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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 8/4/2026 wherein claims 1, 2, 10-12, and 19 were amended; claims 3-9, 17, and 20 were canceled; and claims 21-28 were added.
Note(s): Claims 1, 2, 10-16, 18, 19, and 21-28 are pending.
Priority
This application claims benefit to PRO 63/743,025 filed 1/8/2025.
Note(s): The earliest effective filing date is the actual filing date of the application. Specifically, Applicant is not entitled to the filing date of the provisional application because the pending invention is not fully disclosed within the document. If Applicant disagrees with the Examiner, it is respectfully requested that one point to page and line (or paragraph) numbers wherein support may be found for the pending invention.
Claim Interpretation
Independent claim 1 is directed to a chewable composition comprising (1) calcium carbonate in an amount of from about 10% to about 20% by weight; (2) carrageenan in an amount from about 0.5% to about 2.5% by weight; (3) a bulk matrix comprising a reducing sugar and a non-reducing sugar present in the chewable composition in an amount from about 65% to about 80% by weight, wherein the bulk matrix composition includes grained particles; and (4) water wherein the chewable composition has a dissolvability of greater than 10, a rubberiness between 1 and 3, a toothpull of less than 2.5, a hardness of less than 10,000 g, and a cohesion between 0.05 and 0.3.
Claim 19 is directed to a composition for oral administration comprising (1) calcium carbonate present in an amount from about 10% to about 20% by weight; (2) carrageenan present in an amount from about 0.5% to about 2.5% by weight; (3) a bulk matrix present in an amount from about 65% to about 80% by weight wherein the bulk matrix includes a non-reducing sugar and a reducing sugar, and wherein the bulk matrix composition includes grained particles; and (4) water wherein the composition has a dissolvability of greater than 10, a rubberiness between 1 and 3, a toothpull of less than 2.5, a hardness of less than 10,000 g, and a cohesion between 0.05 and 0.3 and wherein the mass ratio of the non-reducing sugar to the reducing sugar ranges from 85:15 to 60:40.
Applicant’s Election
Applicant elected the species wherein the primary ingredient is an active pharmaceutical ingredient that is calcium carbonate (an antiacid); the hydrocolloid is carrageenan; the bulk matrix is a combination of glucose (a reducing sugar) and sucrose (a non-reducing sugar); and an additional agent, a sweetener is present. Pending claims 1, 2, 10-12, 16, 18, 19, and 21-28 read on the elected species.
Note(s): The search was not extended beyond the elected species because prior art was found which could be used to reject the claims.
Withdrawn Claims
Claims 13-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species.
Information Disclosure Statement
The two information disclosure statements filed on 7/9/2026 were considered.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 8/4/2026 to the rejection of claims 1-12 and 16-19 made by the Examiner under 35 USC 103 and/or 112 have been fully considered and deemed persuasive-in-part for the reasons of record and those set forth below.
112 Second Paragraph Rejections
All outstanding 112 second paragraph rejections are WITHDRAWN because Applicant amended the claims to overcome the rejections.
103 Rejection
Note(s): The 13 rejection is modified to adjust to the amended claims.
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.
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.
Claims 1, 2, 10-12, 16, 18, 19, and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kabse et al (US 2015/0201644) in view of Pirsa et al (Food Chemistry, 2023, Food Chemistry, Vol. 399, No. 133967, pages 1-14).
Independent claim 1 is directed to a chewable composition comprising (1) calcium carbonate that is present in an amount from about 10% to about 20% by weight; (2) carrageenan is present in an amount from about 0.5% to about 2.5% by weight; (3) a bulk matrix present in an amount from about 65% to about 80% by weight, wherein the bulk matrix composition includes grained particles; and (4) water wherein the composition has a dissolvability of greater than 10, a rubberiness between 1 and 3, a toothpull of less than 2.5, a hardness of less than 10,000 g, and a cohesion between 0.05 and 0.3 and wherein the mass ratio of the non-reducing sugar to the reducing sugar ranges from 85:15 to 60:40.
Claim 2 is directed to the chewable composition of claim 1, wherein the calcium carbonate, carrageenan, the bulk matrix, and water are uniformly distributed in the chewable composition.
Claim 11 is directed to the chewable composition of claim 9, wherein the reducing sugar is selected from the group consisting of glucose, fructose, galactose, psicose, isomaltulose, tagatose, trehalose, and any combination thereof.
