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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/04/2026 is/are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copies of PTO-1449.
Status of Application
Applicants' arguments/remarks filed 02/17/2026 are acknowledged. Claim 1 is/are currently amended. Claims 15, 36, 38-40, 47 and 53-55 are newly canceled. Claims 61-68 are newly added. Claims 1-14, 26, and 61-68 are examined on the merits within and are currently pending.
Withdrawn Rejections
With applicants' amendment filed 01-17-2025 and with respect to the objection:
Claims 36, 38-40, 47, 53-55 were withdrawn, but now are canceled!
The rejection under 35 U.S.C. 103 of Claim 15 is withdrawn due to the cancellation of the claim;
The rejection of Claims 1-6, 8-9, 15 and 26 under 35 U.S.C. 103 as being unpatentable over Alshawa et al., Banach et al., Bas et al., Paques et al., Dmitrieva et al. and Liu et al. has been withdrawn;
The rejection of Claims 1 and 7 under 35 U.S.C. 103 as being unpatentable over Alshawa et al., Banach et al., Bas et al., Paques et al., Dmitrieva et al., Liu et al. and Shi et al., has been withdrawn;
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 non-obviousness.
Claims 1-6, 8-14, 26, 61-68 are rejected under 35 U.S.C. 103 as being unpatentable over Alshawa et al., (Alshawa et al., Hygroscopic Growth and Deliquescence of NaCl Nanoparticles Coated with Surfactant AOT. J. Phys. Chem. A 2009, 113, 7678–7686) in view of Banach et al. (WO 2018/130876 Al), Bas et al., (Bas et al., Synthesis of Amphiphilic Triblock Copolymers for the Formation of Magnesium Fluoride (MgF2) Nanoparticles. Journal of Applied Polymer Science, Vol. 126, 998–1007, 2012), and Paques et al., (Paques et al., Alginate submicron beads prepared through w/o emulsification and gelation with CaCl2 nanoparticles. Food Hydrocolloids 31 (2013) 428-434), and further in view of Dmitrieva et al., (Dmitrieva et al., Analysis of DNA breaks, DNA damage response, and apoptosis produced by high NaCl. Am J Physiol Renal Physiol 295: F1678–F1688, 2008), Liu et al. (CN 114106831 B) and Huang et al., (Huang et al., Copper Sulfide Nanoparticles with Phospholipid-PEG Coating for In Vivo Near-Infrared Photothermal Cancer Therapy. Chem. Asian J. 2015, 10, 370 – 376).
Claims 1-6, 8-9 and 26, 61-68
Alshawa et al. teach NaCl nanoparticles coated with surfactant AOT (Title), sodium bis(2-ethylhexyl) sulfosuccinate, the organic layer confined to the surface, (pg. 7679, left col., last par.). Dry NaCl particles have a cubic shape (pg. 7681, left col., 2nd par.). The preparation of a stable suspension of nanoparticles of potassium salt or magnesium salt improves their bioavailability and efficacy. (pg. 5, last par.). The extent and rate of the hygroscopic growth is a sensitive function of both the particle’s initial diameter and the chemical composition. For highly soluble inorganic particles, such as NaCl, and certain highly soluble organic particles, such as
malonic acid, grow factor (GF) may experience a discontinuity at a well-defined deliquescence relative humidity (DRH) corresponding to a phase transition from a solid to a dissolved state, (pg. 7678, right col., 1st par.), to release high salt concentrations.
Banach et al. teach nanoparticles of potassium salt or magnesium salt, where a water solution of potassium salt or magnesium salt, a water solution of lecithin, and a solution of dispersing agents in oil. (Abs). Preferably the potassium salt or the magnesium salt is a potassium chloride or a magnesium chloride. (pg. 6, 3rd par.). Patent application US20050196434Al discloses a transdermal pharmaceutical composition which includes a therapeutically effective amount of a pharmaceutically acceptable salt of magnesium and a pharmaceutically acceptable carrier. The pharmaceutically acceptable carrier used in the transdermal pharmaceutical composition of the invention preferably includes a pluronic lecithin organogel. (pg. 4, last par.).
