DETAILED ACTION
Claims 1-30 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 September 27 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 18 2023, December 7 2023 and May 14 2025 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 because
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 1D, 2, 3, 4, 5, 7B, 8, 9A, 10B and 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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 depends from claim 1. Claim 1 already recites the compound is Formula I. Therefore, claim 12 (and its dependents) fail to further limit the claim from which they depend as the structure in claim 12 is of no different scope than claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-30 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). 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 four or five repeating units and each repeating unit is liked to a nitrogen of the core, wherein the core has the following structure:
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wherein each repeating unit is a degradable diacyl having the formula
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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 same core (formula IV wherein X3 is NR6, R3 and R4 are alkylamino), repeating unit (formula VII) and terminating group (formula VIII) are claimed. Specific compounds claimed are:
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which falls within the scope claimed as they contain five repeating units with S-alkyl groups falling within the scope of claims 2-4, 8-9, 18-19, 21-23 and 26-28.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 1-30 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). 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 IV, X3 is NR6, R3 and R4 are alkylamino; 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.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 11858884. 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 IV, X3 is NR6, R3 and R4 are alkylamino (see also claim 10 which claims the same core as the instant claims); 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 ‘884 claims and the instant application overlap and thus they are obvious variants of one another.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12357580. 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) which is the same as instantly claimed when the core is Formula IV, X3 is NR6, R3 and R4 are alkylamino (see also claim 10 which claims the same core as the instant claims); 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 ‘580 claims and the instant application overlap and thus they are obvious variants of one another.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11999683. 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 ‘683 claims a method comprising a compound with the structure of core-repeating unit-terminal group (claim 1) which is similar to instantly claimed when the 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 ‘683 is the core. Patent ‘683 claims a core of:
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. Thus the difference is the presence of a methyl instead of a hydrogen on the central nitrogen of the core.
It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S.P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C.P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963): In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O. B.A. 1960) MPEP 2144.08.
Therefore, the scopes of the Patent ‘683 claims and the instant application overlap and thus they are obvious variants of one another.
Claims 1-4, 7-9, 12-15, 17-19, 21-23 and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of US Patent No. 12121610. 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 ‘610 claims a composition which comprises a dendrimer ionizable cationic lipid which has the following structure:
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This has the same linker structure of VII wherein A1 and A2 are O, Y3 is a C2 alkanediyl, R9 is C1 alkanediyl and the terminating group wherein Y4 is C7 alkanediyl and R10 is H.
The difference between the instant claims and patent ‘610 is the core. Patent ‘610 claims a core of:
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. Thus the difference is the presence of a methyl instead of a hydrogen on the central nitrogen of the core.
It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S.P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C.P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963): In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O. B.A. 1960) MPEP 2144.08.
Regarding claims 23 and 28, the difference between the instant claims and the Patent ‘610 is that the instant claims contain one more carbon. Thus the instant claims and the compound of Patent ‘610 are homologs which different by one carbon and thus are obvious variants. Note: MPEP 2144.09.
Therefore, the scopes of the Patent ‘610 claims and the instant application overlap and thus they are obvious variants of one another.
Claims 1-4, 7-9, 12-15, 17-19, 21-23 and 26-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 120 and 130 of copending Application No. 18312305 (USPGPUB No. 20230338411, 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 ‘305 claims a composition comprising an ionizable cationic lipid
which is 4A3-SC7 which has the following structure:
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This has the same linker structure of VII wherein A1 and A2 are O, Y3 is a C2 alkanediyl, R9 is C1 alkanediyl and the terminating group wherein Y4 is C7 alkanediyl and R10 is H.
The difference between the instant claims and copending ‘305 is the core. Copending ‘305 claims a core of:
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. Thus the difference is the presence of a methyl instead of a hydrogen on the central nitrogen of the core.
It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S.P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C.P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963): In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O. B.A. 1960) MPEP 2144.08.
Regarding claims 23 and 28, the difference between the instant claims and the copending ‘305 is that the instant claims contain one more carbon. Thus the instant claims and the compound of copending ‘305 are homologs which different by one carbon and thus are obvious variants. Note: MPEP 2144.09.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another.
