DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 19-20 are withdrawn.
Claims 1-10 and 12-17 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 11/14/2025 has been entered.
Claims 1-3 and 10 were amended. No new material was added.
Applicant’s amendments have overcome the previous rejections under 35 U.S.C. 112(b).
The rejections of claims 1-10 and 12-17 under 35 U.S.C. 103 have been modified to address the amendments and maintained.
Response to Arguments
Applicant’s arguments, see Remarks (pages 6-8), filed 11/14/2025, with respect to the rejection of claims 1-2 under 35 U.S.C. 103 over McCullough and Buehler have been fully considered and are persuasive due to the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McCullough, Buehler, and Carmella, as previously applied to claim 8.
Applicant's arguments with respect to the rejections of claims 3-6, 10, and 12-17 under 35 U.S.C. 103 over McCullough and Buehler have been fully considered but they are not persuasive.
Applicant argues that McCullough is completely silent with regard to using wet gel sucralfate (Remarks, page 6). This argument is not persuasive, because as previously stated, McCullough teaches sucralfate as a viscous gel in acid pH 3-4 (i.e., wet gel sucralfate; McCullough, column 5, line 21), which suggests a wet gel sucralfate.
Applicant argues that McCullough only describes that magnesium alginate treats via formation of a raft, but not sucralfate, and Applicant showed that magnesium alginate alone does not provide a suitable raft (Remarks, pages 6-7). This argument is not persuasive, because as stated previously, McCullough teaches sucralfate as a viscous gel in acid pH 3-4 (i.e., wet gel sucralfate; McCullough, column 5, line 21), which suggests a wet gel sucralfate, and therefore suggests the use of magnesium alginate and sucralfate. Therefore, showing that magnesium alginate alone does not provide a suitable raft does not overcome the rejection. McCullough teaches magnesium alginate is particularly useful for the formation of gelatinous foam or rafts which float on the stomach contents (McCullough, column 2, lines 37-39), and Buehler teaches the use of two different viscosity magnesium alginates in order to form a stable, well-knitted raft (Buehler, columns 3-4), suggesting raft formation is known in the art and one of ordinary skill would desire to produce a composition capable of raft formation.
Applicant argues that Buehler requires two different alginates, while the claimed combination contains only one (Remarks, pages 7-8). This argument is not persuasive, because McCullough does not teach the presence of more than one alginate, as demonstrated in the previous rejections. Further, regarding claims 3-10 and 12-17, there is no limitation in the claims requiring the presence of only one alginate.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 1-10 and 12-17 are considered to have an effective filing date of 01/04/2021.
Modified/Maintained 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.
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 3-6, 10, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 5447918 A; IDS reference, 05/17/2022) in view of Buehler (EP 179858 B1) and Caramella (EP 0286978 A1). References were cited previously by the Examiner.
Regarding claim 3, McCullough teaches a pharmaceutical composition (McCullough, column 1, line 15), which can be a liquid formulation in water (i.e., aqueous) comprising magnesium alginate, sucralfate, sorbitol (i.e., an excipient), and magnesium carbonate (McCullough, column 14, example 5). McCullough teaches sucralfate as a basic aluminum hydroxide salt of sucrose octasulfate and teaches the compound results in viscous gel in acid (McCullough, column 5, line 21). McCullough does not specifically teach the liquid formulation is an oral formulation, but does teach co-administration with aspirin (McCullough, column 6, line 33) and teaches aspirin is widely administered orally (McCullough, column 1, line 67), suggesting the composition to also be orally administered. As above, McCullough does not teach a specific magnesium alginate, but does teach magnesium alginate is an epigastralgia-relieving agent (McCullough, column 7, line 47). Buehler teaches an antacid composition comprising magnesium alginate and magnesium carbonate (Buehler, claim 1) in which the magnesium alginate can have a ratio of mannuronic acid to guluronic acid of 1.56 (i.e., an M/G ratio greater than 1.0; Buehler, page 4, table 1). McCullough teaches magnesium alginate is particularly useful for the formation of gelatinous foam or rafts which float on the stomach contents (McCullough, column 2, lines 37-39), and Buehler teaches the use of two different viscosity magnesium alginates in order to form a stable, well-knitted raft (Buehler, columns 3-4), suggesting raft formation is known in the art.
