DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 12/02/2025 has been entered. Claims 1-23 are cancelled. Claims 24-43 are pending in this application. Claims 39-43 are withdrawn. Claims 24-38 are currently under examination.
Priority
This application is a 371 of PCT/NL2021/050218 filed on 04/02/2021 and claims foreign priority of NETHERLANDS 2025263 filed on 04/02/2020 and NETHERLANDS 2025261 filed on 04/02/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. NETHERLANDS 2025263 or NETHERLANDS 2025261, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 25, 31, and 32 recite “at least 120 degrees Celsius”, “antimicrobial preservatives”, and/or “pH value between 3.7 and 3.9”, which are not disclosed or supported by the prior-filed Application No. NETHERLANDS 2025263 or NETHERLANDS 2025261. Thus, the priority date of claims 25, 31, and 32 is 04/02/2021.
Withdrawn Claim Objections/Rejections
The objection of claims 24, 27, 28, and 38 because of incorrect recitation, as set forth on page 3 of the Non-Final Rejection mailed on 09/02/2025, is withdrawn in view of amended claims.
The rejection of claims 24-38 under 35 U.S.C. 112(b), as set forth on pages 4 to 5 of the Non-Final Rejection mailed on 09/02/2025, is withdrawn in view of amended claims 24, 28, 30-33, 37, and 38. Claims 25-27, 29, and 34-36 depend from claim 24.
New (necessitated by amendment)/Claim Rejections - 35 USC § 102/103
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.
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 nonobviousness.
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.
(I) Claims 24, 26, 28, 31-35, 37, and 38 are or remain rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Krnic et al. (US 8,895,093, Nov. 25, 2014, hereinafter referred to as Krnic ‘093) as evidenced by Südzucker (Invert Sugar Syrup 72,7/67, Südzucker AG, March 2024), Siejak et al. (Sustainability 16, 5877, 2024, p. 1-12, hereinafter referred to as Siejak ‘2024), and Necas et al. (Veterinarni Medicina, 58(4): 187–205, 2013, hereinafter referred to as Necas ‘2013).
With regard to structural limitations “method comprising the subsequent steps of: a) providing an aqueous glucose solution (or free of antimicrobial preservatives) comprising at least 20% by weight of glucose; b) adding at least one first fraction of citric acid (or between 0.8 and 1.3% by weight) such that said solution reaches a pH value in a range between 3.5 and 4.1 (or between 3.7 and 3.9; or at least one buffer solution, comprising trisodium citrate, is added); c) adding at least one gelling agent (or between 1.5 and 2.5% by weight) and mixing the solution and gelling agent such that a gel composition having a viscosity in the range of 1000 to 5000 mPa*s (or 1800 to 3000 mPa*s) is obtained; d) providing at least one container, and filling said container with at least one fraction of the gel composition; and e) conducting at least one thermal sterilization step to said filled container, wherein the temperature during at least part of the thermal sterilization step is at least 100 degrees Celsius (or carried out at a pressure between 1.05 bar and 5 bar; or followed by a cooling step wherein a supporting pressure is applied at least temporarily)” (claims 24, 26, 28, 31-35, 37, and 38):
Krnic ‘093 disclosed formulations for the liquid jelly confectionery material. Example No. 13 , 14:
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. Where pectin is the hydrocolloid gelling agent, then this is mixed in the required amount with sugar, water and acid, and other ingredients are added in the required quantities following cooking of this preliminary pectin solution. Where acid addition is referred to, the acid composition is selected from the range of acids referred to in Table 3, at the % level indicated in Table 1.
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(page 35/44, Table 1; page 29/44, col. 11, lines 17-20; page 41/44, col. 36, lines 34-36 and Table 3). Südzucker (cited here as evidence only) indicates viscosity of invert sugar (20 °C): 500 mPas ± 60 mPas (page 3 of 4). Siejak ‘2024 (cited here as evidence only) disclosed results of pectin viscosity (Pa*S) measurements:
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(page 6 of 12, Table 3). Necas ‘2013 (cited here as evidence only) disclosed viscosity of food-grade carrageenan defined as not less than 5 cps at 75 °C for a 1.5% solution; viscosity ranges from 5 to 800 cps for 1.5% solution at 75 °C (page 188, Table 1).
Thus, these teachings of Krnic ‘093 as evidenced by Südzucker, Siejak ‘2024, and Necas ‘2013 anticipate Applicant’s claims 24, 26, 28, 31-35, 37, and 38 because (a) the acid solution ID# A, H, I, or J provides pH of 3.1 to 4.0 based on pKa1= 3.13 of citric acid and at least 1.5-fold weight ratio over the sodium citrate, (b) the combination of viscosities from 4.52% invert sugar, 1.04% pectin, and 0.32% carrageenan (or 0.43% pectin + 1.90% carrageenan) is from 1100 to 1900 mPa*s, and (c) both cooking and depositing (lower than cooking) temperatures in the tank or container are higher than 100° C that require air pressure of higher than ambient 1.1 bar to achieve; or in the alternative, the pH and viscosity are readily optimized.
