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 .
In the event the determination of the status of the application as subject to AIA 35
U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 8, 19, 21-22, 35, 40-42, 44-45, 51-52, and 56-58), in the reply filed on 12 March 2026, is acknowledged.
Applicant’s election of
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in the reply, without traverse, filed on 03/12/2026, is acknowledged.
A prior art search for the elected species did not retrieve any applicable prior art reference.
An extended search to the full scope of genus formula I of instant claim 1 has not returned any prior art (see Search 6 of the attached search notes). Thus, the election requirement of 01/16/2026 is rendered moot. Therefore, the Election of Species Requirement of 01/16/2026, is withdrawn, as the claims are free of the prior art.
Claims 1, 2, 8, 19, 21, 22, 35, 40-42, 44, 45, 51, 52, 56, 58 and 67-69 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 67-69, directed to the process of using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142
have been rejoined, the restriction requirement and election of species requirement as set forth in the Office action mailed on 01/16/2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
6. All claims have been examined on the merits.
Current Status of 18/476,775
7. Claims 1, 2, 8, 19, 21, 22, 35, 40-42, 44, 45, 51, 52, 56, 58 and 67-69 have been examined on the merits. Claims 2, 8, 19, 21, 22, 35, 41, 44, 52 and 58 are previously presented. Claims1 and 56 are original.
Priority
8. The application claims the benefit of Serial #: 63/377,940, filed on 09/30/2022. However, in ‘940, variable p on R12 was not disclosed (see the screen shot below). In this regard, it is considered that US63/377,940 does not disclose, in an enabling manner, compounds of Formula (I) of claim 1, wherein p is 0. Since all the other claims are depended (directly or indirectly) on claim 1, the priority date for all the claims is the filing date of the current application, which is 09/28/2023.
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9. The effective filing date is 09/28/2023.
Information Disclosure Statement
10. The information disclosure statement (IDS) submitted on 03/12/2026, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objection to Specification
11. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: The current title ”Bicyclic Compounds” is too general and broad. It could mean biphenyl or naphthalene. So, please submit a more descriptive title.
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.
12. Claim 68 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
1). Claim 68 is missing a period at the end. It’s unclear if the claim is complete and that renders unclear the metes and bounds of claim 68 and thus making claim 68 indefinite.
2). Claim 68 lacks antecedent basis. It refers to hepatitis D to claim 67, where hepatitis D doesn’t exist at all.
To render moot this rejection, please move claim 68 to claim 67 and combine HBV and HDV as “HBV and/or HDV” like presented throughout the specification.
Conclusion
13. The following is an examiner’s statement of reasons for allowance: claims 1, 2, 8, 19, 21, 22, 35, 40-42, 44, 45, 51, 52, 56, 58 and 67, 69 are allowable as written.
14. Claims 68 is not presently allowable as written.
15. There is no known prior art reference that either teaches or anticipates the genus
formula (I) of instant claim 1.
The reference GROSSE (WO2020/182990 A1, pub date: 09/17/2020) discloses fused ring pyrimidone derivatives, pharmaceutical compositions thereof, and their use in the treatment of HBV and/or HDV infection (Abstract; Ln 16, p 26, to Ln 28, p 27), Numerous compounds are exemplified on pages 123-588, including, for example, Compounds C129, C265, C289, C304, C327, C328 (on pages 186, 205-213), among many others. The compounds are similar to the presently claimed compounds but do not satisfy at least -C(=O)NR¹¹R¹² of present Formula (I) since -C(=O)NR¹1R¹² does not encompass -C(=O)NHMe in the reference.
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R⁹ is a substituted phenyl, a substituted monocyclic heteroaryl Compound C129 from WO ‘990
or a substituted fused- bicyclic heteroaryl, wherein the substituted
phenyl, the substituted monocyclic heteroaryl or the substituted
fused-bicyclic heteroaryl is substituted with -C(=O)NR¹¹R¹² and
the substituted phenyl, the substituted monocyclic heteroaryl or
the substituted fused-bicyclic heteroaryl is optionally further
substituted;
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Formula (I) of instant claim 1
Another reference LIU (WO 2022/053010 A1, pub date: 03/17/2022, cited #5 in the IDS of 12/07/2023 and provided by Applicants) describes fused ring pyrimidone derivatives, pharmaceutical compositions thereof, and their use in the treatment of HBV and/or HDV infection (Abstract; Lns 17-28, p19). Various compounds are exemplified on pgs. 90-98, including, for example, Compound I-2-3 (on pages 91 and 137-140). Compound I-2-3 is similar to the presently claimed compounds but does not satisfy -C(=O)NR¹¹R¹² of present Formula (I) since -C(=O)NR¹¹R¹² does not encompass -C(=O)NHMe.
None of the references discloses a compound of Formula (I) in the instant claim 1. Furthermore, there is no known rationale (and no known prior art reference
providing said rationale) to permit modifying the references to arrive at the instant application.
15. Regarding double patenting, two closed related references VENDEVILLE (US2023/0051483 A1, pub. 2/16/2023, cited #13 in the IDS of 3/12/2026 and provided by Applicants) and VENDEVILLE (US 2022/0119385 A1, pub, 4/21/2022, cited #1 in the IDS of 12/07/2023 and provided by Applicants) disclose fused ring pyrimidone compounds of Formula (I), pharmaceutical compositions thereof, and their use in the treatment of hepatitis B/D. Although the fuse ring core structure is same in these applications, the distinction is that the R12 (specifically R14) in the art does not satisfy the instantly described moiety (see the whole documents) as with other references discussed above. There is no non-statutory double patenting.
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/B.T./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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