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 .
DETAILED ACTION
This Office Action is responsive to Applicant’s Amendment and Remarks, filed July 5, 2026. The amendment, filed July 5, 2026, is acknowledged, wherein claims 1, 4, 9 – 10, and 19 are amended, claims 2 – 3, 5 – 8, 12 – 18, and 20 are canceled, and claims 21 – 23 are new.
Claims 1, 4, 9 – 11, 19, and 21 – 23 are pending in this application and are currently examined.
Priority
This application is a domestic application, filed July 1, 2022, which claims benefit of provisional application 63/218,488, filed July 5, 2021.
Responses to Applicant’s Remarks:
As the amended claim 1 no longer recites “a stabilizer comprising polylysine”, the priority date of claims 1, 4, 9 – 11, and 19 is July 5, 2021.
Withdrawn Rejections
The rejection of claims 1 – 2, 4, 10 – 11, and 19 in the previous Office Action, dated February 5, 2026, under 35 U.S.C. 102(a)(1) as being anticipated by Reflux Gourmet has been considered and is withdrawn in view of the amended claim 1.
The rejection of claims 1 – 2, 4, 7, 9 – 12, and 19 in the previous Office Action, dated February 5, 2026, under 35 U.S.C. 103 as being unpatentable over Reflux Gourmet in view of Larsen has been considered and is withdrawn in view of the amended claim 1.
The rejection of claims 1 – 2, 4, 10 – 11, and 19 in the previous Office Action, dated February 5, 2026, under 35 U.S.C. 103 as being unpatentable over Smolarz with evidence provided by Adusumilli et al. in view of Dettmar et al., Jade, and Franco has been considered and is withdrawn in view of the amended claim 1.
The rejection of claims 7, 9, and 12 in the previous Office Action, dated February 5, 2026, under 35 U.S.C. 103 as being unpatentable over Smolarz with evidence provided by Adusumilli et al. in view of Dettmar et al., Jade, and Franco as applied to claims 1 – 2, 4, 10 – 11, and 19 above, and further in view of Larsen has been considered and is withdrawn in view of the amended claim 1.
The rejection of claims 1 – 2, 10, and 19 in the previous Office Action, dated February 5, 2026, on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 18/755,489 in view of Dettmar et al., Adusumilli et al., and Jade has been considered and is withdrawn in view of the new claim set filed August 15, 2026.
The following are new grounds of rejection necessitated by Applicant’s Amendment, filed July 5, 2026, wherein claims 1, 4, 9 – 10, and 19 are amended, claims 2 – 3, 5 – 8, 12 – 18, and 20 are canceled, and claims 21 – 23 are new. Previously and newly cited references have been used to establish the new grounds of rejection.
New 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.
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.
Claims 1, 4, 9 – 11, 19, and 21 – 23 are rejected under 35 U.S.C. 103 as being unpatentable over Reflux Gourmet (Amazon, June 2020, cited in the PTO-892 on October 21, 2024) in view of Withington (US4140760), Kawashima et al. (US6451351B1), and Larsen (CA2795521A1, cited in the PTO-892 on January 3, 2024).
