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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 17, 2025 has been entered.
DETAILED ACTION
3. Claims 1 – 2, 4, 7, 9 – 12, and 19 are pending in this application. Applicant’s Amendment and Remarks, filed November 17, 2025, is entered, wherein claims 7 and 10 are amended and claims 3, 5 – 6, 8, 13 – 18, and 20 are canceled.
Priority
4. This application is a domestic application, filed July 1, 2022, which claims benefit of provisional application 63/218,488, filed July 5, 2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/218,488, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The domestic application 63/218,488 does not provide support for the limitation of “stabilizer comprises polylysine” recited in claim 1. Since claims 2, 4, 7, 9 – 12, and 19 depend from claim 1, thus, the priority date of these claims is July 1, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/20/2025 was filed after the mailing date of the previous Office Action on May 15, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections
6. The objection of claim 10 in the previous Office Action, mailed May 15, 2025, is withdrawn in view of the amended claim 10.
Withdrawn Rejections
7. The rejection of claim 7 in the previous Office Action, mailed May 15, 2025, has been considered and is withdrawn in view of the amended claim 7.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 – 2, 4, 10 – 11, and 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reflux Gourmet (Amazon, 2020, cited in the previous Office Action).
a. Independent claim 1 is directed to a composition for providing relief against acid reflux in a subject, said composition comprising an alginate-based product (AP), wherein the AP comprises an alginate, a dextrose solution, grapefruit seed extract, a stabilizer comprising polylysine, an alkaline salt, and a calcium-containing agent comprising Vitamin B5, wherein the AP forms a stable protect raft of gel-like composition that serves as a mechanical barrier reducing gastric regurgitation from the stomach to the esophagus and throat of the subject, the raft coats the tissue of the throat and esophagus thereby providing relief against acid reflux, a combination of the alginate and the dextrose solution also enhances the acid reflux-dampening effect of AP, Vitamin B5 enhances the strength and cohesiveness of the raft, wherein the dextrose solution, the grapefruit seed extract and polylysine combine to form a preservative for the AP, and wherein the dextrose solution reduces the water content of AP. Dependent claim 2 is directed to the composition, wherein the alginate is sodium alginate. Dependent claim 4 is directed to the composition, wherein the composition further comprises excipients. Independent claim 10 is directed to a composition for providing relief against acid reflux in a subject, said composition comprising an AP, wherein the AP comprises sodium alginate, sodium bicarbonate, polylysine, grapefruit seed extract, an alkaline salt, a dextrose solution, and a calcium-containing agent comprising calcium pantothenate, wherein the AP forms a stable protective raft of gel-like composition that serves as a pH neutral mechanical barrier reducing gastric regurgitation and floats on top of stomach contents, wherein the dextrose solution, the grapefruit seed extract, and the polylysine combine to form a preservative for AP; wherein calcium pantothenate enhances raft strength and reduces acid reflux; and whereby a combination of the alginate and the dextrose enhances the acid reflux-dampening effect of AP. Dependent claim 11 is directed to the composition, wherein the composition further comprises a carrier. Independent claim 19 is directed to a composition for providing relief against acid reflux in a subject, said composition comprising an AP, wherein the AP comprises sodium alginate, polylysine, a dextrose and optionally other sugars, calcium pantothenate, grapefruit seed extract, and an alkaline salt, wherein the AP forms a stable protective raft of gel-like composition that serves as a mechanical barrier reducing gastric regurgitation, wherein calcium pantothenate enhances raft strength and reduces acid reflux, and the alginate enhances the acid reflux-dampening effect of AP; whereby the protective raft provides relief against the partially regurgitated low pH constituents of the stomach characteristics of gastroesophageal reflux.
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?). As the structural limitations have been met, the properties or intended results, such as “for mitigating the harmful effects of stomach acid in a subject”, 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.
For these reasons, Reflux Gourmet anticipates the claimed invention.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed November 17, 2025, have been fully considered and are found to be not persuasive.
Regarding Reflux Gourmet, Applicant argues that the record of Amazon listing established does not disclose all of the claim critical ingredients in combination as of the asserted 2020 date. Applicant argues that the record copy of Amazon listing omits at least vitamin B5 and sodium bicarbonate. Applicant argues that the single Amazon printout has reflected a later update in “Supplement Facts”. Applicant argues that “Date first available” is tied to listing creation, but not proof that any particular image or ingredient list was publicly shown on that date and Amazon listing recites the legal disclaimer regarding “manufactures may alter their ingredient lists”, which implies that the listing is not authoritative for a formulation on any particular date. Applicant further argues that one cannot assume anything on the page is the same since 2020 because the reviews/Q&A section clearly shows entries made after the presumed 2020 date.
