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 .
Priority
The instant application was filed 09 March 2023 and is the national stage entry of PCT/EP2021/080074 filed 29 October 2021. The Applicant claims priority to foreign documents, EP 20208906.6 and EP20204891.4, filed 20 November 2020 and 30 October 2020. English-translated copies of the documents have been provided. Therefore, the effective filing date of the instant application is 30 October 2020.
Examiner’s Note
The Applicant's amendments and arguments filed 04 May 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 04 May 2026, it is noted that claim 13-15 and 20 have been amended and claims 21-24 have been newly added. Support for the amendments and new claims can be found on at least pg. 5 of the specification. No new matter has been added. Claims 25-27 are herein withdrawn due to being drawn to a nonelected invention.
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.
Claim 23 is 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.
Claim 23 recites “insulin” as a soluble fiber. Insulin is not known in the art as a soluble fiber. The metes and the bounds of the limitation cannot be determined. “Insulin” in claim 23 is herein interpreted as “inulin.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 12, 13, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 2012/0035277 A1).
Regarding claims 12 and 13, Davis teaches a center-filled chewable gummy (abs, entire teaching) with an outer shell (para. 10). In some embodiments, the composition is a soft gelatin shell with a liquid or semisolid filled center (para. 45). The composition includes a delivery vehicle, which may comprise an active ingredient, such as vitamins (abs). the delivery vehicle may also include gelatin (para. 23), which is interpreted as addressing a second gelatin product within the filling, as Davis teaches an embodiment where the center may be semisolid. Davis describes various deposition methods, such as a dual or single deposit process (paras. 55, 58), which is interpreted as preventing leakage and resulting in a seamless center-filled gummy (pg. 2, lns. 11-14; pg. 2, lns. 25-26 of instant specification).
Regarding claim 20, Davis teaches vitamins as an active ingredient in their center-filled chewable gummy (abs).
Regarding claim 21, soluble and insoluble fiber may be included in the gummy composition (abs).
Regarding claim 22, the gummy candy may include fractionated coconut oil (para. 11).
Davis does not teach an exact combination of a gelatinous shell and a filling comprising an active ingredient and second gelatin product in claim 13.
In regards to selecting the combination of a gelatinous shell and a filling comprising an active ingredient and second gelatin product, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Davis teaches a center-filled chewable gummy comprising vitamins and an outer shell, whereas the claimed invention is directed towards a seamless center filled gummy comprising a gelatinous shell and a filling with an active ingredient and another optional ingredient. Since Davis teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 2012/0035277 A1) as applied to claims 12, 13, and 20-22 above, in view of banagelatin.com.
In regards to claim(s) 12, 13, and 20-22, Davis, as applied supra, is herein applied in its entirety for its teachings of a center-filled chewable gummy comprising vitamins and an outer shell.
Davis does not teach a gel strength or a viscosity in claims 14 and 15.
Banagelatin.com teaches examples of gelatin strength and viscosity for edible gelatin products. For example, candy may have a gel strength of 140-160 g Bloom or 170-190 g Bloom and a viscosity of 25-35 mPs (2.5-3.5 mPa.s) or 28-38 mPs (2.8-3.8 mPa.s) for candy (pg. 3). Jelly or marshmallows may have a gel strength of 190-210 g Bloom or 240-260 g Bloom and a viscosity of 28-38 mPs (2.8-3.8 mPa.s) or 30-40 mPs (3.0-4.0 mPa.s) (pg. 3).
Since Davis does not teach a gel strength or a viscosity in claims 14 and 15, one of ordinary skill in the art would have been motivated to use banagelatin.com’s teaching of gel strength and viscosity for edible gelatin products. Banagelatin.com’s gelatin strengths and viscosities are interpreted as a general range and therefore addresses the conditions specified by the Gelatin Manufacturers of Europe, as recited in claims 14 and 15. A skilled artisan would have been led to combine the teachings, as banagelatin.com teaches general gelatin strengths and viscosities for edible gelatin products, and Davis teaches a gummy product comprising gelatin. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 2012/0035277 A1) in view of banagelatin.com, as applied to claims 12-25 and 20-22 above, and further in view of Ervin (US 2011/0313055 A1).
In regards to claim(s) 12-15 and 20-22, Davis and banagelatin.com, as applied supra, is herein applied in its entirety for its teachings of a center-filled chewable gummy comprising vitamins and an outer shell.
Davis does not teach inulin in their composition in claim 23.
Ervin teaches a flavored chewy or gummy candy (abs) that may include inulin as a beneficial dietary fiber component, which helps to improve texture and mouth feel and provide positive health attributes (para. 17).
Since Davis does not teach inulin in their composition in claim 23, one of ordinary skill in the art would have been led to use Ervin’s teaching of using inulin as a fiber source with a reasonable expectation of success. A skilled artisan would have been motivated to combine the teachings, as inulin would improve the texture and mouthfeel and provide health benefits, which would enhance the gummy composition taught by Davis. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 2012/0035277 A1) in view of banagelatin.com and Ervin (US 2011/0313055 A1), as applied to claims 12-25 and 20-23 above, and further in view of ulprospector.com.
In regards to claim(s) 12-15 and 20-23, Davis, banagelatin.com, and Ervin, as applied supra, is herein applied in its entirety for its teachings of a center-filled chewable gummy comprising vitamins and an outer shell.
Davis does not teach maltodextrin in their composition in claim 24.
Ulprospector.com teaches that maltodextrin can increase the viscosity, prevent crystallization and melting, reduce sweetness, change taste, and prolong the shelf life of candies (pg. 1).
Since Davis does not teach maltodextrin in their composition in claim 24, one of ordinary skill in the art would have been led to use ulprospector.com’s teaching of using maltodextrin to increase the viscosity, prevent crystallization and melting, reduce sweetness, change taste, and prolong the shelf life of candies with a reasonable expectation of success. A skilled artisan would have been motivated to combine the teachings to improve the viscosity and shelf life of Davis’ gummy candy composition. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Response to Arguments
Applicant's arguments filed 04 May 2026 have been fully considered but they are not persuasive.
The teachings of Yusuf, Kim, and Yunoki have been removed as prior art, in response to Applicant’s amendments. Therefore, the arguments against Yusuf, Kim, and Yunoki will not be addressed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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