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 .
Formal Matters
Applicants’ claim set filed on 10 October 2024 is acknowledged and has been fully considered. Claims 1-11 are pending. Claims 1-11 are under consideration in the instant office action.
Priority
The effective filing date of the instant application is determined to be 21 March 2017, which is the filing date of PRO 62/474,456.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09 January 2025 is noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the information disclosure statement. A signed copy is herein attached.
Objection to the title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title of the instant application is “COMPOSITIONS FOR TREATING PERIODONTAL DISEASES”. The title should be brief but technically accurate and descriptive and should contain fewer than 500 characters. The title does not reflect the main inventive concept of Applicant’s invention and the major components of the “COMPOSITIONS FOR TREATING PERIODONTAL DISEASES”. The title is generic and can be applicable to any “COMPOSITIONS FOR TREATING PERIODONTAL DISEASES”. The examiner advises Applicant to consider including major components of the composition and method in the title to precisely reflecting the inventive concept. Inasmuch as the words "new," "improved," "improvement of," and "improvement in" are not considered as part of the title of an invention, these words should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. Similarly, the articles "a," "an," and "the" should not be included as the first words of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues.
Claim Objection
Claim 9 is objected to because of the following informalities: The term “ant-inflammatory” for consistency should recite as “anti-inflammatory agent”. Appropriate correction is required.
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 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (US 2012/0321566, published December 20, 2012, IDS reference 01/09/2025) and as evidenced by Sinha et al. (Biochemical and Biophysical Research Communications 444, (2014), 205–211).
Note: Sinha et al. is incorporated in the rejection to prove that application of PGG to will inhibit or decrease MMP-2 expression. Sinha et al. disclose that abdominal aortic aneurysms (AAA) are progressive dilatations of infra-renal aorta causing structural weakening rendering the aorta prone to rupture. AAA can be potentially stabilized by inhibiting inflammatory enzymes suchas matrix metalloproteinases (MMP); however, active regression of AAA is not pos sible without new elastic fiber regeneration. Here we report the elastogenic benefit of direct delivery of polyphenols such as pentagalloyl glucose (PGG), epigallocatechin gallate (EGCG), and catechin, to smooth muscle cells obtained either from healthy or from aneurysmal rat aorta. Addition of 10 lg/ml PGG and ECGC induce elastin synthesis, organization, and crosslinking while catechin does not. Our results indi cate that polyphenols bind to monomeric tropoelastin and enhance coacervation, aid in crosslinking of elastin by increasing lysyl oxidase (LOX) synthesis, and by blocking MMP-2 activity. Thus, polyphenol treatments leads to increased mature elastin fibers synthesis without increasing the production of intra cellular tropoelastin (see abstract). Gelatin zymography revealed that the total MMP-2 (66 kDa) activity was 2-fold greater in the EaRASMCs when compared to healthy RASMCs, which was reduced by 24% by PGG, 17% by EGCG and 34% by catechin. Healthy cells did not display any difference in their MMP-2 activity under the influence of polyphenols (Fig. 4A). Additionally, when polyphenols were added extraneously to development buffer of cellular protein lysates, PGG inhibited MMP-2 activity by 97% and EGCG by 82% (Fig. 4B) (see page 209).
