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 . Claims 1-20 filed June 06, 2024 are currently pending.
Priority
Acknowledgement is made of Applicant’s claim to priority from foreign application 202410177509.7 filed 02/08/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 6 and 12 are objected to because of the following informalities: Claims 6 and 12 recite the phrase “The emulsifier”. Appropriate correction from “The emulsifier” to “the emulsifier” is required.
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.
Claim(s) 1-2, 4, 6 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chamberlin (U.S Patent 10,874,116 published 12/29/2020).
Chamberlin (U.S Patent 10,874,116 published 12/29/2020) teaches a pectin gel composition comprising a gelling pectin, an emulsifying pectin, the fat soluble substance docosahexaenoic acid (DHA), wherein DHA is present in 4-20% of the gel, the mass ratio of gelling pectin: emulsifying pectin is 4:1 to 1:1, and the amount of emulsifying pectin is 0.1-2% wt. of the composition. (col. 13 lines 35-40, Table 5, claim 1, 3, 5-6, 10). Chamberlin teaches that the gelling pectin in a high methoxymethyl pectin, with a degree of esterification of 50% or greater (col. 6 lines 30 through col. 7 lines 10). As evidenced by [0010] of the instant specification, docosahexaenoic acid reads on “a fat soluble substance”. As shown in Table 5, the mass ratio of gelling pectin to emulsifying pectin is 1.3:1.0, which reads on the present claims. Regarding claim 6, Chamberlin teaches that the emulsifying pectin comprises higher protein content, including beet pectin with a protein content of 10%, or an apple, pear or potato which comprises a protein content of 2-3%, which reads on the limitations found in [0027] of the present specification (col. 7 lines 30-60). Chamberlin teaches that the high methoxymethyl pectin comprises a pH of 2.5-4.0 (col. 7 lines 1-10, claim 1). Regarding claim 20, Chamberlin teaches that said pectin gel composition is in a dosage form of a confectionary gummy candy.
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.
Claim(s) 1-4, 6-9, 13-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Chamberlin (U.S Patent 10,874,116 published 12/29/2020) and Goto (US2012/0029017 published 02/02/2012).
Chamberlin (U.S Patent 10,874,116 published 12/29/2020) teaches a pectin gel composition comprising a gelling pectin, an emulsifying pectin, the fat soluble substance docosahexaenoic acid (DHA), wherein DHA is present in 4-20% of the gel, the mass ratio of gelling pectin: emulsifying pectin is 4:1 to 1:1, and the amount of emulsifying pectin is 0.1-2% wt. of the composition. (col. 13 lines 35-40, Table 5, claim 1, 3, 5-6, 10). Chamberlin teaches that the gelling pectin in a high methoxymethyl pectin, with a degree of esterification of 50% or greater (col. 6 lines 30 through col. 7 lines 10). As evidenced by [0010] of the instant specification, docosahexaenoic acid reads on “a fat soluble substance”. As shown in Table 5, the mass ratio of gelling pectin to emulsifying pectin is 1.3:1.0, which reads on the present claims. Regarding claim 6, Chamberlin teaches that the emulsifying pectin comprises higher protein content, including beet pectin with a protein content of 10%, or an apple, pear or potato which comprises a protein content of 2-3%, which reads on the limitations found in [0027] of the present specification (col. 7 lines 30-60). Chamberlin teaches that the high methoxymethyl pectin comprises a pH of 2.5-4.0 (col. 7 lines 1-10, claim 1). Regarding claim 20, Chamberlin teaches that said pectin gel composition is in a dosage form of a confectionary gummy candy.
Regarding claim 3, Chamberlin also teaches that Vitamin B12 is a suitable therapeutically active agent to incorporate into the pectin gel composition (col. 3 lines 1-5). As evidenced by Vitamins and Minerals (University of Maryland Extension, Published 04/29/2022) Vitamin B12 is a water soluble vitamin (pages 1-2), which reads on a “water soluble physiologically active substance” as found in paragraphs [0011]-[0012] of the instant specification.
