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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 16, 2026 has been entered.
The amendment filed January 16, 2026 has been entered. Claims 1, 6, 11, and 18 have been amended and claims 2-5, 7, 9, 12-17, and 19-20 are cancelled.
Applicant's arguments filed January 16, 2026 have been fully considered but they are not persuasive.
Rejections and response to arguments in how they apply to the current rejections are addressed below.
Claims 1, 6, 8, 10-11, and 18 are pending in this application.
Claim Objections
Claims 11 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 6. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112 (b)
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 8 and 18 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.
Claim 8 recites, “The method of claim 1, wherein administering the effective amount of dextrose contributes to desiccation of the product which facilitates its action as a preservative.”. However, claim 1 is directed towards administration of an alginate-based product (AP), not the administration of dextrose. As written it is unclear whether this claim is merely describing a property of the dextrose within the AP, or is meant to add an additional step of administering dextrose separately from the AP. The lack of clarity renders the claim indefinite.
Claim 18 recites the phrase “non-synthetic”. The phrase “non-synthetic” renders the claim indefinite because it is unclear how a person of ordinary skill in the art would be capable of ascertaining the difference between a synthetic and non-synthetic ingredient. Additionally, it is unclear what would be considered non-synthetic based on the lack of a clear, explicit definition in the instant specification. The instant specification merely states, “….all ingredients of AP are non-synthetic, thus ameliorating digestive and organ filtering issues.” (pg. 9, para. 0041). In the next paragraph, the instant specification describes alginate is obtained from Chilean seaweed (pg. 9, para. 0042). Would the subsequent extraction and conversion to sodium alginate, a salt derived from extracted alginate, constitute a synthesis? Thus claim 18 is rendered indefinite.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 8: Claim 8 recites, “The method of claim 1, wherein administering the effective amount of dextrose contributes to desiccation of the product which facilitates its action as a preservative.”. However, this limitation merely recites a property of dextrose that is already included in claim 1. Thus, claim 8 fails to further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 8, 10-11, 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), and Banning (US 6395307, IDS filed October 6, 2022) as evidenced by 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, 8, 11, 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 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, such as 10 mg to 100 mg, 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 the sodium alginate is derived from lessonia nigrescens and has a 60/40 (M/G) ratio. The instant claims further differ from Smolarz in that Smolarz does not teach wherein the AP is in liquid form.
However, Bor teaches alginates produced from different seaweeds have different chemical compositions and physical properties, only certain alginates have the right characteristics to be used to manufacture effective reflux-suppressant products (pg. S112, col. 2, last para.). Bor teaches the typical M and G profiles for alginates from lessonia nigrescen have a M/G ratio of 60/40 (pg. S112, table 1). Bor teaches that sodium alginate from lessonia nigrescens are capable of forming rafts for reflux treatment, albeit are weaker than laminaria hyperborea (pg. S113, figure 4, table 2, col. 1, para. 1). A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use (See MPEP 2123 (II)). Additionally Banning teaches an aqueous pourable liquid composition comprising a high concentration of sodium alginate and an alkali metal bicarbonate wherein the mannuronic acid (i.e. M) and guluronic acid residues (i.e. G) can vary (abstract). Banning teaches the alginate compositions can be utilized to treat reflux esophagitis (col. 1, lines 5-12). Banning teaches that thickening problems associated with high guluronic acids can be mitigated by utilizing alginates with higher mannuronic acid residues to guluronic acid residues that are typically used in liquid products (col. 3, lines 15-21, 38-42). Banning teaches that such an alginate can be extracted from Lessonia nigrescens (col. 4, lines 27-30).
Taken together it would have been prima facie obvious to modify the method such that the alginate is sourced with lessonia nigrescen have a M/G ratio of 60/40 as taught by Bor and Banning. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as alginate sourced from this species is contemplated, albeit nonpreferred, as a raft forming alginate for the treatment of reflux related conditions. Additionally Banning recognizes that alginates with higher M/G ratios can alleviate thickening issues in liquid alginate products.
The instant claims further differ from Smolarz in that Smolarz does not teach wherein dextrose is present from 0.1 to 15% w/v.
However, as discussed above, Adusumilli teaches an AP that comprising dextrose as a bulk sweetener (pg. 8, para. 0097), thereby rendering obvious its inclusion in an alginate based product. Adusumilli further teaches dextrose can be present as a sweetener in 8% to 40% w/w. Banning teaches liquid compositions comprising sodium alginate based products. Banning further teaches the compositions may include sweeteners that are preferably present in an amount of 0.01 to 1% w/v (col. 11, lines 20-27).