Applicant’s Arguments/Remarks filed on 12/02/2025 have been fully considered. Applicant argued “Krnic does not disclose method step e) of sterilizing the container. Furthermore, Krnic does not disclose a sequence of five steps where citric acid is added in an intermediate step b) which precedes step c) of adding gelling agent into order to achieve a certain viscosity… the current claims are directed to a gel composition suitable for direct oral application to a patient, specifically a child… other cited references Sudzucker, Siejak, and Necas do not make up for the deficiencies in Krnic since they are only directed to the viscosity of various solutions” (p. 10, last para.; p. 11, para. 1 and 2).
In response, these arguments are found not persuasive because of the following reasons. First, the sterilizing is not specifically defined and would encompasses the at least 100° C cooking and/or depositing step(s) of Krnic ‘093. Second, the claimed method is very broad, which does not require sequential a), b), and c) steps. Also, steps a), b), and c) are adding required components and there is no evidence that change in the step sequence would alter the structure of the composition. Third, the liquid jelly confectionery material of Krnic ‘093 is suitable for direct oral application to a patient, specifically a child. Lastly, the Sudzucker, Siejak, and Necas references are provided as evidence here. Alternatively, the pH and viscosity are readily optimized; and thus, in response to applicant's argument that Sudzucker, Siejak, and Necas do not make up for the deficiencies, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). To overcome this 102/103 rejection, Applicant is advised to incorporate additional limitation that is not taught by the reference(s). Any amendment after Final may not be entered if new issue arises and/or extensive search is needed.
(II) Claims 24-38 remain rejected under 35 U.S.C. 103 as being unpatentable over Ishimoto et al. (US 2007/0092625, Apr. 26, 2007, hereinafter referred to as Ishimoto ‘625) in view of Kershaw et al. (WO 2018/065608, April 12, 2018, hereinafter referred to as Kershaw ‘608) and Emoto et al. (EP 1046 347, hereinafter referred to as Emoto ‘347, cited in previous Office Action).
With regard to structural limitations “method comprising the subsequent steps of: a) providing an aqueous glucose solution (or free of antimicrobial preservatives) comprising at least 20% (or at least 60%) by weight of glucose (defined as “any monosaccharide suitable for oral consumption”, in the specification); b) adding at least one first fraction of citric acid (or between 0.8 and 1.3% by weight) such that said solution reaches a pH value in a range between 3.5 and 4.1 (or between 3.7 and 3.9; or at least one buffer solution, comprising trisodium citrate, is added); c) adding at least one gelling agent (or between 1.5 and 2.5% by weight) and mixing the solution and gelling agent such that a gel composition having a viscosity in the range of 1000 to 5000 mPa*s (or 1800 to 3000 mPa*s) is obtained; d) providing at least one container, and filling said container (or a single serve container) with at least one fraction of the gel composition; and e) conducting at least one thermal sterilization step to said filled container, wherein the temperature during at least part of the thermal sterilization step is at least 100 degrees Celsius (or at least 120 degrees Celsius; or carried out at a pressure between 1.05 bar and 5 bar or a second pressure higher than a first pressure; or followed by a cooling step wherein a supporting pressure is applied at least temporarily)” (claims 24, 26, 28, 30-35, 37, and 38):
Ishimoto ‘625 disclosed Beverage (Water-Soluble Soybean Polysaccharide): An aqueous solution containing 3% of a commercially available milk whey protein isolate, 13% of fructose-glucose liquid Sugar and 1.5% of water-soluble Soybean polysaccharide was adjusted to pH 3.5 with citric acid, and heat-sterilized in boiling water for 10 minutes to prepare an acidic protein beverage. Ice Cream (Water-Soluble Soybean Polysaccharide): Ten parts of T prepared in Preparation Example 2, 0.2 parts of water-soluble soybean polysaccharide, 120 parts of a concentrated orange juice (cloudy type), 180 parts of granulated Sugar and 50 parts of glucose were mixed, and added to the mixture of 100 parts of coconut oil and 540 parts of water which had been melted by warming to 60°C. The mixture was heated to 70° C., and dissolved with stirring for 15 minutes. Then, the solution was homogenized with a homogenizer at pressure of 100 kg/cm, and heated with a UHT plate sterilizer at 120° C for 15 seconds. The sterilized mixture was cooled to 5°C, and aged for 20 hours in a refrigerator to obtain an ice cream mix. Jelly Beverage (Water-Soluble Soybean Polysaccharide) is packed in a Cheer Pack, a flexible container with a cap having a straw-like spout, to prepare a jelly beverage containing acidic protein. The beverage was pH 3.5 (page 7/7, [0073, 0074, and 0079-0082]).
