DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of invention group I, claims 1-15, in the reply filed on 06/12/2026, is acknowledged. The traversal is on the ground(s) that there is no evidence that invention groups I-IV are distinct. This is not found persuasive because invention groups I-Iv are indeed distinct as discussed in the restriction requirement. After the elected invention is found allowable, the withdrawn invention that requires all the limitation of allowable invention will be rejoined for examination under guidance provided in the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/12/2026.
Applicants further dimyristoyl glycerol polyethylene glycol maleimide (a-01).as specific compound of formula (a); compound b(02) as specific compound of formula (b); structure forming lipid as specific additional lipid in claim 6 and mRNA as specific active agent. Claims 1-15 read on the elected species and are under examination.
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Claims 1-30 are pending, claims 1-15 are under examination.
Priority
Acknowledge is made for priority claiming from Japan patent application JP2023214079, filed on 12/19/2023.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/12/2024 and 04/21/2025 is being considered by the examiner.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 6-7 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (CN116332776A, Google translation) in view of Mori et al. (WO2022065263; English translation relied on equivalent US20230365750).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Guo et al. teaches a cationic lipid compound, a composition and application thereof. In order to provide more choices for delivery of nucleic acid drugs, genetic vaccines, small molecule drugs and other formulations. The vector prepared by the cationic lipid compound has high encapsulation efficiency on nucleic acid molecules, and can successfully transport and express the nucleic acid molecules into cells (abstract). The nucleic acid drug is mRNA (page 3). The composition is nanoparticle composition further comprises neutral lipids include one or more of Phosphatidylcholine (PC), phosphatidylethanolamine (PE), sphingomyelin (SM), ceramide (Cer), sterols,
and derivatives thereof. More specifically, the neutral lipids include, but are not limited to DSPC, DPPC, DMPC, POPC, DOPC, DOPE, DOCP, DGTS, SM, cer, sterols and
derivatives thereof. The carrier further comprises a polymer conjugated lipid, the molar ratio of the cationic lipid to the polymer conjugated lipid is 10-90:1, more preferably 10-60:1, still more preferably 15-50:1, and even more preferably 20-35:1.
The polymer conjugated lipid mainly comprises a disclosed or unpublished PEG modified lipid compound, which can improve the stability of liposome and reduce
protein absorption of liposome, such as one or more of polyethylene glycol-phosphoethanolamine (PEG-PE), polyethylene glycol-phosphatidic acid (PEG-PA),
polyethylene glycol-ceramide (PEG-Cer), polyethylene glycol-dimyristoyl glycerol (PEG-DMG), polyethylene glycol-dialkylamine, polyethylene glycol-diacylglycerol and
polyethylene glycol-dialkylglycerol. More specifically, the polymer conjugated lipid may be PEG-DMG, PEG-DAG, PEG-OLPE, PEG-DMPE, PEG-DSPE, PEG-DPPC, PEG-c-DOMG, cer-PEG2000, cholPEG2000, PEG-PE, PEG-S-DMG, PEG-Cer, DMG-PEG-NH2, DMG-PEG-MAL, DMG-PEG-COOH, DMG-PEG-SH, DMG-PEG-OH, DMG-PEG-FA, DMG-PEG-Biotin, DSPE-PEGSH, DSPE-PEG-NH2, DSPE-PEG-Biotin, DSPE-PEG-Silane, DSPE-PEG-MAL, DSPE-PEG-COOH, DSPE-PEG-OH, DSPE-PEG-SP94, DSPE-PEG-Mannose, DSPE-NBD (page 14). One or more of a pharmaceutically acceptable excipient or diluent is also included in the composition (page 14).
Mori et al. teaches maleimide polyethylene glycol lipid (abstract). In the field of drug delivery systems, studies on lipid nanoparticles (hereinafter referred to as LNP(s)) containing nucleic acids have been widely conducted. The LNPs are fine particles composed of phospholipids, cholesterol, polyethylene glycol (PEG) lipids, and cationic lipids. A surface of the LNP is covered with PEG, and thus the LNP is useful for protection of nucleic acids to be rapidly decomposed by enzymes. Therefore, the LNP exhibits high blood retention, and further interacts with cells (hepatocytes, endothelial cells, B cells, and Kupffer cells) in the liver and accumulates therein, so that the LNP is used for nucleic acid delivery targeting hepatocytes. However, there is an example of delivery to the liver by the LNP since the LNP has such characteristics, and in order to deliver nucleic acids to a wider variety of organs, it is necessary to introduce a ligand for recognizing a receptor on a cell surface, such as an antibody, an aptamer, a peptide, and a sugar chain, into a PEG terminal on the surface of the LNP to improve targeting ability to a target organ. PEG on the surface of the LNP is derived from a PEG lipid which is a constituent component of the LNP, so that if an active group capable of bonding a ligand can be introduced into a PEG terminal of the PEG lipid, the ligand can be immobilized on the surface of the LNP, and targeting ability to a target organ can be imparted. Therefore, it is important to select an appropriate active group that reacts with the ligand, and a thiol group in a cysteine side chain is exemplified as a reactive site in an antibody. It is known that the thiol group is likely to react with a maleimide group. Therefore, it is considered to be effective to use a maleimide PEG lipid obtained by introducing a maleimide group to the PEG terminal of the PEG lipid ([0002-0003]).
