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
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 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bromley et al. (USP 8,282,977) in view of Frykman et al. (WO2005/041657 of record) and further in view of Dushenkov et al. (WO2006/128032 of record) and (JP2010-235538 of record).
Bromley et al. discloses compositions containing non-polar compounds, see title. Bromley et al. teaches use of non-polar compounds such as phytosterols, oils, omega-3 fatty acids and phytochemicals, (see abstract and column 2, lines 8-15). Bromley teaches concentrates comprising surfactants, non-polar active ingredients and polar solvents wherein the desired properties include clarity of the liquid dilution compositions, such as compositions that are clear or about as clear as the aqueous medium in the absence of the concentrate and/or in the absence of the non-polar active ingredient; particle size, such as particle size of less than 200 nm or less than about 200 nm, less than 100 nm or less than about 100 nm, less than 50 nm or less than about 50 nm, or less than 25 nm or less than about 25 nm, at most or on average; turbidity, such as a Nephelometric Turbidity Units (NTU) value of less than 200 or about 200, less than 100 or about 100, less than 50 or about 50, less than 30 or about 30, less than 25 or about 25, or less than 10 or about 10; and the lack of visible particles, visible crystals, phase separation, and/or ringing, see column 2, lines 35-46. Bromley et al. teaches the liquid nanoemulsions include surfactant, a polar solvent such as water, dihydric alcohol and glycerin, see column 2, lines 50-54. The surfactants include polyethylene glycol derivatives of vitamin E, see column 2, lines 64-65. The amount of surfactant ranges from about 16% to about 30% (w/w) of concentrate, see column 2, lines 66-67. The amount of polar solvent ranges from about 60% to about 79%, see column 3, lines 14-16. Use of tocopherol-PEG derivatives such as TPGS and tocotrienol derivatives is taught in column 3, lines 35-40. Bromley teaches that phosphatidylcholine (amphiphilic fat) can be used as a surfactant and the amount ranges from about 0.1% to about 1% by weight of the concentrate, see column 7, lines 14-50. Bromley teaches the nanoemulsions contain micelles, column 23, lines 17-18 and 30-35. Bromley teaches in different embodiments, liposomes can be formed of a single layer or multilamellar vesicles wherein the liposomes can be used to encapsulate hydrophobic and hydrophilic active ingredients. Liposomes are advantageous because they are stable and protect active ingredients from degradation, see column 31, lines 10-25.
Bromley et al. as discussed above teach 16% to about 30% (w/w) of concentrate, see column 2, lines 66-67. The amount of polar solvent ranges from about 60% to about 79%, the amount of amphiphilic fat, phosphatidylcholine ranges from about 0.1% to about 1% by weight of the concentrate as discussed above, the amount of non-polar compound taught in Bromley ranges from about 5-10% of the concentrate, the amount of TPGS surfactant can be about 25.2% and the amount of water can be about 68.79%, see column 8, lines 10-25. Therefore, the reference teaches the known and useful amount of the surfactant, amphiphilic fat, non-polar active ingredient and associating oil in a nanoemulsion and liposomal formulation, based on the guidance provided by the art, one of ordinary skill would manipulate the amount or the ratio within the components for obtaining clear and transparent formulation to be administered for nutritional benefits and their bioavailability, by performing experimental optimization of the components.
Bromley as discussed above teaches use of flavonoids, phytosterols and lipophilic drugs in the micelle, however the reference does not teach use of solid powder toxin and liver detoxification.
Frykman et al. teaches Zeolites help in removal of toxins such as heavy metals, see abstract.
Dushenkov et al. composition and methods for the prevention and treatments of condition associated with inflammation, see title. The reference teaches use of zeolites, aloe, charcoal, bentonite and silica gels in a powder form in a dietary composition, see table and claims.
JP2010-235538 teaches activated charcoal helps in detoxification, see description. The oral tablet comprises bentonite, colloidal silicic acid and charcoal, see description.
It would have been obvious to one of ordinary skill to have utilized the toxin remover zeolites, activated charcoal, bentonite, silica and aloe and have it utilized in Bromley’s nutritional composition, for removal of toxins motivated by the teachings of Frykman et al., Dushenkov et al. and JP2010-235538 which teaches use of such in an oral preparation and as toxin removers.
Nonstatutory double patenting rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 of (US Patent 12,121,558 B2).
The instant claims recite a solid powder toxin binding composition for irreversibly binding toxins in the bowel, the composition comprising: a thiol-functionalized silica binder; a zeolite binder; an activated charcoal binder; a bentonite clay binder; a chitosan binder; a mucosal lining repair agent; and a mucosal lining lubricating agent. The patented claims recite a liver detoxification method for an animal, comprising: holding from 4 to 6 milliliters of a nanoemulsion blend under the tongue of an animal from 30 seconds to 2 minutes, where the nanoemulsion blend comprises at least one monolayer surfactant bound particle, where the at least one monolayer surfactant bound particle comprises at least one amphiphilic fat, a polyethylene glycol surfactant form, an associating oil, and milk thistle; at least one bilayer liposome, where the at least one bilayer liposome comprises the at least one amphiphilic fat and the polyethylene glycol surfactant forming a capsule, where an interior of the capsule includes myrrh dissolved in water, ethanol, and glycerin; and a continuous phase comprising water, ethanol, and glycerin; where the at least one amphiphilic fat is associated with R-Lipoic acid, the blend is a stable dispersion that is transparent, and the at least one monolayer surfactant bound particle and the at least one bilayer liposome have an average particle diameter from 10 to 100 nanometers as carried by the continuous phase; waiting from approximately 20 minutes to 40 minutes; consuming from 2 to 6 grams of a solid powder toxin binding composition suspended in water, where the solid powder toxin binding composition comprises a thiol-functionalized silica binder, a zeolite binder, an activated charcoal binder, a bentonite clay binder, a chitosan binder, a mucosal lining repair agent, and a mucosal lining lubricating agent; and excreting the solid powder toxin binding composition. The patented claims reciting the solid powder toxin binding composition comprises a thiol-functionalized silica binder, a zeolite binder, an activated charcoal binder, a bentonite clay binder, a chitosan binder, a mucosal lining repair agent, and a mucosal lining lubricating agent; and excreting the solid powder toxin binding composition reads on the instant claims. The open-ended comprising language of instant claims do not preclude reading additional components in the claims.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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