Regarding claim 7, Chamberlin teaches that the gelling pectin is a high methoxymethyl pectin comprises a pH of 2.5-4.0 and a degree of esterification greater than 50% (col. 7 lines 1-10, col. 13 line 35-40 claim 1). Chamberlin teaches the mass ratio of gelling pectin: emulsifying pectin is 4:1 to 1:1, and the amount of emulsifying pectin is 0.1-2% wt. of the composition. As such, claim 1 of Chamberlin embraces a composition wherein the emulsifying pectin is present in 0.5% wt. of the composition and the gelling pectin is present in 4:1 mass ratio of gelling pectin: emulsifying pectin. Said composition results in a mass percentage of 2% wt. high methoxymethyl gelling pectin, which overlaps with the amounts embraced in claim 7. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 13, Chamberlin also teaches that the gelling pectin may also be a low methoxymethyl pectin comprising a pH of 2.5-4.0 and a degree of esterification less than 50% (col. 6 lines 40-50, col. 7 lines 10-15, col 11 line 10-20, col. 13 line 35-40, col. 16-col. 17 line 15, Example 7, claim 1). Chamberlin teaches the mass ratio of gelling pectin: emulsifying pectin is 4:1 to 1:1, and the amount of emulsifying pectin is 0.1-2% wt. of the composition. As such, claim 1 of Chamberlin embraces a composition wherein the emulsifying pectin is present in 0.5% wt. of the composition and the gelling pectin is present in 4:1 mass ratio of gelling pectin: emulsifying pectin, said composition results in a mass percentage of 2% wt. low methoxymethyl gelling pectin, which overlaps with the amounts embraced in claim 7. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The difference between the pectin gel composition of Chamberlin and the present claims is that Chamberlin does not specifically teach the incorporation of calcium ions in a mass percentage between 0.02-0.24% to the pectin gel composition. In addition, Chamberlin does not specifically teach incorporating an amino acid into the pectin gel composition.
Goto (US2012/0029017 published 02/02/2012) teaches pectin gel compositions for oral administration of poorly soluble therapeutic agents (abstract; [0023]). Goto teaches that the pectin comprises a degree of esterification of 20-35% ([0024]). Pectin is present in 1-3% wt. of the composition ([0025]). Goto teaches incorporating calcium salts into the pectin composition, such as calcium lactate to stabilize the pectin composition, in amounts of 0.005-0.1% wt. of the composition. Said amount of calcium salt overlaps with the amount embodied in claim 16 and 18 ([0026]). Goto also teaches that said pectin composition comprises a pH of 2.5-4 and teaches employing pH adjusters to maintain the desired pH. Amino acids glycine and alanine are taught by Goto as desirable pH adjusting agents to maintain said pH ([0031]-[0032]). Regarding the limitation of claim 9, Goto teaches incorporation of a combination of glycerol and erythritol to enhance the rupture strength of the pectin composition, wherein the glycerol: erythritol weight ratio is from 1:1.5 ([0033]-[0036], Table 4).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to incorporate calcium ions in a mass percentage between 0.02-0.24% to the pectin gel composition of Chamberlin as well as utilize an amino acid as the pH adjusting agent in the pectin gel composition of Chamberlin comprising a gelling pectin, an emulsifying pectin and the fat soluble substance docosahexaenoic acid in view of Goto.
MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, it was known in the prior art to incorporate calcium lactate in overlapping 0.005-0.1% wt. amounts to pectin compositions to improve stability coupled with the knowledge that amino acids alanine and glycine are suitable pH adjusting agents to maintain the pH of the pectin composition between 2.5-4. Accordingly, said artisan would have combined the prior art teachings of calcium ions and amino acid pH stabilizers in pectin gel compositions of Goto, and apply them to the pectin gel composition of Chamberlin, arriving at the presently claimed with a reasonable expectation of success.
