DETAILED ACTION
Status of Application
The amendments and response filed 13 July 2026 are acknowledged and have been considered in their entireties. Claim 39 is new and dependent upon examined claim 1. Thus, claims 1-8, 15-17, 19, 21, 23, 30-32 and 35-39 are pending; Claims 4-8, 30-32 and 35-38 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1-3, 15-17, 19, 21, 23 and 39 are subject to examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 May 2026 has been considered by the examiner. See initialed and signed PTO/SB/08.
Withdrawal of Previous Objections/Rejections
Claim Objections
The objection to claim claims 1 and 2 for extraneous periods in the claims is withdrawn in view of the amendments to remove them.
The rejection of claims 1-3, 15-17, 19, 21 and 23 are rejected under 35 U.S.C. 112(a), written description is withdrawn in view of the amendments to claim 1, requiring at least 90% sequence identity to SEQ ID NO: 8 (the elected species; as well as SEQ ID NOs: 1-7 and 21-26).
The rejection of Claim(s) 1, 3, 15-17, 19, 21 and 23 under 35 U.S.C. 102(a)(1) as being anticipated by Kugler et al. (Molecular and Cellular Neuroscience, 2001 – cited previously) is withdrawn in view of the of the amendments to claim 1, requiring at least 90% sequence identity to SEQ ID NO: 8 (the elected species). Kugler et al. was cited as teaching a variant of SEQ ID NO: 8 having the same function as SEQ ID NO: 8 and having 2.4% sequence identity to SEQ ID NO: 8.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 21, 23 and 39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without additional elements that integrate the judicial exception into a practical application. An analysis with respect to the claims as a whole reveals that they do not include additional elements that integrate the judicial exception into a practical application. See MPEP 2106.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
Step (1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
Step (Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
Step (Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
Step (2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG)).
Step 1: Yes; the claims are directed to a composition of matter.
Step 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a naturally occurring product/promoter.
Step 2A – Prong 2: No, the claims do not recite any additional elements that integrate the judicial exception into a practical application because the claims are merely drawn to what already exists in nature. It is noted, elected species SEQ ID NO: 8, is a naturally occurring nucleic acid found in humans (See Supplemental Content, 20260123_121938_us-17-919-710-8.rge file, Result #1). Despite the claims reciting “synthetic CNS-specific promoter”, there is nothing in the claims which differentiates this naturally occurring promoter/nucleic acid in terms of structure and/or function. Thus, there is ultimately nothing in the claims which integrates the judicial exception into a practical application. Even for the claims which recite that the protein is in a pharmaceutical composition (claim 21) or found in a cell (claim 23), there is nothing in the claims or specification which distinguishes that found in nature from that produced in human cells.
Step 2B: As noted in answering that of 2A – Prong 2 above, there is nothing in the claims which amounts to significantly more in terms of structure and/or function and the claims read on naturally occurring enzymes. Thus, the claims are drawn to a judicial exception, namely, a naturally occurring product.
Applicant’s Remarks and Examiner’s Rebuttal:
Applicant’s traverse the rejection of record and state the claims are not drawn to a judicial exception. This is because, the definition of a “synthetic promoter” in the specification states it is non-naturally occurring (See Remarks, p. 6, and Specification at paragraph [0225]). It is noted, that one of the elements of the definition is that it simply may be a shorter, truncated version of a naturally occurring promoter. This ultimately means that the claimed sequence(s) are drawn to a judicial exception because they do not occur in nature.
These arguments have been considered but are not convincing. In the first instance, simply saying something is non-naturally occurring does not differentiate what is naturally occurring and what is synthetically made. For example, a protein can be recombinantly made and expressed in a heterologous host cell, but it can have the same amino acid sequence and structure of that which occurs naturally and it can be impossible to differentiate what is the natural protein vs the recombinantly made protein. Here, the promoter of SEQ ID NO: 8 is just a naturally occurring shorter version of what exists on human chromosome 4, and thereby what naturally occurs in nature by the means of isolation of said promoter from its natural human source (See Supplemental Content, 20260123_121938_us-17-919-710-8.rge file, Result #1-6). However, it will have the same structure and function and given that the claims recite “comprising”, it still reads on the full length naturally occurring promoter(s).
