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 .
Priority
The present application is a continuation of International Application No. PCT/EP2022/054316 having an International Filing Date of February 22, 2022 and which claims benefit under 35 U.S.C.§119 to International Application No. PCT/CN2021/077651 having an International Filing Date of February 24, 2021.
Status of the Claims
Claims 1-23 are pending and examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on January 8th, 2024 (20 references) has been received entered into the present application, in compliance with the provisions of 37CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the Examiner.
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 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10, 12-14, 17 and 20 of copending Application No. 18/319,860 (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; both referred to as formula (I) where L can be a spiro in the instant application and the compound in 18/319,860 of formula (I) where L is a spiro [3.3] heptan-2-yl, for example:
Compound formula (I) Claim 1 18/454,315
Compound formula (I) Claim 1 18/319,860
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L is a spiro or fused ring
Circled group is spiro
The methods of using the compound of formula (I) in 18/319,860 and the instant application; specifically;
Use of formula (I) 18/454,315 (instant application
Use of formula (I) 18/319,860 (reference application
Claim 16 -pharmaceutical composition comprising a compound or a pharmaceutically acceptable salt
thereof according to claim 1, and a pharmaceutically acceptable excipient
Claim 13- pharmaceutical composition comprising a compound or a pharmaceutically acceptable salt
thereof according to claim 1, and a pharmaceutically acceptable excipient
Claim 19 -use of a compound or a pharmaceutically acceptable salt thereof according claim 1 for
the treatment of HBV infection
Claim 14- The use of a compound according to claim 1, or a pharmaceutically acceptable salt thereof, for the treatment of HBV infection.
Claim 20-use of a compound or a pharmaceutically acceptable salt thereof according claim 1 for
the treatment of HBV infection
Claim 15-use of a compound according to claim 1, or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for the treatment of HBV infection
Claim 21- use of a compound or a pharmaceutically acceptable salt thereof according to claim 1 for
the inhibition of HBeAg.
Claim 17- use of a compound according to claim 1, or a pharmaceutically acceptable salt thereof,
for the inhibition of HBsAg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Closest Prior Art
WO 2011123719
WO 2011002635 and US 8993604
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A is required to be heteroaryl; A is a piperiedine.
L is required to be a cycloalkyl; L is a benzyl.
R2 can't be substituted by a heterocycle; R2 is a heterocycle.
A is required to be heteroaryl; Ais a phenol.
L is required to be a cycloalkyl; L is a benzyl.
R2 can't be substituted by a heterocycle; R2 is a heterocycle.
The compounds identified in the table below show in WO 2011123719, WO 2011002635 and US 8993604 are the closest prior art and show the differences of the variables L (as defined on pg. 5 of the specification as a “saturated carbon ring”), A and R2. The compounds are similar, but differ from the Applicant’s application as shown below.
Conclusion
Claims 1-23 are rejected.
No Claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL RANDALL GAUGER whose telephone number is (571)272-1325. The examiner can normally be reached M-F 7:30-5:00.
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/P.R.G./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629