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 .
DETAILED ACTION
Claims 1, 16, 20, 26-27, 32-33, 37-38, 41, 43-48, 50-52, 54, 62-65, 75-80 are pending. Claims 62-63 and 65 are withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/27/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 06/24/2026 is acknowledged and has been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1,16,20,26-27,32-33,37-38,41,43-48,50-52,54,64 and 75-80 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims require a peptide of the peptide-lipid conjugate to consist of 8 to 52 amino acids with at least 25% of the amino acids in the peptide of the peptide-lipid conjugate are proline. The claims are rejected as not having proper written description. Applicant cites several examples of peptide sequences disclosed in Table 1 of the specification. The claimed peptide of the peptide-lipid conjugate comprises the sequences listed in Table 1. These sequences have 4 or more amino acids. However, these peptide sequences are not disclosed properly as they are not identified with proper sequence identifiers (i.e., SEQ ID NOs) as required by 37 CRF 1.821. Therefore the claims do not have proper written description. Applicant may refer to MPEP 2426 to amend the specification, add a sequence listing and CRF, and identify the sequences disclosed in the specification with sequence identifiers in order to obviate the rejection.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20, 26, and 75-76 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites wherein 28% to 80% of the amino acids in the peptide of the peptide-lipid conjugate have a hydrophilic side chain. Claim 1 requires at least 25% of the amino acids in the peptide of the peptide-lipid conjugate are proline. Proline is an amino acid with a hydrophobic side chain. A peptide having 25% proline cannot have 80% hydrophilic amino acids.
Claims 26 and 75-76, which depend from claim 20 do not cure the indefiniteness and are also rejected.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 16, 20, 26-27, 32-33, 37, 41, 43, 45, 48, 50-52, and 80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahmad (WO 2019/222400 A2, published 11/21/2019, of record in IDS).
Regarding claims 1, 16, 20, 27, 32-33, 51-52, and 80, Ahmad teaches a composition comprising a peptide, a cargo, and a delivery vehicle ([0005]). Ahmad teaches that the cargo is DNA, siRNA, microRNA ([0178]) and that the delivery vehicle comprises a lipid composition selected from a liposome, a liposomal polyplex, a lipid nanoparticle, and a lipoplex ([0007], [0009]). Ahmad teaches that the peptide is conjugated directly to a lipid structure comprised by the delivery vehicle ([0007], claim 21) and that the conjugation is covalent ([0073]). Ahmad teaches peptide TSHTDAPPARSP (Table 3 SEQ ID NO: 34) comprising 12 amino acids, 3 prolines (i.e., 25% prolines), 7 amino acids with hydrophilic side chain (T, S, H, D, and R) (i.e., 58% amino acids with hydrophilic side chain), and no glycine. Ahmad teaches a formulation DODMA/DOPE/DMG-PEG2000/Dil/ SEQ ID NO. 1 with a %mol ratio of 45/45/10/0.5/0.32 (i.e., peptide is 0.32 mol% relative to the total lipid content of DODMA,DOPE, and PEGylated DMG).
Regarding claim 26, Ahmad teaches peptide TSHTDAPPARSP and peptide HPGSPFPPEHRP (12 amino acids, 41% prolines, 41% hydrophilic amino acids) which comprise a combination of threonine, serine, histidine, aspartic acid, glutamic acid, and arginine (Table 3 SEQ ID NO: 12 and 34).
Regarding claims 37 and 50, Ahmad teaches that the lipids can be cationic lipids mixed with helper lipids and cholesterol (i.e., a sterol) ([0128], [0136], [0137]).
Regarding claim 41, Ahmad teaches that the delivery vehicle partially or fully encapsulates the nucleic acid ([0009]).
Regarding claim 43, Ahmad teaches linking the peptide to the lipid using a PEG linker ([0138], [0245]).
Regarding claim 45, Ahmad teaches that the lipid comprises DMG and DOTAP ([0137], [0252]).
Regrading claim 48, Ahmad teaches that the lipid comprises cationic lipid such as DOGS and DOTAP ([0136]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 16, 20, 26-27, 32-33, 37-38, 41, 43, 45, 48, 50-52, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad (WO 2019/222400 A2, published 11/21/2019, of record in IDS) in view of Sen Gupta (US 2018/0318443 A1 published 11/08/2018).
