Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/31/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-4, 6, 7, and 9-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schrader (EP 2359698) in view of US 2007/0160738 (Van Bokkelen), Bell (National Starch Food Innovation at Bell Flavors and Fragrances, 2010) and US 2009/0317532 (Bromley) (cited on IDS filed 12/16/2025) and evidenced by “Kemtrak, Turbidity units-explained”.
Schrader teaches an emulsion that is considered to be a nanoemulsion based upon the average particle size of 140nm or less [0019]. Schrader teaches that the microemulsion (i.e. nanoemulsions) can be added to beverages or in concentrated form [0005] and have the advantage of being transparent or clear when sufficiently diluted due to the very small size of the dispersed oil-droplets (less than 140 nm) [0007].
Schrader teaches that the nanoemulsion has an aqueous phase and oil phase (hence an emulsion) and a preferred emulsifier of quillaja (quillaic) saponins [0023-0026]. The quillaja saponin used is Q-Naturale 200 which has more than 10% saponin content [0064].
Regarding the weight ratio of quillaja to the liquid flavor oil, in Table 1, examples 1-3, Q-Naturale is present at 30 parts and the flavor oil is 29.9 parts which falls within the claimed ratio. The other examples also fall within the broad ratio claimed of 0.1-3.0.
As demonstrated in Table 1, the FNU values were between 1-5 and are turbidity values of the microemulsions when applied in a soft drink. Schrader states that all microemulsions when applied in the soft drink had an FNU value between 1-5. This demonstrates the ability of the microemulsion to provide a beverage having turbidity of less than 10 NTU. NTU and FNU are considered to have equal units as explained by “Kemtrak, Turbidity units-explained”. Kemtrak states that NTU stands for Nephelometric Turbidity Unit and FNU stands for Formazin Nephelometric Unit and that 1NTU=1FNU.
Claim 1 was amended to require the particle size in the range of 100-122 nm. Schrader discloses less than 140 nm which overlaps the claimed range and presents a prima facie case for obviousness.
Claim 1 was amended to require at least one monosaccharide or disaccharide at a concentration of 10-50wt% if the emulsion. Schrader discloses in their examples the addition of inverted sugar syrup 72Bx and further discloses that the carbohydrates may be present as sugar syrup (a mixture of sucrose, glucose and fructose [0062]), glucose syrup, and fructose syrup [0040]. The amounts of carbohydrate are determined relative to the solvents where the ratio of the amount of propylene glycol and glycerol to the sugars is 1:3 to 5:3 (0.33-1.66) [0039]. The solvents propylene glycol and glycerol (glycerine) are consistent with applicant’s disclosed examples. Moreover, the ratios disclosed by Schrader are consistent with applicant’s examples. For instance, Example 1 (Table 6) contains 350 total g/kg of propylene glycol and glycerine and 538.50 g/kg sugar syrup for a ratio of 0.64 which is within the range disclosed by Schrader. These amounts are also similar to the Examples of Schrader. For instance, Example 1 has 365 g/kg total propylene glycol and glycerol and 565 g/kg syrup for a ratio of 0.65. Thus, one of ordinary skill in the art would have found it obvious to adjust the monosaccharide and disaccharide in a ratio consistent with that disclosed by Schrader and the ratio and amounts are consistent with applicant’s examples. Adjusting the amount of sugars would also affect the taste as well as total carbohydrate amounts of the concentrate and ultimately the beverage. One of ordinary skill would have found it obvious to vary the amounts of saccharides, in this case syrups, to adjust the taste and carbohydrate amounts desired in the concentrate and beverage formed from the concentrate. Absent a showing that the amount of carbohydrate added is critical, one of ordinary skill would have found it obvious to adjust the amount based upon the total solvents (the ratio range of Schrader) and the taste and desired carbohydrate amounts.
Schrader does not expressly teach the pH of the aqueous phase is 4.0 maximum. Schrader does teach that quillaja saponins are extremely stable to acid pH [0028]. Schrader also teaches that citric acid or other organic acids may be added to the beverage formulation [0060].