Bas et al. teach H80S20, one of amphiphilic copolymers of HEMA and PDMS, amphiphilic poly(2-hydroxyethyl methacrylate)-b-polydimethylsiloxane-b-poly(2-hydroxyethyl methacrylate) (pHEMA-b-PDMS-b-pHEMA) (A-B-A) triblock copolymers as stabilizer to prepare MgF2 nanoparticles. Well-controlled organic/inorganic (acrylic/polydimethylsiloxane) hybrid copolymers were synthesized as block or graft-copolymers with varying compositions to determine structure/property relationship for different applications such as thermoplastic elastomers, compatibilizers, emulsifiers, membranes, drug-delivery systems, and biosensors. (Abs and pg. 1000, right col., last par.), as compositions in pharmaceutical applications.
Paques et al. teach Calcium Chloride, CaCl2, nanoparticles, with external gelation with alginate solution and triglyceride (MTC) oil and stabilized with polyricinoleate. (Abs). (Polyglyceryl-3 Polyricinoleate, PGPR) is a surfactant and emulsifier, an amphiphilic polymer). Alginate hydrogel beads can enhance the mechanical stability of cells encapsulated in its interior, and protect its contents from immune responses, while remaining permeable for exchange of
valuable components, such as nutrients. Most research on alginate hydrogel beads focusses on prevention of immune responses, and protection of encapsulated materials against harmful conditions, such as the acidity in the stomach, (pg. 428, right col., 1st par.), which can increase these nanoparticles half-life as compared to nanocrystal absent the hydrophilic coating. After emulsification the alginate emulsion droplets are gelled with CaCl2 nanoparticles, and
remain suspended in the oil phase, (pg. 429, left col., 1st par.), which is Alginate submicron beads prepared through w/o emulsification and gelation with CaCl2 nanoparticles a solid in liquid colloidal suspended in gel.
Dmitrieva et al. teach high concentration of NaCl can cause DNA breaks, damage and apoptosis, (Title), osmotic stress, (Abs), osmotic tolerance differs widely among cell types, (pg. F1686, right col., 1st par.), Hela cells (cancer cells) have a lower osmotic tolerance than mIMCD3 (normal kidney epithelial cells), (pg. F1679, left col., 2nd par.). Acute elevation of NaCl to a total osmolality of 600 mosmol/kgH2O kills all HeLa cells by apoptosis within a few hours (Figs. 1, 2 and 5), whereas most mIMCD3 cells survive (25). Acute elevation to 700 mosmol/kgH2O eventually kills all mIMCD3 cells, but the time of death varies widely from cell to cell and is delayed compared with HeLa cells. (pg. F`1686, right col., 1st par.). A model of high NaCl-induced DNA breaks, DNA damage response, and apoptosis is presented in Fig. 10.
Each particular type of cell has a threshold of tolerance for acute elevation of NaCl. Below that threshold, cells continue to proliferate (after an initial cell cycle delay) (reviewed in Ref. 3) and function more or less normally. Acutely elevating NaCl above the threshold kills the cells by apoptosis within several hours (reviewed in Ref. 3). Regardless of whether the threshold is exceeded, the number of DNA breaks increases immediately. (pg. F1687, left col, last par.). In a high-salt environment, a lower osmotic tolerance leads to cellular dehydration, disruption of bodily functions, and ultimately, cell death. Because of different tolerance of cells, then the effective salt concentrations to cause osmotic lysis in cells will be different.
Liu et al. teach lithium fluoride nanoparticles not only can carry out fluorescence location and mark to the tumor cell, but also can synchronously use photo-thermal effect to kill the located tumor cell. (pg. 2, 2nd par.). Liu et al.’s application is about preparation of lithium fluoride nanoparticles, but it teaches that alkali metal halide salt encapsulated in nanoparticles to be taken by cancer cell, has been done, and cancer cells uptake high levels of nanoparticles than normal cells is common knowledge.
