-23 would also be allowable once the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejection, outlined above have been overcome. The following is a statement of reasons for the indication of allowable subject matter: The instant invention is drawn to products of Formula PNG media_image1.png 168 306 media_image1.png Greyscale as defined in claim 1. The invention is also directed to method of using the aforementioned products. The products of the instant claims are novel and non-obvious over the prior art. The closest prior art is US Patent No. 8,481,547 which discloses products of Formula, PNG media_image2.png 129 302 media_image2.png Greyscale , and their use in the treatment and conditions modulated by DPP-1. The instant claimed products has a mandatory bridged cyclic group moiety. US Patent No. 8,481,547 fail to disclose or suggest the modifications necessary to arrive at Applicant's claimed compounds. None of the published products anticipated, or rendered obvious, the products as described in this application. Therefore, claims 1, 18 and 25 are allowable. Telephone Inquiry Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kamal Saeed whose telephone number is (571) 272-0705. The examiner can normally be reached on Monday-Friday, 10am-7pm EST. 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, Mr. 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. Communication via Internet e-mail regarding this application, other than those under 35 U.S.C. 132 or which otherwise requires a signature, may be used by applicant and should be addressed to [Symbol font/0x5B]adam.milligan@uspto.gov[Symbol font/0x5D]. All Internet e-mail communications will be made of record in the application file. PTO employees will not communicate with applicant via Internet e-mail where sensitive data will be exchanged or where there exists a possibility that sensitive data could be identified unless there is of record an express waiver of the confidentiality requirements under 35 U.S.C. 122 by the applicant. See the Interim Internet Usage Policy published by the Patent and Trademark Office Official Gazette on February 25, 1997 at 1195 OG 89. 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 only. For more information about the pair system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197. /Kamal A Saeed/ Primary Examiner, Art Unit 1626
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Prosecution Timeline

May 18, 2023
Application Filed
Dec 09, 2025
Non-Final Rejection — §101, §112, §Other (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
84%
Grant Probability
93%
With Interview (+9.0%)
2y 3m
Median Time to Grant
Low
PTA Risk
Based on 1194 resolved cases by this examiner. Grant probability derived from career allow rate.

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