Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
Applicant’s election of claims 1-14 in part, and as species specific compound (claim 3); a neutral lipid (claim 5); DOPE (claim 6); SEQ ID NO: 15 (claim 9); mono-unsaturated or poly-unsaturated C12-C18 alkenyl (claim 12); mono-unsaturated or poly-unsaturated C12-C18 alkenyl (claim 13); and Rl is -(CO)C18 mono-unsaturated or poly-unsaturated alkenyl (claim 14) without traverse in the reply filed on 07/22/2026 is acknowledged.
Priority
Applicants’ claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a DIV of 17/133,036 filed on 12/23/2020 now US Patent 12,065,665 which is a CON of 16/197,989 filed on 11/21/2018 now US Patent 10,883,118, which is a DIV of 15/707,740 filed on 09/18/2017 now US Patent 10,138,497, which is a DIV of 14/994,059 filed on 01/12/2016 now US Patent 9,765,359, which is a CON of 14/054,825 filed on 10/16/2013 now US Patent 9,259,475, which is a CON of PCT/US2012/036951 filed on 05/08/2012, which is a CIP of PCT/US2012/033847 filed on 04/16/2012.
Information disclosure statement
The information disclosure statements (IDS) submitted on 09/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Double patenting rejection
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-14 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over: (i) Claims 1-36 of Jesse et al., (US 9,259,475 B2, in IDS); (ii) Claims 1-10 and 15-18 of Jesse et al., (US 9,765,359 B2, in IDS); (iii) Claims 1-10 of Jesse et al., (US 10,138,497 B2, in IDS); (iv) Claims 1-15 of Jesse et al., (US 10,883,118 B2, in IDS); and (v) Claims 1-11 of Jesse et al., (US 12,065,665 B2) in view of Manoharan et al., (US 9,687,550 B2, in IDS) and Smith et al., (US 6,344,436 B1, in IDS). An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claims are not patentably distinct from the reference claims, because the examined claims are either anticipated by, or would have been obvious over reference claims. 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other. Claims 1-14 of the instant application are directed to a compound having a structure … (as in claims 1, 3 and 12-14); a composition comprising said compound and a nucleic acid (as in claims 2 and 4-11); and said composition further comprising a neutral lipid…surface ligand (as in claim 5), said neutral lipid is DOPE (as in claim 6); said surface ligand is an RGD-containing peptide, amphipathic peptide of SEQ ID NO: 15 (as in claims 8-9).
(i) Claims 15-16 of Jesse et al., (US 9,765,359 B2, in IDS); and (ii) Claims 1-10 of Jesse et al., (US 10,138,497 B2, in IDS) of reference patents are also directed to a compound having a structure; said reference compound structures having identical or similar structure of the instant invention. Furthermore, the preferred embodiments in said reference patents: (i) US 9,259,475 B2, in IDS; (ii) US 9,765,359 B2, in IDS; (iii) US 10,138,497 B2, in IDS; (iv) US 10,883,118 B2, in IDS; and (v) (US 12,065,665 B2) are also directed to a composition comprising said compound and a nucleic acid including RNA: applicants’ are directed to the following sections of reference patent Jesse et al., (US 9,765,359 B2, in IDS), column 7, lines 1-56; col. 15, lines 18-51; col. 16, lines 1-21; col.20, lines 20-26. Additionally the following references of prior art clearly teaches the use of transfection agents comprising a neutral lipid, amphipathic peptide and use of said reference transfection agent in the transfection of mRNA and compositions comprising neutral lipids DOPE, see Manoharan et al., (US 9,687,550 B2, in IDS): see col. 1, lines 30-67; col. 8, lines 1-7; col. 61, lines 35-67; and reference of Smith et al., (US 6,344,436 B1, in IDS) lipophilic peptides for macromolecule deliver and said refence peptide having 100% sequence identity to SEQ ID NO: 15 of the instant invention (see provided sequence alignment) and said references provide Teaching, Suggestion and Motivation for compositions and a method of transfection of mRNA and said compositions comprising neutral lipids DOPE and amphipathic peptide.