Huang et al. teach amphiphilic poly(ethylene glycol)-conjugated phospholipid (DSPE-PEG2000) (1,2-Distearoyl-sn-glycero-3-phosphoethanolamino-polyethylene glycol2000) to transfer these hydrophobic CuS NPs into the aqueous phase. DSPE-PEG2000 adsorbed to the surface of CuS NPs by hydrophobic interaction rendering the CuS NPs dispersible in water (Abs and pg. 776, 1st par.). The biodistribution of the CuS@DSPE-PEG NPs into heart, liver, spleen, lung, kidney and tumor was found that the highest uptake of the CuS@DSPE-PEG NPs is in liver, followed by spleen and tumor which have similar nanoparticles uptake, while the accumulations in kidney, lung and stomach are at a rather low level. The higher uptake of CuS@DSPE-PEG NPs by tumors can be attributed to the EPR effect and the longer circulation time resulted from the PEG layer outside the CuS NPs. (Pg. 373, left col, 1st par.). It would be obvious that DSPE-PEG2000 coated CuS nanoparticles are up-taken highly in cancer cells, then hydrophilic coated alkali/earth alkali/halide nanoparticles would be highly up-taken into cancer cells.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to prepare coated alkali metal or alkali earth metal halide salt nanoparticles, which are dissolved taught by Alshawa et al., Banach et al., Bas et al. and Paques et al., where nanoparticles are coated by amphiphilic polymers, taught by Banach et al., Bas et al. and Paques et al., and it would be obvious that the composition composes multiple nanoparticles, taught by Alshawa et al., Banach et al., Bas et al. and Paques et al., and cancer cells has lower tolerance to osmotic lysis leading to apoptosis than normal cells, taught by Dmitrieva et al., and cancer cells can uptake alkali halide nanoparticles, taught by Liu et al., and these coated particles are taken up highly by cancer cells, taught by Huang et al., since each one has taught different part to work out the composition to prepare alkali halide nanoparticle coated by amphiphilic external layer. However, the tolerability of osmotic lysis and apoptosis is varied among cell lines, so the effective concentration to osmotic lysis and apoptosis can be varied to treat cancers. Also the composition claims of the concentration of nanoparticles being effective to treat cancer has no patentable weight.
With regard to claims 10-14,
Alshawa et al., Banach et al., Bas et al. and Paques et al., do not teach the pharmaceutical composition of claim 9, wherein the hydrophilic coating or hydrophilic external layer is formed of (l,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[amino(polyethylene glycol)-2000].
Huang et al. teach amphiphilic poly(ethylene glycol)-conjugated phospholipid (DSPE-PEG2000) (1,2-Distearoyl-sn-glycero-3-phosphoethanolamino-polyethylene glycol2000) to transfer these hydrophobic CuS NPs into the aqueous phase. DSPE-PEG2000 adsorbed to the surface of CuS NPs by hydrophobic interaction rendering the CuS NPs dispersible in water (Abs and pg. 776, 1st par.). It would be obvious that DSPE-PEG2000 can be coated on CuS, then it would be feasible to coat DSPE-PEG2000 on NaCl nanoparticles.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Alshawa et al., (Alshawa et al., Hygroscopic Growth and Deliquescence of NaCl Nanoparticles Coated with Surfactant AOT. J. Phys. Chem. A 2009, 113, 7678–7686) in view of Banach et al. (WO 2018/130876 Al), Bas et al., (Bas et al., Synthesis of Amphiphilic Triblock Copolymers for the Formation of Magnesium Fluoride (MgF2) Nanoparticles. Journal of Applied Polymer Science, Vol. 126, 998–1007, 2012), and Paques et al., (Paques et al., Alginate submicron beads prepared through w/o emulsification and gelation with CaCl2 nanoparticles. Food Hydrocolloids 31 (2013) 428-434), and further in view of Dmitrieva et al., (Dmitrieva et al., Analysis of DNA breaks, DNA damage response, and apoptosis produced by high NaCl. Am J Physiol Renal Physiol 295: F1678–F1688, 2008), Liu et al. (CN 114106831 B), Huang et al., (Huang et al., Copper Sulfide Nanoparticles with Phospholipid-PEG Coating for In Vivo Near-Infrared Photothermal Cancer Therapy. Chem. Asian J. 2015, 10, 370 – 376), and Shi et al., (Shi et al., Two-dimensional Na–Cl crystals of unconventional stoichiometries on graphene surface from dilute solution at ambient conditions. Nature Chemistry. Vol 10, Jul 2018, 776–779).
Alshawa et al., Banach et al., Bas et al., Paques et al., Dmitrieva et al., Liu et al., and Huang et al.’s teachings are described in claim 1 above.
Alshawa et al., Banach et al., Bas et al., Paques et al., Dmitrieva et al., Liu et al., and Huang et al. do not teach NaCl nanoparticles comprising the molar ratio of sodium and chloride about 1:1.