Taken together, it would have been prima facie obvious to optimize the amount of dextrose present in the composition and arrive at the claimed range, given that the art establishes concentration of dextrose in alginate products can vary, and ranges overlapping with the claimed range are encompassed. A person of ordinary skill in the art would have the motivation to do so to optimize for appropriate flavor.
Regarding claim 10: Smolarz further teaches solid dosage forms for oral administration may be prepared with one or more carriers, fillers, binders and/or excipients (pg. 11, para 0086).
Maintained Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 8, 10-11, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/755489 (Frank, US 2024/0423938, cited in previous action) in view of Franco (Reflux Gourmet, 2019, cited in previous action) Smolarz (WO 2019/169137, IDS filed on March 9, 2023, cited in previous action), 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), Bor (Turk. J. Gastroenterol., 2019, cited in previous action), and Banning (US 6395307, IDS filed October 6, 2022) as evidenced by 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). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1, 6, 8, 10-11, and 18, the copending claims teach a composition for forming a protective barrier in the stomach comprising sodium bicarbonate, sodium alginate, calcium pantothenate (i.e. alginate based product, claim 6). Calcium pantothenate is the calcium salt of pantothenic acid, i.e. vitamin B5. The copending claims teach a method for treating gastroesophageal reflux disease (GERD) in a subject, comprising administering a composition comprising said ingredients (claim 11). The copending claims teach the composition can further comprise dextrose (claim 10). The copending claims teach wherein the dextrose sugars and/or other natural free sweeteners facilitate desiccation and preservation (claim 15). The copending claims teach the composition can further comprise a blend of natural and synthetic polymers. (claim 5). The composition forms a raft on top of the stomach contents (claims 13).
The copending claims do not teach wherein Vitamin B5 enhances the strength and cohesiveness of the raft.
However, Franco (Reflux Gourmet, 2019) establishes that the use of vitamin B5 in alginate compositions as a source of calcium ions to form the alginate raft is a known mechanism in the art, thus this is an expected property of the composition (pg. 5, para. 1). 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).
The copending claims do not teach wherein a demulcent barrier on the mucosal lining of the throat, esophagus and stomach in order to provide relief against gastroesophageal reflux.
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.), thus this is an expected property of the composition.
The copending claims do not teach inclusion of additional cofactors, excipients, vitamins, carriers, surfactants, and/or binders. The copending claims do not specify the amount of alginate, vitamin B5, and sodium bicarbonate.
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 teaches solid dosage forms for oral administration may be prepared with one or more carriers, fillers, binders and/or excipients (pg. 11, para 0086). Taken together it would have been prima facie obvious to a person of ordinary skill in the art to include one or more carriers, fillers, binders and/or excipients in the composition as taught by Smolarz. A person of ordinary skill in the art would have had the motivation to do so as it is a routine practice in the art of alginate based products for the treatment of acid reflux. 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)). Wherein the art establishes vitamin B5 and calcium carbonate are equivalent sources of calcium, a person of ordinary skill in the art would recognize the benefit in utilizing values for calcium carbonate when replacing with vitamin B5.
The copending claims do not teach the inclusion of polylysine and grapefruit extract, wherein polylysine and grapefruit extract combine to form a preservative for the alginate product.
However, Dettmar ‘294 teaches an alginate-based product comprising a water-soluble salt of alginic acid and cationic polymer polylysine (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 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). Aloui teaches that grapefruit seed extract preserves the activity of alginate based products (abstract). 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). 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 the copending claims 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 and 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.. 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 copending claims further differ from the instant claims in that they do not teach wherein the sodium alginate is derived from lessonia nigrescens and has a 60/40 (M/G) ratio. The copending claims further differ from the instant claims in that they do not teach wherein the AP is in liquid form.
