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 without traverse of group I (claim 1-16) in the reply filed on 7/7/2026 is acknowledged.
Claims 17-48 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/7/2026.
Claim Rejections - 35 USC § 112
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.
Claim 15-16 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 15 recites the limitation "a mixture thereof to form a further mixture" in lines 2-3 it is unclear if “a mixture” is referring to the polymer fixture in line 1 and it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as “a combination thereof to form a final mixture”. Also, claim 5 is not clear if claim 15 is a method of making claim or it is a device claim. The examiner will interpret the limitation such as it is a device claim so the examiner needs to find the a microneedle with sugar from the presented groups of surges.
claim 16 is not clear if it a method of making claim or it is a device claim. The examiner will interpret the claim such as it is a device claim so the examiner needs to find the a microneedle with nucleic acid drug.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rinti et al. (US 20210322743 A1) (“Rinti”) in view of Henderson (US 20170196966 A1).
Re Claim 1, Rinti discloses a microneedle patch (Fig. 1-7, abstract, ¶0049) comprising a substrate (103) and a plurality of microneedles disposed on the substrate ( microneedle has 101, 102), wherein each of the plurality of microneedles comprises:(i) one or more polymers dissolvable in human skin layer (102, ¶0049), (ii) a plurality of lipid nanoparticles, (101, ¶0049) and(iii) a drug encapsulated by the plurality of lipid nanoparticles (¶0048);wherein each of the plurality of microneedles is defined with a tip end portion that enables dermal penetration ( tip of microneedle, Fig. 1, ¶0049), and wherein the microneedle patch is adapted to be stored at room temperature ( it is capable to be used and stored in room temperature), but it fails to disclose that the drug is a nucleic acid drug.
However, Henderson discloses a microneedle array (Fig. 1-20) and wherein lipid nanoparticle (¶0024, ¶0096, ¶0167) and the drug is a nucleic acid drug (¶0094, ¶0144 ¶0167).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify drug of Rinti so that the drug is a nucleic acid drug as taught by Henderson for the purpose of gene therapy such as for immunization or cosmetic therapy (Henderson, ¶0042, ¶0085).
Re Claim 2, Rinti fails to disclose wherein the nucleic acid drug is selected from a group consisting of plasmid DNA (pDNA), minicircular DNA (mcDNA), messenger RNA (mRNA), microRNA (miRNA), antisense oligonucleotides (ASOs), small interfering RNA (siRNA), aptamers, and ribozymes.
However, Henderson discloses a microneedle array (Fig. 1-20) and wherein lipid nanoparticle (¶0024, ¶0096, ¶0167) and wherein the nucleic acid drug is selected from a group consisting of plasmid DNA (pDNA), minicircular DNA (mcDNA), messenger RNA (mRNA), microRNA (miRNA), antisense oligonucleotides (ASOs), small interfering RNA (siRNA), aptamers, and ribozymes (at least mRNA, siRNA, micro-RNA (miRNA), ribozymes, ¶0035).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify drug of Rinti so that the nucleic acid drug is selected from a group consisting of plasmid DNA (pDNA), minicircular DNA (mcDNA), messenger RNA (mRNA), microRNA (miRNA), antisense oligonucleotides (ASOs), small interfering RNA (siRNA), aptamers, and ribozymes taught by Henderson for the purpose of gene therapy such as for immunization or cosmetic therapy (Henderson, ¶0042, ¶0085).