Reflux Gourmet teaches a composition comprising sodium alginate, calcium pantothenate, sodium bicarbonate, dextrose, grapefruit seed extract, deionized water, natural flavor, and polylysine (page 1, Supplement Facts). Reflux Gourmet teaches that the alginate forms a protective gel “raft” that floats on top of the stomach to block the acid reflux when the alginate reaches the stomach (page 4, How Does it Work?). Thus, Reflux Gourmet teaches a composition that block acid reflux by forming a protective raft, wherein the composition comprises sodium alginate, calcium pantothenate, sodium bicarbonate, dextrose, grapefruit seed extract, deionized water, natural flavor, and polylysine, which corresponds to the limitations “providing relief against acid reflux”, “sodium alginate”, “dextrose”, “grapefruit seed extract”, “polylysine”, sodium bicarbonate”, “calcium pantothenate”, and “forms a stable protective raft of gel-like composition” of claims 1, 10, and 19. The composition of Reflux Gourmet does not contain “added calcium carbonate” and does not contain “an added salt comprising a cross-linking polyvalent metal ion”, other than the calcium pantothenate, which corresponds to the limitations of claims 1, 10, and 19. Furthermore, the composition of Reflux Gourmet comprises natural flavor and water, which reads on the limitations “excipients” of claim 4 and “carrier” of claim 11. Reflux Gourmet further teaches that the dosage is 5 mL taken after meals and before bed (page 2, line 39), which indicates that the composition is a liquid composition recited in claims 1, 10, and 19. As the structural limitations have been met, the properties or intended results, such as “mechanical barrier reducing gastric regurgitation from the stomach to the esophagus and throat of the subject”, “coats the tissue of the throat and esophagus thereby providing relief against acid reflux”, “enhances the acid reflux-dampening effect of AP”, “enhances the strength and cohesiveness of the raft”, “to form a preservative for the AP”, “reduce the water content of AP”, and etc would also be achieved.
However, Reflux Gourmet does not teach the composition contains about 75 mg to about 400 mg sodium alginate, 100 mg to about 300 mg sodium bicarbonate, 100 mg to about 350 mg calcium pantothenate. Reflux Gourmet does not teach “at least 70% of the alkali metal carboxylic acid groups of the sodium alginate are available for reaction with stomach acid and are not reacted with a cross-linking polyvalent metal ion” before administration. Reflux Gourmet does not teach that the alkaline salt is mixed with a surfactants. Reflux Gourmet also does not explicitly teach that the calcium pantothenate is about 170 mg recited in claims 21 – 23.
Withington teaches a pharmaceutical composition for the suppression of gastric reflux comprises a low viscosity grade sodium alginate, from 0.16 to 2.60 parts by weight of sodium bicarbonate per part by weight of sodium alginate (Abstract). The composition is presented in liquid form. In particular, the liquid composition comprises an aqueous medium containing 2.5 to 8.0% weight/volume of a low viscosity grade sodium alginate and 1.3 to 6.5% weight/volume of sodium bicarbonate (Col. 2, lines 39 – 48). Thus, Withington teaches the relative amount of sodium alginate and sodium bicarbonate based on unit of weight/volume.
Kawashima et al. teach a method for preparing a gel composition, such as alginate gel beads, using a proper concentration of calcium pantothenate as a gelling agent (Abstract). The concentration of calcium pantothenate used in this preparation ranges usually from about 0.03 M to about 0.4 M (Col. 3, lines 66 – 67; Col. 4, line 1).
Larsen teaches alginate-based compositions for treatment of acid reflux in which premature cross-linking of the alginate by polyvalent metal ions is avoided. (page 6, lines 16 – 25; page 12, lines 10 – 14). In particular, Larsen teaches that the formation of a raft can be avoided or reduced by limiting the content of calcium or aluminum ions. Hereby, the carboxylic acid salt groups of the alginate become available for reaction with the stomach acid (page 7, lines 19 – 22). In a preferred embodiment, at least 70% of the alkali metal carboxylic acid groups of the alkali metal alginate are available for reaction with the stomach acid, i.e., is not reacted with a cross-linking polyvalent metal ion (page 12, lines 27 – 31). Thus, Larsen teaches maintaining the alginate free of pre-administration cross-linking by polyvalent metal ions so that the alginate remains available to react under gastric conditions and form the desired protective raft. Moreover, Larsen teaches that the alkaline salt may be mixed with a surfactant (page 13, lines 28 – 29), which corresponds to the limitation of claim 9.