However, the arguments are not persuasive. The Amazon prior art provided by the examiner along with the Office Action mailed on October 31, 2024 clearly shows the ingredients including vitamin B5 and sodium bicarbonate on page 5. For the argument regarding the later update, Applicant does not specifically disclose where in the prior art and when is the later update. The examiner is not able to determine the validity of this argument. The legal disclaimer is a general caution and does not establish that the ingredient disclosure shown, which was relied-upon, is inaccurate. The information shows the ingredients as publicly displayed on Amazon and Applicant has not provided sufficient evidence that the disclosure was absent or incorrect as of that date. Finally, the examiner has found a proof (Amazon Q&A, 2020, Reference included with PTO-892) to show that sodium bicarbonate and vitamin B5 have been in the formulation since 2020. On the additional reference, an answer posted by a customer on Amazon Q&A section reveals that sodium carbonate and vitamin B5 was listed as one of the ingredients. Therefore, the rejection is proper and is maintained.
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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
Claims 1 – 2, 4, 7, 9 – 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Reflux Gourmet (Amazon, 2020, cited in the previous Office Action) in view of Larsen (CA2795521A1, cited in the previous Office Action). Claims 1 – 2, 4, 10 – 11, and 19 are rejected here because they have been rejected by the primary reference under 102 above.
b. Regarding claims 1 – 2, 4, 7, 9 – 12, and 19, 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?).
However, Reflux Gourmet does not teach the composition further comprising liquid potassium bicarbonate and at least 10% w/v sodium alginate (claim 7). Reflex Gourmet also does not teach the alkaline salt is mixed with a surfactant (claim 9).
Larsen teaches a pharmaceutical composition comprising an alkaline metal alginate, an alkaline salt, and less than % by weight based on the weight of the alkaline metal alginate of a calcium salt (Abstract). The composition may be administered orally to reacts with gastric acid to form a raft on the contents of the stomach (page 4, lines 3 – 4). Larsen discloses a pharmaceutical liquid composition comprising potassium bicarbonate and at least 8% w/v sodium alginate that has an improved pourability (page 4, lines 9 – 12). Furthermore, Larsen also teaches that the alkaline salt may be mixed with a surfactant prior to mixing (page 13, lines 28 – 29).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of a composition comprising sodium alginate, calcium pantothenate, sodium bicarbonate, dextrose, grapefruit seed extract, deionized water, natural flavor, and polylysine as taught by Reflex Gourmet with the amount of sodium alginate and the addition of surfactant in view of Larsen because Larsen’s invention is a pharmaceutical composition that comprises sodium alginate and alkaline salt as well as other excipients that will form a raft. One would have been motivated to combine Reflux Gourmet in view of Larsen because both references teach the formation of raft and the combination will yield predictable results. Therefore, one of the skills in the art would have a reasonable expectation of success by combining the teachings of a composition comprising sodium alginate, calcium pantothenate, sodium bicarbonate, dextrose, grapefruit seed extract, deionized water, natural flavor, and polylysine as taught by Reflex Gourmet with the amount of sodium alginate and the addition of surfactant in view of Larsen as Reflux Gourmet teaches the composition comprising sodium alginate, calcium pantothenate, sodium bicarbonate, dextrose, grapefruit seed extract, deionized water, natural flavor, and polylysine and Larsen teaches the common formulation of sodium alginate products that will yield to predictable results.
Claims 1 – 2, 4, 10 – 11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Smolarz (WO2019/169137A1) with evidence provided by Adusumilli et al. (US2005/0202084A1) in view of Dettmar et al. (US6391294B1), Jade (University Health News, 2020, Reference included with PTO-892), and Franco (Reflux Gourmet, 2019, Reference included with PTO-892).
c. Regarding claims 1 – 2, 10 – 11, and 19, Smolarz teaches a pharmaceutical composition for the treatment of acid reflux diseases by creating a mechanical barrier or raft (para. [0001] and [0042])). The pharmaceutical composition comprising alginate salts in an amount from about 800 mg to about 1200 mg, sodium bicarbonate in an amount from about 30 mg to about 70 mg, calcium carbonate in an amount from about 50 mg to about 70 mg, citric acid in an amount from about 400 mg to about 600 mg, and one or more natural or artificial sweetener or flavorants in an amount from about 400 mg to about 600 mg (para. [0031]). In an aspect, the alginate salt comprises sodium alginate (para. [0024]). In another aspect, natural flavorants may be an extractive that contains flavoring constituents derived from fruit (para. [0069]). A solid dosage forms for oral administration may be prepared by mixing the active ingredients with one or more pharmaceutically acceptable carriers or one or more pharmaceutically acceptable excipients (para. [0086] and [00110]), wherein the pharmaceutically acceptable carrier might be an aqueous solution of dextrose (para. [00113]).