However, Bor teaches alginates produced from different seaweeds have different chemical compositions and physical properties, only certain alginates have the right characteristics to be used to manufacture effective reflux-suppressant products (pg. S112, col. 2, last para.). Bor teaches the typical M and G profiles for alginates from lessonia nigrescen have a M/G ratio of 60/40 (pg. S112, table 1). Bor teaches that sodium alginate from lessonia nigrescens are capable of forming rafts for reflux treatment, albeit are weaker than laminaria hyperborea (pg. S113, figure 4, table 2, col. 1, para. 1). A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use (See MPEP 2123 (II)). Additionally Banning teaches an aqueous pourable liquid composition comprising a high concentration of sodium alginate and an alkali metal bicarbonate wherein the mannuronic acid (i.e. M) and guluronic acid residues (i.e. G) can vary (abstract). Banning teaches the alginate compositions can be utilized to treat reflux esophagitis (col. 1, lines 5-12). Banning teaches that thickening problems associated with high guluronic acids can be mitigated by utilizing alginates with higher mannuronic acid residues to guluronic acid residues that are typically used in liquid products (col. 3, lines 15-21, 38-42). Banning teaches that such an alginate can be extracted from Lessonia nigrescens (col. 4, lines 27-30).
Taken together it would have been prima facie obvious to modify the method such that the alginate is sourced with lessonia nigrescen have a M/G ratio of 60/40 as taught by Bor and Banning. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as alginate sourced from this species is contemplated, albeit nonpreferred, as a raft forming alginate for the treatment of reflux related conditions. Additionally Banning recognizes that alginates with higher M/G ratios can alleviate thickening issues in liquid alginate products.
The copending claims further differ from the instant claims in that they do not teach wherein dextrose is present from 0.1 to 15% w/v.
However, as discussed above, Adusumilli teaches an AP that comprising dextrose as a bulk sweetener (pg. 8, para. 0097), thereby rendering obvious its inclusion in an alginate based product. Adusumilli further teaches dextrose can be present as a sweetener in 8% to 40% w/w. Banning teaches liquid compositions comprising sodium alginate based products. Banning further teaches the compositions may include sweeteners that are preferably present in an amount of 0.01 to 1% w/v (col. 11, lines 20-27).
Taken together, it would have been prima facie obvious to optimize the amount of dextrose present in the composition and arrive at the claimed range, given that the art establishes concentration of dextrose in alginate products can vary, and ranges overlapping with the claimed range are encompassed. A person of ordinary skill in the art would have the motivation to do so to optimize for appropriate flavor and these are known values in the art.
Response to Arguments
Applicant's arguments filed January 16, 2026 have been fully considered but they are not persuasive.
On page 6 of Applicant’s response, Applicant argues that newly amended claims specify the product is in liquid form comprising specific amounts of dextrose, sodium alginate, vitamin B5 and sodium bicarbonate (para. 3). Applicant argues that the newly amended claims also specify the sodium alginate is sourced from lessonia nigrescens, 60/40 (M/G) (para. 4). Applicant argues the Examiner does not identify any teaching in the cited art that these specific limitations were known to be result-effective variables, nor does it explain why a person of ordinary skill in the art would have selected these particular parameters absent hindsight reasoning (para. 4). Bor teaches the typical M and G profiles for alginates from lessonia nigrescen have a M/G ratio of 60/40 (pg. S112, table 1). Bor teaches that sodium alginate from lessonia nigrescens are capable of forming rafts for reflux treatment, albeit are weaker than laminaria hyperborea (pg. S113, figure 4, table 2, col. 1, para. 1). Banning teaches the alginate compositions can be utilized to treat reflux esophagitis (col. 1, lines 5-12). Banning teaches that thickening problems associated with high guluronic acids can be mitigated by utilizing alginates with higher mannuronic acid residues to guluronic acid residues that are typically used in liquid products (col. 3, lines 15-21, 38-42). Thus, it would have been obvious to source alginate from lessonia nigrescens which has a higher M/G ratio in a liquid alginate product to avoid thickening problems.
However, see modified 103 rejections above which account for the new claim limitations. Specifically, 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)). Wherein it would be obvious to substitute calcium carbonate with vitamin B5, a person of ordinary skill in the art would be motivated to utilize the amount of calcium described by Smolarz, which overlaps with the claimed range, in order to keep appropriate calcium concentrations.
On page 7 of Applicant’s response, Applicant similarly argues that the newly added limitations, specifically the sodium alginate is sourced from lessonia nigrescens, 60/40 (M/G), the product is in liquid form comprising specific amounts of dextrose, sodium alginate, vitamin B5 and sodium bicarbonate, render the claims patentably distinct from the copending application.
However, see response to arguments and modified double patenting rejections above which account for the new claim limitations.
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 and double patenting rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693