It would have been prima facie obvious for one of ordinary skill in the art to modify the composition of Reflux Gourmet to employ the sodium alginate and sodium bicarbonate in the amounts in view of Withington because Withington teaches liquid pharmaceutical composition for suppression of gastric reflux containing 2.5 – 8.0% w/v sodium alginate and 1.3 – 6.5% w/v sodium bicarbonate. Reflux Gourmet teaches administration of a 5 mL dose. Accordingly, at a 5 mL dosage, Withington’s sodium alginate concentration corresponds to 125 – 400 mg sodium alginate, calculated as 2.5 g/100 mL x 5 mL = 0.125 g or 125 mg at the lower end and 400 mg at the upper end. Thus, the 125 – 400 mg amount based on the combination of Reflux Gourmet and Withington overlaps the claimed range of about 75 – 400 mg sodium alginate as well as the amount of about 200 mg recited in claims 21 – 23. Similarly, the 1.3 – 6.5% w/v sodium bicarbonate corresponds to 65 – 325 mg sodium bicarbonate per 5 mL. Thus, the claimed range of about 100 – 400 mg sodium bicarbonate, as well as the amount of about 200 mg recited in claims 21 – 23, is encompassed by Withington’s disclosed range. One of ordinary skill in the art would have been motivated to employ amounts within these known operative ranges because Withington teaches these concentrations for the same purpose of suppressing gastric reflux using a liquid sodium alginate composition. One of ordinary skill would have had a reasonable expectation of success because the same components are known to function together for the same purpose and selection of amounts within the known overlapping ranges would predictably maintain the reflux-suppressing and raft-forming function.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Reflux Gourmet to employ calcium pantothenate in an amount within the presently claimed range in view of Kawashima et al. because Kawashima et al. teach calcium pantothenate as a gelling agent for sodium alginate at a concentrations of about 0.03 M to about 0.4 M. Based on the molecular weight of 476.5 g/mol for calcium pantothenate, the claimed range of 100 – 350 mg calcium pantothenate corresponds to approximately 14.3 – 190.6 g/L, or approximately 71.5 – 953 mg per 5 mL. Thus, the presently claimed range of about 100 – 350 mg calcium pantothenate, as well as the amount of about 170 mg recited in claims 21 – 23, falls within the range taught by Kawashima et al. It would have been obvious for one of ordinary skill in the art to select an amount of calcium pantothenate within this known operative range because Reflux Gourmet already contains sodium alginate and calcium pantothenate and is intended to form a protective alginate gel-like raft, while Kawashima et al. teach calcium pantothenate as a gelling agent for sodium alginate. One of ordinary skill in the art would have had a reasonable expectation of success because Kawashima et al. demonstrate that calcium pantothenate at concentrations within the disclosed range is effective for gelling sodium alginate. Accordingly, selection of an amount within the known range would have amounted to selection of a known operative amount to obtain the predictable result of promoting alginate gel formation.
It would have been prima facie obvious to one of ordinary skill in the art to modify the Reflux Gourmet composition in view of Larsen such that at least 70% of the alkali-metal carboxylic acid groups of the sodium alginate remain available for reaction with stomach acid and are not reacted with a cross-linking polyvalent metal ion prior to administration because Larsen teaches that at least 70% of the alkali-metal carboxylic acid groups of the alginate may remain available for reaction with stomach acid, and further teaches embodiments having 80% and preferably at least 90% availability. Thus, Larsen encompasses the presently claimed minimum of at least 70%. One of ordinary skill in the art would have been motivated to maintain at least this degree of available alginate because Larsen teaches that limiting premature cross-linking by polyvalent metal ions preserves the carboxyl groups for subsequent reaction with gastric acid. One of ordinary skill would have had a reasonable expectation of success because Larsen teaches that maintaining the alginate in this substantially unreacted condition permits the alginate to react under gastric conditions and form the desired protective raft.
It would have been prima facie obvious to one of ordinary skill in the art to modify the Reflux Gourmet composition by mixing the alkaline salt with a surfactant as taught by Larsen because Larsen teaches that the alkaline salt may be mixed with a surfactant. One of ordinary skill in the art would have been motivated to employ this known formulation technique in the alkaline-salt-containing alginate composition of Reflux Gourmet to facilitate dispersion and interaction of the alkaline salt within the formulation. One of ordinary skill would have had a reasonable expectation of success because Larsen teaches the use of a surfactant with the alkaline salt in an alginate-based reflux composition, and application of that known formulation technique to a similar alginate/alkaline-salt reflux composition would have been expected to perform its known formulation function without disrupting the acid-triggered raft-forming mechanism.