Mori et al. teaches a method for producing a maleimide polyethylene glycol lipid represented by the following general formula (2), the method comprising:
a reaction step of deprotecting a maleimide polyethylene glycol lipid having a protective group, which is represented by the following general formula (1), by heating the maleimide polyethylene glycol lipid having a protective group in a solvent in the presence of silica gel,
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wherein R1, R2, R3, and R4 are each independently a group selected from a hydrogen atom, an alkyl group, a halogen, a cyano group, a formyl group, an acyl group, a carboxy group, an acyloxy group, and an alkylcarbonyloxymethyl group, n is an integer of 2 to 10 which represents a repeating unit number of a methylene group, m is an integer of 10 to 2000 which represents a repeating unit number of polyethylene glycol, Z represents a group selected from an ether group, a methylene group, and a dimethylvinylidene group, Y is any group represented by the following general formulas (3) to (6):
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wherein M represents Na or K, and l represents an integer of 1 to 5 which represents a repeating unit number of a methylene group, and
A is a group represented by the following general formula (7) or (8):
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wherein R5 and R6 are each independently a group selected from a hydrogen atom, a saturated or unsaturated acyl group having 8 to 24 carbon atoms, or a saturated or unsaturated alkyl group having 8 to 24 carbon atoms.
2. The production method according to claim 1, wherein R1, R2, R3, and R4 in the general formula (1) are each independently a hydrogen atom or an alkyl group.
3. The production method according to claim 1, wherein A in the general formulas (1) and (2) is a group represented by the formula (7), and R5 and R6 are each independently selected from a saturated or unsaturated acyl group having 8 to 24 carbon atoms or a saturated or unsaturated alkyl group having 8 to 24 carbon atoms.
4. The production method according to claim 1, wherein Y in the general formulas (1) and (2) is a group represented by the formula (3).
5. The production method according to claim 1, wherein n in the general formulas (1) and (2) is an integer of 2 to 6.
6. The production method according to claim 1, wherein n in the general formulas (1) and (2) is 2.
7. The production method according to claim 1, wherein m in the general formulas (1) and (2) is an integer of 20 to 150 (claims 1-7). On example is lipid-J ([0086]).
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The compound of formula (2) encompassing applicant’s claimed compound a-01, in view of compound J; since m is 20-150, saturated or unsaturated acyl group having 8 to 24 carbon atoms; when m is 44 instead of 45, and –C(=O)-(CH2)16-CH3 is replaced by –C(=O)-(CH2)12-CH3, the compound of formula (2) is applicant’s claimed compound a-01. Therefore, Mori et al. teaches applicant’s claimed compound a-01 dimyristoyl glycerol polyethylene glycol maleimide.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Guo et al. is that Guo et al. do not expressly teach Mori et al. This deficiency in Guo et al. is cured by the teachings of Mori et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Guo et al., as suggested by Mori et al., and produce the instant invention.
Guo et al. teaches a nanoparticle comprising mRNA and lipid DMG-PEG-MAL (dimyristoyl glycerol-PEG-MAL), but silent that DMG-PEG-MAL having structure dimyristoyl glycerol polyethylene glycol maleimide (a-01) because the linkers between DMG, PEG and MAL are not specified.
One of ordinary skill in the art would have been motivated to prepare lipid particle comprising lipid dimyristoyl glycerol polyethylene glycol maleimide (a-01) because lipid (a-01) is a known and suitable lipid in lipid particle. MPEP 2144.07. Under guidance from Guo et al. teaching DMG-PEG-MAL encompassing lipid (a-01) as species, Mori et al. teaching dimyristoyl glycerol polyethylene glycol maleimide (a-01) in lipid particle for drug delivery, it is obvious for one of ordinary skill in the art to prepare lipid particle comprising lipid dimyristoyl glycerol polyethylene glycol maleimide (a-01) and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-3 and 7, prior art teaches nanoparticle comprising mRNA and lipid dimyristoyl glycerol polyethylene glycol maleimide (a-01) for delivery mRNA to cell.