Regarding claims 1, 16, 20, 26-27, 32-33, 37-38, 41, 43-45, 48, 50-52, and 80, Ahmad teaches a composition comprising a peptide, a cargo, and a delivery vehicle ([0005]). Ahmad teaches that the cargo is DNA, siRNA, microRNA ([0178]) and the delivery vehicle comprises a lipid composition selected from a liposome, a liposomal polyplex, a lipid nanoparticle and a lipoplex ([0007], [0009]). Ahmad teaches that the peptide is conjugated directly to a lipid structure comprised by the delivery vehicle ([0007], claim 21). Ahmad teaches peptide TSHTDAPPARSP (Table 3 SEQ ID NO: 34) comprising 12 amino acids, 3 prolines (i.e., 25% prolines), 7 amino acids with hydrophilic side chain (T, S, H, D, and R) (i.e., 58% amino acids with hydrophilic side chain), and no glycine. Ahmad teaches a formulation DODMA/DOPE/DMG-PEG2000/Dil/ SEQ ID NO. 1 with a %mol ratio of 45/45/10/0.5/0.32 (i.e., peptide is 0.32 mol% relative to the total lipid content of DODMA,DOPE, and PEGylated DMG). Ahmad teaches peptide TSHTDAPPARSP and peptide HPGSPFPPEHRP (12 amino acids, 41% prolines, 41% hydrophilic amino acids) which comprise a combination of threonine, serine, histidine, aspartic acid, glutamic acid, and arginine (Table 3 SEQ ID NO: 12 and 34). Ahmad teaches that the lipids can be cationic lipids mixed with helper lipids and cholesterol (i.e., a sterol) ([0128], [0136], [0137]). Ahmad teaches the delivery vehicle partially or fully encapsulates the nucleic acid ([0009]). Ahmad teaches that the lipid comprises DMG and DOTAP ([0137], [0252]). Ahmad teaches that the lipid comprises cationic lipid such as DOGS and DOTAP ([0136]). Ahmad teaches in some cases the composition may be modified with PEG and teaches a comparable delivery vehicle or liposomal structure without a modification or a delivery vehicle or liposomal structure with a modification comprising PEG. Ahmad teaches linking the lipid of the peptide-lipid conjugate to the peptide via PEG (i.e., a linker). Ahmad does not teach the peptide-lipid conjugate comprises 1 mol % of all lipids in the lipid composition.
However, Sen Gupta teaches a lipid composition containing a therapeutic agent such as nucleic acid (Abstract, [0086], [0090]). Sen Gupta teaches that the composition comprises peptide-modified liposomes and that the final peptide-lipid conjugate content of the liposome was at 1 mol % ([0162], Table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Ahmad by incorporating a concentration of 1 mol % of peptide-lipid conjugate content in the liposome as suggested by Sen Gupta. One of ordinary skill in the art would be motivated to do so in order to form a liposome with the desired size and stability. Since Ahmad and Sen Gupta teach a desire to form peptide-modified liposomes, there is a reasonable expectation of success.
Claims 1, 16, 20, 26-27, 32-33, 37, 41, 43-45, 48, 50-52, and 79-80 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad (WO 2019/222400 A2, published 11/21/2019, of record in IDS) in view of Lee (US-20200385721 A1, published 12/10/2020, of record in Office Correspondence mailed on 07/15/2025).