Shi et al. teach NaCl in a 1:1 stoichiometry is the only known stable form of the Na–Cl crystal under ambient conditions, and non-1:1 Na–Cl species can only form under extreme conditions, such as high pressures. (Abs and pg. 776, 1st par.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to prepare coated alkali metal or alkali earth metal halide salt nanoparticles, which are dissolved taught by Alshawa et al., Banach et al., Bas et al. and Paques et al., where nanoparticles are coated by amphiphilic polymers, taught by Banach et al., Bas et al. and Paques et al., and it would be obvious that the composition composes multiple nanoparticles, taught by Alshawa et al., Banach et al., Bas et al. and Paques et al., and cancer cells has lower tolerance to osmotic lysis leading to apoptosis than normal cells, taught by Dmitrieva et al., and cancer cells can uptake alkali halide nanoparticles, taught by Liu et al., and these coated particles are taken up highly by cancer cells, taught by Huang et al., with sodium:chloride ratio 1:1, taught by Shi et al, since each one has taught different part to work out the composition to prepare alkali halide nanoparticle coated by amphiphilic external layer. However, the tolerability of osmotic lysis and apoptosis is varied among cell lines, so the effective concentration to osmotic lysis and apoptosis can be varied to treat cancers. Also the composition claims of the concentration of nanoparticles being effective to treat cancer has no patentable weight.
Response to Arguments
Rejections Under 35 U.S.C. § 103:
Applicant argues that the art cited by the Examiner is largely drawn of industrial applications and/or observational studies that are unrelated to pharmaceutical/biomedical applications, and references provide no motivation to modify them for this purpose. For example, independent claim 1, as amended, defines a pharmaceutical composition which is a lyophilized composition or is a colloidal solution. None of the references of record, alone or in any combination, disclose or suggest such a pharmaceutical composition for at least the reasons explained below.
Applicant's arguments have been fully considered but they are not persuasive because Bas teaches MgF2 nanoparticles for different applications such as thermoplastic elastomers, compatibilizers, emulsifiers, membranes, drug-delivery systems, and biosensors, which are obvious compositions for pharmaceutical applications. In addition, Paques teaches Patent application US20050196434Al discloses a transdermal pharmaceutical composition which includes a therapeutically effective amount of a pharmaceutically acceptable salt of magnesium and a pharmaceutically acceptable carrier. The pharmaceutically acceptable carrier used in the transdermal pharmaceutical composition of the invention preferably includes a pluronic lecithin organogel. Obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Applicant argues that Claims 1-6, 8-9, 15, and 26 are not obvious over any combination of Alshawa, Banach, Bas, Paques, Dimitrieva, and Liu. Applicant points out in details each prior art teaches something differently from applicant’s invention like Alshawa relates to aerosolized nanoparticles of NaCl; Banach is drawn to a method of manufacturing a suspension of salt nanoparticles; Bas is specifically drawn to copolymers for formation of magnesium fluoride nanoparticles; Paques is merely drawn to alginate submicron beads prepared through emulsification and gelation with calcium chloride nanoparticles; Dmitrieva merely describes an analysis of DNA breaks, DNA damage response, and apoptosis produced by high NaCl; Liu merely describes lithium fluoride nanoparticles to fluorescently locate and mark tumor
cells and which are also said to provide a photothermal effect to kill the located tumor cells; and none of them teach lyophilizing or colloidal solution.
Applicant's arguments have been fully considered but they are persuasive that the previous office actions that did not respond to amended claims to wherein the pharmaceutical composition is a lyophilized composition or is a colloidal solution. However, applicant's arguments are not persuasive according to this modified office action, where Paques teaches CaCl2 nanoparticles a solid in liquid colloidal suspended in gel. In addition, One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things and one with skill in the art, is known for solving the same problem, is represented with design choices, may modify the teachings of the prior arts until they can achieve better outcome results. And the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious.
Applicant argues that Shi, however, cannot make up for any of the deficiencies found in Alshawa, even if combined with any of the additional art of record, because Shi is drawn to formation of sodium chloride crystals on a graphene surface.
