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 listing of 6/22/2023 includes claims 1-29, which are examined in the application.
Claim Objections
Claims 5, 7,16, 18, 21 are objected for the following informalities:
Claims 5 and 21 are objected to because of the following informalities: in claim 5, line 2, “magnesium chloride” is followed by “.”, a period, the period should be replaced by a “,” Comma. Claim 21 in line 2 also has the same issue with a period after “magnesium chloride”, it should also be replaced by a comma. Appropriate correction is required.
Claim 7, line 3 has a typographical error: “erythiol” should be “erythritol”. Appropriate correction is required.
Claim 16 is objected to for the recitation of “a composition for an additive” in line 1, which should be “a composition of an additive”. Appropriate correction is required.
Claim 18 is objected to for the recitation of “claims 17”in line 1, which should be “claim 17”. Appropriate correction is required.
Claim 21 is further objected to for typographical error where term “potassium”, appears between “potassium tartaric” and “zinc lactate” without any other acidic suffix. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (second Paragraph)
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 5, 7, 10, 13-15, 18, 20-21, 24-27 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 pre-AIA the applicant regards as the invention.
Claim 5 is indefinite for the recitation of “The agent of claim 1, wherein the salt comprises zinc sulfate, tripotassium phosphate, calcium chloride, magnesium chloride. potassium chloride , sodium chloride, sodium, potassium, magnesium, calcium, and zinc salts of carboxylic acids such as: gluconic, glucaric, citric, lactic, maleic, tartaric or a combination thereof” where the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further, even disregarding the limitations after “such as” recitation of claim 5 is still unclear as it appears to indicate salt comprises all of “zinc sulfate, tripotassium phosphate, calcium chloride, magnesium chloride. potassium chloride , sodium chloride,” as well as “sodium, potassium, magnesium, calcium, and zinc salts of carboxylic acids or a combination thereof”, which is not supported by claim 1, which requires “a salt”, i.e., one salt. Correction and /or clarification is required.
Further for the purposes of this office action claim will be interpreted as “The agent of claim 1, wherein the salt comprises any one of zinc sulfate, tripotassium phosphate, calcium chloride, magnesium chloride. potassium chloride , sodium chloride, sodium, potassium, magnesium, calcium, and zinc salts of carboxylic acids
Claim 7 is indefinite for the recitation of “wherein the sweetening agent comprises acesulfame potassium, alitame, aspartame, cyclamate, saccharin, sucralose, monk fruit, stevioside and thaumatin; maple syrup, honey, molasses, glucose, fructose, erythritol, mannitol, xylitol, sorbitol, tagatose, or combinations thereof.”, where improper use of Markush language render the claim indefinite.
the MPEP mentions two acceptable phrases for Markush language:
-wherein R is a material selected from the group consisting of A, B, and C
-wherein R is A, B, or C
However, as recited the claim includes both “wherein the sweetening agent comprises acesulfame potassium, alitame, aspartame, cyclamate, saccharin, sucralose, monk fruit, stevioside and thaumatin; maple syrup, honey, molasses, glucose, fructose, erythritol, mannitol, xylitol, sorbitol, tagatose, or combinations thereof.”, which appears to indicate sweetening agent comprises all of the sweeteners from “acesulfame potassium, alitame, aspartame, cyclamate, saccharin, sucralose, monk fruit, stevioside and thaumatin;” and in addition sweetener includes one from the list of “maple syrup, honey, molasses, glucose, fructose, erythritol, mannitol, xylitol, sorbitol, tagatose, or combinations thereof”
Claim 10 recites the limitation " An ingestible composition comprising the composition of claim 7" in line 1. There is insufficient antecedent basis for “the composition” in the claim, as claim 7 does not recite a “composition” but recites a “sweetener”. Correction and /or clarification is required.
For the purpose of this office action the recitation will be regarded as “sweetener of claim 7”.
Claim 13 recites the limitation " A caffeinated beverage comprising the composition of any of claims 1 to 7" in line 1. There is insufficient antecedent basis for “the composition” in the claim, as claims 1- 7 do not recite a “ composition” but claims 1-5 recite an “agent” or “bitter masking agent”, claim 6 recites a sweetener comprising …the bitter masking agent” and 7 recite a “sweetener”. Correction and /or clarification is required. in the interest of expediting prosecution the recitation will be regarded as “the agent of” for claims 1-6 and/or “sweetener of claim 7”.
For the purpose of prior art application will be regarded as either “the agent of” for claims 1-6 or “sweetener of claim 7”.