Ishimoto ‘625 did not explicitly disclose the limitations (a) “at least 20% (or at least 60%) by weight of glucose”, “a gel composition having a viscosity in the range of 1000 to 5000 mPa*s (or 1800 to 3000 mPa*s)”, and “the gelling agent comprises hydroxyethyl cellulose”, and (b) “a pH value in a range between 3.7 and 3.9 (or at least one buffer solution, comprising trisodium citrate, is added)”, required by claims 24, 32, and 35-37.
With regard to the limitation (a) above, Kershaw ‘608 disclosed a desire to provide improved compositions which provide some of the antimicrobial benefits provided by honey. Preferably, the composition comprises at least two sugars or sugar derivatives (e.g. including glucose and fructose). An example of a suitable buffer is a citric acid/NaOH buffer, such as a 50 mMol citric acid/NaOH buffer. Compositions may be buffered at a pH of 5 or less, e.g. 3 to 5 (such as about pH 4). Compositions may comprise thickening or gelling agents that increase the viscosity of a liquid without substantially changing its other properties. Suitable gelling or thickening agents include hydroxyethyl-cellulose or hydrocolloids. If a greater viscosity is desired, glycerol (= 1412 mPa.s) may be preferred. Heat-set gels require the application of heat to gel (for example, curdian, konjac glucomannan, methyl cellulose, starch and globular proteins). Synthetic Honey Compositions (pH 4.03 buffered samples):
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(page 2/129, lines 34 to 35; 14/129, lines 10-22; page 17/129, lines 23-25; page 22/129, lines 2-10; page 34/129, lines 30-33; page 75/129, lines 20-35).
With regard to the limitation (b) above, Emoto ‘347 disclosed a gelatinous food product for supplying balanced nutrition, which has a pH of 3.3 to 4. Example 1: citric acid as organic acid, sucrose and dextrin as saccharide, and casein and lactalbumin as protein were added to water preheated to 70°C. The mixture was stirred in a homogenizer at 9000 rpm for 5 minutes. To the resulting liquid were added refined rice oil as lipid and enzyme-decomposed lecithin as emulsifying agent. The mixture was emulsified (10000 rpm, 20 minutes) and adjusted to pH 3.9 by addition of sodium citrate as organic acid salt (pH adjusting and buffering agent). Example 5: malic acid as organic acid, glucose and lactosucrose as saccharide, and soybean protein (powder) and whey protein concentrate (powder) as protein were added to water. The emulsion was adjusted to pH 3.7. To the resulting emulsion were added gelatin and guar gum as gelling agent. The obtained emulsion was filled into a soft bag having a nozzle (page 3/14, [0013]; page 6/14, [0045 and 0046]; page 9/14, [0064-0067]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the generic amount of glucose/fructose with gelling agent and citric/NaOH buffer as taught by Ishimoto ‘625 with at least 30% by weight of glucose/fructose with hydroxyethyl cellulose in view of Kershaw ‘608 and citric acid/sodium citrate buffer in view of Emoto ‘347, respectively, to prepare a jelly beverage containing acidic protein because (a) at least 60% by weight of glucose/fructose has antimicrobial activity and hydroxyethyl cellulose increase the viscosity of a liquid without substantially changing its other properties, and (b) citric acid/sodium citrate buffer to provide pH 3 to 4 is commonly used in food product, described above. Thus, one of skill in the art would have a reasonable expectation that by substituting substitute the generic amount of glucose/fructose with gelling agent and citric/NaOH buffer as taught by Ishimoto ‘625 with at least 60% by weight of glucose/fructose with hydroxyethyl cellulose in view of Kershaw ‘608 and citric acid/sodium citrate buffer in view of Emoto ‘347, respectively, to prepare a jelly beverage containing acidic protein, one would achieve Applicant’s claims 24-38, and would also achieve the property “a viscosity in the range of 1000 to 5000 mPa*s (or 1800 to 3000 mPa*s)”. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I].
Applicant’s Arguments/Remarks filed on 12/02/2025 have been fully considered. Applicant argued “The citric acid in Ishimoto is used to change the flavor profile of the food only. Ishimoto does not in any way teach or describe using citric acid to adjust the pH of the solution… the Kershaw reference is not merely directed to a glucose solution… the current claims recite a sterilizing step to sterilize the solution itself and not to provide a sterilizing effect to someone who ingests the solution… The Emoto reference, like the Ishimoto reference, discloses changing pH to enhance the flavor of the supplement to be provided to a person” (p. 13, para. 1 and 3; p. 14, para. 1 and 2).
In response, these arguments are found not persuasive because of the following reasons. First, in response to applicant's argument that the references does not in any way teach or describe using citric acid to adjust the pH of the solution, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Second, the sterilizing is not specifically defined and would encompasses the heat-sterilized in boiling water of Ishimoto ‘625. Lastly, in response to applicant's argument that Kershaw reference is not merely directed to a glucose solution, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). To overcome this 103 rejection, Applicant is advised to incorporate additional limitation that is not taught or suggested by the references. Any amendment after Final may not be entered if new issue arises and/or extensive search is needed.
Conclusion
No claims are allowed.
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.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691