DETAILED ACTION
Claims 1-29 are pending.
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 .
Priority
This application is a CON of 17/566,666 (12/30/2021) which is a CON of 15/265,064 (09/14/2016; PAT 11,247,968) which claims benefit of 62/218,412 (09/14/2015) as reflected in the filing receipt issued on December 5 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 13 2024, May 14 2025 and April 20 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to for the following reasons: 37 CFR 1.84 (u)(1) states “Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter.” In the current case, the view numbers for the partial views for Figures 1-5, 7-11, that appear on several sheets are followed by "Cont." instead of a capital letter such as FIG. 1A, FIG. 1B, etc.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 16 is objected to because of the following informalities: in line 4 the claim recites wherein the core “has is” selected from. This is ungrammatical. Applicants should choose either “has: or “is” to be utilized before selected from. Appropriate correction is required.
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 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11247968 (cited on PTO Form 1449) in view of Alabi et al. (WO2014210356). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims a compound of Formula I: core-repeating unit-terminating group wherein the core is linked to two repeating units and each repeating unit is linked to a nitrogen of the core, wherein the core has a structure of formula II:
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wherein each repeating unit is a degradable diacyl having the formula
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326
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The examiner notes that the recitation “alkanediyl(C≤12)”, for example, is clearly defined (see page 40, lines 3-14 of the instant specification).
Patent ‘968 claims a composition comprising a dendrimer or pharmaceutically acceptable salt thereof that has the structural formula Core-Repeating Unit-Terminating group. The core is linked to one or more repeating units.
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406
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The same degradable diacyl group is claimed. The same terminating group is claimed.
Regarding the claimed core, the c and d of Patent ‘968 read on instantly claimed “a”. X3 correspond to X1 and the open claim language allows for additional functionality on the core.
The difference between the instant claims and patent ‘968 is that Patent ‘968 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
Alabi et al. is directed to multi-tailed lipids and uses thereof. Exemplary compounds include formula I-1 to I-31.
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which include I-1, I-2, I-13, I-20:
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83
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(page 4; paragraph 0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘968 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of Patent ‘968. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in Patent ‘968. Since Patent ‘968 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of US Patent No. 11766408 (cited on PTO Form 1449) in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘408 claims a composition comprising an ionizable cationic lipid which is a compound having the formula core-repeating unit-terminating group (claim 1) which is the same as instantly claimed when the core is Formula III; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another as the compounds of Patent ‘408 overlaps in scope with the instantly claimed compounds.
The difference between the instant claims and patent ‘408 is that Patent ‘408 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teaching of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘408 and Alabi et al. and utilize core such as I-1, I-13 and I-20 of Alabi et al. in the compound of Patent ‘408. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in Patent ‘408. Since Patent ‘408 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 11858884 (cited on PTO Form 1449) in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘884 claims a method comprising a compound with the structure of core-repeating unit-terminal group(claim 1) which is the same as instantly claimed when the core is Formula III; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and patent ‘884 is that Patent ‘884 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘884 and Alabi et al. and utilize core such as I-1, I-13 and I-20 of Alabi et al. in the compound of Patent ‘884. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in Patent ‘884. Since Patent ‘884 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12357580 (cited on PTO Form 1449) in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘580 claims a method comprising a lipid composition comprising a cationizable lipid having the structure of formula I: core-repeating unit-terminal group(claim 1); linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed. Regarding the claimed core, the c and d of Patent ‘580 read on instantly claimed “a”. X3 correspond to X1 and the open claim language allows for additional functionality on the core.
