DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of Group I, and species of compound
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, in the reply filed on November 11, 2025 is acknowledged.
3. Examination followed guidelines provided by MPEP 803.02. The elected species was not allowable. Furthermore, the search was extended to the nonelected species of
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which was found to be anticipated by the prior art. Therefore, the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration. The search was performed to the extent of the elected species and the nonelected species shown above.
4. Claims 47, 48, 50, 51, 54-56, 58, 60, 62, 64 and 65 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on November 11, 2025.
Status of Claims
5. Claims 46-65 are pending. Claims 46 (independent), 49, 52, 53, 57, 59, 61 and 63 encompass the elected species and are elected. Claims 47, 48, 50, 51, 54-56, 58, 60, 62, 64 and 65 are withdrawn.
Information Disclosure Statement
6. The information disclosure statements (dated November 11, 2025 and July 29, 2024 and December 18, 2023) were compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claim(s) 46,49, 52, 53, 57, 59, 61 and 63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 1058398-86-9 (
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) and as evidenced by RN 1058398-86-9-properties. The reference RN 1058398-86-9 has a date of October 8, 2008 which antedates the present claims having an effective filing date of May 28, 2021 and priority claim to provisional application dated May 29, 2020.
The compound corresponds to the present claims in the following manner: X1=S; R1=option #1; n=0; R2=R3=R5=H; R4=R6=F; R7=SO2(Rb1=Me). The compound also corresponds to the third compound on page 11 of claim 61. The compound is taught in a pharmaceutical composition in water, see RN 1058398-86-9-properties.
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.
8. Claim 46, 49, 52, 53, 57, 59, 61 and 63 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of copending Application No. 18,700,468 (reference application, US 20250026746). Although the claims at issue are not identical, they are not patentably distinct from each other for the reason provided below.
The claims of the copending application are directed to the compounds of
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and
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, pharmaceutically acceptable salt thereof, pharmaceutical compositions thereof, and methods of using the compounds. The compounds correspond to and thus anticipate the presently elected species. The compounds are enantiomers of the elected species which is the chemical compound of
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that includes all enantiomer(s). The methods of using the compounds teach and thus anticipate the presently elected species.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621