Thus, the rejection of record is maintained. To overcome this type of rejection, it is suggested that the promoter(s) is operably linked to a heterologous nucleic acid of interest.
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 1-3, 15-17, 19, 21, 23 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 27 and 115 of copending Application No. 18027293 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because anticipate the instant claims.
The instant claims in their broadest are drawn to a synthetic CNS-specific promoter comprising a sequence according to any one of SEQ ID NOs 1-8, 21-26 or a functional variant thereof (SEQ ID NO: 8 as the elected species) – Claim 1. Wherein dependent claims recite the promoter is in an expression cassette and operably linked to a nucleic acid sequence encoding an expression product; the promoter is in a vector and the promoter is in a cell (claims 15, 16 and 23, respectively).
The claims to the ‘293 in their broadest are drawn to methods of treating a neurological disorder in a subject by administering (a) an isolated nucleic acid encoding a transgene encoding one or more miRNAs; and (b) an isolated nucleic acid encoding a CYP46A1 protein (Claim 2). Dependent claim 27 recites wherein the transgene comprises a promoter and dependent claim 115 recites wherein the promoter is selected from SEQ ID NOs: 152, 74-98 and 112-127.
The promoters comprising the sequences of SEQ ID NOs: 97, 98, 118, 119, 125 of the ‘293 application have 100% sequence identity to instant SEQ ID NO: 8 – See Supplemental Content, 20260123_121939_us-17-919-710-8.rnpbm file, Results #1-3 and Duplicates thereof.
As such, while the claims differ in that the ‘293 claims are drawn to method claims using overlapping promoters that have 100% sequence identity to instant SEQ ID NO: 8, said promoters still necessarily anticipate the instant claims.
Claims 1-3, 15-17, 19, 21, 23 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 27 and 28 of copending Application No. 18833081 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because anticipate the instant claims.
The instant claims in their broadest are drawn to a synthetic CNS-specific promoter comprising a sequence according to any one of SEQ ID NOs 1-8, 21-26 or a functional variant thereof (SEQ ID NO: 8 as the elected species) – Claim 1. Wherein dependent claims recite the promoter is in an expression cassette and operably linked to a nucleic acid sequence encoding an expression product; the promoter is in a vector and the promoter is in a cell (claims 15, 16 and 23, respectively).
The claims to the ‘081 in their broadest are drawn to methods of treating a neurological disorder in a subject by administering (a) an isolated nucleic acid encoding a transgene encoding one or more miRNAs; and (b) an isolated nucleic acid encoding a CYP46A1 protein (Claim 1). Dependent claim 27 recites wherein the transgene comprises promoter and dependent claim 28 recites wherein the promoter is selected a synapsin-1 or any from Tables 10-13, wherein the promoters in Tables 10-13 include promoters comprising the sequences of SEQ ID NOs: 97, 98, 118, 119, 125 of the ‘081 application which have 100% sequence identity to instant SEQ ID NO: 8 – See Supplemental Content, 20260123_121939_us-17-919-710-8.rnpbm file, Results #1-3 and Duplicates thereof.
As such, while the claims differ in that the ‘293 claims are drawn to method claims using overlapping promoters that have 100% sequence identity to instant SEQ ID NO: 8, said promoters still necessarily anticipate the instant claims.
These both are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Applicant’s Remarks and Examiner’s Rebuttal:
Applicant’s suggest that the amendments to the claims, e.g. that the promoter sequences now have at least 90% sequence identity to SEQ ID NO: 8 (as elected species), overcome both NSDP rejections of record.
However this is not convincing because as noted in both rejections of record/above, the claimed promoter sequences of from both the 18027293 and 18833081 applications have 100% sequence with instant SEQ ID NO: 8. Thus, while they differ in that the claims to both applications are drawn to methods comprising utilizing the promoters, the method claims and promoters recited herein nonetheless anticipate the instantly claimed identical promoter(s).
Conclusion
No claim is allowed. The search has not yet been extended beyond the elected species.
THIS ACTION IS MADE FINAL. 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 SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 26 August 2026
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