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 .
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.
Response to Amendment
The amendment filed July 13, 2026 has been entered. Claims 1, 6, 10, and 18 have been amended and claims 2-5, 7, 9, 12-17, and 19-20 are cancelled. The terminal disclaimer over copending Application No. 18/755489 is approved and thus the double patenting rejections set forth in the Non-Final Office action mailed February 13, 2026 are hereby withdrawn. Applicant’s amendments have overcome the 112(b), 112(d) and 103 rejections previously set forth, thus they are hereby withdrawn. New/Modified rejections and response to arguments in how they apply to the current rejections are addressed below.
Claims 1, 6, 10, and 18 are pending in this application.
Modified/New 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.
Claims 1, 6, 10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Smolarz (WO 2019/169137, IDS filed on March 9, 2023, cited in previous action) in view of Dettmar 294' (US 6,391,294, IDS filed on March 9, 2023, cited in previous action), Adusumilli (US 2005/0202084, IDS filed on March 9, 2023, cited in previous action), Aloui (Int. J. Food Science and Technology, 2014, cited in previous action), Jade (University Health News, 2020, cited in previous action), Franco (Reflux Gourmet, 2019, cited in previous action), Bor (Turk. J. Gastroenterol., 2019, cited in previous action), Larsen (WO 2011/131203, cited on PTO-892), Bousser (EP 0382654, IDS filed on March 9, 2023, cited in previous action) and Dettmar et al (Drug Development and industrial Pharmacy, 2017, cited in previous action). The English translation of Bousser relied upon by the examiner has been provided in a previous action.
Regarding claims 1, 6, and 18: Smolarz teaches a method for neutralizing stomach acid in a subject, comprising: administering to a subject an effective amount of an alginate-based product (AP), wherein AP forms a raft in the stomach of the subject, and wherein AP comprises sodium alginate (abstract, para 0042). Smolarz defines acid reflux disease as any disease or condition characterized by stomach contents coming back up, or refluxing, into the esophagus resulting in symptoms or complications (pg. 12 para. 0098). Smolarz teaches a method wherein the AP is further adapted to neutralize acid reflux (pg. 7, paras 0043, 0049). Smolarz teaches the composition further comprises sodium bicarbonate (alkaline salt) and calcium carbonate (stabilizer, secondary alkaline agent, salt comprising calcium) (pg. 7, paras. 0044-0048). Smolarz teaches the composition can comprise 250 mg to about 2000 mg of alginate salts and between 10 mg to about 100 mg of sodium bicarbonate and calcium carbonate (pg. 4, para. 0020). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 (I)). The addition of sodium bicarbonate allows for a reaction between gastric acid and sodium bicarbonate, which gives off carbon dioxide (pg. 7, para. 0046). The carbon dioxide aids in lifting the raft to the surface of the stomach contents where the raft can prevent reflux (pg. 7, para. 0046). The addition of calcium carbonate provides a further source of carbon dioxide, as well as a source of calcium ions (pg. 7, para. 0047). Calcium ions are useful for cross-linking the alginic acid polymer formed by reacting sodium alginate with gastric acid, thereby stabilizing the alginic acid raft for prolonged reflux relief (pg. 7, para. 0047). Smolarz further teaches that sodium bicarbonate is a known antacid (pg. 8, para 0058). Therefore, the composition of Smolarz comprising both sodium alginate and sodium bicarbonate is adapted to act both as an antacid and as a mechanically acting reflux-preventing raft. Smolarz teaches suitable formulations of the present invention include gels (pg. 11, para. 0085). Smolarz teaches that the inclusion of a sweetener can be natural or artificial (pg. 4, para. 0025). Smolarz teaches the inclusion of parabens is optional (pgs. 16-17, para. 00114). Thus, Smolarz teaches a formulation that is paraben free and comprised of non-synthetic ingredients (sodium alginate, calcium carbonate, and sodium bicarbonate). Bor discloses 3 modes of action for alginates for the prevention of gastric reflux: 1.Reaction between Na alginate and acid in the stomach, producing a viscous gel that floats on the top of the stomach, forming a physical barrier that protects esophageal mucosa and prevention of postprandial reflux via eliminating or displacing acid pocket identified in GERD patients; 2. Inhibition of pepsin and bile acids; 3. Topical protection of vulnerable and sensitive esophageal mucosa, reducing the risk of inflammation as a result of components of the gastric refluxate via formation of layers on contact with the esophageal mucosa (i.e. demulcent barrier) and demonstrates bioadhesive potential (pg. S114, cols. 1-2, bridging para.).
Smolarz does not teach a method wherein the AP further comprises dextrose, grapefruit seed extract, polylysine and vitamin B5 in an amount of 100-350 mg. Smolarz does not explicitly teach wherein the raft is a pH neutral mechanical barrier reducing gastric regurgitation or creating a demulcent barrier.
