DETAILED ACTION
The preliminary amendment submitted on November 30, 2023 has been entered. Claims 1-17, 19, and 23-24 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284. 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 (i.e., changing from AIA to pre-AIA ) 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.
Claim Rejections – 35 USC § 112(a)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 23-24 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating HBV infection, does not reasonably provide enablement for preventing it. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
As an initial matter, the examiner notes that “treatment” and “treating” are defined in applicant’s specification (p. 54) as including a person with the mere “potential to develop an HBV infection,” so the word “treating” in claim 23 reads on “preventing” even though that word is not specifically recited in claim 23.
The following reference is cited as being representative of the prior art: Rajbhandari et al., BMJ 2025;389:e079579 is a review of the state of the art as it concerns the treatment and management of hepatitis B. See, in particular, Table 2 (p. 6) for a summary of current approved first-line treatments for hepatitis B.
The specification (pp. 65-279) includes a long discussion of working examples illustrating the synthesis of compounds of Formula (I). It also includes (pp. 279-285) in vitro experiments with human liver microsomes. Nowhere, however, are there any working examples that show that these compounds prevent HBV or an HBV-induced disease from occurring. The examiner therefore concludes that one of skill in the art would be burdened with undue experimentation when attempting to practice the invention as claimed.
Claim Rejections – 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims partic-ularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The substituents Y1, Y2, Y3, and Y4 lack antecedent basis in claim 1 (although it appears to be applicant’s intention that claim 13 should depend from claim 12).
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differ-ences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-17, 19, and 23-24 are rejected under 35 U.S.C. 103 as being obvious over WO 2020/243135 A1 by Grosse et al.
Grosse (cited in applicant’s IDS1) discloses (p. 3) compounds of Formula (I):
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wherein R1 is phenyl substituted with one or more substituents (p. 3); R2 is methyl (p. 11, l. 13), including stereoisomers thereof (p. 3, l. 2); n is 0 (p. 3); W is CHR3 (p. 3), wherein R3 is C1-4 alkyl (p. 10, l. 19), such as methyl (p. 52, ll. 1-2), including stereoisomers thereof (p. 3, l. 2); X is CH2 (p. 3); Y is NR5 (p. 3), wherein R5 is C1-4alkyl [such as methyl (p. 52, ll. 1-2)] “substituted with a 5- to 10-membered monocyclic or bicyclic aromatic ring, wherein the 5- to 10-membered mono-cyclic or bicyclic aromatic ring optionally contains one, two, three or four heteroatoms, the heteroatoms independently being selected from N, O and S” (p. 7, ll. 13-16); and Z is C(=O) (p. 3).
The foregoing compounds are within the scope of instant claim 1. Although the reference does not disclose any specific individual compounds within the scope of the instant claims, one nevertheless would have viewed the claimed subject matter as being a matter of reduction to practice of the compounds generally disclosed in the cited reference and therefore prima facie obvious. It is the natural motivation of the skilled artisan to read and follow the instructions of the prior art. For example, one would be motivated to make the compounds of the reference in order to produce a therapy for hepatitis B (see, e.g., the reference at pp. 1-2). One would have had a reasonable expectation of success because the implicit disclosure of the reference is that all of the compounds disclosed therein, either specifically disclosed as individual chemical compounds or generically taught, would be effective for treating hepatitis B.
With respect to instant claims 2-3, the reference discloses that “R¹ is phenyl substituted with one or more substituents” (p. 6, l. 24). With respect to claim 5, the reference discloses that this phenyl group is substituted with one or more halogens (p. 6, l. 24).
With respect to claim 6, the reference discloses that the alkyl group, i.e., methyl group, in question is “substituted with one of more F” (p. 3, l. 25), including all stereoisomers thereof (p. 3, l. 2). With respect to claim 7, the reference provides for an ethyl group (p. 52, l. 3) instead of a methyl group as the R5 substituent.
With respect to claims 8-12 (and maybe claim 132), the reference discloses that the corresponding substituent is a “5- to 10-membered monocyclic or bicyclic aromatic ring” (p. 3, ll. 27-28), such as phenyl, pyridyl, pyrimidinyl, isoxazolyl, oxazolyl, and so forth (p. 10, l. 4-10). With respect to claims 15-16, the reference discloses that the ring is “optionally substituted with one or more substituents, in particular one to three substituents, each independently selected from the group consisting of halogens, CN, CF3,” and so forth (p. 10, ll. 8-10).
With respect to claim 14, it is well known that fluorine, chlorine, and bromine are halogens.
With respect to claim 17, and taking together all of the teachings outlined above, the reference discloses a compound of Formula (I) including all stereoisomers (p. 3),
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wherein “R1 is phenyl substituted with one or more substituents, in particular one to three substituents, each independently selected from the group consisting of … Cl or … CN” (p. 10, ll. 16-18); R2 is methyl (p. 11, l. 13); n is zero (p. 11, l. 14); W is CHR3 (p. 11, l. 15), and R3 is C1-4alkyl (p. 3, l. 18), such as methyl (p. 52, ll. 1-2); X is CH2 (p. 3, l. 20); Y is NR5 (p. 3, l. 21), and R5 is a C2alkyl group substituted with a phenyl group (p. 3, ll. 26-27), in which this phenyl group is substituted with a “OCF2H” group (p. 9, l. 15). The examiner therefore concludes that the reference suggests the first compound recited in claim 17.
With respect to claims 19 and 23-24, the reference discloses pharmaceutical composi-tions (pp. 35 et seq.), a method of treating HBV infection (pp. 36 et seq.), and combination phar-maceutical products (pp. 42 et seq.).
The examiner therefore concludes that instant claims 1-17, 19, and 23-24 are drawn to subject matter that is prima facie obvious over Grosse et al.
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 possi-ble 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 provi-sions 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 accompa-nied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejec-tion 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.
Claim 1-17, 19, and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 18-20, and 22-23 of copending Application No. 18/326,737 (reference application). Although the claims at issue are not identi-cal, they are not patentably distinct from each other for substantially the same reasons discussed above, mutatis mutandis, with respect to Grosse et al. Briefly, the ‘737 Application claims compounds of Formula (I):
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or a stereoisomeric thereof, wherein R1 is selected from the group consisting of phenyl, pyridyl, pyrimidinyl, and so forth, each of which is substituted with 1, 2 or 3 substituents; R2 is hydrogen or alkyl; Q represents a ring selected from the group consisting of phenyl, a five-membered aromatic heterocyclic ring, and a six-membered aromatic heterocyclic ring; n represents 1, 2 or 3; each R³ independently represents a substituent selected from the group consisting of CF₃, CHF₂, OCHF2, and so forth; W is CHR⁴ and X is CHR⁵, wherein R⁴ and R⁵ are hydrogen, CONR⁶R⁷, phenyl, etc. Dependent claims 19-20 and 22-23 in the ‘737 Application are directed to composi-tions and methods for treating hepatitis B infection. The examiner therefore concludes that the instant claims are prima facie obvious over the claims of the ‘737 Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday through Thursday, 8:00 am to 7:00 pm (Eastern Time). 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 encour-aged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interview practice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organ-ization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
January 22, 2026
(revised February 12, 2026)
1 See the information disclosure statement (IDS) submitted on November 30, 2023.
2 See the rejection under § 112(b), above.