Re Claim 3, Rinti discloses wherein the plurality of lipid nanoparticles are formed from at least a component selected from a group consisting of (4-hydroxybutyl) azanediyl bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 1,2-di-O-octadecenyl-3-trimethylammonium-propane (DOTMA), 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE), 1,2-dioleoyl-3-trimethylammonium- propane (DOTAP), Dimethyldioctadecylammonium bromide (DDAB), 2,3-dioleyloxy-N-[2- (sperminecarboxamido)ethyl]-N,N-dimethyl-1-propanaminium trifluoroacetate (DOSPA), (2S)-2,5-bis(3- aminopropylamino)-N-[2-(dioctadecylamino)acetyl]pentanamide (DOGS; Transfectam), N1-[2-((1S)-1- [(3-aminopropyl)amino]-4-[di(3-aminopropyl)amino]butylcarboxamido)ethyl]-3,4-di[oleyloxy]-benzamide (MVL5), DC-Cholesterol59, N4-cholesteryl-spermine (GL67), (6Z,9Z,28Z,31Z)-heptatriaconta- 6,9,28,31-tetraen-19-yl 4-(dimethylamino) butanoate (DLin-MC3-DMA; MC3), di((Z)-non-2-en-1-yl) 9- ((4-(dimethylamino)butanoyl)oxy)heptadecanedioate (L319), biodegradable lipids heptadecan-9-yl 8- ((2-hydroxyethyl)(8-(nonyloxy)-8-oxooctyl)amino)octanoate (Lipid 5), heptadecan-9-yl 8-((2- hydroxyethyl)(6-oxo-6-(undecyloxy)hexyl)amino) octanoate (Lipid H (SM-102))78 and ((4- Page 2 of 10 hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315), 3,6-bis(4-(bis(2- hydroxydodecyl)amino)butyl)piperazine-2,5-dione (cKK-E12), (2-hexyldecanoate), 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol- 2000 (PEG2000-DMG), 1,2-distearoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000- DSG), 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy(polyethylene glycol)-2000] (DSPE-PEG(2000)) 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-dioleoyl-sn-glycero-3- phosphoethanolamine (DOPE), Dipalmitoylphosphatidylcholine (DPPC), N-bis(2-hydroxyethyl)-N- methylethan-1-aminium bromide (BHEM-Cholesterol), and 3p-[N-(N',N'-dimethylaminoethane)- carbamoyl]cholesterol (DC-Cholesterol) (Rinti, ¶0055 at least DOPE) .
Re Claim 4, Rinti fails to disclose that the lipid nanoparticles are formed from an ionizable cationic lipid, a polyethylene glycol (PEG), a cholesterol, and a helper lipid.
However, Henderson discloses a microneedle array (Fig. 1-20) and wherein lipid nanoparticle (¶0024, ¶0096, ¶0167) and wherein the lipid nanoparticles are formed from an ionizable cationic lipid (¶0094, DOTAP), a polyethylene glycol (PEG, ¶0049 PEG), a cholesterol, and a helper lipid (helper lipid DPPC ¶0094).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify drug of Rinti so that the lipid nanoparticles are formed from an ionizable cationic lipid, a polyethylene glycol (PEG), a cholesterol, and a helper lipid as taught by Henderson for the purpose of gene therapy such as for immunization or cosmetic therapy (Henderson, ¶0042, ¶0085).
Re Claim 5, Rinti fails to disclose wherein the ionizable cationic lipid is 1,2- dioleoyl-3-trimethylammonium-propane (DOTAP).
However, Henderson discloses a microneedle array (Fig. 1-20) and wherein lipid nanoparticle (¶0024, ¶0096, ¶0167) and wherein the lipid nanoparticles are formed from an ionizable cationic lipid (¶0094, DOTAP), a polyethylene glycol (PEG, ¶0049 PEG), a cholesterol, and a helper lipid (helper lipid DPPC ¶0094).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify drug of Rinti so that the ionizable cationic lipid is 1,2- dioleoyl-3-trimethylammonium-propane (DOTAP) as taught by Henderson for the purpose of gene therapy such as for immunization or cosmetic therapy (Henderson, ¶0042, ¶0085).
Re Claim 6, Rinti fails to disclose wherein the polyethylene glycol (PEG) is 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy-(polyethylene glycol)-2000] (DSPE- PEG(2000)).
However, Henderson discloses a microneedle array (Fig. 1-20) and wherein lipid nanoparticle (¶0024, ¶0096, ¶0167) and wherein the lipid nanoparticles are formed from an ionizable cationic lipid (¶0094, DOTAP), a polyethylene glycol (PEG, ¶0049 PEG can be any chain as it is in general), a cholesterol, and a helper lipid (helper lipid DPPC ¶0094).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify drug of Rinti so that the polyethylene glycol (PEG) is 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy-(polyethylene glycol)-2000] (DSPE- PEG(2000)) as taught by Henderson for the purpose of gene therapy such as for immunization or cosmetic therapy (Henderson, ¶0042, ¶0085).