Regarding claim 6, Guo et al. teaches DOPE, which is structure forming lipid according to applicant’s specification (page 20) and claim 19.
Regarding claims 11-12, prior art teaches a composition comprising lipid particle and a excipient (considered as carrier) to deliver an mRNA into cells
Regarding claims 13-15, they are intended use, not limiting.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over ISHIHARA et al. (US20200270217) in view of Guo et al. (CN116332776A, Google translation) in view of Mori et al. (WO2022065263; English translation relied on equivalent US20230365750).
Determination of the scope and content of the prior art
(MPEP 2141.01)
ISHIHARA et al. teaches a compound represented by the formula (1): Q-CHR2 (1) (Q is a nitrogen-containing aliphatic group containing two or more tertiary nitrogens but no oxygen, and R is an aliphatic group containing a biodegradable group). From the compound in combination with other lipids such as a lipid capable of reducing aggregation, lipid particles can be formed. Further, the compound can be used for a pharmaceutical composition to deliver an activator into cells (abstract). The example of compound of formula (1) is compound 1-02 ([0057, 0062]).
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The lipid particles according the embodiment contain the compound represented by the above formula (1), and preferably further contain a lipid forming a membrane and a lipid capable of reducing aggregation ([0064]). Examples of the lipid forming a membrane include: diacyl phosphatidylcholine, diacyl phosphatidyl-ethanolamine, ceramide, sphingomyelin, dihydro-sphingomyelin, cephalin, and cerebroside. As the lipid forming a membrane, various substances are known. Examples thereof include: 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE), 1,2-stearoyl-sn-glycero-3-phosphoethanolamine (DSPE), 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphatidylcholine (POPC). Those lipids not only have a function of forming a membrane of liposomes but also can show an effect of membrane fusion ([0066-0067]). PEG-modified lipids such as PEG-DMG are capable of reducing aggregation used in the embodiment fulfills a function of reducing aggregation among the particles in preparation thereof. PEG-modified lipids also have influence on stability of the lipid particles or liposomes ([0068-0070]). The lipid particles of the embodiment can still further contain an activator. In the embodiment, “activator” means a substance that gives a specific effect to cells, tissues, organs or specimens. Typical examples of the activator are nucleic acids. For example, the activator is selected from the group consisting of plasmid, oligonucleotide, polynucleotide, small interfering RNA (siRNA), microRNA (miRNA), DNA, aptamer, and ribozyme. In addition, it is also possible to adopt antisense oligonucleotide, antago-mir, aDNA, plasmid, ribosomal RNA (rRNA), transfer RNA (tRNA), small nuclear RNA (snRNA), or mRNA. Further, it is also possible to adopt a combination of different kinds of DNAs or RNAs ([0099-0100]). If containing a nucleic acid, the lipid particles of the embodiment can further contain a compound combinable with the nucleic acid. The compound is, for example, a basic protein or a basic peptide ([0103]). The lipid particles of the embodiment can furthermore contain a compound controlling expression of the nucleic acid in cells. This compound is preferably incorporated because expression of nucleic acid in cells can be controlled so that cells to which liposomes are delivered may be visualized or led to cell death. Examples of the compound include retinoic acid, cyclic adenosine monophosphoric acid (cAMP), and ascorbic acid ([0104]). The lipid particles according to the embodiment can be used in the form of a composition. For example, the composition comprises the lipid particles of the embodiment and a medium. That composition is applicable to medical use. The medium can be optionally selected from known ones, and examples thereof include water, sodium chloride solution such as physiological saline, aqueous glycine solution, and buffer solution. In addition to those media, glycoproteins such as albumin, lipoproteins, apolipoproteins and globulin can be incorporated therein for the purpose of improving the stability ([0102-0103]).