Regarding claims 1, 16, 20, 26-27, 32-33, 37, 41, 43-45, 48, 50-52, and 80, Ahmad teaches a composition comprising a peptide, a cargo, and a delivery vehicle ([0005]). Ahmad teaches that the cargo is DNA, siRNA, microRNA ([0178]) and the delivery vehicle comprises a lipid composition selected from a liposome, a liposomal polyplex, a lipid nanoparticle and a lipoplex ([0007], [0009]). Ahmad teaches that the peptide is conjugated directly to a lipid structure comprised by the delivery vehicle ([0007], claim 21). Ahmad teaches peptide TSHTDAPPARSP (Table 3 SEQ ID NO: 34) comprising 12 amino acids, 3 prolines (i.e., 25% prolines), 7 amino acids with hydrophilic side chain (T, S, H, D, and R) (i.e., 58% amino acids with hydrophilic side chain), and no glycine. Ahmad teaches a formulation DODMA/DOPE/DMG-PEG2000/Dil/ SEQ ID NO. 1 with a %mol ratio of 45/45/10/0.5/0.32 (i.e., peptide is 0.32 mol% relative to the total lipid content of DODMA,DOPE, and PEGylated DMG). Ahmad teaches peptide TSHTDAPPARSP and peptide HPGSPFPPEHRP (12 amino acids, 41% prolines, 41% hydrophilic amino acids) which comprise a combination of threonine, serine, histidine, aspartic acid, glutamic acid, and arginine (Table 3 SEQ ID NO: 12 and 34). Ahmad teaches that the lipids can be cationic lipids mixed with helper lipids and cholesterol (i.e., a sterol) ([0128], [0136], [0137]). Ahmad teaches the delivery vehicle partially or fully encapsulates the nucleic acid ([0009]). Ahmad teaches that the lipid comprises DMG and DOTAP ([0137], [0252]). Ahmad teaches that the lipid comprises cationic lipid such as DOGS and DOTAP ([0136]). Ahmad teaches in some cases the composition may be modified with PEG and teaches a comparable delivery vehicle or liposomal structure without a modification or a delivery vehicle or liposomal structure with a modification comprising PEG. Ahmad teaches linking the lipid of the peptide-lipid conjugate to the peptide via PEG (i.e., a linker). Ahmad does not teach the linker has a structure comprising succinyl (-(O)CCH2CH2C(O)-).
However, Lee teaches lipid particles comprising lipid conjugates and teaches PEG can be substituted by other linker such as amido (-C(O)NH-), amino (-NR-), carbonyl (-C(O)-), carbamate (-NHC(O)O-), urea (-NHC(O)NH-), disulphide (-S-S-), ether (-0-), succinyl (-(O)CCH2CH2C(O)-), succinamidyl (-NHC(O)CH2CH2C(O)NH-), and ether ([0237], [0242]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Ahmad by substituting Lee’s linker comprising succinyl for Ahmad’s PEG, as suggested by Lee. MPEP 2144.06 II states that it is obvious to substitute equivalents know for the same purpose. Lee teaches these linkers are equivalents and used for the same purpose.
Claims 1, 16, 20, 26-27, 32-33, 37, 41, 45-48, 50-52, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad (WO 2019/222400 A2, published 11/21/2019, of record in IDS) in view of Boesen (US20190030115, of record in IDS, hereinafter “Boesen”).
The teachings of Ahmad as they pertain to claims 1, 16, 20, 26-27, 32-33, 37, 41, 43, 45, 48, 50-52, and 80 are discussed above and applied herein.
Regarding claims 46-47, Ahmad teaches the peptide is conjugated to the lipid at its N-terminus ([0245]). Ahmad does not teach wherein the peptide is conjugated to the lipid of the peptide-lipid conjugate at its C-terminus and the amino group of the N-terminus of the peptide is substituted with one or two C1.6 alkyl groups or amido groups and wherein the peptide is conjugated to the lipid of the peptide-lipid conjugate at its N-terminus, and the amino acid at the C-terminus of the peptide is alkylated to form a C1.6 alkyl ester or is amidated.
However, Boesen teaches a method of producing peptides ([0002]), and that peptides can be linked at the N- and/or C-terminus to make them less susceptible to degradation ([0006]). Boesen teaches that amino-alkyl amino acid residue is covalently linked to the N-terminus of peptide or covalently linked to the C-terminus ([0031]). Boesen teaches such modification improves the peptide feature such as increasing its stability ([0011]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Ahmad by modifying the non-conjugated terminus, C-terminus or N-terminus, with amino-alkyl amino acid residue as suggested by Boesen. One of ordinary skill in the art would be motivated to do so in order to increase the stability of the peptide. Since Ahmad and Boesen teach a desire to modify and link peptides, there is a reasonable expectation of success.
Claims 1, 16, 20, 26-27, 32-33, 37, 41, 45, 48, 50-52, 54, 64, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad (WO 2019/222400 A2, published 11/21/2019, of record in IDS) in view of Blair (Cancer Research 78.13_Supplement (2018): 724-724, of record in Office Correspondence mailed on 04/10/2024).
The teachings of Ahmad pertaining to claims 1, 16, 20, 26-27, 32-33, 37, 41, 43, 45, 48, 50-52, and 80 are discussed above and applied herein.
