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 Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 26 May 2026, have been entered in full. Claims 141-154 are withdrawn from consideration as being drawn to a non-elected invention. Claims 1-125, 128 and 131 are canceled. Claims 126, 127, 129, 133 and 136 are amended. Claims 126, 127, 129, 130, 132-140 are under examination.
Information Disclosure Statement
The information disclosure statement(s) (IDS) (filed 3/9/2026 and 5/28/2026) were received and comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. They have been placed in the application file and the information referred to therein has been considered as to the merits.
Withdrawn Objections And/Or Rejections
The objection to claim 133, as set forth at page 4 of the previous Office Action (24 February 2026), is withdrawn in view of the amendment (26 May 2026).
The rejection to claims 126, 127, 129, 130, 132-140 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,538,571, as set forth at pages 7-11 of the previous Office Action (24 February 2026), is withdrawn in view of the amendment (26 May 2026).
The provisional rejection to claims 126, 127, 129, 130, 132-140 on the ground of nonstatutory double patenting as being unpatentable over claims 30-35 and 39 of copending Application No. 16/925,174 (reference application), as set forth at pages 11-13 of the previous Office Action (24 February 2026), is withdrawn in view of the amendment (26 May 2026).
Claim Rejections - 35 USC § 102
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.
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.
(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.
Claims 126, 127, 129, 130, 132-140 remain rejected under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Greenberg et al. (US 2019/0161529; published May 30, 2019).
The basis for this rejection is set forth at pages of pages 4-7 of the previous Office Action (24 February 2026).
APPLICANT'S ARGUMENTS: Applicant cites MPEP 2152.02(b) and argues in order for a prior art document to anticipate a claimed invention under 35 U.S.C. 102(a1) and 102(a2), the reference must disclose all elements of the claimed invention arranges as they are in the claim and also provide sufficient guidance to enable a person skilled in the art to make the claimed invention. Applicant argues that claim 126 has been amended to recite, in part, an engineered receptor comprising a ligand binding domain derived from human α7-nAChR, wherein the ligand binding domain comprises a first amino acid substitution corresponding to R101F, R101M, or R101W. Applicant submits that Greenberg does not disclose mutating R101 of SEQ ID NO: 4 to the specific substitutions now recited in claim 126, i.e., F, M, or W. Applicant maintains that claims 126 and dependent claims 127, 129, 130 and 132-140 are not anticipated by Greenberg.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. Greenberg et al. teach the following:
“In some embodiments, the ligand binding domain comprises one or more amino acid substitutions at a residue corresponding to a residue of α7-nAChR selected from the group consisting of W77, Y94, R101, W108, Y115, T128, N129, V130, L131, Q139, L141, Y151, S170, W171, S172, S188, Y190, Y210, C212, C213 and Y217. In some embodiments, the one or more amino acid substitutions is a loss of function mutation that decreases the potency of acetylcholine on the receptor while substantially maintaining the potency of a non-native ligand on the receptor. In certain such embodiments, the substitution is selected from a substitution corresponding to L131S, L131T, L131D, or S172D of α7-nAChR. In certain such embodiments, the non-native ligand is selected from AZD-0328, TC6987, ABT-126 and Facinicline/RG3487. In other embodiments, the one or more amino acid substitutions is a gain of function mutation that increases the potency of acetylcholine on the receptor. In certain such embodiments, the substitution is selected from a substitution corresponding to L131N, L141W, S170G, S170A, S170L, S170I, S170V, S170P, S170F, S170M, S170T, S170C, S172T, S172C, S188I, S188V, S188F, S188M, S188Q, S188T, S188P, or S188W of α7-nAChR” (see para 0022).
“In some embodiments, the one or more substitutions decreases, e.g. 2-fold or more, 3-fold or more, 4-fold or more. 5-fold or more, 10-fold or more, 20-fold or more, 30-fold or more, 50-fold or more, or 100-fold, the responsiveness of an engineered receptor to acetylcholine and a non-native ligand. In some such embodiments, the one or more substitutions corresponds to an amino acid substitution in an α7-nAChR sequence described in FIGS. 8A-F and 8H. In certain embodiments, the one or more substitutions is a substitution corresponding to R101I, R101S, R101D, Y115L, Y115M, Y115D, Y115T, T128M, T128R, T128I, N129I, N129V, N129P, N129W, N129T, N129D, N129E, L131P, L131T, L131D, L131S, L141S, L141R, W171F, W171H, S172F, S172Y, S172R, S172D, C212A, C212L, or C213P of α7-nAChR” (see para 0124).
The Examiner notes that amended independent claim 126 recites that the engineered receptor must have mutation R101F or R101M or R101W.
Fig 8A of Greenberg et al. teaches mutations R101F and R101M. Additionally, Fig 8E teaches mutations Y210F and Y210W. Fig 8B teaches mutation Y115E.
Greenberg et al. teach the following:
“Typically, the amino acid residue that is mutated in the subject engineered receptor is not an amino acid corresponding to R27, E41, Q79, Q139, 141, G175, Y210, P216, Y217, or D219 of wild type α7 nAChR (SEQ ID NO:4). More typically still, the substitution is not a substitution corresponding to W77F, W77Y, W77M, Q79A, Q79Q, Q79S, Q79G, Y115F, L131A, L131G, L131M, L131N, L131Q, L131V, L131F, Q139G, Q139L, G175K, G175A, G175F, G175H, G175M, G175R, G175S, G175V, Y210F, P216I, Y217F, or D219A in wild type α7 nAChR. Alternatively, if such a substitution does exist within the engineered receptor, it exists in combination with one or more of the amino acid mutations described herein “(see para 0126).
The Examiner maintains that the teachings of Greenberg et al. anticipate instant claims 126, 127, 129(a-h, m, o, p, r, v, w, y, z, ab, ac), 130, 132-135, 136(SEQ ID Nos: 65, 66, 69-72, 74-76), 137-140. Sequence search alignment results for instant SEQ ID Nos: 65, 66, 69-72, 74-76 submitted upon request.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
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 126, 127, 130, 132-135, 137-140 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, 18, 20- 22, 25, 28 and 31 of copending Application No. 18/839,199 (reference application).
Claims 126, 127, 129, 130, 132-135, 137-140 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 18, 32, 51, 52, 58, 61, 64, 67 of copending Application No. 18/839,624 (reference application).
The basis for this rejection is set forth at pages of pages 13-16 of the previous Office Action (24 February 2026).
Applicant requests that the provisional nonstatutory double patenting rejections be held in abeyance until the instant claims are otherwise deemed allowable.
Applicant’s arguments have been fully considered but are not found persuasive because Applicant argues that since this rejection is provisional, no response is made at this time. Applicant requests that it be held in abeyance until a patent is granted on the ‘304 application.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
Applicant’s attention is respectfully directed to M.P.E.P. § 804(I)(B)(1), which states:
“A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional”.
“As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03. Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995 (emphasis added)”.
Accordingly, the rejection is maintained for reasons of record and is expressly not held in abeyance. The scientific reasoning and evidence as a whole indicates that the rejections should be maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 8/4/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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