With respect to the recitation of a “dextrose solution,” Reflux Gourmet teaches dextrose and deionized water as ingredients of its liquid composition. Under the broadest reasonable interpretation consistent with the specification, “dextrose solution” encompasses dextrose dissolved in an aqueous phase and does not require that the dextrose solution be separately prepared prior to incorporation into the composition. Because dextrose is water soluble, the dextrose present together with deionized water in the disclosed liquid Reflux Gourmet composition would dissolve in the aqueous phase, thereby forming a dextrose solution and satisfying the recited limitation.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed July 5, 2026, has been fully considered but are moot because the new ground(s) of rejection does not rely on the same combination of references in the prior rejection of record. However, upon further consideration, a new ground(s) of rejection is made in view of the new combination of references.
Applicant argues that the cited Reflux Gourmet does not disclose the specific amounts of sodium alginate, calcium pantothenate, and sodium bicarbonate now recited in independent claims 1, 10, and 19. Applicant contends that Reflux Gourmet merely identifies a 425 mg propriety alginate complex comprising calcium pantothenate, sodium alginate, and sodium bicarbonate, without identifying the individual amount of each component. Applicant therefore argues that the proprietary-complex disclosure does not establish the claimed individual quantitative ranges. Applicant further argues that neither Reflux Gourmet nor Larsen teaches the claimed quantitative amount of calcium pantothenate and that the previously cited references fail to establish why one of ordinary skill would have selected calcium pantothenate in the claimed amount. However, the argument is moot with respect to the rejection presently made. The present rejection does not rely upon the 425 mg proprietary-complex disclosure of Reflux Gourmet as teaching the individual claimed amounts. Instead, Withington is relied upon for the known amounts of sodium alginate and sodium bicarbonate used in liquid compositions for suppression of gastric reflux. When the teaching of Withington is applied to the 5 mL dosage taught by Reflux Gourmet, the concentrations correspond to approximately 125 – 400 mg sodium alginate and 65 – 325 mg sodium bicarbonate. Thus, Withington’s sodium alginate range overlaps the claimed range of about 75 – 400 mg, and its sodium bicarbonate range encompasses the claimed range of about 100 – 300 mg. The presently claimed ranges therefore represent selection of amounts within known operative ranges for the same components used for the same purpose of suppressing gastric reflux. Kawashima et al. explicitly teach calcium pantothenate as a gelling agent for sodium alginate and teach that calcium pantothenate may be employed at concentrations of about 0.03 M to 0.4 M. Kawashima et al. therefore establish that the concentration, and consequently the amount, of calcium pantothenate used in conjunction with sodium alginate is a known formulation parameter affecting alginate gel formation. Reflux Gourmet already contains both sodium alginate and calcium pantothenate and is intended to form a protective alginate gel-like raft. It therefore would have been obvious to one of ordinary skill in the art to select and optimize the amount of calcium pantothenate in the Reflux Gourmet’s composition in view of Kawashima et al. to provide the desired alginate-gelling characteristics, with a reasonable expectation of success because Kawashima et al. demonstrate successfully gelation of sodium alginate using calcium pantothenate over the disclosed concentration range.
Applicant argues that the amended claims require the absence of added calcium carbonate and other added salts comprising a cross-linking polyvalent metal ion, other than calcium pantothenate, and asserts that the previously applied references do not teach or suggest this negative limitation. Applicant argues that Larsen does not disclose or suggest the amended requirement that, prior to administration, at least 70% of the alkali metal carboxylic acid groups of the sodium alginate are available for reaction with stomach acid and are not reacted with a cross-linking polyvalent metal ion. However, the argument is not persuasive because the disclosed ingredient listing of Reflux Gourmet does not identify calcium carbonate or an additional cross-linking polyvalent metal salt apart from calcium pantothenate. More significantly, Larsen teaches avoiding added salts comprising cross-linking polyvalent metal ions. Larsen explains that polyvalent metal ions may react with and occupy alginate carboxyl groups, thereby decreasing the number of groups available for subsequent reaction with stomach acid. Larsen therefore provides a technical reason for avoiding additional cross-linking polyvalent metal salts. It would have been obvious to one of ordinary skill in the art to formulate the composition of Reflux Gourmet without such additional cross-linking salts as taught by Larsen in order to preserve the alginate carboxy groups for subsequent reaction under gastric conditions, with a reasonable expectation of maintaining the desired raft forming functionality.