However, Smolarz does not teach the composition comprises polylysine, grapefruit seed extract, and vitamin B5.
Dettmar et al. teach 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).
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).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition comprising sodium alginate, alkaline salt, such as sodium bicarbonate and calcium carbonate, and dextrose solution as taught by Smolarz by including polylysine in view of Dettmar et al. because of the predictive result of a bioadhesive coating to adhere the active agents to the stomach for the purpose of neutralizing stomach acid in a subject. It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition comprising sodium alginate, alkaline salt, such as sodium bicarbonate and calcium carbonate, dextrose solution and polylysine as taught by Smolarz and Dettmar et al. by choosing dextrose because Adusumilli et al. provide evidence to support that it is known in the art to use dextrose commonly as a bulk sweetener with alginate product for the suppression of gastric reflux (Abstract; page 8, para. [0097]). It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition comprising sodium alginate, alkaline salt, such as sodium bicarbonate and calcium carbonate, dextrose solution and polylysine as taught by Smolarz and Dettmar et al. by including grapefruit seed extract in view of Jade because Jade teaches that grapefruit seed extract is an antioxidant and is known to treat digestive disturbances. It would have been obvious to modify the composition as taught by Smolarz and Dettmar et al. to include grapefruit seed extract because it is known in the art to combine components that are used for the same purpose. It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition comprising sodium alginate, alkaline salt, such as sodium bicarbonate and calcium carbonate, dextrose solution, polylysine, and grapefruit seed extract as taught by Smolarz, Dettmar et al., and Jade by including vitamin B5 in view of Franco because it is a known alternative source of calcium ions that has been used commonly along with alginate to form the alginate raft. Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to modify the composition comprising sodium alginate, alkaline salt, such as sodium bicarbonate and calcium carbonate, and dextrose solution as taught by Smolarz with evidence provided by Adusumilli et al. to include polylysine, grapefruit seed extract, and vitamin B in view of Dettmar et al., Jade, and Franco because it is well known to combine components that are used for the same purpose.
Claims 7, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Smolarz (WO2019/169137A1) with evidence provided by Adusumilli et al. (US2005/0202084A1) in view of Dettmar et al. (US6391294B1), Jade (University Health News, 2020, Reference included with PTO-892), and Franco (Reflux Gourmet, 2019, Reference included with PTO-892) as applied to claims 1 – 2, 4, 10 – 11, and 19 above, and further in view of Larsen (CA2795521A1, cited in the previous Office Action).
d. Regarding claims 7, 9, and 12, the references teach the limitations discussed above.
However, these reference do not teach the composition further comprising liquid potassium bicarbonate and at least 10% w/v sodium alginate (claim 7) and do not teach the alkaline salt is mixed with a surfactant (claim 9).
Larsen teaches a pharmaceutical composition comprising an alkaline metal alginate, an alkaline salt, and less than % by weight based on the weight of the alkaline metal alginate of a calcium salt (Abstract). The composition may be administered orally to reacts with gastric acid to form a raft on the contents of the stomach (page 4, lines 3 – 4). Larsen discloses a pharmaceutical liquid composition comprising potassium bicarbonate and at least 8% w/v sodium alginate that has an improved pourability (page 4, lines 9 – 12). Furthermore, Larsen also teaches that the alkaline salt may be mixed with a surfactant prior to mixing (page 13, lines 28 – 29).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the composition comprising sodium alginate, vitamin B5, sodium bicarbonate, dextrose solution, grapefruit seed extract, and polylysine as taught by Smolarz, Dettmar et al., Jade, and Franco with the amount of sodium alginate and the addition of surfactant in view of Larsen because Larsen’s invention is a pharmaceutical composition that comprises sodium alginate and alkaline salt as well as other excipients that will form a raft. One would have been motivated to combine the teachings of Smolarz, Dettmar et al., Jade, and Franco in view of Larsen because these references teach the formation of raft using alginate and the combination will yield predictable results. Therefore, one of the skills in the art would have a reasonable expectation of success combine the composition comprising sodium alginate, vitamin B5, sodium bicarbonate, dextrose solution, grapefruit seed extract, and polylysine as taught by Smolarz, Dettmar et al., Jade, and Franco with the amount of sodium alginate and the addition of surfactant in view of Larsen because the combination of Smolarz, Dettmar et al., Jade, and Franco teach the composition comprising sodium alginate, vitamin B5, sodium bicarbonate, dextrose, grapefruit seed extract, and polylysine for the treatment of digestive system and forming a raft and Larsen teaches the common formulation of sodium alginate products that will yield to predictable results.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed November 17, 2025, have been fully considered and are found to be not persuasive.
