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.
Election/Restrictions
Claims 1-11, 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 25 November 2025.
Applicant's election with traverse of Group II (claims 12-15) in the reply filed on 25 November 2025 is acknowledged. The traversal is on the ground(s) that Yusuf does not teach the special technical feature and teaches away from using a filling comprising a bulking agent. This is not found persuasive because Yusuf teaches a liquid center filled gummy comprising a gelatin shell (abs), an active ingredient, such as vitamin c (para. 49), which is an active ingredient according to pg. 10 of the instant specification. The filling material may include maltodextrins (para. 46), which is a bulking agent according to pg. 5 of the instant specification and an optional ingredient according to the instant claims.
The requirement is still deemed proper and is therefore made FINAL.
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 13-15, 18, 19 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.
Regarding claims 14 and 15, the word "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 13, 18, and 19, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 14 and 15 recite “described by the GME” or “according to GME.” It is unclear what GME is and the metes and scopes of the limitation cannot be determined from the lack of clarity.
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) 12-15, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yusuf et al. (US 2005/0260329 A1), as evidenced by kimherringe.com.au and Yunoki et al. (Accurate and Precise Viscosity Measurements of Gelatin Solutions Using a Rotational Rheometer, Food Science and Technology Research, 2019).
Yusuf teaches a liquid center filled gummy comprising a gelatin shell (abs; entire teaching). The filling material may be made with maltodextrins (para. 46; bulking agent according to pg. 5 of the instant specification) and vitamin c (para. 49; active ingredient according to pg. 10 of the instant specification), addressing claims 12, 13 and 17-20. The gummy composition is interpreted as seamless because it is able to prevent leakage or bleeding out (abs). Additionally, Yusuf teaches co-deposition of the filling and shell (para. 21), which is a similar method of processing described in the instant specification as a single (“one-shot”) step of deposition in order to prevent leakage and result in a seamless center-filled gummy (pg. 2, lns. 11-14; pg. 2, lns. 25-27). The gelatin may have a bloom range from 200-300 (para. 46), such as 250 bloom (para. 79), which describes the strength of the gelatin (evidenced by kimherringe.com.au), addressing claim 14. The gelatin shell may be filled 2.5% or more and the liquid filling component may be filled at least 10% (para. 25). Temperature of the shell may range from 160-220°F (para. 18) and the temperature of the filling component may be less than or equal to 120°F (para. 21). Manufacturing humidity may be about 30% humidity (para. 107). The viscosity of the filling component may be about 1.31 poise at 85°C (para. 103). However, a low viscosity during deposition is desirable (para. 14), where a low viscosity of gelatin is defined as 1-20 mPa.s (as evidenced by Yunoki, pg. 20).
Yusuf does not specifically teach an exact combination of gelatin, vitamin c, and maltodextrin in claim 13 or a viscosity of at least 1 mPa.s in claim 15.
In regards to selecting the combination of gelatin, maltodextrin, and vitamin c, “[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.”
Yusuf teaches a liquid center filled gummy comprising a gelatin shell, with maltodextrins and vitamin c filling components, 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 Yusuf 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.
In regards to the gelatin strength and viscosity conditions presented in claims 14 and 15, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, it would be obvious to adjust the gelatin strength and viscosity conditions to improve or maintain a stable composition for the intended purpose, e.g. for consumption or as a dietary supplement, food ingredient or additive, a medical food or a nutraceutical.
Conclusion
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