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 .
Status of the Claims
Claims 1-49 and 78-87 are pending. Claims 7, 9, 14, 26, 29-39, 41, 44-45, 47-49, 78-79, and 82-87 are withdrawn. Claims 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, 46, and 80-81 are rejected.
Information Disclosure Statement
The Information Disclosure Statements (IDS’s) submitted on 5/29/2025, 7/17/2025, and 5/8/2026 were considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group I and the species:
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in the reply filed on 5/8/2026 is acknowledged.
Claims 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, 46, and 80-81 embrace Applicant’s elected species and are therefore under examination. The elected species is not allowable and has been rejected below.
Claims 7, 9, 14, 26, 29-39, 41, 44-45, 47-49, 78-79, and 82-87 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 46 is objected to because of the following informalities:
Line 1 at the beginning of the claim should read: “The compound of claim 1, selected from the group consisting of:”.
At the end of the claim (p. 8), there should be an “and” between the last two compounds.
Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(1 of 4) Claim(s) 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, 46, and 80-81 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Perni et al. (US12065405).
The applied reference has a common applicant and (some) inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding instant claims 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, and 46, Perni et al. disclose the following compound in column 37 (Table 4):
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, which is Applicant’s elected species and embraced by a compound of instant formula (I-A):
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, wherein A = C-VR16, V = absent, R16 = H; E = C-ZR5, Z = absent, R5 = H; B = C-YR4, Y = absent, R4 = H; R7 – R10 and R13-R14 = H; R1 and R2 = alkyl (methyl); R11= -O-; R12 = -OH; W = NR6, R6 = H; X = absent and R3 = H.
Regarding instant claims 80-81, Perni et al. teaches the following at the bottom of column 37 (lines 61-64):
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, wherein a skilled artisan would understand that a pharmaceutically acceptable carrier and excipient are interchangeable substances.
(2 of 4) Claim(s) 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, 46, and 80-81 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Perni et al. (US20230357146).
The applied reference has a common applicant and (some) inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding instant claims 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, and 46, Perni et al. disclose the following compound on p. 20, Table 4:
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, which is Applicant’s elected species and embraced by a compound of instant formula (I-A):
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, wherein A = C-VR16, V = absent, R16 = H; E = C-ZR5, Z = absent, R5 = H; B = C-YR4, Y = absent, R4 = H; R7 – R10 and R13-R14 = H; R1 and R2 = alkyl (methyl); R11= -O-; R12 = -OH; W = NR6, R6 = H; X = absent and R3 = H.
Regarding instant claims 80-81, Perni et al. teaches the following in para. [0283]:
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, wherein a skilled artisan would understand that a pharmaceutically acceptable carrier and excipient are interchangeable substances.
( 3 of 4) Claim(s) 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, 46, and 80-81 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Perni et al. (US11643391).
The applied reference has a common applicant and (some) inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding instant claims 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, and 46, Perni et al. disclose the following compound in column 37 (Table 4):
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, which is Applicant’s elected species and embraced by a compound of instant formula (I-A):
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, wherein A = C-VR16, V = absent, R16 = H; E = C-ZR5, Z = absent, R5 = H; B = C-YR4, Y = absent, R4 = H; R7 – R10 and R13-R14 = H; R1 and R2 = alkyl (methyl); R11= -O-; R12 = -OH; W = NR6, R6 = H; X = absent and R3 = H.
Regarding instant claims 80-81, Perni et al. teaches the following in column 38 (lines 4-8):
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, wherein a skilled artisan would understand that a pharmaceutically acceptable carrier and excipient are interchangeable substances.
( 4 of 4) Claim(s) 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, 46, and 80-81 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Perni et al. (US20230066720).
The applied reference has a common applicant and (some) inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding instant claims 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, and 46, Perni et al. disclose the following compound on p. 20 (Table 4):
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, which is Applicant’s elected species and embraced by a compound of instant formula (I-A):
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, wherein A = C-VR16, V = absent, R16 = H; E = C-ZR5, Z = absent, R5 = H; B = C-YR4, Y = absent, R4 = H; R7 – R10 and R13-R14 = H; R1 and R2 = alkyl (methyl); R11= -O-; R12 = -OH; W = NR6, R6 = H; X = absent and R3 = H.
Regarding instant claims 80-81, Perni et al. teaches the following in para. [0269]:
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, wherein a skilled artisan would understand that a pharmaceutically acceptable carrier and excipient are interchangeable substances.
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 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11643391. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-6, 8, 10-13, 15-25, 27-28, 40, 42-43, and 46, US11643391 discloses the following compound in claim 3:
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, which is Applicant’s elected species and embraced by a compound of instant formula (I-A):
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, wherein A = C-VR16, V = absent, R16 = H; E = C-ZR5, Z = absent, R5 = H; B = C-YR4, Y = absent, R4 = H; R7 – R10 and R13-R14 = H; R1 and R2 = alkyl (methyl); R11= -O-; R12 = -OH; W = NR6, R6 = H; X = absent and R3 = H.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
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