Regarding Larson, Applicant argues that Larson does not teach or suggest raising alginate to ≥ 10% w/v in the present of all natural preservative system while maintaining pourability. Applicant argues that there is no teaching in Larson to use vitamin B5 as the calcium containing agent. Applicant argues that the amended claim 7 now recites “further comprising” potassium bicarbonate and at least a 10% w/v sodium alginate in combination with polylysine, dextrose, and grapefruit seed extract and Larson does not address this limitation because Larson only discloses ≥ 8% w/v alginate, but not ≥ 10% w/v of sodium alginate. The disclosure of the alginate used in the liquid composition by Larson is within the claimed range. Based on the disclosure of Larson, one would have performed routine experimentation to discover the best amount of alginate for the optimal treatment and physical characteristics. Moreover, Larson is relied to cure the deficiency of the limitations “liquid potassium bicarbonate and at least 10% w/v sodium alginate” and “the alkaline salt is mixed with a surfactant”. Reflux Gourmet from the Amazon listing teaches vitamin B5 in the composition. The combination of Reflux Gourmet and Larson teaches the claimed composition, thereby, the intended results recited in the claims will be achieved.
Regarding claim 9, Applicant argues that the limitation “the alkaline salt is mixed with a surfactant” is not taught in Larson for the liquid, preservative defined context at issue. However, claim 9 depends from claim 1 and claim 1 does not explicitly recite the composition as a liquid. Therefore, the argument is not persuasive.
The rejections are proper and, therefore, are 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 – 2, 10, and 19 are provisionally rejected 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. (US6391294B1), Adusumilli et al. (US2005/0202084A1), and Jade (University Health News, 2020, Reference included with PTO-892).
a. Regarding claims 1 – 2, 10, and 19, ‘489 teaches a composition for forming a protective barrier in the stomach comprising sodium alginate, sodium bicarbonate, calcium pantothenate, ginger root powder, celery root powder, and aloe vera powder (claim 6).
However, ‘489 does not teach a composition comprising polylysine, grapefruit seed extract, and dextrose solution.
Dettmar et al. teach 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 et al. provide evidence to support that it is known in the art to use dextrose commonly as a bulk sweetener with alginate product for the suppression of gastric reflux (Abstract; page 8, para. [0097]) and the composition may be in liquid form (claim 107).
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).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition comprising sodium alginate, alkaline salt, such as sodium bicarbonate, and calcium pantothenate as taught by ‘489 by including polylysine in view of Dettmar et al. because of the predictive result of a bioadhesive coating to adhere the active agents to the stomach for the purpose of neutralizing stomach acid in a subject. It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition comprising sodium alginate, alkaline salt, such as sodium bicarbonate, calcium pantothenate, and polylysine as taught by ‘489 and Dettmar et al. by including dextrose in view of Adusumilli et al. because Adusumilli et al. provide evidence to support that it is known in the art to use dextrose commonly as a bulk sweetener with alginate product for the suppression of gastric reflux. It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition comprising sodium alginate, alkaline salt, such as sodium bicarbonate, calcium pantothenate, polylysine, and dextrose as taught by ‘489, Dettmar et al., and Adusumilli et al. by including grapefruit seed extract in view of Jade because Jade teaches that grapefruit seed extract is an antioxidant and is known to treat digestive disturbances. It would have been obvious to modify the composition as taught by ‘489 in view of Dettmar et al., Adusumilli et al., and Jade arrived the claimed composition because it is known in the art to combine components that are used for the same purpose, which is treating diseases of the stomach. Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to modify the composition comprising sodium alginate, alkaline salt, such as sodium bicarbonate, and calcium pantothenate as taught by ‘489 by including polylysine, dextrose, and grapefruit seed extract in view of Dettmar et al, Adusumilli et al., and Jade because it is well known to combine components that are used for the same purpose.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found to be allowable.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693