Claim 14 recites the limitation “A cannabinoid-containing ingestible product comprising the composition of any of claims 1 to 7" in line 1. There is insufficient antecedent basis for “the composition” in the claim, as claims 1-7 do not recite a “ composition” but claims 1-5 recite an “agent” or “bitter masking agent, claim 6 recites a sweetener comprising …the bitter masking agent” and 7 recite a “sweetener”. Correction and /or clarification is required. In the interest of expediting prosecution the recitation will be regarded as “the agent of” for claims 1-6 and/or “sweetener of claim 7”.
For the purpose of this office action the recitation will be regarded as “the agent of” for claims 1-6 and “sweetener of claim 7”.
Claim 21 recites the limitation ”The composition of any of claims 16-20, wherein the salt is” in line 1. There is insufficient antecedent basis for “the salt” in the claim, as claims 16-20 do not recite “ a salt” but just a “a chelant sodium salt”.
Correction and /or clarification is required.
For the purpose of this office action the recitation of claim 21 will be regarded where the compositions of claims 16-20 further comprise a salt.
Claim 25 recites the limitation ” The composition of claim 16, wherein the counter-cation comprises” in line 1. There is insufficient antecedent basis for “the counter cation” in the claim, as claim 16 do not recite “a cation” or “counter cation”. Correction and /or clarification is required.
For the purpose of this office action the recitation of claim 25 will be regarded as “The composition of claim 16, wherein the composition is additive to reduce bitterness.
Claim 26 recites the limitation ” The composition of claim 16, wherein in the food is a cannabinoid” in line 1. There is insufficient antecedent basis for “the food” in the claim, as claim 16 do not recite “a food” or “food”. Correction and /or clarification is required.
For the purpose of this office action the recitation of claim 26 will be regarded as “The composition of claim 16, wherein the composition is added to a food and wherein the food comprises a cannabinoid”.
Claim 27 recites the limitation “The composition of claim 16, wherein the cannabinoid is” " in line 1. There is insufficient antecedent basis for “the cannabinoid” in the claim, as claims 16 does not recite a “cannabinoid” but claim 14 and claim 26 recite a cannabinoid. Correction and /or clarification is required.
For the purpose of this office action the recitation will be regarded as depending from claim 26 as “The composition of claim 26, wherein the cannabinoid is”.
Rejection of claims 18, 20 and 25 is based on claims 16 and 17 and recitation of both these claims is provided below and refers to all three 112 rejections below:
In the instant case claim 16 recites “A composition …an additive to reduce bitterness comprising: a chelant sodium salt comprising an aldonic, uronic, or aldaric acid.” And claim 17 recites “The composition of claim 16, wherein the composition is added to a food and wherein the food comprises coffee or caffeine.”
Claim 18 recites “The composition of claims 17, wherein the food is a sweetener.”, which as recited is unclear as claim 18 depends from claim 17, where the composition is a food but not a sweetener but rather “wherein the food comprises coffee or caffeine” which in turn depends from claim 16, which is directed to “an additive comprising: a chelant sodium salt comprising an aldonic, uronic, or aldaric acid”, thus the recitation of “food is a sweetener” renders the claims indefinite, as the food product “a sweetener” differs from the product “comprising coffee or caffeine” of claim 17 or the composition of claim 16, which does not recite any food composition. It is further unclear whether the metes and bounds of “food is a sweetener” is intended to narrow the limitation of claim 17, where the food comprises coffee or caffeine and further comprises a sweetener OR merely intended to be depending from claim 16 and phrased for another food product, such as, “The composition of claim 16, wherein the composition is added to a food and wherein the food comprises a sweetener” as an alternate food item. Correction and/or clarification is required.
As the metes and bounds of claim 18 are unclear, the claim will be treated broadly where the composition of either claim 16 or 17 contain a sweetener.
Claim 20 recites ”The composition of claim 17, wherein the food is a mineral salt.”, which as recited is unclear as claim 20 depends from claim 17, where the composition is a food but not a sweetener but rather “wherein the food comprises coffee or caffeine” which in turn depends from claim 16, which is directed to “an additive comprising: a chelant sodium salt comprising an aldonic, uronic, or aldaric acid”, thus the recitation of “food is a mineral salt” renders the claims indefinite, as the food product “a mineral salt” differs from the product “comprising coffee or caffeine” of claim 17 or the composition of claim 16, which does not recite any food composition. It is further unclear whether the metes and bounds of “food is a mineral salt” is intended to narrow the limitation of claim 17, where the food comprises coffee or caffeine and further comprises a mineral salt OR merely intended to be depending from claim 16 and phrased for another food product, such as, “The composition of claim 16, wherein the composition is added to a food and wherein the food comprises a mineral salt” as an alternate food item. Correction and/or clarification is required.