Liu et al. disclose an anti-biofilm composition and a method to inhibit or prevent cell adhesion and/or biofilm formation by a microorganism, in which use of 1,2,3,4,6-penta-O-galloyl-D-glucopyranose (PGG) is involved therein (see abstract). A method to prevent or inhibit cell adhesion and/or biofilm formation by a microorganism, comprising applying to a site in need of such treatment a composition containing 1,2,3,4,6-penta-O-galloyl-D-glucopyranose (PGG) (see claim 1). The method of claim 4, wherein the film-forming material is selected from the group consisting of polyaniline, poly(acrylic acid), polypyrrole, poly(ethylene glycol), poly N-methylaniline, chitosan, alginate, pectimic acid, dextran, collagen, polyvinyl, polyethylene, polyurethane, polypropylene, silicone, polymethacrylic acid, polymaleic acid, poly-(maleic acid monoester), poly(ethylene glycol), polyaspartic acid, polyglutamic acid, polycarboxylic acid anhydrides, polyamines, polyethylene imine, polyvinylamine, polylysine, poly-(dialkylaminoethyl methacrylate), poly-(dialkylaminomethyl styrene), poly-(vinylpyridine), poly-(2-methacryloxyethyl trialkyl ammonium ion), poly-(vinylbenzyl trialkyl ammonium ions), poly-(N,N-alkylpyridinium ion), poly-(dialkyloctamethylene ammonium ion), polysulfonates, poly-(vinyl sulfonate), poly-(styrene sulfonate), collodion, nylon, rubber, plastic, polyesters, Dacron™ (polyethylene tetraphthalate), Teflon™ (polytetrafluoroethylene), latex, elastomers and Dacron (sealed with gelatin, collagen or albumin), cyanoacrylates, methacrylates, homopolymer of lactide, homopolymer of glycolide (PGA), copolymer of PLA and PGA (which is PLGA or PGLA), and combinations thereof (see claim 5 and paragraph 0075). According to this invention, the polymeric materials include, but are not limited to, polyaniline, polypyrrole, poly N-methylaniline (PNMA), chitosan, alginate, dextran, collagen, polyvinyl, polyethylene, polyurethane, polypropylene, silicone (e.g., silicone lassoers and silicone adhesives), poly(acrylic acid) (PAA), polymethacrylic acid, polymaleic acid, poly-(maleic acid monoester), poly(ethylene glycol) (PEG), polyaspartic acid, polyglutamic acid, aginic acid or pectimic acid, polycarboxylic acid anhydrides (e.g., polymaleic anhydride, polymethacrylic anhydride or polyacrylic acid anhydride), polyamines, polyethylene imine, polyvinylamine, polylysine, poly-(dialkylaminoethyl methacrylate), poly-(dialkylaminomethyl styrene), poly-(vinylpyridine), poly-(2-methacryloxyethyl trialkyl ammonium ion), poly-(vinylbenzyl trialkyl ammonium ions), poly-(N,N-alkylpyridinium ion), poly-(dialkyloctamethylene ammonium ion), polysulfonates, poly-(vinyl sulfonate), poly-(styrene sulfonate), collodion, nylon, rubber, plastic, polyesters, Dacron™ (polyethylene tetraphthalate), Teflon™ (polytetrafluoroethylene), latex, elastomers and Dacron (sealed with gelatin, collagen or albumin), cyanoacrylates, methacrylates, and derivatives thereof (paragraph 0074). The PPG may be in solution or coated on solid surfaces (carriers) (paragraphs 0014 and 0072). The compositions can be used in the treatment of dental plaque and periodontal diseases (oral administration, periodontitis) (paragraphs 0109-0110; claims 26-28). Periodontal disease is caused by microorganisms in the subgingival plaque (gingivitis, subgingival administration) (paragraphs 0109-0110). The method of claim 1, wherein the composition further comprises an antimicrobial agent selected from the group consisting of iodoacetamide, N-acetylcysteine, N-phenyl maleimide, triclosan, rifampicin, cefamandole nafate, ciprofloxacin, oxacillin, clarithromycin, cefazolin, azithromycin, tobramycin, polymyxin, linezolid, colistin, gentamycin, vancomycin, daptomycin, tigecycline, nitrofurazone, bismuth ethanedithiol, chitosan, Epigallocatechin gallate, sodium usnate, 5-fluorouracil, detergents, chelating agents, silver compounds, bacteriophage, antimicrobial enzymes, sugar alcohols, maleimides, cadexomer iodine, methylene blue, gentian violet, medium chain dextrans, and mixtures thereof (see claim 6). The anti-biofilm composition of this invention can be prepared using known methods. Generally, PGG is dissolved in a suitable solvent, such as water, buffer solutions, phosphate buffered saline, saline, or organic solvents such as DMSO, and may further comprise ingredients such as, but not limited to: antibiotics such as antibacterials and antifungals; anti-cancer drugs; binding, bonding or coupling agent, cross-linking agent; or a pH adjuster.