Guo et al. and Mori et al. teaching have already been discussed in the above 103 rejection and are incorporated herein by reference.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and ISHIHARA et al. is that ISHIHARA et al. do not expressly teach dimyristoyl glycerol polyethylene glycol maleimide. This deficiency in ISHIHARA et al. is cured by the teachings of Guo et al. and Mori et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of ISHIHARA et al., as suggested by Guo et al. and Mori et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to replace DMG-PEG-MAL for DMG-PEG in the nanoparticle because this is simple substitution of one known PEG conjugated lipid for another to stabilize liposome. MPEP 2143, it is prima facie obviousness for simple substitution of one known element for another to obtain predictable results. Under guidance from ISHIHARA et al. teaching DMG-PEG to stabilize liposome, and Guo et al. teaching DMG-PEG-MAL as alternative to DMG-PEG to stabilize liposome; it is obvious for one of ordinary skill in the art to replace DMG-PEG-MAL for DMG-PEG in the nanoparticle and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to prepare lipid particle comprising lipid dimyristoyl glycerol polyethylene glycol maleimide (a-01) as DMG-PEG-Mal because lipid (a-01) is a known and suitable lipid in lipid particle. MPEP 2144.07. Under guidance from Guo et al. teaching DMG-PEG-MAL encompassing lipid (a-01) as species, Mori et al. teaching dimyristoyl glycerol polyethylene glycol maleimide (a-01) in lipid particle for drug delivery, it is obvious for one of ordinary skill in the art to prepare lipid particle comprising lipid dimyristoyl glycerol polyethylene glycol maleimide (a-01) as DMG-PEG-Mal and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-5, 7, prior art teaches a lipid particle comprising mRNA, dimyristoyl glycerol polyethylene glycol maleimide and compound 1-02 (compound b(02).
Regarding claim 6, ISHIHARA et al. teaches diacyl phosphatidylcholine as lipid forming a membrane, considered as structure forming lipid.
Regarding claims 8-9, ISHIHARA et al. teaches a basic protein or a basic peptide, combinable (binds) with nucleic acid.
Regarding claim 10, ISHIHARA et al. teaches retinoic acid, cyclic adenosine monophosphoric acid (cAMP), or ascorbic acid that controls expression of the nucleic acid in cells.
Regarding claims 11-12, prior art teaches a composition comprising lipid particle and a medium (such as buffer, considered as carrier) to deliver an mPNA into cells
Regarding claims 13-15, they are intended use, not limiting.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19314485 in view of Mori et al. (WO2022065263; English translation relied on equivalent US20230365750). The copending application teaches lipid particle comprising compound (1-02) in claim 4 and maleimide DMG-PEG in claim 8, but silent about specific maleimide DMG-PEG (dimyristoyl glycerol polyethylene glycol maleimide), in view of Mori et al. teaching dimyristoyl glycerol polyethylene glycol maleimide in nanoparticle, it is obvious to include dimyristoyl glycerol polyethylene glycol maleimide as maleimide DMG-PEG and produce applicant’s claimed inventio with reasonable exp[excitation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19314008 in view of Mori et al. (WO2022065263; English translation relied on equivalent US20230365750). The copending application teaches lipid particle comprising compound (1-02) in claim 1 and maleimide lipid-PEG in claim 8, but silent about specific maleimide lipid-PEG (dimyristoyl glycerol polyethylene glycol maleimide), in view of Mori et al. teaching dimyristoyl glycerol polyethylene glycol maleimide in nanoparticle, it is obvious to include dimyristoyl glycerol polyethylene glycol maleimide as maleimide lipid-PEG and produce applicant’s claimed inventio with reasonable exp[excitation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11548857 in view of Guo et al. (CN116332776A, Google translation) and Mori et al. (WO2022065263; English translation relied on equivalent US20230365750). The reference patent teaches nanoparticle comprises compound of 1-02 and mRNA (claim 16), in view of Guo et al. and Mori et al. teaches dimyristoyl glycerol polyethylene glycol maleimide to stabilize liposome, it is obvious to include dimyristoyl glycerol polyethylene glycol maleimide and produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-12, 14, 17-23 of copending Application No. 17711528 in view of Guo et al. (CN116332776A, Google translation) and Mori et al. (WO2022065263; English translation relied on equivalent US20230365750). The reference application teaches nanoparticle comprises compound of 1-02 and RNA (claim 8), in view of Guo et al. and Mori et al. teaches dimyristoyl glycerol polyethylene glycol maleimide to stabilize liposome, it is obvious to include dimyristoyl glycerol polyethylene glycol maleimide and produce applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18468102in view of Guo et al. (CN116332776A, Google translation) and Mori et al. (WO2022065263; English translation relied on equivalent US20230365750). The reference applicantion teaches nanoparticle comprises compound of 1-02 and nucleic acid(claim 6), in view of in view of Guo et al. and Mori et al. teaches dimyristoyl glycerol polyethylene glycol maleimide to stabilize liposome, it is obvious to include dimyristoyl glycerol polyethylene glycol maleimide and produce applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
Prosecution Insights