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 .1
Status of Claims
Claims 1-8,14-21,29 and 31-32 are pending and based off the three species elections (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, CAT22 from Table 1, paragraph 187 of the specification.
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This compound is also known as ATX-0126 (and has been identified as such by Applicant in the response to the non-final office action).
Response to Arguments
Applicant’s arguments and amendment of claim 1, file July 24 2025, with respect to the rejection of Claims 1-4, 9 and 31-32 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, as being indefinite have been fully considered and are persuasive.
Rejected indefinite claim 1 deleted “alkylene chain” rendering it indefinite.
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Claim 1 has been amended to recite:
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The rejection of claims 1-4, 9 and 31-32 has been withdrawn.
Applicant’s arguments and amendment of claim 1, file July 24 2025, with respect to the rejection of Claim(s) 1, 2, 4, 31, and 32 under 35 U.S.C. 102(a)(1) as being anticipated by US Pub 20180170866 (aka US Pub 866) have been fully considered and are persuasive. Claim 1 has been amended to recite:
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As claim 1 has been amended to exclude anticipatory compound ATX-0126,
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the rejection Claim(s) 1, 2, 4, 31, and 32 has been withdrawn
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.
RESPONSE TO ATTORNEY ARGUMENTS:
Applicant requested that these rejections be held in abeyance until the identification of patentable subject matter. The claims remain rejected as detailed above, and therefore, the double patenting rejections are maintained.
Claims 1-8,14-21,29 and 31-32 are provisionally rejected 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. 18276527 (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.
Rejected claims 1-8 are directed to the claimed compounds of Formula I, wherein A, X, L1, L2, L3, R1 and R2 are defined therein.
Claims 2-8 further limit the scope of claim 1, in particular, pending claim 3 requires that the compound of Formula I-b requires A is a 4-7 heterocycle ring as taught by CAT7 detailed below.
Regarding pending claims 1-8 and 14, the reference application discloses generic formulas that encompass claimed formula I and compound CAT7.
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See Claims 176-182. See claims 182-183 for the teachings of individual compounds including CAT7.
Pending claims 5-8 are directed to individual compounds, including elected species CAT7 of Table 1.
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as well as other species including compounds CAT1, compounds CAT3 to CAT7, and compounds CAT9 to CAT12, compounds CAT14 to CAT35 from Table 1. As noted above, reference claims 176-183 teach CAT7 among other species.
Regarding pending claim 15 disclosing various polyethylene glycols of Formula A, reference claim 184 disclose the same Formula (A) and the same species of polyethylene glycol, inclusive of a species where n is 45. See also reference claim 191.
Pending claim 16 requires the limitation of an LN further comprising elected species DSPC. Reference claim 194 discloses such LNPs, including elected species DSPC and a steroid so as to render it obvious.
Regarding pending claim 17 and the limitation of an LNP further comprising the ionizable lipid CAT7, helper lipid DSPC, and structural lipid cholesterol and the PEG-lipid where HO-(CH2CH2O)n-CH2C(O)O-(CH2)13CH3, wherein n is on average 45, these limitations are disclosed by the reference application as noted above. The reference application discloses CAT7 and the lipid is DSPC.
Regarding pending claims 18-19 and the limitations of molar ratios of helper lipid, a structural lipid and a PEG-lipid, such limitation is disclosed by reference claim 198. The particular ratios of pending claim 19 fall within those of reference claim 198.
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Regarding pending claims 20-21 and a payload molecule, reference claim 199 discloses a payload molecule.
Regarding pending claim 29 and the limitation of treating a disease/disorder in a patient, reference claims 202-203 disclose treating a patient of a disease or disorder.
Regarding claims 31-32 where R1 and R2 C10-C20 alkyl and claim 32 where L1 and L2 are C1-C5 alkylene, these limitations are taught by claim 176 and also the various species of the claims such as compound CAT7.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 14-16, 20-21, 29 and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 226, 229, 235 and 256 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.
The disclosure of claims 1-4, 14-16, 20-21, 29 and 31-32 are discussed and incorporated herein.
Regarding pending claims 1-4 and 14, reference claims 226 and 229-230 are directed to a lipid nanoparticle (LNP) comprising a compound of Formula I
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of similar scope as applicant’s Formula I, see specifically claim 230 reciting the cationic lipid is a compound of formula I.
Regarding pending claim 15 disclosing various polyethylene glycols of Formula A, reference claim 235 disclose similar Formula (A”) and the same species of polyethylene glycol, inclusive of species where n is 10-200.
Regarding pending claim 16 and the limitation of an LNP as claimed, reference claim 235 discloses such LNPs, including elected species DSPC; as well as structural lipid such as cholesterol.
Regarding pending claims 20-21 and the limitation of a payload molecule and a compound of Formula I, reference claim 229 discloses said Formula I and reference claim 226 discloses a payload molecule of synthetic RNA.
Regarding pending claim 29 and the limitation of treating a patient with a disease, including elected species lung cancer, reference claim 256 disclose treatment of lung cancer.
Regarding claim 31 where R1 and R2 C10-C20 alkyl and claim 32 where L1 and L2 are C1-C5 alkylene, these limitations are taught by claim 230 and also the various species of the claims such as compound CAT7.
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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. 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
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a CON of 18/276,527 08/09/2023
18/276,527 is a 371 of PCT/US2022/011463 01/06/2022
PCT/US2022/011463 has PRO 63/181,917 04/29/2021
PCT/US2022/011463 has PRO 63/181,899 04/29/2021
PCT/US2022/011463 has PRO 63/147,959 02/10/2021
2 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.