Therefore, claims 1-14 of the of the instant application cannot be considered patentably distinct over: (i) Claims 1-36 of Jesse et al., (US 9,259,475 B2, in IDS); (ii) Claims 1-10 and 15-18 of Jesse et al., (US 9,765,359 B2, in IDS); (iii) Claims 1-10 of Jesse et al., (US 10,138,497 B2, in IDS); (iv) Claims 1-15 of Jesse et al., (US 10,883,118 B2, in IDS); and (v) Claims 1-11 of Jesse et al., (US 12,065,665 B2) in view of Manoharan et al., (US 9,687,550 B2, in IDS) and Smith et al., (US 6,344,436 B1, in IDS), when there is specifically disclosed embodiment in the reference patents: (i) US 9,259,475 B2, in IDS; (ii) US 9,765,359 B2, in IDS; (iii) US 10,138,497 B2, in IDS; (iv) US 10,883,118 B2, in IDS; and (v) (US 12,065,665 B2) that supports claims of those reference patents and falls within the scope of the claims 1-14 herein i.e., a compound having a structure … (as in claims 1, 3 and 12-14); a composition comprising said compound and a nucleic acid (as in claims 2 and 4-11); and said composition further comprising a neutral lipid…surface ligand (as in claim 5), said neutral lipid is DOPE (as in claim 6); said surface ligand is an RGD-containing peptide, amphipathic peptide of SEQ ID NO: 15 (as in claims 8-9), because it would have been obvious to one having ordinary skill in the art to modify i) Claims 1-36 of Jesse et al., (US 9,259,475 B2, in IDS); (ii) Claims 1-10 and 15-18 of Jesse et al., (US 9,765,359 B2, in IDS); (iii) Claims 1-10 of Jesse et al., (US 10,138,497 B2, in IDS); (iv) Claims 1-15 of Jesse et al., (US 10,883,118 B2, in IDS); and (v) Claims 1-11 of Jesse et al., (US 12,065,665 B2) in view of Manoharan et al., (US 9,687,550 B2, in IDS) and Smith et al., (US 6,344,436 B1, in IDS) by selecting a specifically disclosed embodiment that supports those claims of the reference patents. One of ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being preferred embodiment within (i) Claims 1-36 of Jesse et al., (US 9,259,475 B2, in IDS); (ii) Claims 1-10 and 15-18 of Jesse et al., (US 9,765,359 B2, in IDS); (iii) Claims 1-10 of Jesse et al., (US 10,138,497 B2, in IDS); (iv) Claims 1-15 of Jesse et al., (US 10,883,118 B2, in IDS); and (v) Claims 1-11 of Jesse et al., (US 12,065,665 B2).
Claim Rejections: 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 3, 5-6 and 12-14 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by either one of Nantz et al., (US 5,527,928 in IDS).
Nantz et al., taught cationic lipids of the general structure (Abstract; Col. 2; Col. 4 reproduced below; and entire document):
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Col. 2
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.
Col. 4
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See e.g. the US 5,527,928 patent at column 4, lines 10-28. Thus Nantz et al., generally disclosed diquaternary diamine compounds. It is noted that these compounds include those in which each R3 is an H atom. The instantly claimed structures lack any such H atom and are claimed in an electrically neutral state. However, the specification as filed refers to them as cationic, and it appears that they would be protonated and cationic in aqueous medium at neutral pH. Accordingly, the uncharged compounds set forth in the instant claims are considered to be equivalent to the charged compounds of Nantz et al., in which both instances of R3 are H atoms, because this H atom is dissociable in the aqueous media in which the compounds are intended to be used. For example, embodiments of Nantz et al., in which R1 is an alkyl group from 1-3 carbons, R3 is H, n is 2-8, and R2 is alkyl, alkenyl, alkylacyl or alkenylacyl group (such as oleoyl, column 5, line 64 and column 7, lines 36-40) will anticipate instant claim 1. Such structures would anticipate instant compounds of claim 1 wherein R1 was C(O)C17 alkenyl, Rx was C1-C3 alkyl, and Ry was -CH2(CH2)0-6CH2-OH. An example of this type of compound is presented as compound 5 at column 7, lines 15-22 of Nantz et al.,
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Thus, Nantz et al., anticipates the claims 1, 3, 5-6 and 12-14 and rejected under pre-AIA 35 U.S.C. 102(b).
Claim Rejections: 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-6 and 10-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nantz et al., (US 5,527,928 in IDS).