Secondly, said skilled artisan would have found it prima facie obvious to incorporate a combination of the sugar alcohol erythritol and glycerol to the pectin gel composition of Chamberlin in view of Goto, in order to improve the rupture strength of pectin gel composition as taught by Goto.
It is noted that the combination of Chamberlin and Goto do not specifically teach wherein the content of soluble solids is 55% wt. or more in the pectin gel composition (claim 8, 14), the ratio of glycerol: erythritol is 5:1 to 75:1 (claim 9), or the amino acid pH adjusting agent is present in less than 10% wt. of the composition (claim 19). However, it is considered well within the capabilities of one of ordinary skill in the art to optimize the content of soluble solids, the ratio of glycerol: erythritol and the amount of pH adjusting amino acid in the pectin gel composition to provide optimal solubility conditions for the fat soluble substance in the pectin gel composition. The content of soluble solids, the ratio of glycerol: erythritol and the amount of pH adjusting amino acid in the pectin gel composition are each a result effective parameter that will affect the physical properties of the final composition and as recited in both Chamberlin and Goto. Said properties are clearly a results effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal percentage of soluble solids, the ratio of glycerol: erythritol and the amount of pH adjusting amino acid in the pectin gel composition to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claim(s) 1-4, 6-7, 10-12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Chamberlin (U.S Patent 10,874,116 published 12/29/2020) and Fang (US2008/0124437 published 05/29/2008).
Chamberlin (U.S Patent 10,874,116 published 12/29/2020) teaches a pectin gel composition comprising a gelling pectin, an emulsifying pectin, the fat soluble substance docosahexaenoic acid (DHA), wherein DHA is present in 4-20% of the gel, the mass ratio of gelling pectin: emulsifying pectin is 4:1 to 1:1, and the amount of emulsifying pectin is 0.1-2% wt. of the composition. (col. 13 lines 35-40, Table 5, claim 1, 3, 5-6, 10). Chamberlin teaches that the gelling pectin in a high methoxymethyl pectin, with a degree of esterification of 50% or greater (col. 6 lines 30 through col. 7 lines 10). As evidenced by [0010] of the instant specification, docosahexaenoic acid reads on “a fat soluble substance”. As shown in Table 5, the mass ratio of gelling pectin to emulsifying pectin is 1.3:1.0, which reads on the present claims. Regarding claim 6, Chamberlin teaches that the emulsifying pectin comprises higher protein content, including beet pectin with a protein content of 10%, or an apple, pear or potato which comprises a protein content of 2-3%, which reads on the limitations found in [0027] of the present specification (col. 7 lines 30-60). Chamberlin teaches that the high methoxymethyl pectin comprises a pH of 2.5-4.0 (col. 7 lines 1-10, claim 1). Regarding claim 20, Chamberlin teaches that said pectin gel composition is in a dosage form of a confectionary gummy candy. Regarding claim 3, Chamberlin also teaches that Vitamin B12 is a suitable therapeutically active agent to incorporate into the pectin gel composition (col. 3 lines 1-5). As evidenced by Vitamins and Minerals (University of Maryland Extension, Published 04/29/2022) Vitamin B12 is a water soluble vitamin (pages 1-2), which reads on a “water soluble physiologically active substance” as found in paragraphs [0011]-[0012] of the instant specification
Regarding claim 7, Chamberlin teaches that the gelling pectin is a high methoxymethyl pectin comprises a pH of 2.5-4.0 and a degree of esterification greater than 50% (col. 7 lines 1-10, col. 13 line 35-40 claim 1). Chamberlin teaches the mass ratio of gelling pectin: emulsifying pectin is 4:1 to 1:1, and the amount of emulsifying pectin is 0.1-2% wt. of the composition. As such, claim 1 of Chamberlin embraces a composition wherein the emulsifying pectin is present in 0.5% wt. of the composition and the gelling pectin is present in 4:1 mass ratio of gelling pectin: emulsifying pectin. Said composition results in a mass percentage of 2% wt. high methoxymethyl gelling pectin, which overlaps with the amounts embraced in claim 7. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Regarding claims 10-12, Chamberlin teaches that additional emulsifiers are suitable to incorporate into the pectin gel composition in order to enhance the texture of the pectin gel composition including the phospholipid lecithin, gum Arabic, carboxymethylcellulose (col. 9 lines 10-25).