Claims 1-4, 7-9, 12-15, 17-19, 21-23 and 26-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 120 of copending Application No. 18311274 (USPGPUB No. 20230293429, 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 ‘274 claims a composition comprising an ionizable cationic lipid
which is 4A3-SC7 which has the following structure:
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This has the same linker structure of VII wherein A1 and A2 are O, Y3 is a C2 alkanediyl, R9 is C1 alkanediyl and the terminating group wherein Y4 is C7 alkanediyl and R10 is H.
The difference between the instant claims and copending ‘274 is the core. Copending ‘274 claims a core of:
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. Thus the difference is the presence of a methyl instead of a hydrogen on the central nitrogen of the core.
It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S.P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C.P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963): In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O. B.A. 1960) MPEP 2144.08.
Regarding claims 23 and 28, the difference between the instant claims and the copending ‘274 is that the instant claims contain one more carbon. Thus the instant claims and the compound of copending ‘274 are homologs which different by one carbon and thus are obvious variants. Note: MPEP 2144.09.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-31 of copending Application No. 19362276. 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 ‘276 claims an ionizable cationic lipid comprising a core-repeating unit-terminating group (I) with a linker of formula VII (which is the same as instantly claimed) and a terminating group of formula VIII (which is the same as instantly claimed). The same core is claimed (claim 30). One specific compound claimed is:
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Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 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). 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) which is the same as instantly claimed when the core is Formula IV, X3 is NR6, R3 and R4 are alkylamino; 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 copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 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). 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) which is the same as instantly claimed when the core is Formula IV, X3 is NR6, R3 and R4 are alkylamino; 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 copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 140 of copending Application No. 18556614 (USPGPUB No. 20240207442). 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 Formula IV, X3 is NR6, R3 and R4 are alkylamino; 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 copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 103 of copending Application No. 18283406 (USPGPUB No. 20240216515). 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 ‘406 claims a method comprising a lipid composition comprising an ionizable cationic lipid having formula 5A2-SC8 which has the following structure:
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Regarding claims 22 and 27, the difference between the instant claims and the copending ‘406 is that the instant claims contain one less carbon. Thus the d the instant claims and 5A2-SC8 are homologs which different by one carbon and thus are obvious variants. Note: MPEP 2144.09.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 80 of copending Application No. 18419370 (USPGPUB No. 20240261440). 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 Formula IV, X3 is NR6, R3 and R4 are alkylamino; 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 copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 72 of copending Application No. 18553975 (USPGPUB No. 20250281580). 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 Formula IV, X3 is NR6, R3 and R4 are alkylamino; 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 copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19235388. 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 IV, X3 is NR6, R3 and R4 are alkylamino; 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 same core is claimed (claim 18).
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 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). 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 Formula IV, X3 is NR6, R3 and R4 are alkylamino; 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 copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-64 of copending Application No. 18724775. 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 ‘775 claims a composition comprising a lipid composition comprising an ionizable cationic lipid which is the same as instantly claimed when the core is
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; linker overlaps with the scope of the instant claims; and terminating group includes alkylthiols. The alkylthiols of claim 63 overlap in scope with the instant claims. A specific compound claimed is:
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The difference between the instant claims and copending ‘775 is the core. Copending ‘775 claims a core of:
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. Thus the difference is the presence of a methyl instead of a hydrogen on the central nitrogen of the core.
It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S.P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C.P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963): In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O. B.A. 1960) MPEP 2144.08.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19297252. 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 ‘252 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 IV, X3 is NR6, R3 and R4 are alkylamino; 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 copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-75 of copending Application No. 19343104. 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 ‘104 claims a composition comprising a lipid composition comprising cationic ionizable lipid having the formula core-repeating unit-terminating group (claim 140) which is the same as instantly claimed when the core is Formula IV, X3 is NR6, R3 and R4 are alkylamino; 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 copending claims and the instant application overlap and thus they are obvious variants of one another as the compounds of copending application overlaps in scope with the instantly claimed compounds.
Conclusion
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636