Regarding claims 54 and 64, Ahmad does not teach the composition is a vaccine and wherein the nucleic acid is mRNA or a self-replicating mRNA.
However, Blair teaches srRNA formulated with a lipid nanoparticle (LNP), which facilitates efficient cellular uptake of the RNA and enhances antigen expression as well as the resulting immune response (page 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lipid composition taught by Ahmad by using self-replicating mRNA as the nucleic acid as suggested by Blair, with a reasonable expectation of success. One of ordinary skill in the art would be motivated to do so in order to use the composition as a vaccine as suggested by Blair. Since Ahmad and Blair teach a desire to form a lipid composition encapsulating a nucleic acid, there is a reasonable expectation of success.
Claims 1, 16, 20, 26-27, 32-33, 37, 41, 43, 45, 48, 50-52, 76-78, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Galeotti (US 20120219578-A1, published 08/30/2012, of record in Office Correspondence mailed on 07/15/2025) in view of Ahmad (WO 2019/222400 A2, published 11/21/2019, of record in IDS) and Sagan (Current medicinal chemistry 11.21 (2004): 2799-2822, of record in Office Correspondence mailed on 04/10/2024, hereinafter “Sagan”).
Regarding claims 1, 16, 20, 26-27, 32-33, 37, 41, 43, 45, 48, 50-52, 76-78, and 80, Galeotti teaches PSTQPSSTQP (ProSerThrGlnProSerSerThrGlnPro) (SEQ ID NO: 4993) comprising 10 amino acids with 30% prolines, 70% hydrophilic amino acids serine, threonine, and glutamine and no glycine. Galeotti teaches that this peptide is used as vaccine diagnostic reagent, immunogenic compositions, and teaches that liposomes are acceptable carriers (Abstract, [0114]). Galeotti does not teach linking the peptide to lipid of a lipid composition comprising a nucleic acid.
However, Ahmad teaches a composition comprising a peptide, a cargo, and a delivery vehicle ([0005]). Ahmad teaches that the cargo is DNA, siRNA, microRNA ([0178]) and the delivery vehicle comprises a lipid composition selected from a liposome, a liposomal polyplex, a lipid nanoparticle and a lipoplex ([0007], [0009]). Ahmad teaches that the peptide is conjugated directly to a lipid structure comprised by the delivery vehicle ([0007], claim 21). Ahmad teaches a formulation DODMA/DOPE/DMG-PEG2000/Dil/ peptide with a %mol ratio of 45/45/10/0.5/0.32 (i.e., peptide is 0.32 mol% relative to the total lipid content of DODMA,DOPE, and PEGylated DMG). Ahmad teaches that the lipids can be cationic lipids mixed with helper lipids and cholesterol (i.e., a sterol) ([0128], [0136], [0137]). Ahmad teaches the delivery vehicle partially or fully encapsulates the nucleic acid ([0009]). Ahmad teaches linking the peptide to the lipid using a PEG linker ([0245]). Ahmad teaches that the lipid comprises DMG and DOTAP ([0137], [0252]). Ahmad teaches that the lipid comprises cationic lipid such as DOGS and DOTAP ([0136]). Ahmad teaches in some cases the composition may be modified with PEG and teaches a comparable delivery vehicle or liposomal structure without a modification or a delivery vehicle or liposomal structure with a modification comprising PEG.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide taught by Galeotti by liking it to the lipid composition taught by Ahmad. One of ordinary skill in the art would be motivated to do so in order to effectively deliver the peptide. Since Galeotti and Ahmad teach a desire to use liposomes as carriers for peptides, there is a reasonable expectation of success.
Galeotti and Ahmad do not teach the peptide comprises methyl serine and methyl threonine.
However, Sagan teaches methylation is used in peptide modifications to induce effects on the conformation of the peptide, on its stability towards enzymatic degradation and / or on its biological activity (page 2799 left column para. 3) and teaches serine and threonine can be methylated (page 2800 para. “Methylation of protected amino acids).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the peptide taught by Galeotti by methylating amino acids such as serine and threonine as suggested by Sagan. One of ordinary skill in the art would be motivated to do so in order to induce effects on the conformation of the peptide, on its stability towards enzymatic degradation and/or on its biological activity as taught by Sagan.
