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 .
Applicants' arguments, filed July 21, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Comments and Notes
Given the length nature of the list present in currently amended claim 1, amended claim 19 and new 22, it is respectfully suggested that semicolons be used between the various components of the core in particular. It might also be helpful to set the ingredients of the casing shell as a separate paragraph so that required individual items and those from which at least one is selected can be more readily discerned.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 1 – 3, 5 – 14 and 16 – 22 were 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. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 12, 2026 and those set forth herein.
While the amendments to claim 1 have resolved several issues identified in the Office Action mailed April 21, 2026, the claims remain indefinite for the reasons set forth below.
Applicants argue that alternative definitions of syrup other than those relating to general table use would be most appropriate in a nutraceutical delivery composition. Maltitol, identified in the specification as an example of a syrup ingredient is well known to be available in syrup form. There is accordingly no inconsistency between the specification and the ordinary meaning of syrup and no particular constriction is adopted by these remarks.
These arguments are unpersuasive. The disclosure as filed sets forth a specific definition of syrup at ¶ [0041] of the disclosure as filed that only references the sugar or sugar alcohol portion, which would appear to contradict all of the ordinary and customary meanings of a syrup being a liquid. As water is a separate required ingredient, solid sugar or sugar alcohols, comprising 55 – 85% of the composition in combination with a separate 10 – 20% water to form a solution that would meet the ordinary and customary definition of “syrup”. The question is whether aqueous solutions of a sugar or sugar alcohol fall within the scope of “syrup” as set defined in the disclosure as originally filed as the special definition makes no mention of water. This is an important distinction as the water present in the solution of sugar or sugar alcohol may or may not be included in the weight percent of syrup or the weight percent of the water required by the claims. The claims recite the composition of the core in terms of the final amounts and not in a product-by-process format that would make it clear that if 55 – 85% by weight of an aqueous solution of a s sugar or sugar alcohol was combined with something containing 10 – 20% water by weight of the final composition, the water in the syrup would not be included in the amount of water present in the claim. Therefore it is still not clear if syrup as defined in the specification must be the solid form of a sugar or sugar alcohol or can be syrups, which as stated by Applicants are well known forms of at least some sugars or sugar alcohols.
Claim 21 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 21 uses the phrase “the at least one of the core composition is selected from the group consisting of” followed by a short list of items. However, there is no antecedent basis for the at least one of the core composition. The core composition set forth in claim 1 requires syrup, water, stevia leaf extract, pectin and at least of one of a long list of alternative components but the introductory language to that list does not include the phrase “core composition”. It is not clear if claim 21 is only further limiting the items in the core that are not syrup, water, stevia leaf extract and pectin or possible completely defining the core composition to something other than the ingredients required by claim 1 given the lack of antecedent basis. Please clarify.
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.
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.
Claim(s) 1, 3, 5, 6 and 19 – 21 were rejected under 35 U.S.C. 103 as being unpatentable over Romanoschi et al. (US 11,154,495) in view of Stoll (US 2013/0309291) further in view of Kingtung (AU 2021100330). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 12, 2026 and those set forth herein.
Kingtung discloses the use of gamma-aminobutyric acid (GABA), which is recited in the Markush group of amended claim 1 and also the use of theanine, recited in new claim 21 and it would have been obvious to one of ordinary skill in the art to select these two active ingredients for compositions for the treatment of insomnia.
No arguments regarding Kingtung are presented for the Examiner to address herein.
Claim(s) 1 – 3, 5, 6 and 19 – 21 are rejected under 35 U.S.C. 103 as being unpatentable over Romanoschi et al. (US 11,154,495) in view of Stoll (US 2013/0309291) further in view of Kingtung (AU 2021100330) as applied to claims 1, 3, 5, 6 and 19 – 21 above, further in view of Gudjonson (CA 2979452).
Please see the April 21, 2026 Office Action for the discussion of the complete teachings of Romanoschi et al., Stoll and Kingtung.
The use of carnuba (carnauba) wax specifically is not disclosed.
Gudjonson discloses a gummy matrix derived from ingredients comprising a gelling agent, a sweetener and texturizing agent and one or more components derived from an alcoholic beverage (whole document, e.g., abstract). Suitable texturizing agents include edible waxes, a genus which includes carnauba wax (¶ [0037]). Suitable amounts of texturizing agent are 0.5 – 5 wt% (table 1, ¶ [0064]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use an edible wax such as carnauba wax in the gummy composition of Romanoschi et al., Stoll and Kingtung. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Romanoschi et al. discloses that waxes can be included and Gudjonson provides additional disclosure as to specific waxes and amounts of those agents that are suitable for use when preparing gummy matrixes. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. There is no evidence of record as the criticality of the specific materials selected and/or claimed amount of those ingredients.