Claim 12 is directed to the chewable composition of claim 1, wherein the non-reducing sugar is selected from the group consisting of sucrose, maltose, trehalose, sorbose, raffinose, and any combination thereof.
Claim 16 is directed to the chewable composition of claim 1, further comprising an emulsifier, a solubilizing agent, a buffering agent, a stabilizing agent, a colorant, a sweetener, a preservative, a flavoring agent, a surfactant, or any combination thereof.
Claim 21 is directed to the non-reducing sugar being sucrose.
Claim 23 is directed to a composition pH of about 7.5 to about 9.5.
Claim 24 is directed to a composition pH of about 8 to about 9.
Claim 25 is directed to the calcium carbonate being present in an amount of about 10% to about 15% by weight.
Claim 26 is directed to a mass ration of non-reducing sugar to reducing sugar ranging from 85:15 to 60:40.
Claim 27 is directed to the carrageen being kappa carrageenan.
Kabse et al is directed to chewing gum compositions comprising chewy cooked candy ingredients (see entire document, especially, abstract). One embodiment of Kabse et al comprises a chewing gum composition that includes a gum base and a chewy cooked candy comprising (1) a saccharide, sugar alcohol, or a combination thereof (one may have both a saccharide and sugar alcohol present), (2) a flavorant, (3) an emulsifier, (4) a fat, (5) a hydrocolloid, and optionally (6) a fondant, food acid or salt thereof, a sweetener, a sensate, or a combination thereof (page 1, paragraph [0004]).
Note(s): It should be noted that the saccharide and sugar alcohol components of Kabse et al are equivalent to Applicant’s bulking matrix. In addition, the gum base component of Kabse et al is equivalent to Applicant’s active pharmaceutical ingredient.
The chewy cooked candy may be fully amorphous, predominantly amorphous (for example, partially grained), but not fully grained (page 1, paragraph [0011]). Suitable saccharides for the chewy cooked candy include sucrose and glucose which are both components of Applicant’s elected species. But more importantly, Kabse et al disclose that one may have a combination of saccharides; hence, both sucrose and glucose may be present (page 2, paragraph [0015]; page 13, claim 7). In addition, other suitable bulking agents (sugars and sugar alcohols) that may be utilized include galactose, fructose, isomaltulose, tagatose, and trehalose among many others (page 2 (paragraphs [0015] – [0016]; page 5, paragraph [0042; page 13, claims 6 and 7]). The compositions of Kabse et al may comprise flavorants (page 2, paragraph [0024]).
The chewy cooked candy composition may also contain a hydrocolloid. Possible hydrocolloid materials include gums and starch such as pectin, gum Arabic, agar, carrageenan (Applicant’s elected hydrocolloid), guar gum, locust bean gum, gelatin, and konjac (page 3, paragraph [0033]). The composition may also contain coloring agents (pages 5-6, paragraph [0051]).
The sweetener (bulking agent) comprising a saccharide, a sugar alcohol, or a combination thereof present in the chewy cooked candy is about 30 to about 95 wt% based on the total weight of the chewy cooked candy (page 2, paragraph [0018]). The cooked candy generally comprises a flavorant in an amount of about 0.01 to about 20 wt% based on the total weight of the cooked candy (page 2, paragraph [0027]). The hydrocolloid is present in an amount of about 0.01 to about 10 wt% based on the total weight of the cooked candy (page 3, paragraph [0034]). The mineral adjuvant may be present in an amount greater than about 0 to about 60 wt% based on the total weight of the gum base (page 8, paragraph [0087]).
The mixing of the composition may be continued until a uniform or homogeneous mixture of the chewing gum is obtained (page 9, paragraph [0094]). The chewing gum characteristics are dependent upon the hardness of the coating (pages 9-10, paragraph [0103]).