It must be recognized that reading claim 11 the required step is administering a composition comprising 1,2,3,4,6-penta-O-galloyl-D-glucopyranose (PGG) with a pharmaceutically acceptable carrier to the gingival tissue of the patient, which is clearly met by Liu et al. as described above. Application of PGG would result in the inhibition of MMP-2 is also clearly evidenced by the teachings of Sinha et al. Furthermore, "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). From a product perspective, a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."). From a method of treatment or use perspective, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Regarding, the recitation “A method of decreasing MMP-2 expression in gingival tissue” it is a physiological outcome which results from administration of the composition. Liu et al. apply an identical composition to the gingival tissue which will inherently decrease MMP expression as evidenced by Sinha et al.
Claims 1, 3, and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ranjan et al. (US 2014/0065061) and as evidenced by Hassan et al. (Asian Pacific Journal of Cancer Prevention, Vol 13, 2012, 3259-3264).
Note: Hassan et al. is incorporated in the rejection to prove that application of curcumin will inhibit or decrease MMP-2 expression. Hassan et al. disclose Curcumin (CM) possesses anti-cancer activity against a variety of tumors. Matrix metalloproteinases (MMPs) play an important role in remodeling the extracellular matrix and their activities are regulated by tissue inhibitor of metalloproteinases (TIMPs) family. Control of MMP and TIMP activity are now of great significance. In this study, the effect of CM is investigated on metastatic MMPs and anti-metastatic TIMPs genes on MDA breast cancer cells cultured in a mixture of DMEM and Ham’s F12 medium and treated with different concentrations of CM (10, 20 and 40μM for various lengths of time. Reverse transcription followed by quantitative real time PCR was used to detect the gene expression levels of MMPs and TIMPs in CM-treated versus untreated cases and the data were analyzed by one-way ANOVA. At high concentrations of curcumin, TIMP-1, -2, -3 and -4 genes were up-regulated after 48 hours of treatment, their over-expression being accompanied by down-regulation of MMP-2 and MMP-9 gene expression levels in a concentration- and time-dependent manner. These results suggest that curcumin plays a role in regulating cell metastasis by inhibiting MMP-2 and MMP-9 and up-regulating TIMP1 and TIMP4 gene expression in breast cancer cells (see abstract).
Ranjan et al. disclose a composition for treating cancer comprising: a polymeric nanoparticle core comprising one or more polymers and at least one of curcumin or curcuminoids; and at least one layer of one or more lipids on the surface of the polymeric core, wherein the at least one of the curcumin or curcuminoids nanoparticles, wherein the composition does not cause QT prolongation when provided to a subject (see abstract). The nanoparticle composition of claim 1, wherein the one or more polymers comprise at least one of poly(lactic-co-glycolic acid) (PLGA), poly(lactic acid), polylactide (PLA), or poly-L-lactide-co-ε-caprolactone (PLCL) (see claim 2). The nanoparticle composition of claim 1, further comprising at least one targeting agent, wherein the targeting agent selectively targets the nanoparticle to diseased tissue/cells, thereby minimizing whole body dose (see claim 6). The nanoparticle composition of claim 1, further comprising at least one targeting agent, wherein the targeting agent comprises an antibody or functional fragment thereof, a small molecule, a peptide, a carbohydrate, an siRNA, a protein, a nucleic acid, an aptamer, a second nanoparticle, a cytokine, a chemokine, a lymphokine, a receptor, a lipid, a lectin, a ferrous metal, a magnetic particle, a linker, an isotope and combinations thereof (see claim 7). The organic phase may comprise PLGA in a concentration of 2-90 mg/ml; and/or curcumin in a concentration of 1-15 weight/volume % (paragraph 0011). The present invention includes methods and compositions comprising a polymeric nanoparticle core comprising one or more polymers and one or more active agents; and at least one layer of one or more lipids on the surface of the polymeric core. The one or more polymers may comprise PLGA; and/or at least one polymer selected from the group consisting of poly(lactic acid), polylactide (PLA), and poly-L-lactide-co-ε-caprolactone (PLCL). In certain aspects, the one or more active agents comprise curcumin or a curcuminoid. The active agent may comprise at least one anti-cancer drug; and/or be selected from at least one of an anti-cancer drug, an antibiotic, an antiviral, an antifungal, an antihelminthic, a nutrient, a small molecule, a siRNA, an antioxidant, and an antibody. In certain aspects, the nanoparticle composition does not cause QT prolongation. In certain aspects, the nanoparticle composition has high bioavailability. In certain aspects, the active agent may comprise a conventional radioisotope (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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2012/0321566, published December 20, 2012, IDS reference 01/09/2025) in view of Ranjan et al. (US 2014/0065061) and Buchman et al. (US 2019/0008984) and as evidenced by Sinha et al. (Biochemical and Biophysical Research Communications 444, (2014), 205–211) and Hassan et al. (Asian Pacific Journal of Cancer Prevention, Vol 13, 2012).