Van Bokkelen teaches a beverage emulsion where the pH of the aqueous phase is preferably between 2.5-4 and the aqueous phase comprises citric acid [0091, 0094]. Bell also teaches forming a beverage emulsion by pre-treating the aqueous phase by dissolving citric acid in water, adding Q-Naturale 200 to the water phase and subsequently adding the oil-phase. Van Bokkelen demonstrates that one of ordinary skill would find it obvious to provide a pH of the aqueous phase within the range claimed using citric acid to make a beverage emulsion and Bell teaches that citric acid is added to a water phase of a beverage emulsion and subsequently used with Q-Naturale 200 (page 6) and teaches that the formulation is “almost transparent” and has a particle size of less than 150 nm (page 5) with an average oil droplet diameter of less than 100nm (pages 11-12). Further, Schrader recognizes that Q-Naturale 200 is extremely stable with acid pH. Based upon, the express teaching in Schrader that Q-Naturale 200 is stable under acid pH, and Van Bokkelen’s teaching that the aqueous phase of beverage emulsions is preferably between 2.5-4, and Bell’s teaching of using citric acid to pre-treat the aqueous phase with citric acid, one of ordinary skill in the art would have found it obvious to provide the aqueous phase of the beverage emulsion of Schrader with a pH between 2.5 and 4 with a reasonable expectation of successfully forming a beverage emulsion that can be used in the same manner and with the same clarity. Schrader uses Q-Naturale 200 and its stability at low pH and Bell expressly teaches the benefits of Q-Naturale 200 of low particle size which leads to lower turbidity. Based upon the pH teaching in Van Bokkelen, the acid-stable use of Q-Naturale 200 and the use of citric acid in both Van Bokkelen and Bell, one of ordinary skill would have found it obvious to provide the acidic pH to Schrader to optimize the stability of the Q-Naturale 200 with a reasonable expectation of successfully forming a nanoemulson beverage concentrate. Still further, Bromley discloses liquid nanoemulsion concentrates [0009] that that typical aqueous phase ingredients include pH adjusters such as citric and/or phosphoric acid, surfactants such as quillaja saponins and preservatives [0493]. Bromley discloses that typically, pH adjusters are added to the concentrates to achieve the desired pH which is typically pH 2-4 [0061, 0396]. Thus, taking the disclosures of Van Bokkelen, Bell and Bromley, one of ordinary skill in the art would have found it obvious to adjust the pH of the concentrate of Schrader as it is well-known in the art of beverage concentrates. Note that Bromley also discloses that the particle size of the emulsion may be less than 200 nm to less than 5nm [0151, 0173].
Regarding claims 2-4, Schrader teaches that the surfactant system (emulsifier) has a ratio of saponins to lecithin of up to 4:1 which overlaps the claimed values [0036] and is prima facie obvious.
Regarding claim 6, Schrader teaches the use of lecithin as an additional surfactant (emulsifier) [0041].
Regarding claim 7, Schrader teaches flavor oils may include lemon or orange oils [0034-0035].
Regarding claims 9 and 10, as noted above, Schrader discloses glucose, sucrose and fructose.
Regarding claims 11-13, Schrader teaches the addition of propylene glycol, glycerol and sucrose and teaches that the amounts may be varied relative to one another [0037-0039]. Absent a showing of unexpected results, it would have been obvious to one of ordinary skill to modify the amounts of these co-solvents (propylene glycol, glycerol) and sugars (sucrose) and Schrader teaches that the skilled person will select the co-solvent in particular consideration of the substances comprised in the oil phase and that preferably, it is a combination of propylene glycol and glycerol [0038].
Regarding claims 14 and 15, as explained above, the use of citric acid is obviated by Van Bokkelen and Bell and Bromley.
Regarding claim 16, Schrader teaches preserving agents may be added such as sodium benzoate [0060]. Moreover, Bell teaches the addition of sodium benzoate to the aqueous phase.
Regarding claim 19, Schrader teaches forming a clear beverage (low turbidity) by combining the emulsion with soda (Table 1 and [0071]).
Claims 1-7, and 9-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tran (US 2011/0236558) in view of Schrader (EP 2359698), Van Bokkelen (US 2007/0160738), Bell (National Starch Food Innovation at Bell Flavors and Fragrances, 2010) and US 2009/0317532 (Bromley) (cited on IDS filed 12/16/2025) and evidenced by “Kemtrak, Turbidity units-explained”.
Tran teaches a nanoemulsion useful in beverages comprising a liquid flavor oil and an emulsifier of quillaja (Q-Naturale 200). In Example 1, the wt% of quillaja is 7.5% and orange oil is 48.9wt% for a ratio of 0.15 which falls within the range claimed. Further regarding claim 1, Tran teaches that the emulsions are useful in forming clear beverages and that clear means any beverage with NTU less than 100 which overlaps, and therefore obviates, the claimed range [0031]. Further regarding claim 17, Tran teaches the formation of particle sizes that are less than 150 nm, which overlaps the claimed range [Example 1, Figure 1]. Moreover, Figure 1 shows the presence of particles in the range of 100-122 nm, thus meeting the limitation “the nanoemulsion comprises particles… in the range of 100 nm to 122 nm”. The presence of particles outside of this range is not precluded by the claim.
Tran does not expressly teach the pH of the aqueous phase is 4.0 maximum. Schrader teaches that quillaja saponins are extremely stable to acid pH [0028] and are used in beverage emulsions. Schrader also teaches that citric acid or other organic acids may be added to the beverage formulation [0060].