However, Dettmar ‘294 teaches an alginate-based product comprising a water-soluble salt of alginic acid and cationic polymer polylysine, which can be in liquid form (abstract, col 2, lines 5-10 and 28-33). Introduction of a cationic polymer, such as polylysine, results in a bioadhesive formulation that may be used to adhere active agents to specific sites in the body (col. 1, lines 9-14, 40-55). The formulation can be contained in a controlled-release capsule containing the alginate and polylysine that opens in the stomach, forming a bioadhesive film (col. 6, lines 53-59). Adusumilli teaches an alginate composition for gastric reflux (abstract). Adusumilli teaches 200 mg of alginic acid is more consistent than other levels of alginic acid (pg. 4, para. 0052). Adusumilli teaches an AP that comprising dextrose as a bulk sweetener (pg. 8, para. 0097). Bousser discloses that in addition to acting as a flavoring agent, dextrose acts as a drying agent (desiccant) for organic products (English translation, pg. 3, paras. 0011-0013). This leads to conservation of the active properties of the product (English translation, pg. 4, para. 0015). Jade teaches grapefruit seed extract (GSE) uses are numerous due to its action as a highly concentrated, natural general antimicrobial and antioxidant (pg. 1). A GSE dosage may come in a number different delivery forms and concentrations (pg. 1). GSE is also used as a preservative in products (pg. 1). GSE is also known to treat digestive disturbances (pg. 3). Franco teaches vitamin B5 has been utilized in alginate based products for the treatment of acid reflux as a source of calcium ions to bind with the alginic acid to form the raft as an alternative to calcium carbonate in typical antacids (pg. 4, para. 1, pg. 6, para. 1). Additionally, Dettmar (Drug Development) discloses that alginate products can be refluxed preferentially into the esophagus and exert a demulcent effect (abstract). The effects of the variation in the amounts and ratios of the active ingredient sodium alginate and the antacids (calcium carbonate and sodium bicarbonate) has on the raft formation has been well documented (pg. 38, col. 1, para. 3). The presence of the alginate in the raft allows for antacid entrapment which in turn provides a pH neutral barrier preferentially refluxed ahead of any gastric acidity into the esophagus (i.e. demulcent effect, pg. 38, col. 1, para. 3).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of Smolarz by: including polylysine as taught by Dettmar ‘294 in order to result in a bioadhesive coating to adhere the active agents to the stomach for the purpose of neutralizing stomach acid in a subject; including dextrose as a sweetener and desiccant to enhance preservation taught by Adusumilli and Bousser; including grapefruit seed extract as taught by Aloui and Jade as an antioxidant that is known to treat digestive disturbances capable of preserving the action of alginate products; and replacing calcium carbonate with vitamin B5 as taught by Franco as a known alternative source of calcium ions to form the alginate raft. By replacing calcium carbonate with vitamin B5 (i.e. calcium pantothenate), a person of ordinary skill would be motivated to utilize the amount specified in Smolarz, Adusumilli and Larsen which overlaps with the claimed range. In summary, whereas it would have been obvious to include sodium alginate, sodium bicarbonate, calcium pantothenate (vitamin B5), dextrose, and polylysine in a composition for the treatment of gastroesophageal reflux disease, the claimed explanation of the ingredients functioning are expected properties of the composition, absent a showing of unexpected results.
The instant claims further differ from Smolarz in that Smolarz does not teach wherein 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, Larsen teaches an alginate composition for the treatment of dyspepsia (abstract). Larsen teaches the composition is for neutralizing stomach acid (pg. 1, title). Larsen teaches a composition comprising 267 mg sodium bicarbonate and 160 mg calcium carbonate (pg. 15, lines 25-30). Larsen teaches The pharmaceutical composition of the invention may contain a minor amount of a salt comprising a cross-linking polyvalent metal ion to support the gelation, if desired, when contacted with the gastric juice. The cross-linking polyvalent metal ion may be ions of calcium and aluminium and the salt may as an example be selected among calcium carbonate, CaHPO4, aluminium carbonate and aluminium hydroxide (pg. 12, lines 5-10). In a preferred embodiment at least 70%, such as 80%, preferably at least 90% 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 (pg. 12, lines 27-31).
Taken together it would have been prima facie obvious to modify the method such that the alginate has at least 70% of the alkali metal carboxylic acid groups of the alkali metal alginate are available for reaction with the stomach acid as taught by Larsen. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success in order to make more groups available for reaction with the stomach acid, thereby enabling the alginate to act as an antacid.
Regarding claim 10: Smolarz further teaches carriers and excipients may be included in the composition (pg. 15, paras 0112-0113).