The difference between the pectin gel composition of Chamberlin and the present claims is that Chamberlin does not specifically teach the incorporation said phospholipid in 0.1-5% wt. of the composition, nor modified starch in 0.1-4% wt. of the composition nor gum arabica in 1:1.5 to 1:4 weight ratio to the pectin.
Fang (US2008/0124437 published 05/29/2008) teaches preparation of compositions comprising the emulsifiers gum Arabica or modified starch with pectin. Said emulsifiers behave like conventional emulsifiers but increase the emulsifying capacity of the composition (abstract, [0017], [0034]). Fang teaches utilizing the emulsifiers gum arabica or modified starch in 1% wt. of the composition, Additionally, Fang teaches compositions wherein gum Arabic: pectin is 5:1 ratio, which reads on the amount embraced within the claims ([0034], Table 1).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to employ a phospholipid such as lecithin as an emulsifier, or alternatively employ gum arabica or modified starch as the emulsifier in the pectin gel composition of Chamberlin, as each emulsifier was taught as a suitable emulsifier for the pectin gel composition (col. 9 lines 10-25). Additionally, said skilled artisan would have found it prima facie obvious to employ the emulsifier of phospholipid, modified starch or gum arabica in 1% wt. of the composition in view of Fang, as said emulsifiers behave like conventional emulsifiers but increase the emulsifying capacity.
It is noted that the combination of Chamberlin and Fang does not specifically teach wherein the mass of gum Arabic: the mass of high-esterified pectin in the pectin gel composition is from 1-1: 1.5-8 (claim 12). However, it is considered well within the capabilities of one of ordinary skill in the art to optimize the ratio of gum Arabic to high-esterified pectin in the pectin gel composition to provide optimal emulsifying conditions for the pectin gel composition. The ratio of gum Arabic to high-esterified pectin in the pectin gel composition is a result effective parameter that will affect the physical properties of the final composition and as recited in both Chamberlin and Fang, clearly a results effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio of emulsifier gum Arabic to high-esterified pectin in the pectin gel composition to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claim(s) 1-4, 6, 13, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Chamberlin (U.S Patent 10,874,116 published 12/29/2020) and Buckley (U.S Patent 3,973,051 published 08/03/1976)
Chamberlin (U.S Patent 10,874,116 published 12/29/2020) teaches a pectin gel composition comprising a gelling pectin, an emulsifying pectin, the fat soluble substance docosahexaenoic acid (DHA), wherein DHA is present in 4-20% of the gel, the mass ratio of gelling pectin: emulsifying pectin is 4:1 to 1:1, and the amount of emulsifying pectin is 0.1-2% wt. of the composition. (col. 13 lines 35-40, Table 5, claim 1, 3, 5-6, 10). Chamberlin teaches that the gelling pectin in a low methoxymethyl pectin, with a degree of esterification of 50% or lower (col. 6 lines 30 through col. 7 lines 15, Example 7). As evidenced by [0010] of the instant specification, docosahexaenoic acid reads on “a fat soluble substance”. As shown in Table 5, the mass ratio of gelling pectin to emulsifying pectin is 1.3:1.0, which reads on the present claims. Regarding claim 6, Chamberlin teaches that the emulsifying pectin comprises higher protein content, including beet pectin with a protein content of 10%, or an apple, pear or potato which comprises a protein content of 2-3%, which reads on the limitations found in [0027] of the present specification (col. 7 lines 30-60). Chamberlin teaches that the high methoxymethyl pectin comprises a pH of 2.5-4.0 (col. 7 lines 1-10, claim 1). Regarding claim 20, Chamberlin teaches that said pectin gel composition is in a dosage form of a confectionary gummy candy. Regarding claim 3, Chamberlin also teaches that Vitamin B12 is a suitable therapeutically active agent to incorporate into the pectin gel composition (col. 3 lines 1-5). As evidenced by Vitamins and Minerals (University of Maryland Extension, Published 04/29/2022) Vitamin B12 is a water soluble vitamin (pages 1-2), which reads on a “water soluble physiologically active substance” as found in paragraphs [0011]-[0012] of the instant specification.