Applicant Claims
Applicants claim a pharmaceutical composition comprising the ingredients as recited. Dependent claims thereof recite different features that further define the independent claim. Claim 11 recites a method of use of the pharmaceutical composition.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Liu et al., Ranjan et al. Sinha et al., and Hassan et al. are described above in detail and are incorporated by reference herein.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Liu et al. do not teach combining curcumin and deferoxamine with PGG. These deficiencies are cured by the teachings of Ranjan et al. and Buchman et al.
Ranjan et al. teach a composition for treating cancer comprising: a polymeric nanoparticle core comprising one or more polymers and at least one of curcumin or curcuminoids; and at least one layer of one or more lipids on the surface of the polymeric core, wherein the at least one of the curcumin or curcuminoids nanoparticles, wherein the composition does not cause QT prolongation when provided to a subject (see abstract). The nanoparticle composition of claim 1, wherein the one or more polymers comprise at least one of poly(lactic-co-glycolic acid) (PLGA), poly(lactic acid), polylactide (PLA), or poly-L-lactide-co-ε-caprolactone (PLCL) (see claim 2). The nanoparticle composition of claim 1, further comprising at least one targeting agent, wherein the targeting agent selectively targets the nanoparticle to diseased tissue/cells, thereby minimizing whole body dose (see claim 6). The nanoparticle composition of claim 1, further comprising at least one targeting agent, wherein the targeting agent comprises an antibody or functional fragment thereof, a small molecule, a peptide, a carbohydrate, an siRNA, a protein, a nucleic acid, an aptamer, a second nanoparticle, a cytokine, a chemokine, a lymphokine, a receptor, a lipid, a lectin, a ferrous metal, a magnetic particle, a linker, an isotope and combinations thereof (see claim 7). The organic phase may comprise PLGA in a concentration of 2-90 mg/ml; and/or curcumin in a concentration of 1-15 weight/volume % (paragraph 0011). The present invention includes methods and compositions comprising a polymeric nanoparticle core comprising one or more polymers and one or more active agents; and at least one layer of one or more lipids on the surface of the polymeric core. The one or more polymers may comprise PLGA; and/or at least one polymer selected from the group consisting of poly(lactic acid), polylactide (PLA), and poly-L-lactide-co-ε-caprolactone (PLCL). In certain aspects, the one or more active agents comprise curcumin or a curcuminoid. The active agent may comprise at least one anti-cancer drug; and/or be selected from at least one of an anti-cancer drug, an antibiotic, an antiviral, an antifungal, an antihelminthic, a nutrient, a small molecule, a siRNA, an antioxidant, and an antibody. In certain aspects, the nanoparticle composition does not cause QT prolongation. In certain aspects, the nanoparticle composition has high bioavailability. In certain aspects, the active agent may comprise a conventional radioisotope (paragraph 0010).