Re Claim 7, Rinti fails to disclose the helper lipid is Dipalmitoylphosphatidylcholine (DPPC).
However, Henderson discloses a microneedle array (Fig. 1-20) and wherein lipid nanoparticle (¶0024, ¶0096, ¶0167) and wherein the lipid nanoparticles are formed from an ionizable cationic lipid (¶0094, DOTAP), a polyethylene glycol (PEG, ¶0049 PEG), a cholesterol, and a helper lipid (helper lipid is DPPC ¶0094, DPP can be any chain as it is in general).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify drug of Rinti so that the helper lipid is Dipalmitoylphosphatidylcholine (DPPC) as taught by Henderson for the purpose of gene therapy such as for immunization or cosmetic therapy (Henderson, ¶0042, ¶0085).
Re Claim 8, Rinti discloses wherein the lipid nanoparticles are 50- 220 nm or 100-150 nm in size (Rinti, Fig, 5-6).
Re Claim 9, Rinti discloses wherein the lipid nanoparticles are 120 ± 30 nm in size, with size distribution (PDI) less than 0.2 (.(Rinti, Fig, 5-6).
Re Claim 10, Rinti discloses wherein the one or more polymers are selected from a group comprising polyvinylpyrrolidone, polyvinyl alcohol, hyaluronic acid, collagen, polyethylene glycol, their derivatives or a mixture thereof (¶0005, ¶0055, at least Polyvinyl alcohol (PVA), Polyvinyl pyrrolidone (PVP)).
Re Claim 11, Rinti discloses wherein the one or more polymers is a polymer mixture of polyvinylpyrrolidone and polyvinyl alcohol (¶0005, ¶0055, at least Polyvinyl alcohol (PVA), Polyvinyl pyrrolidone (PVP)).
Re Claim 12, Rinti discloses wherein the polyvinylpyrrolidone is in a ratio of 0:100 to 100:0(%) against the polyvinyl alcohol (¶0005, ¶0055, at least Polyvinyl alcohol (PVA), Polyvinyl pyrrolidone (PVP)).
Re Claim 13, Rinti discloses wherein the polyvinylpyrrolidone has a molecular weight of 23000-32000 or 35000-51000 Daltons (¶0005, ¶0055, at least Polyvinyl pyrrolidone (PVP) has molecular weight which is a chemical properties).
Re Claim 14, Rinti discloses wherein the polyvinyl alcohol has a molecular weight of 72600-81400, 81400-94600 or 17600-26400 Daltons (¶0005, ¶0055, at least polyvinyl alcohol has molecular weight which is a chemical properties).
Re Claim 15, Rinti discloses wherein the polymer mixture is further mixed with a sugar selected from a group consisting of sucrose, trehalose, dextrose and a mixture thereof to form a further mixture, and wherein the sugar has a concentration of 0.1-10% (w/w) in the further mixture (¶0008, trehalose or a mixture of maltose and dextran).
Re Claim 16, Rinti fails to disclose wherein the nucleic acid drug is adapted to retain more than 50% of original activity in a sealed centrifuge tube at room temperature for a period of at least 42 days, and remains biologically active for at least 60 days.
However, Henderson discloses a microneedle array (Fig. 1-20) and wherein the nucleic acid drug is adapted to retain more than 50% of original activity in a sealed centrifuge tube at room temperature for a period of at least 42 days (¶0003, ¶0165) as the humidity will be evaporate after driving the solution), and remains biologically active for at least 60 days (¶0059).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify drug of Rinti so that the nucleic acid drug is adapted to retain more than 50% of original activity in a sealed centrifuge tube at room temperature for a period of at least 42 days, and remains biologically active for at least 60 days as taught by Henderson for the purpose of gene therapy such as for immunization or cosmetic therapy (Henderson, ¶0042, ¶0085).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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