McCullough and Buehler are both considered to be analogous to the claimed invention, because all are in the same field of pharmaceutical compositions for gastrointestinal disorders. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of McCullough to have included the specific magnesium alginate taught by Buehler to arrive at the claimed invention, because Buehler teaches the proportion of mannuronic to guluronic acid residues varies and depends on the algae source used (Buehler, page 4, line 1), and because one of ordinary skill would desire to produce a composition capable of raft formation based on the teachings of both McCullough and Buehler.
Regarding claim 4, McCullough and Buehler together teach all the elements of the invention as applied to claim 3. McCullough further teaches the composition can comprise potassium bicarbonate (i.e., a carbonate salt of an alkali metal; McCullough, column 7, line 9).
Regarding claim 5, McCullough and Buehler together teach all the elements of the invention as applied to claim 3. As above, Buehler teaches the magnesium alginate can have a ratio of mannuronic acid to guluronic acid of 1.56 (i.e., an M/G ratio greater than or equal to 1.5; Buehler, page 4, table 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of McCullough to have included the specific magnesium alginate taught by Buehler to arrive at the claimed invention, because Buehler teaches the proportion of mannuronic to guluronic acid residues varies and depends on the algae source used (Buehler, page 4, line 1).
Regarding claim 6, McCullough and Buehler together teach all the elements of the invention as applied to claim 3. As above, Buehler teaches the magnesium alginate can have a ratio of mannuronic acid to guluronic acid of 1.56 (i.e., an M/G ratio ranges from 1.5 to 3; Buehler, page 4, table 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of McCullough to have included the specific magnesium alginate taught by Buehler to arrive at the claimed invention, because Buehler teaches the proportion of mannuronic to guluronic acid residues varies and depends on the algae source used (Buehler, page 4, line 1) and teaches algae sources with the claimed M/G ratio to be preferred in pharmaceutical compositions (Buehler, page 4, lines 26-34).
Regarding claim 10, McCullough and Buehler together teach all the elements of the invention as applied to claim 3. McCullough teaches a composition comprising 250-500 mg of sucralfate and 150-300 mg of aluminum hydroxide-magnesium carbonate gel per 5 mL dose (McCullough, column 14, example 5), resulting in 5-10% and 3-6% of the composition respectively, which overlaps the claimed ranges of 10-40% and 1-7%. 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). McCullough further teaches epigastralgia-relieving agents include compounds such as aluminum hydroxide, magnesium carbonate, and gels or mixtures of combinations thereof (McCullough, column 7, lines 39-45), suggesting magnesium carbonate would be a reasonable alternative for an aluminum hydroxide-magnesium carbonate gel. McCullough further teaches the sucralfate gel offers more a mucosal protective effect when compared to a clear solution of sucrose octasulfate (McCullough, column 5, lines 63-66), suggesting the wet gel sucralfate as claimed would be a reasonable alternative for sucralfate. It would have been prima facie obvious to one of ordinary skill in the art that the reasonable alternatives could be used in the same amount. McCullough teaches the composition comprises magnesium alginate (McCullough, column 14, example 5), but not in the claimed amount. Buehler, however, teaches a composition comprising 250 mg of magnesium alginate per 5 mL dose (Buehler, page 6, example 1) resulting in 5% of the composition, which lies within the claimed range of 2.5-7%. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of McCullough to have included the specific magnesium alginate taught by Buehler to be preferred in pharmaceutical compositions (Buehler, page 4, lines 26-34) in the amount taught to be preferable (Buehler, page 6, line 12).
Regarding claim 12, McCullough and Buehler together teach all the elements of the invention as applied to claim 3. McCullough teaches sorbitol (i.e., a pharmaceutically acceptable excipient; McCullough, column 14, example 5).
Regarding claim 13, McCullough and Buehler together teach all the elements of the invention as applied to claim 12. McCullough teaches sorbitol (McCullough, column 14, example 5).
Regarding claim 14, McCullough and Buehler together teach all the elements of the invention as applied to claim 3. McCullough teaches patients receive a 5 mL dose (i.e., a monodose; McCullough, column 11, line 13).
