Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (Claims 1-7) in the reply filed on 09/30/2025 is acknowledged. The traversal is on the ground that the Group II invention is clearly and unambiguously a subset of the Group I invention, and therefore should be examined concurrently with the Group I invention because doing so would place no additional undue burden on the Examiner with regards to the search and examination of these claims. Applicant’s argument is persuasive, therefore, the invention of Group II (Claims 8-15) is hereby rejoined and fully examined for patentability under 37 CFR 1.104. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23 and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While the present specification teaches an improved particle size distribution, it does not appear to provide an adequate support for the limitation “the hydrophobic phase in the emulsion has a particle size distribution wit ha standard deviation of under nm” recited in claims 23 and 24.
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 1-15, 21 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Friedman US 2020/0330378 A1.
Friedman teaches a stable composition for the administration of combinations of at least one cannabinoid emulsified oil-in-water type sub-micron emulsion system that provides improved oral absorption and devoid of bitter after taste. More particularly, compositions and dosage forms of cannabinoids and emulsifiers, which form an oil-in-water type emulsion, having a plurality of particles in the sub-micron or nanoparticle range, improved oral bioavailability through the gastrointestinal tract, much reduced bitter taste and after taste and long shelf-life stability, wherein the emulsion composition is stable at ambient temperature for at least 12-24 months, and wherein the emulsion composition does not separate or cream under accelerated conditions See Abstract and paragraph 0012. According to some other embodiments, there is provided a process for producing a stable composition of this invention by: A) mixing the at least one cannabinoid with the at least one triglyceride oil, the at least two emulsifiers and optionally the at least one terpene and heating to about 75°C, B) vigorous mixing, C) separately, preparing the water phase by heating water, to about 75°C., and dissolving under vigorous mixing inactive ingredients selected from a flavor, a taste masking agent, a colorant, an anti-oxidant, a microbial preservative and combinations thereof, D) mixing the two phases heated at about 75°C. under high shear homogenization. See paragraph 0037. The term “triglyceride oil” is used here is an oil made of three fatty acids conjugated by an esters bond to glycerin or glycerol, whereas the fatty acids are having from C8 C22 carbons. The fatty acids may be unsaturated or saturated and hydrogenated or not. The triglyceride oil may also comprise diglycerides and free fatty acids in small amount. The triglyceride can be liquid or solid at room temperature. A preferred type of triglyceride is capric/caprylic triglyceride that is less prone to oxidation. See paragraph 0073. Glycerin is found in paragraph 0097 and Claims. Emulsified composition comprising from about 0.02% w/w to about 10% w/w of at least one cannabinoid or a mixture of cannabinoids, from about 1% w/w to about 10% w/w of a triglyceride oil, and from about 1% w/w to about 10% w/w of at least two emulsifiers, wherein upon homogenizing in the water external phase of the emulsion or upon mixing with mammals body fluids, the composition obtained exhibits a plurality of particles having a mean particle size of from about 10 nm to about 10 m and more preferably from about 20 nm to about 2,000 nm, or from about 50 nm to about 1,000 nm, or from 80 nm to 800 nm, or from 90 nm to about 600 nm, or from about 100 nm to about 400 nm, or from 10 nm to about 200 nm is found in paragraph 0086. The present invention provides, in one embodiment, an emulsion composition, comprising from about 0.02% w/w to about 10% w/w of at least one cannabinoid, from about 1% w/w to about 10% w/w of a triglyceride oil, and from about 1% w/w to about 10% w/w of at least two emulsifiers, wherein the ratio of the at least one triglyceride oil to at least two emulsifiers is about 1:10 to about 10:1 and more preferably from about 1:1 to about 4:1, and wherein the emulsion composition has a plurality of particles having a mean particle size of from about 10 nm to about 2,000 nm, more preferably from 10 nm to 1,000 nm and more preferable from about 10 nm to 800 nm or from 100 nm to 600 nm. The emulsion composition of this invention is a very fine opaque to translucent emulsion. The sub-micron or nano-size range is from about 10 nm to about 1,000 nm and from about 10 nm to about 800 nm and more particularly from about 10 nm to about 600 nm, or from about 10 nm to about 400 nm, or from about 10 nm to about 300 nm, or from about 10 nm to about 200 nm. In certain embodiments, the “emulsified composition” may be produced as known in the art of emulsion manufacturing, by heating the oil phase and the water phase separately, and mixing them under high shear homogenization process, or producing the oily phase by heating and agitation to produce a composition that forms an emulsion upon mixing with an aqueous medium, such as the external aqueous phase of the emulsion or mammals body fluids, by process of self-emulsification or by applying vigorous mixing such as high shear homogenization. See paragraphs 0087-0089.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Khangaonkar et al. 20150004238 A1.
This rejection has been withdrawn in view of the Amendment filed 04/13/2026.
Claims 1-15, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Khangaonkar et al. 2015/0004238 A1, in view of Friedman US 2020/0330378 A1.