Buchman et al. teach nanoparticles associated (e.g., complexed, conjugated, encapsulated, absorbed, adsorbed, admixed) with angiogenesis-activating-agents, methods of synthesizing the same, devices or compositions comprising such nanoparticles, as well as systems and methods utilizing the nanoparticles (e.g., in therapeutic settings for enhancing and/or activating angiogenesis at targeted tissue region) (see abstract). Such devices or compositions are not limited to a particular type or kind of nanoparticle. In some embodiments, the nanoparticle is selected from the group consisting of sHDL nanoparticle, fullerenes, endohedral metallofullerenes buckyballs, trimetallic nitride templated endohedral metallofullerenes, single-walled and multi-walled carbon nanotubes, branched and dendritic carbon nanotubes, gold nanorods, silver nanorods, single-walled and multi-walled boron/nitrate nanotubes, carbon nanotube peapods, carbon nanohorns, carbon nanohorn peapods, liposomes, nanoshells, dendrimers, any nanostructures, microstructures, or their derivatives formed using layer-by-layer processes, self-assembly processes, or polyelectrolytes, microparticles, quantum dots, superparamagnetic nanoparticles, nanorods, cellulose nanoparticles, glass and polymer micro- and nano-spheres, biodegradable PLGA micro- and nano-spheres, gold nanoparticles, silver nanoparticles, carbon nanoparticles, iron nanoparticles, carboxymethylcellulose and related mixtures, polysaccharides, polyamino acids, polyacrylates, poly-alcohols (e.g. poly vinyl alcohol), polyesters (e.g. poly caprolactones), pluronics, pullulans, and a modified micelle (see paragraph 0008). In some embodiments, the nanoparticle is selected from the group consisting of sHDL nanoparticle, fullerenes, endohedral metallofullerenes buckyballs, trimetallic nitride templated endohedral metallofullerenes, single-walled and multi-walled carbon nanotubes, branched and dendritic carbon nanotubes, gold nanorods, silver nanorods, single-walled and multi-walled boron/nitrate nanotubes, carbon nanotube peapods, carbon nanohorns, carbon nanohorn peapods, liposomes, nanoshells, dendrimers, any nanostructures, microstructures, or their derivatives formed using layer-by-layer processes, self-assembly processes, or polyelectrolytes, microparticles, quantum dots, superparamagnetic nanoparticles, nanorods, cellulose nanoparticles, glass and polymer micro- and nano-spheres, biodegradable PLGA micro- and nano-spheres, gold nanoparticles, silver nanoparticles, carbon nanoparticles, iron nanoparticles, carboxymethylcellulose and related mixtures, polysaccharides, polyamino acids, polyacrylates, poly-alcohols (e.g. poly vinyl alcohol), polyesters (e.g. poly caprolactones), pluronics, pullulans, and a modified micelle (paragraph 0060). In some embodiments, the angiogenesis-activating-agent is deferoxamine (DFO) (paragraph 0080). The present invention is directed to nanoparticles associated (e.g., complexed, conjugated, encapsulated, absorbed, adsorbed, admixed) with angiogenesis-activating-agents, methods of synthesizing the same, devices or compositions comprising such nanoparticles, as well as systems and methods utilizing the nanoparticles (e.g., in therapeutic settings for enhancing and/or activating angiogenesis at targeted tissue region) (paragraph 0006).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the composition of Liu et al. because curcumin and deferoxamine provide an anti-cancer value to the composition of Liu et al. it should be noticed that Liu et al. teach that the anti-biofilm composition of this invention can be prepared using known methods. Generally, PGG is dissolved in a suitable solvent, such as water, buffer solutions, phosphate buffered saline, saline, or organic solvents such as DMSO, and may further comprise ingredients such as, but not limited to: antibiotics such as antibacterials and antifungals; anti-cancer drugs; binding, bonding or coupling agent, cross-linking agent; or a pH adjuster (paragraph 0072). Ranjan et al. teach a composition for treating cancer comprising: a polymeric nanoparticle core comprising one or more polymers and at least one of curcumin or curcuminoids; and at least one layer of one or more lipids on the surface of the polymeric core, wherein the at least one of the curcumin or curcuminoids nanoparticles, wherein the composition does not cause QT prolongation when provided to a subject (see abstract). The nanoparticle composition of claim 1, wherein the one or more polymers comprise at least one of poly(lactic-co-glycolic acid) (PLGA), poly(lactic acid), polylactide (PLA), or poly-L-lactide-co-ε-caprolactone (PLCL) (see claim 2). The nanoparticle composition of claim 1, further comprising at least one targeting agent, wherein the targeting agent selectively targets the nanoparticle to diseased tissue/cells, thereby minimizing whole body dose (see claim 6). The nanoparticle composition