In Table 1 (page 12), a composition is disclosed that comprises a hydrocolloid (gum base, gelatin), a bulking matrix (e.g., sugar alcohol), water, and sweetener. The gum base may include effective amounts of substances such as mineral adjuvants which can serve as fillers and textural agents. Suitable mineral adjuvants include calcium carbonate (Applicant’s elected active pharmaceutical ingredient component), magnesium carbonate, alumina, aluminum hydroxide, aluminum silicate, talc, and tricalcium phosphate. This component may be present in an amount of about 0 to about 60 wt% (page 8, paragraph [0087]). It would have been obvious to the skilled artisan to incorporate the hydrocolloid compound (e.g., calcium carbonate) as not only is the majority of the gum base but has textures which alter the characteristics of the overall chewable composition. Furthermore, as evidenced by Pirsa et al hydrocolloids use in the food industry is well known. Specifically, hydrocolloids influence the viscosity of products as they act as thickeners, gelling agents, emulsion stabilizers, inhibit the growth of sugar crystals, and improve the rheological and textural properties of food (see entire document, especially, abstract, page ‘Introduction’; pages 3-4, bridging paragraph; page 4, Figure 1; pages 7-8, bridging paragraph). Thus, generating a product wherein the rubberiness, dissolvability, hardness, and cohesion (e.g., Fast Melt) of the chewing product may be adjusted depending on the desired chewable product of interest.
Claim 10 is directed to the chewable composition of claim 1 wherein the mass ratio of the non- reducing sugar to the reducing sugar ranges from 90:10 to 30:70.
Claim 19 is directed to a composition for oral administration comprising (1) calcium carbonate present in an amount from about 10% to about 20% by weight; (2) carrageenan present in an amount from about 0.5% to about 2.5% by weight; (3) a bulk matrix present in an amount from about 65% to about 80% by weight wherein the bulk matrix includes a non-reducing sugar and a reducing sugar, and wherein the bulk matrix composition includes grained particles; and (4) water wherein the composition has a dissolvability of greater than 10, a rubberiness between 1 and 3, a toothpull of less than 2.5, a hardness of less than 10,000 g, and a cohesion between 0.05 and 0.3 and wherein the mass ratio of the non-reducing sugar to the reducing sugar ranges from 85:15 to 60:40.
Claim 22 is directed to the non-reducing sugar being sucrose.
Claim 27 is directed to the carrageen being kappa carrageenan.
In regard to the ratio of reducing sugar and non-reducing sugar component (saccharide and sugar alcohol) appearing in claims 10 and 19, the following is noted. Kabse et al disclose that one may have both components present (page 1, paragraph [0004]; page 2, paragraph [0015]). In addition, Kabse et al disclose that the amount of saccharide and sugar alcohol present in the composition is about 30 to about 95 wt% based on the total weight of the composition (page 2, paragraph [0018]). Thus, it would have been obvious to the skilled artisan that if one has a combined reducing sugar and non-reducing sugar present and known the wt% of the recommended sugar content for the overall composition, then it would be obvious to the skilled artisan to optimize the ratio of the sugars to obtain the best overall sugar content for the desired final product. According to MPEP 2144.05, wherein 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. Kabse et al sets forth the wt% of the sugar content. Also, Kabse et al discloses that one may have a single or multiple sugars present. Hence, the skilled artisan recognizing the presence of multiple sugars would then realize that optimizing the sugars to obtain the best possible product would naturally occur. Thus, the limitations of determining the ratio of reducing to non-reducing sugars appearing in claims 10 and 19 would be obvious.
Claim 18 is directed to the chewable composition of claim 1, wherein the composition has a pH of at least 5.
In regard to the pH of claims 18, 23, and 24, while Kabse et al does not specifically discuss the pH of the composition, the skilled artisan would recognize that this is an obvious property of both Applicant’s and the prior art’s composition. Specifically, according to MPEP 2112.01, products of overlapping chemical compositions cannot have mutually exclusive properties. Thus, since a chemical composition and its properties are inseparable, if Applicant’s compositions has a particular property, that property would inherently be present for the composition of the prior art which contains overlapping composition components with that of the pending invention.
Also, it would have been obvious to a skilled artisan that ‘carrageenan’ encompasses specific type of carrageenan including ‘kappa carrageenan’. In Table 1 of Pirsa et al, it is disclosed that K-carrageenan may be used in formulations to improve characteristics of foods. In addition, Pirsa et al disclose that carrageenan, for example, plays an essential role in the food industry because of its ability to stabilize products, control water content, stabilize texture, or give the desired texture to products. Still, it is disclosed that carrageenan is well known in the pharmaceutical and cosmetics industries where it can be used as a thickener or film forming agent. It is set forth that three main types of carrageenan (one is kappa carrageenan) are ideal molecules. Thus, the limitation of claims 18, 23, and 24 would be rendered obvious by the cited prior art as well as being able to alter the characteristic of the composition.