Regarding claim 13, Chamberlin also teaches that the gelling pectin may be a low methoxymethyl pectin comprising a pH of 2.5-4.0 and a degree of esterification less than 50% (col. 6 lines 40-50, col. 7 lines 10-15, col 11 line 10-20, col. 13 line 35-40, col. 16-col. 17 line 15, Example 7, claim 1). Chamberlin teaches the mass ratio of gelling pectin: emulsifying pectin is 4:1 to 1:1, and the amount of emulsifying pectin is 0.1-2% wt. of the composition. As such, claim 1 of Chamberlin embraces a composition wherein the emulsifying pectin is present in 0.5% wt. of the composition and the gelling pectin is present in 4:1 mass ratio of gelling pectin: emulsifying pectin, said composition results in a mass percentage of 2% wt. low methoxymethyl gelling pectin, which overlaps with the amounts embraced in claim 7. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The difference between the presently claimed and that of Chamberlin is that Chamberlin does not specifically teach wherein the low methoxymethyl esterified gelling pectin comprises an amide pectin, with a degree of amidation of the amide pectin is 12-25%.
Buckley (U.S Patent 3,973,051 published 08/03/1976) teaches pectin gel compositions utilizing high-methoxymethyl pectin (degree of esterification >50%), low low-methoxymethyl pectin (degree of esterification of <50%) and low-methoxymethyl pectin amide (abstract, col. 2 lines 1-50). Buckley teaches that low-methoxymethyl pectin amide having a degree of esterification of 20-33% and a degree of amidation of 20-25% has similar gelling properties to that of a low-methoxymethyl pectin (degree of esterification of 35 %) (col. 8 lines 15-40).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to substitute the low-methoxymethyl gelling pectin in the pectin gel composition of Chamberlin with a low-methoxymethyl pectin amide having a degree of esterification of 20-33% and a degree of amidation of 20-25% in view of Buckley, arriving at the presently claimed invention.
MPEP 2143 provides rationale for a conclusion of obviousness including (B): Simple substitution of one known element for another to obtain predictable results;
In the present case, it was known in the art of Buckley that low-methoxymethyl pectin amide having a degree of esterification of 20-33% and a degree of amidation of 20-25% comprises similar gelling properties to that of a low-methoxymethyl pectin (degree of esterification of 35 %). Accordingly, said artisan would have readily predicted that utilizing a low-methoxymethyl pectin amide having a degree of esterification of 20-33% and a degree of amidation of 20-25% as the gelling pectin the pectin gel composition would have resulted in the desired gelled composition.
Claim(s) 1-6, 20 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Chamberlin (U.S Patent 10,874,116 published 12/29/2020), Ibusuki (US2018/0042271 published 02/15/2018) and Colarow (CA2325330 published 12/12/1994).
