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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-10, 52-56 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “configured” in claims 9-10, 52-56, is a relative term which renders the claim indefinite. The term “configured” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “configured” suggests the performance some of modification to the composition for its utility. It is unclear how the composition is or was modified, i.e. “configured” for use such that the artisan would appreciate the metes and bounds of the claimed invention.
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.
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.
Claim(s) 1-6, 8-13, 15-25, 27, 30-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin et al., (US 2011/0313055, cited in IDS) in view of Garti et al. (J. Agric Food Chem, 2001).
Ervin et al. teaches “flavored chewy or gummy candy confections” comprising “a healthier group of edible oils component . . . water component, emulsifier component, . . .” (Abstract).
Ervin et al. teaches an example of a gummy candy comprising 61% of gummy confection candy (gummy base), 20% Fiber, 10-20% water, 0-5% liquid edible oil (blend of canola, soybean oil and sunflower oil), 0-1% coconut oil, 0-1% vanilla powder, 0-2% emulsifier, natural or artificial flavor component, 0.001% tocopherols, and 0-2% or greater gelatin or another hydrocolloid (p. 5, para. [0050]-[0061]).
The reference also teaches, “a water component at about 0% or greater” (p. 4, para. [0032]); and an embodiment having a“4% water component” (Id. para. [0042]), as per claim 8.
Here the embodiment reads on an oil-in-water emulsion, where water is the continuous phase. The water component also suffices as the gummy base water.
The gummy base may comprise “[a]ny disaccharide . . . although sucrose or sugar may be used in the embodiments” (p. 6, para. [0066]), which suffices to address the solid sugar component (clm. 32). The reference further teaches “the monosaccharide and/or disaccharide component may be replaced in whole or impart by a polyol selected from the group consisting of erythritol, sorbitol, maltilol, isomalt, mannitol, xylitol and combinations thereof, or other suitable carbohydrate sweetener acceptable for confectionery use” (p. 6, para. [0066]), as per claim 3. Liquid syrups, such as “corn syrup”, as per claim 4, may be used as the monosaccharide component (Id. para. [0065]). Gelling agents such as “gelatin or pectin” may be used as gelling component (p. 4, para. [0032]), as per claim 5. The compositions can further include “organic food acids” (edible acids), such as “citric acid” (p. 5, para. [0046]), as per claim 6.
Components to be solubilized in the gummy compositions of Ervin et al. include “calcium, potassium, B vitamins, vitamins A, C, D, E, and K, folic acid, other vitamins and minerals commonly known in the art and used for supplementing the diet; . . . beta carotene . . . d-limonene . . . phytosterols [plant sterols]” (p. 8, para. [0078]), as per claims 13, 15-19.
Ervin et al. does not teach a modified oil-in-water microemulsion.
Garti et al. teaches improved oil solubilization in Oil/Water food grade microemulsions based on a five-component mixture of water, oil, surfactants, polyols and ethanol (Abstract). The microemulsions are modified oil-in-water emulsions insofar as they include “water, oil phase . . . , short-chain alcohols (such as ethanol), polyols (propylene glycol and glycerol [clm. 34]), and several surfactants and their corresponding mixtures (nonionic, such as ethoxylated sorbitan esters, polyglycerol esters, sugar ester, and anionic, such as phosphatidylcholine) (Abstract).
Here the phosphatidylcholine suffices as the phospholipid, as claimed (clm. 1, 20-23); the ethoxylated sorbitan ester [e.g. Tween 60; see Materials at p. 2553] suffices as the polyethylene glycol derivative; polyols like propylene glycol and glycerol suffices as the claimed sugar alcohol. Note Tween 60 is also polysorbate 60, as per claim 24-25.
“The possibility of enhancing the solubility of hydrophobic vitamins, flavors, and other nutrients in oil-in-water microemulsions is of great interest, as it can provide a well-controlled and stable medium for the incorporation of these ingredients and may protect the solubilized components from undesired degradative reactions” (p. 2552, left column, 2nd paragraph).
Specifically, Garti et al. teaches solubilizing the monoterpene “limonene” (p. 2553, left column, 6th paragraph), as per claims 13 and 15, and “medium chain triglyceride” (Id.), as per claim 27. Garti et al. further teaches citrus essential oils, which are often used in foods (Id.). Accordingly, it would have been obvious to use oranges or lemons as sources for the citrus oil or lemon oil, as per claim 30.