of claim 1, further comprising at least one targeting agent, wherein the targeting agent comprises an antibody or functional fragment thereof, a small molecule, a peptide, a carbohydrate, an siRNA, a protein, a nucleic acid, an aptamer, a second nanoparticle, a cytokine, a chemokine, a lymphokine, a receptor, a lipid, a lectin, a ferrous metal, a magnetic particle, a linker, an isotope and combinations thereof (see claim 7). The organic phase may comprise PLGA in a concentration of 2-90 mg/ml; and/or curcumin in a concentration of 1-15 weight/volume % (paragraph 0011). The present invention includes methods and compositions comprising a polymeric nanoparticle core comprising one or more polymers and one or more active agents; and at least one layer of one or more lipids on the surface of the polymeric core. The one or more polymers may comprise PLGA; and/or at least one polymer selected from the group consisting of poly(lactic acid), polylactide (PLA), and poly-L-lactide-co-ε-caprolactone (PLCL). In certain aspects, the one or more active agents comprise curcumin or a curcuminoid. The active agent may comprise at least one anti-cancer drug; and/or be selected from at least one of an anti-cancer drug, an antibiotic, an antiviral, an antifungal, an antihelminthic, a nutrient, a small molecule, a siRNA, an antioxidant, and an antibody. In certain aspects, the nanoparticle composition does not cause QT prolongation. In certain aspects, the nanoparticle composition has high bioavailability. In certain aspects, the active agent may comprise a conventional radioisotope (paragraph 0010). Buchman et al. teach nanoparticles associated (e.g., complexed, conjugated, encapsulated, absorbed, adsorbed, admixed) with angiogenesis-activating-agents, methods of synthesizing the same, devices or compositions comprising such nanoparticles, as well as systems and methods utilizing the nanoparticles (e.g., in therapeutic settings for enhancing and/or activating angiogenesis at targeted tissue region) (see abstract). Such devices or compositions are not limited to a particular type or kind of nanoparticle. In some embodiments, the nanoparticle is selected from the group consisting of sHDL nanoparticle, fullerenes, endohedral metallofullerenes buckyballs, trimetallic nitride templated endohedral metallofullerenes, single-walled and multi-walled carbon nanotubes, branched and dendritic carbon nanotubes, gold nanorods, silver nanorods, single-walled and multi-walled boron/nitrate nanotubes, carbon nanotube peapods, carbon nanohorns, carbon nanohorn peapods, liposomes, nanoshells, dendrimers, any nanostructures, microstructures, or their derivatives formed using layer-by-layer processes, self-assembly processes, or polyelectrolytes, microparticles, quantum dots, superparamagnetic nanoparticles, nanorods, cellulose nanoparticles, glass and polymer micro- and nano-spheres, biodegradable PLGA micro- and nano-spheres, gold nanoparticles, silver nanoparticles, carbon nanoparticles, iron nanoparticles, carboxymethylcellulose and related mixtures, polysaccharides, polyamino acids, polyacrylates, poly-alcohols (e.g. poly vinyl alcohol), polyesters (e.g. poly caprolactones), pluronics, pullulans, and a modified micelle (see paragraph 0008). In some embodiments, the nanoparticle is selected from the group consisting of sHDL nanoparticle, fullerenes, endohedral metallofullerenes buckyballs, trimetallic nitride templated endohedral metallofullerenes, single-walled and multi-walled carbon nanotubes, branched and dendritic carbon nanotubes, gold nanorods, silver nanorods, single-walled and multi-walled boron/nitrate nanotubes, carbon nanotube peapods, carbon nanohorns, carbon nanohorn peapods, liposomes, nanoshells, dendrimers, any nanostructures, microstructures, or their derivatives formed using layer-by-layer processes, self-assembly processes, or polyelectrolytes, microparticles, quantum dots, superparamagnetic nanoparticles, nanorods, cellulose nanoparticles, glass and polymer micro- and nano-spheres, biodegradable PLGA micro- and nano-spheres, gold nanoparticles, silver nanoparticles, carbon nanoparticles, iron nanoparticles, carboxymethylcellulose and related mixtures, polysaccharides, polyamino acids, polyacrylates, poly-alcohols (e.g. poly vinyl alcohol), polyesters (e.g. poly caprolactones), pluronics, pullulans, and a modified micelle (paragraph 0060). In some embodiments, the angiogenesis-activating-agent is deferoxamine (DFO) (paragraph 0080). The present invention is directed to nanoparticles associated (e.g., complexed, conjugated, encapsulated, absorbed, adsorbed, admixed) with angiogenesis-activating-agents, methods of synthesizing the same, devices or compositions comprising such nanoparticles, as well as systems and methods utilizing the nanoparticles (e.g., in therapeutic settings for enhancing and/or activating angiogenesis at targeted tissue region) (paragraph 0006).