Chamberlin (U.S Patent 10,874,116 published 12/29/2020) teaches a pectin gel composition comprising a gelling pectin, an emulsifying pectin, the fat soluble substance docosahexaenoic acid (DHA), wherein DHA is present in 4-20% of the gel, the mass ratio of gelling pectin: emulsifying pectin is 4:1 to 1:1, and the amount of emulsifying pectin is 0.1-2% wt. of the composition. (col. 13 lines 35-40, Table 5, claim 1, 3, 5-6, 10). Chamberlin teaches that the gelling pectin in a low methoxymethyl pectin, with a degree of esterification of 50% or lower (col. 6 lines 30 through col. 7 lines 15, Example 7). As evidenced by [0010] of the instant specification, docosahexaenoic acid reads on “a fat soluble substance”. As shown in Table 5, the mass ratio of gelling pectin to emulsifying pectin is 1.3:1.0, which reads on the present claims. Regarding claim 6, Chamberlin teaches that the emulsifying pectin comprises higher protein content, including beet pectin with a protein content of 10%, or an apple, pear or potato which comprises a protein content of 2-3%, which reads on the limitations found in [0027] of the present specification (col. 7 lines 30-60). Chamberlin teaches that the high methoxymethyl pectin comprises a pH of 2.5-4.0 (col. 7 lines 1-10, claim 1). Regarding claim 20, Chamberlin teaches that said pectin gel composition is in a dosage form of a confectionary gummy candy. Regarding claim 3, Chamberlin also teaches that Vitamin B12 is a suitable therapeutically active agent to incorporate into the pectin gel composition (col. 3 lines 1-5). As evidenced by Vitamins and Minerals (University of Maryland Extension, Published 04/29/2022) Vitamin B12 is a water soluble vitamin (pages 1-2), which reads on a “water soluble physiologically active substance” as found in paragraphs [0011]-[0012] of the instant specification.
The difference between the presently claimed and that of Chamberlin is that Chamberlin does not specifically teach wherein the emulsified pectin comprises lipophilic groups of 5-35% and phospholipid emulsifiers comprise phospholipids phosphatidylethanolamine and phosphatidylinositol.
Ibusuki (US2018/0042271 published 02/15/2018) teaches compositions comprising glycerophospholipids and pectin (abstract, [0010]-[0018], [0030]). Ibusuki teaches that the phospholipid phosphatidylethanolamine works synergistically with pectin to provide high storage stability in small amounts in order to avoid unpleasant tastes ([0030]).
Colarow (CA2325330 published 12/12/1994) teaches that pectin stabilizes the phospholipid phosphatidylinositol (page 4 lines 15-25).
Therefore, one of ordinary skill in the art of preparing a pectin gel composition comprising a gelling pectin, an emulsifying pectin, the fat soluble substance docosahexaenoic acid as taught by Chamberlin, said artisan would have found it prima facie obvious to modify the emulsifying pectin with phospholipids phosphatidylethanolamine and phosphatidylinositol in view of Ibusuki and Colarow, arriving at the presently claimed invention.
MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, the combination of Ibusuki and Colarow teach synergistic relationships with pectin and the phospholipids phosphatidylethanolamine and phosphatidylinositol, wherein both phospholipids yield stabilizing effects to pectin. Accordingly, said skilled artisan would have readily predicted that the emulsifying pectin in the pectin gel composition of Chamberlin, further containing the phospholipids phosphatidylethanolamine and phosphatidylinositol would have stabilized the pectin gel composition.
It is noted that the combination of Chamberlin, Ibusuki and Colarow do not specifically teach wherein the content of the lipophilic groups in the emulsified pectin are from 5-35%. However, it is considered well within the capabilities of one of ordinary skill in the art to optimize the lipophilic groups in the emulsifying pectin to provide optimal stability of the pectin gel composition. The percentage of lipophilic groups on the emulsifying pectin in the pectin gel composition is a result effective parameter that will affect the physical properties of the final composition. As recited in both Chamberlin, Ibusuki and Colarow, the amount of phospholipid with pectin is a results effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal percentage of lipophilic groups on the emulsifying pectin in the pectin gel composition to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CLINTON A BROOKS can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
Prosecution Insights