No arguments regarding Gudjonson are presented for the Examiner to address herein.
Claim(s) 1, 3, 5, 6, 9 – 14 and 16 – 22 were rejected under 35 U.S.C. 103 as being unpatentable over Romanoschi et al. (US 11,154,495) in view of Stoll (US 2013/0309291) further in view of Moaseri (US 2023/0079480). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 12, 2026 and those set forth herein.
Moaseri discloses at least one ingredient recited in amended claim 1, amended claim 12 and new claim 22 such as Camellia sinensis.
Applicants traverse this rejection on the grounds that Moaseri never discloses or suggests any relationship between the amount of constituents now recited in claim 1 that are present in a long, undifferentiated list of candidates and any recognized result. A parameter must first be recognized as a results effective variable before determination of the optimum or workable ranges of that variable can be recognized as routine experimentation. A constituent being known in the art does not establish that the constituent was a known results effective variable for any particular property. Camellia sinensis is referenced as a source of saponins for an interface stabilizing agent, a formulation aid unrelated to any nutraceutical benefit. The passage in Moaseri relating to Camellia sinensis in a capacity resembling an active ingredient is present in a different passage not relied upon in the rejection.
These arguments are unpersuasive. There does not need to be an explicit teaching or suggestion that the amount of a particular ingredient is a results effective variable in order to render obvious optimization of the amount of that ingredient. A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton (MPEP 2141(II)(C). The amounts for the ingredients that form the oral, chewable dosage form impose limits on the amount of other ingredients that can be present in the formulation and one of ordinary skill can then work within those limits set by those ingredients for the optimal amount of the remaining ingredients. For example, the description “interface stabilizing agent” provides a function, stabilization of the interface, that can form the basis for optimization of the amount of the ingredient such as Camellia sinensis that is associated with the function even though it is not explicitly described as a results effective parameter. The rationale used in an obviousness rejection need not be the same as Applicants (see MPEP 2144(IV)) such as why an ingredient like Camellia sinensis is added to a formulation. Applicants have not provided evidence that amounts of this ingredient that perform the function of interface stabilization do not at least overlap with the range recited in the instant claims.
Claim(s) 7, 8, and 18 were rejected under 35 U.S.C. 103 as being unpatentable over Romanoschi et al., Stoll and Moaseri as applied to claims 1, 3, 5, 6, 9 – 14 and 16 – 22 above, and further in view of Holzer et al. (US 11,730,715). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 12, 2026 and those set forth herein.
In addition to the teachings of Holzer et al. disclosed in the April 12, 2026 Office Action, Holzer et al. also discloses magnesium glycinate as an active ingredient (col 2, ln 44 – 45; that can be included in the disclosed consumable composition, the additional ingredient required by amended claim 7. About 75 mg to about 150 mg magnesium glycinate is disclosed as a suitable amount in some embodiments (col 3, ln 30 – 37). It would have been obvious to one of ordinary skill in the art to select magnesium glycinate in view of the disclosure of Holzer et al. that such an ingredient can be present in the disclosed consumable products.
Regarding Holzer, Applicants argue that Alpinia galanga is not among the constituents recited in claim 1.
These arguments are unpersuasive. Holzer et al. is used to teach the Alpinia galanga required in dependent claims and the teachings of the other applied references render obvious the subject matter of claim 1 as discussed in the Office Action mailed April 12, 2026 and herein.
Claim(s) 1 - 3, 5, 6, 9 – 14 and 16 – 22 are rejected under 35 U.S.C. 103 as being unpatentable over Romanoschi et al. (US 11,154,495) in view of Stoll (US 2013/0309291) further in view of Moaseri (US 2023/0079480) as applied to claims 1, 3, 5, 6, 9 – 14 and 16 – 22, further in view of Gudjonson (CA 2979452)
Please see the April 21, 2026 Office Action for the discussion of the complete teachings of Romanoschi et al., Stoll and Moaseri.
The use of carnuba (carnauba) wax specifically is not disclosed.
Gudjonson is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use an edible wax such as carnauba wax in the gummy composition of Romanoschi et al., Stoll and Moaseri. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Romanoschi et al. discloses that waxes can be included and Gudjonson provides additional disclosure as to specific waxes and amounts of those agents that are suitable for use when preparing gummy matrixes. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. There is no evidence of record as the criticality of the specific materials selected and/or claimed amount of those ingredients.
No arguments regarding Gudjonson are presented for the Examiner to address herein.
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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