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). The selection of a known material and its amounts based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) Furthermore, in the case where the claimed ranges for amounts of ingredients and actives “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, an ordinary skilled artisan would have had a reasonable expectation of success upon combination of the Liu et al., Ranjan et al., and Buchman et al. because all of them teach pharmaceutical compositions comprising PLGA and anticancer agents.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claims 1-5 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2012/0321566, published December 20, 2012, IDS reference 01/09/2025) in view of Ranjan et al. (US 2014/0065061) and Buchman et al. (US 2019/0008984) and as evidenced by Sinha et al. (Biochemical and Biophysical Research Communications 444, (2014), 205–211) and Hassan et al. (Asian Pacific Journal of Cancer Prevention, Vol 13, 2012) as applied to claims 1-5 and 7-11 above, and further in view of Shin (US 2009/0170788).
Applicant Claims
Applicants claim a pharmaceutical composition comprising the ingredients as recited. Dependent claims thereof recite different features that further define the independent claim. Claim 11 recites a method of use of the pharmaceutical composition.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Liu et al., Ranjan et al., Buchman et al., Sinha et al., and Hassan et al. are described above in detail and are incorporated by reference herein.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Liu et al., Ranjan et al., Buchman et al., do not teach the amount of 1,2,3,4,6-penta-O-galloyl-beta-D-glucose (PGG) in the composition. This deficiency is cured by the teachings of Shin.
Shin teaches novel use of 1,2,3,4,6-penta-O-galloyl-beta-D-glucose. More particularly, the present invention relates to a pharmaceutical composition and cosmetic composition for preventing and treating skin disease, comprising 1,2,3,4,6-penta-O-galloyl-beta-D-glucose represented by formula 1 as an active ingredient. Also, the invention relates to a method for preventing and treating skin disease using 1,2,3,4,6-penta-O-galloyl-beta-D-glucose, and to the use of 1,2,3,4,6-penta-O-galloyl-beta-D-glucose (see abstract and claim 1). The content of 1,2,3,4,6-penta-O-galloyl-beta-D-glucose in the inventive cosmetic composition may be 0.0001-50 wt %, and preferably 0.01-10 wt %, based on the total weight of the cosmetic composition (paragraph 0040). Accordingly, 1,2,3,4,6-penta-O-galloyl-beta-D-glucose of the present invention, which inhibits the expression of collagenase MMP-1 that is increased due to UV light, and inhibits the expression of COX-2 that is overexpressed in skin cancer tissue, is effective for the treatment of skin cancer (paragraph 0119).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the composition of Liu et al., Ranjan et al., Buchman et al., by adding 1,2,3,4,6-penta-O-galloyl-beta-D-glucose in amounts as recited because Shin teaches novel use of 1,2,3,4,6-penta-O-galloyl-beta-D-glucose. More particularly, the present invention relates to a pharmaceutical composition and cosmetic composition for preventing and treating skin disease, comprising 1,2,3,4,6-penta-O-galloyl-beta-D-glucose represented by formula 1 as an active ingredient. Also, the invention relates to a method for preventing and treating skin disease using 1,2,3,4,6-penta-O-galloyl-beta-D-glucose, and to the use of 1,2,3,4,6-penta-O-galloyl-beta-D-glucose (see abstract and claim 1). One of ordinary skill in the art would have been motivated to do so because Shin teaches the content of 1,2,3,4,6-penta-O-galloyl-beta-D-glucose in the inventive cosmetic composition may be 0.0001-50 wt %, and preferably 0.01-10 wt %, based on the total weight of the cosmetic composition (paragraph 0040). Accordingly, 1,2,3,4,6-penta-O-galloyl-beta-D-glucose of the present invention, which inhibits the expression of collagenase MMP-1 that is increased due to UV light, and inhibits the expression of COX-2 that is overexpressed in skin cancer tissue, is effective for the treatment of skin cancer (paragraph 0119). The selection of a known material and its amounts based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) Furthermore, in the case where the claimed ranges for amounts of ingredients and actives “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, an ordinary skilled artisan would have had a reasonable expectation of success upon combination of the Liu et al., Ranjan et al., Buchman et al., and Shin because all of them teach pharmaceutical compositions comprising anticancer agents.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619
Prosecution Insights