Garti et al. teaches, “The growing interest in microemulsions as vehicles for food formulation arises mainly from the advantages of their physicochemical properties, such as spontaneous formation, clear appearance, low viscosity, thermodynamic stability, and high solubilization capacity” (p. 2552, Introduction, 1st paragraph).
The microemulsions of Garti are “visually clear” as claimed insofar as Garti et al. teaches that samples of the five-component system “remained transparent and homogenous after vigorous vortexing” (p. 2553, right column, 3rd paragraph).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use the modified microemulsion system of Garti et al., i.e. the five-component mixture of water, oil, surfactants, polyols and ethanol, in the formulations of Ervin et al. for the advantage of enhancing the solubility of hydrophobic vitamins, flavors, and other nutrients, as well as protecting the solubilized components from undesired degradative reactions in a well-controlled and stable medium. The artisan would have reasonably expected success with the combination insofar as the compositions of Ervin et al. require an edible oil component.
The artisan would have reasonably been expected to modify the ratio of modified oil-in-water microemulsion to gummy base, as per claim 2, as well as the amount of water, oil, surfactant (emulsifier), alcohol in the system, as per claims 8, 35-51, in effort to provide a well-controlled and stable medium for the edible oils therein. Accordingly, "where 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." (see MPEP 2144.05, II. A, quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Since the prior art uses a modified O/W emulsion the properties of claims 52-57 are implied.
Concerning claim 9-10, 52-56, the compositions of the prior art are “configured” insofar as they comprise nonionic surfactants, polyols, and ethanol in addition to the water, oil, and emulsifier, as taught by Garti et al.
Concerning claim 11, the determination of patentability for a product-by-process is based on the product itself, even though product-by-process claims are limited by and defined by the process (see MPEP 2113 citing In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)). The patentability of a product does not depend on its method of production (Id.). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (Id.). The claim is made obvious by the prior art adding nonionic surfactants, polyols, and ethanol in addition to the water, oil, and emulsifier, as taught by Garti et al. This type of modification is supported by the instant specification (see p. 8-9, para. [0021]).
Given the prior art teaching above, it would have been obvious to combine the phospholipid, polyethylene glycol derivative, alcohol, a sugar or sugar alcohol and water with oil to form a modified oil-in-water microemulsion for subsequent addition to a gummy base comprising solid sugar, gelling agent, water, liquid syrup, as per claim 57. In regard to transferring the composition to a mold, Ervin et al. teaches, “The method further includes a final processing process in which the final product is prepared. This process can include, for example, extruding, thermoforming, molding, shaping, cutting, and the like, to form the final product in the desired shape” (p. 10, para. [0097]).
2) Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin et al., (US 2011/0313055, cited in IDS) in view of Garti et al. (J. Agric Food Chem, 2001) as applied to claim 1 above, and further in view of Yusuf et al., (US 2005/0260329).
The combination of Ervin et al. and Garti et al., which is taught above, differs from claim 7 insofar as it does not teach a pH for the compositions.
Yusuf et al. teaches, “Liquid center filled confections, such as gummy or jelly candies or fruit snacks” (Abstract).
“An acid and buffering agent may be employed without adversely affecting a desired level of sweetness or sourness in the final product. In embodiments of the invention, the acid and the buffering agent levels may be adjusted to provide a shell pH of about 3 to about 3.5, preferably about 3.2 to about 3.4” (p. 7, para. [0047]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing for the pH of the gummy of Ervin et al. to fall within the claimed range of 3.3 to 3.5, based on the suitability of its intended use of gummy confections having a pH of about 3 to about 3.5, as taught by Yusuf et al. Here, a prima facie case of obviousness exists insofar as the claimed pH range lies inside the prior art pH range.
3) Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin et al., (US 2011/0313055, cited in IDS) in view of Garti et al. (J. Agric Food Chem, 2001) as applied to claim 11 above, and further in view of Karunaratne et al., (Properties and Uses of Microemulsions, 2017).
The combination of Ervin et al. and Garti et al., which is taught above, differs from claim 12 insofar as it does not teach an average droplet size for the microemulsion.