Response to Arguments
Applicant's arguments filed July 13, 2026 have been fully considered but they are not persuasive.
On page 7 of Applicant’s response, Applicant argues that the newly amended claims which recite at least 70% of the sodium alginate carboxylic acid groups available for crosslinking before administration overcome the previously made rejections. On pages 7-8 of Applicant’s response Applicant argues the rejection does not explain why a person of ordinary skill would select the recited calcium pantothenate, sodium alginate, and sodium bicarbonate amounts while preserving the claimed carboxylate availability in the same liquid AP containing the recited preservative system (bridging para.).
However, see newly amended claims which rely on Larsen as a prior art reference accounting for this amendment. The art establishes each of the claimed components as known variables included for specific purposes. The art establishes that both liquid and solid formulations for neutralizing stomach acid are known in the art. Optimization of result effecting variables is prima facie obvious absent a showing of unexpected results (See MPEP 2144.05 (II)).
On page 8 of Applicant’s response, Applicant argues that calcium carbonate and calcium pantothenate are interchangeable as they have different compositions and formulation roles (para. 2). Applicant argues that the amount calcium overlaps with at most 100 mg which is an endpoint (para. 2). Applicant argues that the amount of calcium pantothenate was recognized as a result-effective variable in the calcium carbonate free liquid AP having the claimed properties. On page 8 of Applicant’s response, Applicant argues the rejection does not identify a disclosure to select all three claimed ranges together in the claimed liquid, calcium-carbonate-free formulation (para. 3).
However, Smolarz teaches the addition of calcium ions, through calcium carbonate, are useful for cross-linking the alginic acid polymer formed by reacting sodium alginate with gastric acid, thereby stabilizing the alginic acid raft for prolonged reflux relief (pg. 7, para. 0047). Prolonged stabilization of the alginic acid raft is preferred as the raft is gradually broken up over time mechanically by stomach contractions (i.e. supporting cohesiveness, pg. 7, para. 0048). Franco teaches vitamin B5 as a source of calcium ions to bind with alginic acid, has improved efficacy over calcium carbonate in other formulations (pg. 5, para. 1). Franco clearly identifies calcium pantothenate as the source of calcium ions, in which the art identifies the amount of calcium in a given alginate composition is an established result effecting variable. According to Larsen, the pharmaceutical composition of the invention may contain a minor amount of a salt comprising a cross-linking polyvalent metal ion to support the gelation, if desired, when contacted with the gastric juice. The cross-linking polyvalent metal ion may be ions of calcium and aluminium and the salt may as an example be selected among calcium carbonate, CaHPO4, aluminium carbonate and aluminium hydroxide (pg. 12, lines 5-10). In a preferred embodiment at least 70%, such as 80%, preferably at least 90% 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 (pg. 12, lines 27-31). Thus a person of ordinary skill in the art would be motivated to optimize the amount of calcium in the composition so as to allow for an appropriate amount of available alkali metal carboxylic acid groups. Additionally, with respect to the single overlap of ranges, Larsen further teaches compositions comprising 267 mg sodium bicarbonate and 160 mg calcium carbonate (pg. 15, lines 25-30), which demonstrate these amounts of these reagents are known useful quantities in the art of alginate compositions for neutralizing stomach acid. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists(See MPEP 2144.05 (I)). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (See MPEP 716.02 (d)).
On page 9 of Applicant’s response, Applicant argues the specific nature of claim 6 is non obvious over the cited references, i.e. 200 mg sodium alginate, 170 calcium pantothenate, 200 mg sodium bicarbonate (pg. 9, para. 1). Applicant argues these values are outside the ranges of the cited prior art.
However, as discussed above, Larsen further teaches compositions comprising 267 mg sodium bicarbonate and 160 mg calcium carbonate (pg. 15, lines 25-30). Adusumilli also recognizes these components can be combined in a liquid pharmaceutical composition (pg. 1, para. 0009). Adusumilli teaches 200 mg of alginic acid is more consistent than other levels of alginic acid (pg. 4, para. 0052). Adusumilli teaches sodium bicarbonate can range from 50 to about 200 mg (pg. 4, para. 0053). Thus the art establishes that lower amounts in the art are known for these types of formulations and would be within the technical grasp of the skilled artisan through routine optimization.
On page 9-10 of Applicant’s response, applicant argues the Bor, Banning and the remaining references do not teach 70% of the metal carboxylic acid groups, or the claimed concentrations argued above (para. 2). Applicant argues dependent claims 6 and 10 remain patentable for the reasons described above.
However, see response to arguments above.
On page 10 of Applicant’s response, Applicant argues the terminal disclaimer overcomes the double patenting rejections (para. 3).
The terminal disclaimer was approved and thus the double patenting rejections have been withdrawn.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
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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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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