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
Restriction/Election
Applicant’s election without traverse of group I, claims 1-7 and 37-39 in the reply filed on 01/30/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant’s election without traverse of the following species is also acknowledged. Species 1) a specific polyphenol - polydopamine (pD) (claim 2), Species 2) a specific immunoadjuvant - ATP (claims 3 and 39), Species 3) a specific nanoparticle - poly(lactic-co-glycolic acid) (PLGA) or PLGA conjugate (claims 4 and 5), Species 4) a specific therapeutic agent -carfilzomib or paclitaxel (claim 6), Species 5) a specific immune checkpoint inhibitor - antibody or antibody fragment targeting PD-L1 (claims 7 and 37).
Claims 1-4, 6 and 38-39 read on the elected species and are under prosecution.
Claims 5, 7 and 37 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/30/26.
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.
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang et al. (CN 109718381, presented in IDS).
Jiang et al. discloses a nanoconstruct (Subcellular targeted nano-drug delivery system, see Title) comprising: a nanoparticle which has an exterior surface (The nano-carrier has a core-shell-hook structure, and adopts MSN (mesoporous silica nanoparticles) as a core material for carrying PTX (Paclitaxel); a polymerized polyphenol (epigallocatechin-3-gallate ( EGCg) as shell material is used, see paragraph [0009]); one or more therapeutic agents encapsulated within the nanoparticle (polymerized polyphenol, (epigallocatechin-3-gallate, EGCg) as shell material is used in encapsulating drugs in MSN, as disclosed in paragraph [0009]); and an immunoadjuvant modified polyphenol compound bound to the exterior surface of the nanoparticle (the resulting polyphenolic coating is capable of adsorbing amino compounds, including amino-modified DNA), as disclosed in paragraph [0007]; the resulting polyphenolic coating is capable of adsorbing amino compounds, including amino-modified DNA. The MSN @ EGCg-dsDNA-Apt nano carrier provided by the disclosure adopts mesoporous silicon dioxide to load a medicine, coats polymerized polyphenol to encapsulate the medicine, and is also provided with double-stranded DNA. dsDNA-Apt. connected with an aptamer AS1411 on the surface, as disclosed in paragraph [0036]. (See instant disclosure, paragraph [0020] and claim 3, which provide deoxyribonucleic acid as an acceptable immunoadjuvant).
Jiang et al. discloses that (the resulting polyphenolic coating is capable of adsorbing amino compounds, including amino-modified DNA, see Paragraph. [0007]; the resulting polyphenolic coating is capable of adsorbing amino compounds, including amino-modified DNA. The MSN @ EGCg-dsDNA-Apt nano carrier provided by the disclosure adopts mesoporous silicon dioxide to load a medicine, coats polymerized polyphenol to encapsulate the medicine, and is also provided with double-stranded DNA. dsDNA-Apt connected with an aptamer AS1411 on the surface, see paragraph [0036]). Jiang et al. teaches (mesoporous silica particles are used as a core material for loading a drug a, and polymerized polyphenol composed of EGCg is used as a shell material for encapsulating pores of mesoporous silica, see paragraph. [0010]).
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (CN 109718381, presented in IDS) in view of Guo et al. (WO 2020/005892 A1).
Jiang et al. discloses a nanoconstruct (Subcellular targeted nano-drug delivery system, see Title) comprising: a nanoparticle which has an exterior surface (The nano-carrier has a core-shell-hook structure, and adopts MSN (mesoporous silica nanoparticles) as a core material for carrying PTX (Paclitaxel, an active ingredient); a polymerized polyphenol (epigallocatechin-3-gallate ( EGCg) as shell material is used, see paragraph [0009]); one or more therapeutic agents encapsulated within the nanoparticle (polymerized polyphenol, (epigallocatechin-3-gallate, EGCg) as shell material is used in encapsulating drugs in MSN, as disclosed in paragraph [0009]); and an immunoadjuvant modified polyphenol compound bound to the exterior surface of the nanoparticle (the resulting polyphenolic coating is capable of adsorbing amino compounds, including amino-modified DNA, as disclosed in paragraph [0007]; the resulting polyphenolic coating is capable of adsorbing amino compounds, including amino-modified DNA. The MSN @ EGCg-dsDNA-Apt nano carrier provided by the disclosure adopts mesoporous silicon dioxide to load a medicine, coats polymerized polyphenol to encapsulate the medicine, and is also provided with double-stranded DNA. dsDNA-Apt.. connected with an aptamer AS1411 on the surface, as disclosed in paragraph [0036], (See instant disclosure, paragraph [0020] and claim 3, which provide deoxyribonucleic acid as an acceptable immunoadjuvant).
Jiang et al. discloses that (the resulting polyphenolic coating is capable of adsorbing amino compounds, including amino-modified DNA, see Paragraph. [0007]; the resulting polyphenolic coating is capable of adsorbing amino compounds, including amino-modified DNA. The MSN @ EGCg-dsDNA-Apt nano carrier provided by the disclosure adopts mesoporous silicon dioxide to load a medicine, coats polymerized polyphenol to encapsulate the medicine, and is also provided with double-stranded DNA. dsDNA-Apt connected with an aptamer AS1411 on the surface, see paragraph [0036]). Jiang et al. teaches (mesoporous silica particles are used as a core material for loading a drug a, and polymerized polyphenol composed of EGCg is used as a shell material for encapsulating pores of mesoporous silica, see paragraph. [0010]).