These teachings of Nantz et al., are discussed above and anticipate, thereby rendering obvious, claims 1, 3, 5-6 and 12-14. Nantz et al., did not disclose an example of a composition comprising a compound according to instant claims 2, 4 and 10-11 also comprising a nucleic acid, a fusion agent, or a neutral lipid. Moreover, Nantz did not disclose any example of the use of a compound of instant claims 2, 4 and 10-11. However, Nantz et al., did disclose that the compounds of the invention were intended to be used to transport nucleic acids, such as plasmids encoding polypeptides, into cells; “Disclosed are novel diamine cationic transporter molecules that facilitate the delivery of such compounds as polynucleotides, polypeptides, and the like into and beyond membrane walls” (see column 2, lines 45-48, and column 8, lines 5-13). Such transport is accomplished through the formation of vesicles which may comprise the neutral fusogenic lipid dioleoylphosphatidylethanolamine (DOPE; see column 8, lines 5-31). Accordingly, it would have been obvious to have used a lipid such as the one disclosed as compound 5, and embraced by the structure at column 4, lines 10-28, in a method of transfecting a cell with a nucleic acid as required by instant claims 2, 4 and 10-11. Moreover, it would have been obvious to have used it in a vesicle comprising the fusogenic lipid DOPE (accounting for limitations of instant claim 6. Finally, since Nantz et al., indicated that the relevant background art pertains to gene therapy (column 1, lines 14-55), it would have been obvious to have formulated the lipids of Nantz et al., with nucleic acids encoding therapeutic polypeptides (as in instant claims 2, 4 and 10-11). Thus, the invention as a whole was prima facie obvious.
Claims 5 and 8-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nantz et al., (US 5,527,928 in IDS) as applied to claims 1-6 and 10-12 above, and further in view of Cullis et al., (US 7,205,273).
The teachings of Nantz et al., are discussed above. Nantz et al., did not teach a composition comprising an amphipathic peptide with a sequence as recited in claim 9.
Cullis et al., disclosed fusogenic liposomes comprising lipopeptides comprising a liposomal lipid conjugated to a peptide that promotes membrane fusion (see Fig. 39; and entire document). Such peptides included instantly claimed FEAALAEALAEALA, Ac-LARLLPRLLARL-NHCH3; GLLEELLELLEELWEELLEG; GWEGLIEGIEGGWEGLIEG; LFEALAEFIEGGWEGLIEG; GGYCLEKWMIVASELKCFGNTA; GGYCLTRWMLIEAELKCFGNTAV; and WEAALAEALAEALAEHLAEALAEALEALAA. See col. 17-18; reproduced below:
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It would have been obvious to have used any of the lipopeptides of Cullis et al., in the invention of Nantz et al., because these lipopeptides confer fusogenic character on the nucleic acid delivery compositions, which is advantageous for transfection. See Cullis et al., at column 17-18. Thus, the invention as a whole was prima facie obvious.
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nantz et al., (US 5,527,928) as applied to claims 1-6 and 10-12 above, and further in view of Hawley-Nelson et al., (US 2003/0069173, in IDS)
The teachings of Nantz et al., are discussed above. Nantz et al., did not teach a composition comprising RGD peptide as required by claim 7.
Hawley-Nelson et al., taught compositions useful for transfecting eukaryotic cells comprising nucleic acid complexes with peptides, wherein the peptide is optionally covalently coupled to a nucleic acid-binding group, and cationic lipids as transfection agents. See Abstract and e.g. claims 6, 10-13, 17. In several embodiments, the peptides comprise an RGD motif as a cell targeting ligand. See paragraphs [0008], [0027], [0060-0062], [0082], and [0088]. In one embodiment, transfection compositions employ fusogenic peptides comprising an RGD peptide, conjugated to dendrimers which are admixed with nucleic acids, and that complex is then admixed with a cationic lipid. See paragraphs [0018] and [0082]. Hawley-Nelson et al., also taught the use of RGD peptides as a conjugate to lipids for targeting(see paragraph [0125]). Hawley-Nelson et al., disclosed a variety of cationic lipids that were useful in the invention including mono- and polyvalent cationic lipids (see e.g. paragraph [0125]). One of ordinary skill in the art would have appreciated that essentially any cationic lipid could be used. Hawley-Nelson et al., taught that the nucleic acids for delivery included DNA and RNA, including ribozymes, and including natural or non-natural bases. The nucleic acids can also express therapeutic proteins.
It would have been obvious to one of ordinary skill in the art at the time of the invention to have combined the teachings of Nantz et al., and Hawley-Nelson et al., and to have arrived at a composition comprising a cationic lipid of instant claim 1 and an RGD peptide as in claim 7. One could have done so by simply substituting the lipid of Nantz et al., into the compositions of Hawley-Nelson et al., since such would have been only the substitution of one functionally equivalent cationic lipid for another.
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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