Van Bokkelen teaches a beverage emulsion where the pH of the aqueous phase is preferably between 2.5-4 and the aqueous phase comprises citric acid [0091, 0094]. Bell also teaches forming a beverage emulsion by pre-treating the aqueous phase by dissolving citric acid in water, adding Q-Naturale 200 to the water phase and subsequently adding the oil-phase. Van Bokkelen demonstrates that one of ordinary skill would find it obvious to provide a pH of the aqueous phase within the range claimed using citric acid to make a beverage emulsion and Bell teaches that citric acid is added to a water phase of a beverage emulsion and subsequently used with Q-Naturale 200 (page 6) and teaches that the formulation is “almost transparent” and has a particle size of less than 150 nm (page 5). Further, Schrader recognizes that Q-Naturale 200 is extremely stable with acid pH. Based upon, the express teaching in Schrader that Q-Naturale 200 is stable under acid pH, and Van Bokkelen’s teaching that the aqueous phase of beverage emulsions is preferably between 2.5-4, and Bell’s teaching of using citric acid to pre-treat the aqueous phase with citric acid, one of ordinary skill in the art would have found it obvious to provide the aqueous phase of the beverage emulsion of Tran with a pH between 2.5 and 4 with a reasonable expectation of successfully forming a beverage emulsion that can be used in the same manner and with the same clarity. Both Tran and Schrader use Q-Naturale 200 which has stability at low pH and Bell expressly teaches the benefits of Q-Naturale 200 of low particle size which leads to lower turbidity. Based upon the pH teaching in Van Bokkelen, the acid-stable use of Q-Naturale 200 and the use of citric acid in both Van Bokkelen and Bell, one of ordinary skill would have found it obvious to provide the acidic pH to Tran to optimize the stability of the Q-Naturale 200 with a reasonable expectation of successfully forming a nanoemulson beverage concentrate. Moreover, both Bell and Tran recognize the formation of very small particle sizes when using Q-Naturale 200, thus one of ordinary skill in the art would reasonably expect to successfully form the low particle sizes in Tran with the modification proposed above. Still further, Bromley discloses liquid nanoemulsion concentrates [0009] that that typical aqueous phase ingredients include pH adjusters such as citric and/or phosphoric acid, surfactants such as quillaja saponins and preservatives [0493]. Bromley discloses that typically, pH adjusters are added to the concentrates to achieve the desired pH which is typically pH 2-4 [0061, 0396]. Thus, taking the disclosures of Van Bokkelen, Bell and Bromley, one of ordinary skill in the art would have found it obvious to adjust the pH of the concentrate of Schrader as it is well-known in the art of beverage concentrates. Note that Bromley also discloses that the particle size of the emulsion may be less than 200 nm to less than 5nm [0151, 0173].
Tran discloses that the emulsion may optionally contain additional food grade components. Such food grade components include without limitation sugar alcohols or other sugar substitutes, pH agents, salinity agents, colorants and thickeners [0025]. Schrader discloses beverage emulsions comprising surfactants, co-solvents and flavoring oil and the addition of sugars selected from sucrose, fructose and glucose. The presence of sugars contributes to the taste of the emulsion and the beverage ultimately formed from the emulsion. Thus, depending upon the desired taste, and sweetness, of the beverage to be formed, one of ordinary skill would have found it obvious to add sugars to the emulsion of Tran in the manner disclosed by Schrader.
Regarding claims 2-6, Tran teaches that the emulsifier may be a mixture of quillaja or other surfactants such as lecithin, sugar esters, and polysorbates [0020]. This teaching is seen to obviate the use of variable amounts of quillaja including 25-75wt% and absent a showing of unexpected results for the particular amounts claimed, it would have been within the purview of one of ordinary skill to provide mixtures of these surfactants in various amounts. In example 1, the quillaja is the only emulsifier present, thus meeting 100 wt% quillaja of claim 5.
Regarding claim 7, the flavor oil may be a fruit oil such as orange [0021].
Regarding claims 9 and 10, as discussed above, Schrader discloses glucose, fructose and sucrose.
Regarding claims 14 and 15, as explained above, the use of citric acid is obviated by Van Bokkelen and Bell.
Regarding claim 16, Tran teaches preserving agents may be added such as sodium benzoate [0025]. Moreover, Bell teaches the addition of sodium benzoate to the aqueous phase.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 and 9-16 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.
Applicant argues that evidence exists of unexpected results and points to Examples 1-16 and Comparative Examples 1-2. Specifically, applicant states that the pH of the aqueous phase is 4 maximum results in the reduced hydrodynamic diameters of 100nm to 122 nm. Schrader already teaches less than 150nm and less than 140nm [0019]. Tran also teaches the claimed particle range. Moreover, Bell discloses particles around 100nm (0.1 micron) in the chart on page 12 as does Bromley. The claims are to a product and the product of Schrader and Bell both indicate particle sizes that overlap or fall within the range claimed. As such, the argument with regard to unexpected results is not persuasive since the art meets the limitation said to be unexpected.
Moreover, the data provided in support of the unexpected results are not commensurate in scope with the claims. Applicant argues that when the pH of the aqueous phase is 4.0 maximum it results in the claimed hydrodynamic diameter and that unexpected results are compared to the closest prior art, not a combination of references. Here, the data in the specification is limited to nanoemulsions with co-solvents propylene glycol and glycerine, a single emulsifier of quillaja saponins, sugar syrup and citric acid. Claim 1 requires no citric acid or solvents, thus it is not clear that the alleged unexpected results would be obtained in a nanoemulsion without these materials present. No clear conclusion as to the alleged unexpected results can be reached since the claims are not commensurate with the data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/Primary Examiner, Art Unit 1793