Karunaratne et al. teaches, “One of the main differences between macroemulsions and microemulsions is that the size of the droplets of the dispersed phase of microemulsions is between 5 and 100 nm, while that to macroemulsions is >100 nm” (1st page, Introduction). Karunaratne et al. further teaches, “Microemulsions considering the small size of the droplets can serve as better delivery vehicles thereby improving the drug solubility, penetrability, and shelf life” (see sec. 3.1.Pharrmaceutics).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing for the combination of Ervin et al. and Garti et al. to have an average droplet diameter of 7 to 30 nanometers since the combination is a microemulsion and microemulsions have a droplet size between 5 and 100 nm, as taught by Karunaratne et al. Since droplet size is considered in regard to drug solubility, penetrability, and shelf life, it would have been obvious to optimize a range for the droplet size in the compositions of Erving et al.
4) Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin et al., (US 2011/0313055, cited in IDS) in view of Garti et al. (J. Agric Food Chem, 2001) as applied to claim 11 above, and further in view of Faraci et al., (WO 2018/152334, cited in IDS).
The combination of Ervin et al. and Garti et al., which is taught above, differs from claim 14 insofar as it does not teach a cannabis extract, e.g. cannabinoid.
Faraci et al. teaches “cannabinoid formulations, including self-emulsifying formulations and micellar dispersions, as well as methods of making and using the same” (Abstract).
“In one embodiment, the composition comprises: a cannabinoid, a D-α-Tocopherol polyethylene glycol 1000 succinate (TPGS), and/or lauryl macrogol 32 glycerides” (p. 21, lines 1-2). The formulations may be in the form of “an edible product” including “gummy candy” (p. 46, lines 6-8).
“The selection of a known material 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)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add a cannabinod to the compositions of Ervin et al. and Garti et al. based on its art recognized suitability for its intended use in gummy candy formulations, as taught by Faraci et al. The artisan would have had a reasonable expectation of success with the combination insofar as cannabinoids are lipophilic, and the formulations of Ervin et al. and Garti et al. are designed for lipophilic ingredients.
5) Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin et al., (US 2011/0313055, cited in IDS) in view of Garti et al. (J. Agric Food Chem, 2001) as applied to claim 11 above, and further in view of Ke et al., (Journal of Controlled Release, 2005).
The combination of Ervin et al. and Garti et al., which is taught above, differs from claim 26 insofar as it does not teach tocopheryl polyethylene glycol 1000 succinate (TPGS).
Ke et al. teaches the use of tocopheryl polyethylene glycol 1000 succinate (TPGS) in a microemulsion as stabilizer (see Abstract).
“The selection of a known material 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)” (see MPEP 2144.07).
It would have been obvious to use tocopheryl polyethylene glycol 1000 succinate (TPGS) in the compositions of Ervin et al. in view of Garti et al. since the combination takes advantage of the microemulsion and TPGS is a known material suitable for use as solubilizer and stabilizer in a microemulsion, as taught by Ke. The artisan would have been reasonably expected to use known ingredients of known compositions with the expectation of obtaining their known function.
6) Claim(s) 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin et al., (US 2011/0313055, cited in IDS) in view of Garti et al. (J. Agric Food Chem, 2001) as applied to claim 1 above, and further in view of Rahn AG, (Cosmetopolitan, August 2015).
The combination of Ervin et al. and Garti et al., which is taught above, differs from claims 28-29 insofar as it does not teach the species of medium chain triglycerides, e.g., caprylic acid.
Garti et al. teaches the use of medium-chain triglycerides and identifies Tegosoft CT as the source of its medium-chain triglycerides. No further details concerning the species of medium-chain triglycerides in Tegosoft CT were provides
The reference to Rahn AG is a brochure, COSMETOPOLITAN, comprising new product in the Rahn portfolio, such as Tegosoft CT, which, according to it’s INCI, comprises Caprylic/Capric Triglyceride (see table at p. 14).
It would have been obvious to a person having ordinary skill in the art at the time applicant’s filing for the compositions of Ervin et al. and Garti et al. to comprise medium chain triglycerides, wherein the medium chain triglycerides are caprylic and capric triglycerides, since Rahn AG evidences that the medium chain triglycerides of Garti et al. (i.e. Tegosoft CT) were in fact caprylic and capric triglycerides.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612