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 Claims and Election/Restrictions
Claims 1-8, 14-21 and 29 are pending and under examination per Applicant’s election of three species (without traverse).
• First Species Election: di(pentadecan-8-yl) 4,4'-((((1-methylpiperidin-4-
yl)thio)carbonyl)azanediyl)dibutanoate, described as compound CAT7 in Table 1
and Example 1.3, which corresponds to the following chemical structure:
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Second Species Election: lung cancer; and
Third Species Election: an LNP comprising a ionizable lipid, a helper lipid, a structural lipid, and a PEG-lipid, and further comprising a payload, wherein IPTS/128754391.4 the molar ratio of ionizable lipid : helper lipid : structural lipid : PEG-lipid is 50 : 7 : 40 : 3.
Additionally, the examination of the claimed species has been expanded to include the following species, CAT21 from Table 1, paragraph 187 of the specification.
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This compound is also known as ATX-0126.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 04/22/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, filed April 22, 2026, with respect to the provisional rejection of claims 1-8, 14-21, 29, and 31-32 on the ground of nonstatutory double patenting as being unpatentable over claims 176-184, 194, 195, 198, 199, and 202-203 of copending Application No. 18/276,527 have been fully considered and are persuasive. The claims of the '527 Application were amended on February 3, 2026, and, as amended, are patentably distinct from the instant claims.
For example, examined claims 1 and 14 are directed to a compound(ionizable lipid) of formula I, as represented by a particular species of claims 5-8.
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In contrast, the claims of the conflict application 18/276,527 have been amended to delete a compound of formula I substantially similar in scope to those of examined formula I, as well as non-distinct species of compounds. The rejection of claims 1-8, 14-21, 29, and 31-32 has been withdrawn.
Applicant’s arguments, filed April 22, 2026, with respect to the provisional rejection of claims 1-4, 14-16, 20-21, and 29, on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/260,375 have been fully considered but they are not persuasive.
Applicant’s full rebuttal stated verbatim, “Without conceding the basis of the rejection, Applicant further submits that the instant claims are patentably distinct from the claims of the '375 Application.” Without further elaboration, this argument is not persuasive. See detailed rejection below.
Claim Objections
Claims 5-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening 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 1-4 ,14-21 and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 262, 268-278, 281, 283 and 284 of copending Application No. 18260375 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the same lipid nanoparticles (LNP) and compounds of Formula I, further comprising PEG-lipids of the same scope, structural lipids, helper lipids as well as polynucleotide payload molecule such as RNA.
The disclosure of claims 1-4, 14 have been discussed and are incorporated herein.
Regarding pending claims 1-4 and 14, reference claims 262, 268-269 and 270-271 recite a composition comprising a synthetic RNA viral genome encoding the Coxsackievirus (CVA21 strain) or the Seneca Valley virus (SVV) therein.
Reference claims 268-270 teach the recombinant RNA is encapsulated in a lipid nanoparticle (comprising cationic lipid, helper lipid, a structural lipid and a PEG-lipid), where the cationic lipid is a compound of formula I, where A, X, R1-R3, RN1, RN2 and L1-L3 are defined therein with the same scope, or substantially same scope as that claimed.
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Regarding claim 14 and the limitations of a PEG-lipid of formula A’, reference claims 270-271 disclose a LNP and a compound of formula A’’.
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Regarding claims 15-16, reference claims 272-278 further detail the PEG-lipid which is in overlapping scope of that claimed.
Regarding claim 17, reference claim 281 teaches, a helper lipid DSPC as claimed, cholesterol as a structural lipid as claimed, and an overlapping PEG-lipid where n is an integer between 10 and 200.
Regarding claims 18-19 and claimed concentrations of molar ratios between helper, structural and PEG-lipid, in particular a ratio of 50:7:40:3, reference claim 283 teaches species of the three lipids where
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Regarding claims 20-21 directed to a pharmaceutical composition comprising an LNP of claim 14 and a payload polynucleotide molecule capable of encoding antigens, proteins, etc., such as an siRNA, etc., reference claims 262 and 268-269 have been amended to recite a composition comprising a synthetic RNA viral genome encoding the Coxsackievirus (CVA21 strain) or the Seneca Valley virus (SVV) therein. Reference claims 268-270 teaches the recombinant RNA is encapsulated in a lipid nanoparticle (comprising cationic lipid, helper lipid, a structural lipid and a PEG-lipid), where the cationic lipid is a compound of formula I, where A, X, R1-R3, RN1, RN2 and L1-L3 are defined therein.
Regarding claim 29 and treatment of a disorder, reference claim 284 teaches treatment of cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion and Correspondence
No claims are allowed. 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 WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 This species has been identified by the Examiner’s SciFinder searches as CAS 2230647-37-5, below, and herein referred to the office action as CAT2.
Prosecution Insights