Khangaonkar teaches an oil-in-water emulsions that include fat-soluble vitamins, and methods of producing the aforementioned emulsions. The emulsions may include any of a number of vitamins, including water-soluble vitamins, but the compositions are particularly amenable for use with fat-soluble vitamins, including those that may be susceptible to thermal and/or photochemical decomposition. A method of preparing an oil-in-water emulsion may, in some embodiments, include addition of at least one fat-soluble vitamin to a suitable solvent, controlled thermal processing to aid in dissolving and/or mixing, addition of an emulsion stabilizer, and high pressure homogenization. See paragraph 0026. The emulsion may include no more than about 25% water, no more than about 50% water, or no more than about 80% water by weight. See paragraph 0028. Emulsions described herein have been found to be stable for a period of time of at least about 3 months to about 4 months. In some embodiments, concentrated emulsions of low-water content that include beta-carotene may be stored for a period of at least 4 months and may be added at any time during storage to other ingredients to form a beverage product that includes a desired color. In some embodiments, beverages made using the emulsions described herein have been found to be stable for at least about 4 months or at least about 6 months. See paragraph 0031. Carrier oil is found in paragraphs 0035-0040. An emulsion comprising an oil-phase homogeneously dispersed within the continuous phase of the emulsion is found in paragraph 0031. Method for forming an emulsion, a solvent oil or part of the solvent oil may be part of a dispersed phase in the emulsion or part of a dispersed phase in a beverage product comprising the emulsion. Fat-soluble vitamins may become trapped or preferentially reside in the dispersed phase of the emulsion, and the emulsion may protect the vitamin from substantial exposure to a surrounding aqueous environment. In some embodiments, use of one or more oils or oils in combination with an emulsion stabilizer may substantially confine a vitamin to the dispersed phase of an emulsion, and confinement of the vitamin may provide an environment wherein thermal and/or photochemical degradation of the vitamin may be substantially inhibited. For example, oxidative reactions may be substantially less than if the vitamin were exposed to water or some lipid environments that include a substantial proportion of unsaturated fatty acids. See paragraph 0033. The size of oil-phase regions of the resultant emulsion was measured using a commercially available dynamic light scattering system, Zetasizer.TM., manufactured by Malvern Instruments Ltd. (Worcestershire, U.K.). As further shown in FIG. 3, the size of oil-phase regions of the emulsion was found to range between about 0.1 micrometers and about 0.15 micrometers. See paragraph 0085. Oil phase comprises particles with an average size of about 0.1 microns to about 0.5 microns. See claim 24.
Khangoankar does not teach the claimed emulsion droplet size.
Friedman teaches a nano-emulsified composition comprising from about 0.02% w/w to about 10% w/w of at least one cannabinoid or a mixture of cannabinoids, from about 1% w/w to about 10% w/w of a triglyceride oil, and from about 1% w/w to about 10% w/w of at least two emulsifiers, wherein upon homogenizing in the water external phase of the emulsion or upon mixing with mammals body fluids, the composition obtained exhibits a plurality of particles having a mean particle size of from about 10 nm to about 10 m and more preferably from about 20 nm to about 2,000 nm, or from about 50 nm to about 1,000 nm, or from 80 nm to 800 nm, or from 90 nm to about 600 nm, or from about 100 nm to about 400 nm, or from 10 nm to about 200 nm is found in paragraph 0086. The present invention provides, in one embodiment, an emulsion composition, comprising from about 0.02% w/w to about 10% w/w of at least one cannabinoid, from about 1% w/w to about 10% w/w of a triglyceride oil, and from about 1% w/w to about 10% w/w of at least two emulsifiers, wherein the ratio of the at least one triglyceride oil to at least two emulsifiers is about 1:10 to about 10:1 and more preferably from about 1:1 to about 4:1, and wherein the emulsion composition has a plurality of particles having a mean particle size of from about 10 nm to about 2,000 nm, more preferably from 10 nm to 1,000 nm and more preferable from about 10 nm to 800 nm or from 100 nm to 600 nm. The emulsion composition of this invention is a very fine opaque to translucent emulsion. The sub-micron or nano-size range is from about 10 nm to about 1,000 nm and from about 10 nm to about 800 nm and more particularly from about 10 nm to about 600 nm, or from about 10 nm to about 400 nm, or from about 10 nm to about 300 nm, or from about 10 nm to about 200 nm. In certain embodiments, the “emulsified composition” may be produced as known in the art of emulsion manufacturing, by heating the oil phase and the water phase separately, and mixing them under high shear homogenization process, or producing the oily phase by heating and agitation to produce a composition that forms an emulsion upon mixing with an aqueous medium, such as the external aqueous phase of the emulsion or mammals body fluids, by process of self-emulsification or by applying vigorous mixing such as high shear homogenization. See paragraphs 0087-0089.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation optimize the teaching in Khangaonkar in view of the teaching in Friedman to obtain an emulsion having the claimed emulsion size and emulsion separation rate. This is because Khangaonkar recognizes the need for shelf stable emulsion having shelf-stable characteristic similar to that of the present invention, namely, an emulsion with low water content, and this is because Friedman teaches a shelf-stable emulsion useful for the delivery of the claimed active agent and a stability of at least 24 months.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Khangaonkar US 2015/0004238 A1, in view of Friedman US 2020/0330378 A1 and Pozzo et al. US 2019/0307908 A1.
Khangaonkar is relied upon for the reason stated above. Khangaonkar does not teach the emulsion particle size distribution with a standard deviation.
Pozzo teaches a nanoemulsion having the claimed particle size and a particle size distribution with a standard deviation of under 20 nm. See abstract; Claims and paragraph 0051.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to obtain a particle size distribution in view of the teaching of Pozzo because Pozzo teaches the claimed standard deviation in a nanoemulsion is known in the art.
Response to Arguments
Applicant’s arguments filed 04/13/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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