The difference between the instant claims and patent ‘580 is that Patent ‘580 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘580 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of Patent ‘580. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in Patent ‘968. Since Patent ‘580 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18508202 (USPGPUB No. 20240116860, cited on PTO Form 1449) in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘202 claims a compound which is a compound having the formula core-repeating unit-terminating group (claim 1); linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘202 is that copending ‘202 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘202 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘202. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘202. Since copending ‘202 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18800894 (USPGPUB No. 20240391869, cited on PTO Form 1449) in view Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘894 claims a compound which is a compound having the formula core-repeating unit-terminating group (claim 1); linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘894 is that copending ‘894 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘894 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘894. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘894. Since copending ‘894 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 140-159 of copending Application No. 18556614 (USPGPUB No. 20240207442, cited on PTO Form 1449) in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘614 claims a method comprising a lipid composition comprising an ionizable cationic lipid having the formula core-repeating unit-terminating group (claim 140) which is the same as instantly claimed when the core is D-II; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘614 is that copending ‘614 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘614 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘614. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘614. Since copending ‘614 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69-88 of copending Application No. 18419370 (USPGPUB No. 20240261440, cited on PTO Form 1449) in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘370 claims a composition comprising an ionizable cationic lipid having a formula of core-repeating unit-terminating group which is the same as instantly claimed when the core is D-II; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘370 is that copending ‘370 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘370 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘370. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘370. Since copending ‘370 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 62-81 of copending Application No. 18553975 (USPGPUB No. 20250281580, cited on PTO Form 1449) in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘975 claims a method comprising a lipid composition wherein the lipid composition comprises an ionizable cationic lipid having a formula of core-repeating unit-terminating group which is the same as instantly claimed when the core is D-II; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘975 is copending ‘975 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘975 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘975. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘975. Since copending ‘975 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19235388 in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘388 claims a composition comprising a lipid composition comprising an ionizable cationic lipid having a formula of core-repeating unit-terminating group which is the same as instantly claimed when the core is formula II; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘388 is that copending ‘388 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘388 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘388. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘388. Since copending ‘388 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, 31, 33-35, 44, 77, 80, 101, 106, 116, 125, 145, 152, 156 and 160 of copending Application No. 18862512 (USPGPUB No. 20250276089, cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘512 claims a composition comprising an ionizable cationic lipid having a formula of core-repeating unit-terminating group (claim 33) which is the same as instantly claimed when the core is D-II; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘512 is that copending ‘512 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘512 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘512. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘512. Since copending ‘512 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19578671 in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘671 claims a method comprising an aminolipid composition comprising dendrimer having the formula core-repeating unit-terminating group (claim 140) which is the same as instantly claimed when the core is Formula II; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘671 is copending ‘671 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘671 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘671. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘671. Since copending ‘671 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-75 of copending Application No. 19683363 in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘363 claims a composition comprising a lipid composition comprising cationic ionizable lipid having the formula core-repeating unit-terminating group which is the same as instantly claimed when the core is Formula II; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘363 is copending ‘363 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘363 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘363. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘363. Since copending ‘363 claims amine containing cores there is a reasonable expectation of success.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-52 of copending Application No. 19760572 in view of Alabi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are set forth above.
Copending ‘572 claims a composition comprising a lipid composition comprising cationic ionizable lipid having the formula core-repeating unit-terminating group (claim 26) which is the same as instantly claimed when the core is Formula II; linker is formula VII which is the same as instantly claimed and terminating group is formula VIII which is the same as instantly claimed.
The difference between the instant claims and copending ‘572 is copending ‘572 does not claim the same core of 2-pyridinyl or N-imidazolyl. However, this deficiency is cured by Alabi et al.
The teachings of Alabi et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘572 and Alabi et al. and utilize a core such as I-1, I-13 and I-20 of Alabi et al. in the compound of copending ‘572. One skilled in the art would have been motivated to utilize any of the specifically taught cores in Alabi et al. with a reasonable expectation of success as Alabi et al. teaches the use of the cores with acyl linkers and thiol terminating groups which are similar to the linkers and terminating groups instantly claimed and taught in copending ‘572. Since copending ‘572 claims amine containing cores there is a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yan et al. (Polymers, 2015) while teaching polymers with groups that correspond to the instantly claimed core (scheme 2), do not teach the instantly claimed linking or terminating groups.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636
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