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, 16, 20, 26-27, 32-33, 37-38, 41, 43-47, 50-52, 64 and 75-80 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 47, 48, 60, 67-69, 70, and 72-73 of copending Application No. 17/737862. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the conflicting claims.
Regarding claims 1, 16, 20, 26-27, 32, 38, 43-45, 51, 75-78, copending claim 67 recites peptide STEP-STEP-STEP linked to a lipid DMG. copending claim 72 recites peptide-lipid conjugate makes up 0.5 to 5 mol % of all lipids in the lipid composition. While the exact concentration is not recited in copending claims, it is generally noted that differences in concentration do not support the patentability of subject matter. One of ordinary skill in the art would be motivated to optimize the concentration of the peptide-lipid conjugate in order to form a stable composition
Regarding claim 33, copending claim 69 recites the lipid composition comprises liposomes or lipid nanoparticles.
Regarding claims 37 and 50, copending claim 73 recites the lipid composition further comprising a cationic lipid, a sterol, and a helper lipid.
Regarding claims 41, 52 and 64, copending claim 70 recites the liposomes or lipid nanoparticles encapsulate a nucleic acid selected from a messenger RNA, a siRNA, a transfer RNA, a microRNA, RNAi, or DNA.
Regarding claims 46-47, copending claim 1 recites the lipid is conjugated to the N-terminus, C-terminus, or an amino acid side chain of the peptide and the peptide of is optionally protected with a neutral group selected from an amide and a C1-6 alkyl ester at its C-terminus when conjugated at its N-terminus or an amino acid side chain.
Regarding claim 79, the copending claims do not recite that the lipid composition comprises polyethylene glycol (PEG).
Regarding claim 80, copending claim 67 recites a peptide covalently linked to a lipid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on 04/27/2026 have been fully considered but they are not persuasive.
Applicant argues that Bilgicer and Rodriguez do not teach a peptide with at least 25% proline. Applicant argues that all of the lipid compositions according to Bilgicer include PEG. Applicant argues Bilgicer does not characterize PEG itself as a linker subject to being replaced
In response to the argument, Bilgicer and Rodriguez are not relied upon in this rejection. Newly cited prior art Ahmad teaches a peptide with an amino acid sequence TSHTDAPPARSP (Table 3 SEQ ID NO: 34) comprising 12 amino acids, 3 prolines (i.e., 25% prolines), 7 amino acids with hydrophilic side chain (T, S, H, D, and R) (i.e., 58% amino acids with hydrophilic side chain), and no glycine.
Applicant argues that the prior art teaches the linker is PEG and it is not obvious to replace PEG by another linker.
In response to the argument, Ahmad teaches linking the peptide to the lipid of the liposome. Ahmad teaches that PEG linkage is a covalent linkage ([0139]). PEG is a chemical linker than covalently links two chemical entities. Ahmad teaches using PEG as a linker. Lee teaches linkers such as succinyl (-(O)CCH2CH2C(O)-). MPEP 2144.06 II states that it is obvious to substitute equivalents know for the same purpose.
Applicant argues that Galeotti does not provide any particular reason for specifically selecting either SEQ ID NO: 37018 or SEQ ID NO: 4993 from among the over 42 thousand other sequences and argues that Galeotti teaches other suitable carriers. Applicant argues that Galeotti does not teach the cited sequences perform any
cell-targeting function.
In response to the argument, Galeotti teaches a peptide that reads on the claimed peptide, and teaches that liposomes are suitable carriers. Galeotti teaches the peptide is suitable as an immunogenic composition. Ahmad teaches peptides can be linked to lipids of liposomes. Since Galeotti and Ahmad teach a desire to use liposomes as carriers for peptides, there is a reasonable expectation of success.
Applicant argues that claim 72 of the '862 application is cited for recitation of peptide-lipid conjugate makes up 0.5 to 5 mol % of all lipids in the lipid composition. However, claim 72 of the '862 application depends from claim 68, which in turn depends from claim 1, and encompasses non-STEP peptides.
In response to the argument, claim 1 encompasses the peptide recited in claim 67. The copending claim recite a range of peptide-lipid conjugate 0.5 to 5 mol % of all lipids in the lipid composition. The range encompasses the claimed concentration. One of ordinary skill in the art would be motivated to optimize the range in order to form a stable lipid composition.
Conclusion
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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