Regarding claim 15, McCullough and Buehler together teach all the elements of the invention as applied to claim 14. McCullough teaches patients receive a 5 mL dose (i.e., a monodose; McCullough, column 11, line 13) of a composition comprising 500-600 mg of magnesium alginate, 250-500 mg of sucralfate, and 150-300 mg of aluminum hydroxide-magnesium carbonate gel per 5 mL (i.e., an individual dosing unit; McCullough, column 14, example 5), which overlaps the claimed ranges of 0.2-2 g, 0.2-2 g, and 0.2-0.5 g, respectively. 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). McCullough teaches epigastralgia-relieving agents include compounds such as aluminum hydroxide, magnesium carbonate, and gels or mixtures of combinations thereof (McCullough, column 7, lines 39-45), suggesting magnesium carbonate would be a reasonable alternative for an aluminum hydroxide-magnesium carbonate gel. It would have been prima facie obvious to one of ordinary skill in the art that the reasonable alternative could be used in the same amount.
Regarding claim 16, McCullough and Buehler together teach all the elements of the invention as applied to claim 3. McCullough teaches a composition absent of calcium salts (McCullough, column 14, example 5).
Regarding claim 17, McCullough and Buehler together teach all the elements of the invention as applied to claim 3. McCullough teaches a composition which is a liquid suspension (i.e., colloidal; McCullough, column 13, line 1) in water (i.e., aqueous; McCullough, column 14, example 5).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 5447918 A; IDS reference, 05/17/2022) and Buehler (EP 179858 B1) as applied to claims 3-6, 10, and 12-17, further in view of McHugh (Food and Agriculture Organization, 1987). References were cited previously by the Examiner.
Regarding claim 7, McCullough and Buehler together teach all the elements of the invention as applied to claim 6. McCullough does not teach a specific magnesium alginate and Buehler teaches examples of magnesium alginate which include alginic acid with M/G ratios of up to 1.95 (Buehler, page 3, line 57; table 1). McHugh, however, teaches examples of commercial alginic acid sources to include M/G ratios of up to 3.18, with alginic acid from Laminaria japonica having an M/G ratio of 2.34-3.18 depending on the time of year the algae is sourced (McHugh, table 1), which suggests that an M/G ratio of 2.5 would be possible depending on the time of year. McCullough, Buehler, and McHugh are considered to be analogous to the claimed invention, because all are in the same field of pharmaceutical compositions comprising alginic acid. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of McCullough and Buehler to have included an alginic acid source with an M/G ratio of 2.5, because McHugh teaches certain sources of alginic acid to grow preferentially in certain geographical areas (McHugh, paragraphs 1-3) and the M/G ratio is dependent on the time of year the algae is sourced (McHugh, table 1).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 5447918 A; IDS reference, 05/17/2022) and Buehler (EP 179858 B1) as applied to claims 3-6, 10, and 12-17, further in view of Caramella (EP 0286978 A1). References were cited previously by the Examiner.
Regarding claim 8, McCullough and Buehler together teach all the elements of the invention as applied to claim 4. McCullough teaches sucralfate as a viscous gel in acid pH 3-4 (i.e., wet gel sucralfate; McCullough, column 5, line 21), but does not specify the percent water content. Caramella teaches a wet gel sucralfate-containing pharmaceutical composition (Caramella, claim 1) for treating gastric ulcers (Caramella, page 2, line 3), in which an acid is used to produce a wet gel sucralfate (Caramella, claim 1) with a water content of 30-80% (Caramella, claim 12), which overlaps the claimed range of 60-80%. 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).
McCullough, Buehler, and Caramella are all considered to be analogous to the claimed invention, because all are in the same field of pharmaceutical compositions for gastrointestinal disorders. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of producing a wet gel sucralfate taught by Caramella in order to obtain the wet gel sucralfate taught by McCullough, because McCullough does not specify the amount of acid needed, while Caramella demonstrates a method known in the field to produce such a sucralfate.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 5447918 A; IDS reference, 05/17/2022) and Buehler (EP 179858 B1) as applied to claims 3-6, 10, and 12-17, further in view of Luber (US 5112813 A). References were cited previously by the Examiner.
Regarding claim 9, McCullough and Buehler together teach all the elements of the invention as applied to claim 4. McCullough teaches antacid substances to neutralize acid, including sodium bicarbonate as an example (McCullough, column 7, line 5), but does not teach sodium carbonate. Luber teaches an antacid composition comprising magnesium alginate and magnesium carbonate (Luber, claim 4) and teaches an antacid material such as sodium carbonate or bicarbonate (Luber, column 3, line 9). McCullough, Buehler, and Luber are all considered to be analogous to the claimed invention, because all are in the same field of pharmaceutical compositions for gastrointestinal disorders. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of McCullough and Buehler to use sodium carbonate in place of sodium bicarbonate, because Luber teaches the two salts to be reasonable alternatives to act as the antacid material (Luber, column 3, line 3).