Applicant argues that the prior rejection lacked an articulated reason with rational underpinning for modifying Reflux Gourmet to arrive at the presently claimed quantitative ranges and pre-administration chemical state. Applicant characterizes the rejection as identifying known ingredients and raft forming principles without explaining why one of ordinary skill would have selected the particular claimed formulation. However, the argument is not persuasive because the applied secondary references provide reasons for the respective modifications. Withington teaches operative concentrations of sodium alginate and sodium bicarbonate specifically in liquid compositions for suppression of gastric reflux and therefore provide a reason to employ amounts within those known ranges in the liquid reflux composition of Reflux Gourmet. Kawashima et al. teach calcium pantothenate as a gelling agent for sodium alginate and establish its concentration as a formulation parameter affecting alginate gel formation, thereby providing a reason to select an operative amount of calcium pantothenate. Larsen teaches preserving alginate carboxyl groups from premature polyvalent metal cross-linking so that the groups remain available for reaction with stomach acid, thereby providing a reason to maintain at least 70% availability and to avoid additional cross-linking polyvalent metal salts. Accordingly the present rejection does not rely merely upon the existence of the individual ingredients, but upon explicit prior art teachings providing technical reasons for respective modifications and a reasonable expectation that the modifications would perform the known functions.
Applicant characterizes the prior obviousness reaction as an impermissible ingredient-by-ingredient reconstruction, arguing that the references fail to provide a reasoned basis for selecting the claimed quantitative and chemical state limitations as a whole. However, the argument is not persuasive because Reflux Gourmet supplies the underlying acid reflux composition comprising sodium alginate, sodium bicarbonate, calcium pantothenate, dextrose, grapefruit seed extract, polylysine, and water and teaches formation of a protective alginate raft. Thus, the present rejection does not reconstruct the basic ingredient combination from unrelated references. Instead, Withington, Kawashima et al., and Larsen are relied upon for known quantitative and formulation parameters associated with components already present in the composition of Reflux Gourmet. Withington supplies known operative amounts for sodium alginate and sodium bicarbonate in liquid gastric reflux compositions; Kawashima et al. supply the known calcium pantothenate alginate gelling teaching; and Larsen supplies the known pre-administration alginate availability and cross-linking teachings. The combination therefore represents application of known formulation teachings to an existing alginate-based reflux composition for the known and predictable purposes rather than reconstruction of the claimed composition using Applicant’s disclosure as a blueprint.
Applicant argues that Larsen’s teachings regarding surfactant mixing do not cure the deficiencies of independent claim 1 and therefore do not render dependent claim 9 obvious. However, the argument is not persuasive because the present rejection separately addresses the limitations of independent claim 1 using Reflux Gourmet in combination with Withington, Kawashima et al., and Larsen. Thus, the deficiencies identified by Applicant with respect to the previous rejection of claim 1 have been addressed. Regarding the additional limitation of claim 9, Larsen explicitly teaches that the alkaline salt may be mixed with a surfactant. It would have been prima facie obvious to one of ordinary skill in the art to mix the alkaline salt of the modified composition of Reflux Gourmet with a surfactant as taught by Larsen because Larsen identifies such mixing as a known formulation technique for an alkaline slat in an alginate-based gastric composition. One of ordinary skill would have had a reasonable expectation of success in applying this known formulation technique to the similar alkaline salt-containing alginate composition.
Conclusion
No claim is found to be allowable.
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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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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