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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 156-158, 160-167, 170-185 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
The claims are broadly drawn to treatment of Dravet Syndrome by administering antisense oligonucleotide (ASO) comprising a sequence of SEQ ID NOs: 42 or 231 at a dose of 0.5-500 milligram, wherein the ASO is present in pharmaceutical composition at a concentration of 0.1-250 mg/ml.
Instant claims encompass treatment of Dravet Syndrome by using specific ASO at a specific amount and concentration.
Instant specification provides extensive description of designing ASOs targeting SCN1A for disease treatment (see Tables 4a, 4b, 5a, 5b, 6a, 6b, 7). Further, specification provides evidence of activity in vitro and in animal models of only one ASO, named ASO-22, without disclosing its sequence (see Examples 2-12, 16). According to Applicant arguments filed 11/10/2025 ASO-22 has a sequence of SEQ ID NO: 42 or 231, which are identical sequences annotating the same DNA or RNA sequence. None of the examples of specification defines amount of ASO and concentration as instantly claimed and relates to actual treatment of Dravet Syndrome. Examples 17-19 actually discuss treatment of Dravet Syndrome by ASO STK-001, which sequence is not specified, in the amount as claimed. Therefore there is no evidence in instant disclosure of actual treatment of Dravet Syndrome by the specific ASO claimed administered in the amount claimed.
Prior art by Aznarez et al (WO 2019/040923, February 2019, cited from IDS) teach that the same ASO as instantly claimed is active in animal models and in vitro, providing essentially the same data as instant disclosure (see Examples 6-8).
Instant specification fails to provide guidance on treatment of Dravet Syndrome by administering ASOs of SEQ ID NOs: 42 or 231 at a dose of 0.5-500 milligram, wherein the ASO is present in pharmaceutical composition at a concentration of 0.1-250 mg/ml.
The guidance provided in the specification relates to only activity of claimed ASO in animal models and in vitro, without specifying the amount and concentration of ASO administered.
In the absence of guidance, undue trial and error experimentation would have been required by one skilled in the art at the time invention was made to treat Dravet Syndrome by administering ASOs of SEQ ID NOs: 42 or 231 at a dose of 0.5-500 milligram, wherein the ASO is present in pharmaceutical composition at a concentration of 0.1-250 mg/ml as instantly claimed. Given the breadth of the claims, unpredictability of the art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
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 156-158, 160-167, 170-185 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 89-91, 116-117, 143, 148 of copending Application No. 19/035483 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘483 recite methods of treatment by administering the same ASO as instantly claimed. According to specification of ‘483 disease to treat can be Dravet syndrome (see Abstract) and the ASO can be administered in the amounts of 0.5-200 mg (see paragraph [0065]) and in concentration of 5-250 mg/ml (see paragraph [0310]), same as instantly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
Previous rejections are withdrawn in view of new amendments, arguments are moot.
New rejections are presented above.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 11/13/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
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/EKATERINA POLIAKOVA-GEORGANTAS/ Primary Examiner, Art Unit 1637