Applicant's arguments have been fully considered but they are not persuasive because Shi teach NaCl in a 1:1 stoichiometry is the only known stable form of the Na–Cl crystal under ambient conditions, so under different nanoparticles, Shi teaches the Na–Cl crystal ratio that one with skill in the art could learn to apply for Na–Cl crystal nanoparticles.
Applicant argues that Claims 1, 9, and 10-14 are not obvious over any combination of Alshawa,
Banach, Bas, Paques, Dimitrieva, Liu, and Huang. Huang merely relates specifically to coated copper sulfide nanoparticles for in vivo near-infrared photothermal cancer therapy. Huang explains that copper sulfide nanoparticles are hydrophobic.
Applicant's arguments have been fully considered but they are not persuasive because Huang teaches amphiphilic poly(ethylene glycol)-conjugated phospholipid (DSPE-PEG2000) (1,2-Distearoyl-sn-glycero-3-phosphoethanolamino-polyethylene glycol2000) coating CuS NPs to make these NPs more hydrophilic in the aqueous phase. One with skill in the art can learn from Huang to prepare alkaline/earth ankali halide nanoparticles, or more specifically NaCl coated by DSPE-PEG2000. Also the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things.
Applicant argues that newly presented independent claim 61 and claims dependent therefrom are novel and non-obvious over any of Alshawa, Banach, Bas, Paques, Dimitrieva, Iiu, Shi, and/or
Huang, or combinations thereof. Independent claim 61 specifies a pharmaceutical composition where the hydrophilic coating or hydrophilic external layer on the nanoparticle is formed of a polyether-lipid conjugate. There is no suggestion or motivation to make the proposed modification.
Applicant's arguments have been fully considered but they are not persuasive because Alshawa, Banach, Bas, Paques, Dimitrieva, Iiu, and Huang actually teach claim 61 in teaching claim 1 since examples of a polyether-lipid conjugate are often PEGylated lipids or lipid-polymer hybrids, involve linking a polyether (usually poly(ethylene glycol), PEG) to a lipid to improve solubility, stability, and circulation time in drug delivery. Key examples include distearoylphosphatidylethanolamine-PEG (DSPE-PEG), PEG-conjugated ceramides or methoxy-PEG-coupled poly(lactic-co-glycolic acid) (PLGA-mPEG). Claim 1 is modified with Huang’s teachings. Huang teaches Huang et al. teach amphiphilic poly(ethylene glycol)-conjugated phospholipid (DSPE-PEG2000) (1,2-Distearoyl-sn-glycero-3-phosphoethanolamino-polyethylene glycol2000) coating hydrophobic CuS NPs. One with skill in the art can learn from Huang to prepare NaCl nanoparticles coated with DSPE-PEG2000, which is a polyether-lipid conjugate. Obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Applicant argues of Unexpected Results that in the Specification, the examples provided showed that coated NaCl nanoparticles can effectively kill cancer cells because the nanoparticles enter cells through endocytosis, bypassing cell regulations on ion transport; when dissolving inside cells, the released ions amount to a surge of osmolarity. This is in contrast to normal cells which are highly resistant to such treatment, a phenomenon believed to be largely due to their intrinsically low Na+ levels relative to cancer cells. Thus, the Inventors advantageously and unexpectedly discovered that coated nano particles of the claimed pharmaceutical composition were effective for killing cancer cells that take up such coated salt nanoparticles.
Applicant's arguments have been fully considered but they are not persuasive because Liu teaches alkali metal halide salt encapsulated in nanoparticles to be taken by cancer cell, has been done, and cancer cells uptake high levels of nanoparticles than normal cells is common knowledge. Dmitrieva teaches acute elevation of NaCl to a total osmolality of 600 mosmol/ kgH2O kills all HeLa cells by apoptosis within a few hours (Figs. 1, 2 and 5), whereas most mIMCD3 cells survive (25), where HeLa cells are cancer cells and mIMCD3 cells are not cancer cells. Huang also teaches DSPE-PEG2000 coated CuS nanoparticles are up-taken highly in cancer cells, then hydrophilic coated alkali/earth alkali/halide nanoparticles would be highly up-taken into cancer cells. Liu, Dmitrieva and Huang teach NaCl nanoparticles can kill cancer cells because they can be highly up taken into cancer cells and cancer cells are killed by high salt concentration. Applicant’s results are not unexpected results.
Conclusion
Applicants' amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Correspondence
No claim is allowed.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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