Jiang et al. do not teach use of polymerized dopamine(pD) as claimed.
Guo et al. teaches modular bio-hybrid systems, some of which suitable for photochemical biosynthesis, are described. These systems are characterized by functionalized photocatalytic nanoparticles that are independently prepared, then assembled and attached to the modified surface of a cell, thereby enabling the cell to absorb light energy and convert it into chemical energy, for example in the form of a redox cofactor. The generated chemical energy then serves as fuel for production pathways of metabolites useful for the manufacturing of fuels, nutraceuticals, pharmaceuticals and cosmetics, see abstract. Guo et al. teaches that since inorganic nanoparticles are not typically incorporated in natural living organisms, the primary rationale behind functionalization of these particles is to enable the particles to assemble onto the biological cell in the hybrid systems of the invention. In one embodiment, the inorganic nanoparticles are functionalized with a phenolic compound, such as a polyphenol. In one embodiment, the polyphenol is tannic acid, polydopamine, resveratrol, ellagitannin, gallic acid, catechol, or a combination thereof. In general, any compound that matches the White-Bate-Smith-Swain-Haslam (WBSSH) definition as set forth in Bate-Smith et al., 1962, 58(371):95- 173 (incorporated herein by reference in its entirety is considered a polyphenol, see [0040].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized polydopamine (a polyphenol) in place of another polyphenol polymerized dopamine. One of ordinary skill would have been motivated to do so because Jiang et al. teach a nanoparticle which is functionalized exteriorly with polymerized polyphenol (epigallocatechin-3-gallate ( EGCg) as shell material and Guo et al. teaches nanoparticles are functionalized with a phenolic compound, such as a polyphenol wherein the polyphenol is tannic acid, polydopamine, resveratrol, ellagitannin, gallic acid, catechol, or a combination thereof, wherein the primary rationale behind functionalization of these particles is to enable the particles to assemble onto the biological cell in the hybrid systems of the invention. Guo thus teaches equivalency among the polyphenols that can be used to functionalize nanoparticle. Therefore, simple substitution of one polyphenol with another would have provided predictable results of obtaining a functionalized nanoparticle for biomedical use.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (CN 109718381, presented in IDS) in view of Guo et al. (WO 2020/005892 A1) and further in view of Josephs et al. (WO 2017/189849 A1).
Jiang et al. does not teach that the nanoparticle uses PLGA.
Josephs et al. discloses a nanoparticle composition which includes an adenosine receptor antagonist, a TGFβ inhibitor in a poly(lactic-co-glycolic acid) (PLGA) copolymer matrix for the nanoparticle composition along with a permeation enhancer. The nanoparticle composition is used in methods to treat cancer and diseases or disorders characterized by immunosuppression, see abstract. In an embodiment the nanoparticle composition comprising an adenosine receptor antagonist, a TGF inhibitor, a permeation enhancer, and a poly(lactic-co-glycolic acid) (PLGA) copolymer as a matrix for the nanoparticle composition, see [0018] and claim 15.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the known PLGA copolymer in making a nanoparticle and use it in the process of Jiang et al. teachings functionalized nanoparticle. One of ordinary skill would have been motivated to do so because Josephs et al. teach use of nanoparticle comprising PLGA copolymer in methods of treating cancer and Jiang teaches cancer treatment drug encapsulated functionalized nanoparticle for targeted drug delivery system.
Claims 3 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (CN 109718381, presented in IDS) in view of Guo et al. (WO 2020/005892 A1) and further in view of Rajabnia et al. (Process biochemistry 65 (2018) 186-196, presented in IDS).
While Jiang teaches use of DNA as immunoadjuvant, Jiang et al. does not teach use of immunoadjuvant, adenosine triphosphate (ATP).
Rajabnia et al. discloses fabrication of adenosine 5'-triphosphate-capped silver nanoparticles: Enhanced cytotoxicity efficacy and targeting effect against tumor cells, see title. Rajabnia further teaches use of such fabrication comprising the ATP used for cancer treatment, see Introduction and section 3.2 on page 189.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the immunoadjuvant Adenosine triphosphate or modified/fabricated Adenosine in place of DNA of Jiang et al. One of ordinary skill would have been motivated to do so because Rajabnia teaches use of fabricated nanoparticles comprising ATP have efficacy towards targeting tumor cells.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (CN 109718381, presented in IDS) in view of Guo et al. (WO 2020/005892 A1) and further in view of Lopez et al. (WO 2016/150521A1).
Jiang et al. does not teach use of an imaging agent.
Lopez et al. discloses functionalized magnetic nanoparticles and the process for preparing said functionalized magnetic nanoparticles. The invention also relates to the pharmaceutical composition comprising the functionalized magnetic nanoparticles. Further, the present invention relates to the therapeutic use of the functionalized magnetic nanoparticles and the pharmaceutical composition of the invention, see abstract. Lopez et al. disclose use of imaging agents such as radionuclide, a magnetic contrast agent or a fluorophore, see claims 14-15. The functionalized nanoparticle is used for cancer therapy and the functionalized magnetic nanoparticles of the present invention have the required properties to be successfully employed in biomedical applications, and particularly in nanomedicine and used as contrast agents, see page 4, lines 1-20.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the imaging agents into the nanoparticle of which has been functionalized for biomedical applications and treatment of disease like cancer or used as contrast agents in nanomedicinal use. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Correspondence
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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