New Claim Rejections - 35 USC § 103
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 5447918 A; IDS reference, 05/17/2022) in view of Buehler (EP 179858 B1) and Caramella (EP 0286978 A1). References were cited previously by the Examiner.
Regarding claim 1, McCullough teaches a composition comprising sucralfate and one or more antiacid epigastralgic relieving agents such as magnesium carbonate (McCullough, claim 8), and further teaches an epigastralgic relieving agent which is a metal salt of alginate (McCullough, claim 10), suggesting the sucralfate, magnesium carbonate, and metal salt of alginate as the only required ingredients. McCullough exemplifies a composition comprising magnesium alginate, sucralfate, and magnesium carbonate McCullough, column 14, example 5), and therefore it would be obvious to one of ordinary skill in the art to utilize magnesium alginate as the metal salt of alginate. McCullough teaches sucralfate as a basic aluminum hydroxide salt of sucrose octasulfate and teaches the compound results in viscous gel in acid (McCullough, column 5, line 21). McCullough teaches magnesium carbonate to neutralize acid (i.e., basic; McCullough, column 7, line 11). McCullough does not teach a specific magnesium alginate, but does teach magnesium alginate is an epigastralgia-relieving agent (McCullough, column 7, line 47). Buehler teaches an antacid composition comprising magnesium alginate and magnesium carbonate (Buehler, claim 1) in which the magnesium alginate can have a ratio of mannuronic acid to guluronic acid of 1.56 (i.e., an M/G ratio greater than 1.0; Buehler, page 4, table 1). McCullough teaches magnesium alginate is particularly useful for the formation of gelatinous foam or rafts which float on the stomach contents (McCullough, column 2, lines 37-39), and Buehler teaches the use of two different viscosity magnesium alginates in order to form a stable, well-knitted raft (Buehler, columns 3-4). McCullough teaches sucralfate as a viscous gel in acid pH 3-4 (i.e., wet gel sucralfate; McCullough, column 5, line 21), but does not specify the percent water content. Caramella teaches a wet gel sucralfate-containing pharmaceutical composition (Caramella, claim 1) for treating gastric ulcers (Caramella, page 2, line 3), in which an acid is used to produce a wet gel sucralfate (Caramella, claim 1) with a water content of 30-80% (Caramella, claim 12), which overlaps the claimed range of 60-80%. 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).
McCullough, Buehler, and Caramella are all considered to be analogous to the claimed invention, because all are in the same field of pharmaceutical compositions for gastrointestinal disorders. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of McCullough to have included the specific magnesium alginate taught by Buehler to arrive at the claimed invention, because Buehler teaches the proportion of mannuronic to guluronic acid residues varies and depends on the algae source used (Buehler, page 4, line 1), and based on the teachings of both McCullough and Buehler, raft formation is known in the art and one of ordinary skill would desire to produce a composition capable of raft formation. Further, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of producing a wet gel sucralfate taught by Caramella in order to obtain the wet gel sucralfate taught by McCullough, because McCullough does not specify the amount of acid needed, while Caramella demonstrates a method known in the field to produce such a sucralfate.
Regarding claim 2, McCullough, Buehler, and Caramella together teach all the elements of the invention as applied to claim 1. McCullough teaches a composition comprising 500-600 mg of magnesium alginate, 250-500 mg of sucralfate, and 150-300 mg of aluminum hydroxide-magnesium carbonate gel (McCullough, column 14, example 5), resulting in a weight ratio ranging from 1.0 / 0.5-1.0 / 0.3-0.6 to 1.0 / 0.4-0.8 / 0.2-0.5, which overlaps the claimed range of 1.0 / 0.5-1.0 / 0.2-0.5. 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). McCullough further teaches epigastralgia-relieving agents include compounds such as aluminum hydroxide, magnesium carbonate, and gels or mixtures of combinations thereof (McCullough, column 7, lines 39-45), suggesting magnesium carbonate would be a reasonable alternative for an aluminum hydroxide-magnesium carbonate gel. McCullough further teaches the sucralfate gel offers more a mucosal protective effect when compared to a clear solution of sucrose octasulfate (McCullough, column 5, lines 63-66), suggesting the wet gel sucralfate as claimed would be a reasonable alternative for sucralfate. It would have been prima facie obvious to one of ordinary skill in the art that the reasonable alternatives could be used in the same amount.
Conclusion
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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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613