Furthermore, in regard to the characteristics of the composition: a dissolvability of greater than 10, a rubberiness between 1 and 3, a toothpull of less than 2.5, a hardness of less than 10,000 g, and a cohesion between 0.05 and 0.3 and wherein the mass ratio of the non-reducing sugar to the reducing sugar ranges from 85:15 to 60:40, the following response is given. In Kabse et al, it is disclosed that the hardness or softness of the product may vary (pages 9-10, bridging paragraph). Thus, it would have been obvious to a skilled artisan prior to the effective date of the pending invention to adjust the characteristics (properties) of the final product depending upon the form (e.g., chewing gum, cookie, or so forth; pages 9-10, bridging paragraph) which includes products that may have a center filled with a liquid, semi-solids, solid, center filled, and layered product (page 10, paragraph [0111]; page 14, claims 28 and 30).
Pirsa et al disclose the significance of carrageenan to the pharmaceutical, cosmetic, and food industries as cited supra. MPEP 2112 (Section I) discloses that something which is old does not become patentable upon the discovery of a new property/characteristic. Thus, the claiming of a new use, function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. MPEP 2112 (Section II) discloses that it is not required that a person of ordinary skill in the art recognize features that are inherent. MPEP 2112 (Section III) is directed to the fact that prior art may be cited even when the prior art is silent toward inherent characteristics/properties that are inherent to a composition, a rejection (e.g., 103) may be made. Specifically, it is disclosed that where Applicant claims a composition in terms of a function, property, or characteristic and the composition of the prior art overlaps with that of the claim but the function is not explicitly disclosed by the reference, the Examiner may make a rejection. MPEP 2112 (Section IV) is directed to the Examiner providing rational or evidence to support their position. As indicated above in the teachings of Kabse et al and Pirsa et al both documents disclose substances and ranges of the applicable substances that read on the Applicant’s invention. In addition, both cited references disclose that components of the mixture (e.g., carrageenan) may be used to alter the texture, stability, ‘hardness’, and so forth of the composition. Thus, for the reasons set forth herein, the prior art renders obvious the claims of the pending invention. Hence, the limitations of all the claim supra are met. Furthermore, since both Kabse et al and Pirsa et al are directed to hydrocolloids, the references may be considered to be within the same field of endeavor. As a result, the reference teachings are combinable.
APPLICANT’S ASSERTIONS
In summary, it is asserted that Applicant has incorporated ‘Fast Melt’ characteristics which are not expressly or implicitly described in any of the compositions of the cited prior art. In addition, it is asserted that reference to textural agents in Kabse et al which include calcium carbonate as one of the eight listed substances may be present in any amount ranging from 0-60%. It is specifically set forth that Kabse et al do not describe the actual effect of calcium carbonate or any textual component that would impact the dissolvability, rubberiness, toothpull, hardness, or cohesion of the composition or any other textural property.
Also, Applicant asserts that some of the examples in the specification meet some of the Fast Melt properties and all of the other properties.
EXAMINER’S RESPONSE
All of Applicant’s arguments were considered and deemed non-persuasive for reasons of record and those of record and detailed supra. In particular, Applicant’s attention is directed to the various citations above which disclose that carrageenan, for example, may alter the characteristics of the composition. In addition, the secondary reference (Pirsa et al) discloses that hydrocolloids (e.g., carrageenan) are used in the food, cosmetic, and pharmaceutical industries and useful in altering concentration, pH, shelf life of a product, food quality, solubility, viscosity, rheology, melting behavior, body emulsification, creaming, heat transfer, transportation of vitamins and lipophilic flavors, tastes, and nutritional value (Pirsa et al, pages 3-4, bridging paragraph). Thus, the skilled artisan would recognize that based on the substance used and the amount, one could alter and optimize the properties/characteristics of a chewable composition. Hence, there is an expectation of success in generating a product with optimized characteristics/properties based on the product of interest (e.g., chewing gum, chewy cookie, and so forth) and optimizing the characteristics/properties for that particular product.
In regard to some products meeting the Fast Melt characteristics and other not, it would have been obvious to a skilled artisan in the art at the time of the invention to modify (optimize) the composition components based on the indicated ranges and product of interest (e.g., chewing gum, chewy cook, or so forth) in order to have the desired dissolvability, toothpull, cohesion, and mass ratio of the non-reducing sugar to the reducing sugar ranges,
For reasons of record, the rejection is still deemed proper.
Conclusion
Claims 1, 2, 10-12, 16, 18, 19, and 21-28 are rejected. Claims 13-15 are withdrawn.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
August 20, 2026
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