As the metes and bounds of claim 20 are unclear, for the purpose of this office action claim 20 and its dependent claims will be treated broadly where the composition of either claim 16 or 17 contain a mineral salt.
Claim 24 is indefinite for the recitation of “The composition of claim 16, wherein the chelant comprises gluconic acid, glucaric acid, glucuronic acid, n-keto-acids and C2-C6 diacids”, where improper use of Markush language render the claim indefinite.
the MPEP mentions two acceptable phrases for Markush language:
-wherein R is a material selected from the group consisting of A, B, and C
-wherein R is A, B, or C
However, as recited the claim includes both “comprises” with “and”, which appears to indicate either that all chelants listed “gluconic acid, glucaric acid, glucuronic acid, n-keto-acids and C2-C6 diacids” are required, which is not taught by the specification, wherein OR one or two or more chelants that fall in the list from “gluconic acid, glucaric acid, glucuronic acid, n-keto-acids and C2-C6 diacids”, but then the claim should indicate that the “chelants are selected from gluconic acid, glucaric acid, glucuronic acid, n-keto-acids and C2-C6 diacids” (emphasis added); OR “chelant comprises gluconic acid, glucaric acid, glucuronic acid, n-keto-acids or C2-C6 diacids” or some other interpretation. Correction and/or clarification is required.
For the purpose of this office action claim 24 will be interpreted as “The composition of claim 16, wherein the chelant comprises gluconic acid, glucaric acid, glucuronic acid, n-keto-acids or C2-C6 diacids.”
Claim 25 recites “The composition of claim 16, wherein the counter-cation comprises of an alkali earth metal of group 1 and group 2.”, which as recited is unclear as claim 25 depends from claim 16, where the composition is “earth metal group 1, where neither a cation nor “counter-cation” is recited (see lack of antecedent rejection above), rendering the claim unclear. Further, claim 25 also recites “an alkali earth metal of group 1 and group 2”, it is noted that earth metals of group 1 (lithium, sodium, potassium, etc.) are designated as “alkali metals” but the earth metals of group 2 (Beryllium, Magnesium, calcium, etc.) are “alkaline earth metals” Thus, as recited it is unclear whether the recitation of “an alkali earth metal of group 1 and group 2” is limited to alkali earth metals of group 1 only (sodium, potassium, etc.) and the mention of “group 2” is in error or if the limitation intended to include cations of alkaline earth metals group 2 as well but missed writing the phrase “alkaline earth metals of” before “group 2” in line 2 of claim. Correction and/or clarification is required.
For the purpose of this office action claim 25 will be interpreted as having any cation from either alkali earth metal group 1, such as, sodium, potassium, or alkaline earth metal group 2, such as, calcium, magnesium, present in an additive to reduce bitterness as recited in claim 16.
Claim 25 is further indefinite for the recitation of “The composition of claim 16, wherein the counter-cation comprises of an alkali earth metal of group 1 and group 2.”, where improper use of Markush language render the claim indefinite.
the MPEP mentions two acceptable phrases for Markush language:
-wherein R is a material selected from the group consisting of A, B, and C
-wherein R is A, B, or C
However, as recited the claim includes both “the counter-cation comprises of an alkali earth metal of group 1 and group 2.”, which appears to indicate either that more than one cation is required, wherein a cation falls in alkali earth metal of group 1 and another cation that falls in alkaline earth metal of group 2 OR a single cation that falls in both groups 1 and 2, which is not possible; OR cation comprises of an alkali earth metal of group 1 or g alkaline earth metal of group 2 or some other interpretation. Correction and/or clarification is required.
For the purpose of this office action claim 25 will be interpreted as having any cation from either alkali earth metal group 1, such as, sodium, potassium, or alkaline earth metal group 2, such as, calcium, magnesium, present in an additive to reduce bitterness as recited in claim 16.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 21 recites the broad recitation “a sodium, potassium, magnesium, calcium, and zinc salts of carboxylic acids”, and the claim also recites sodium gluconic, sodium glucaric, sodium citric, sodium lactic, sodium maleic, sodium tartaric, potassium gluconic, potassium glucaric, potassium citric, potassium lactic, potassium maleic, potassium tartaric,… zinc lactate, or a combination thereof” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Clarification and/or correction is required.
For the purpose of this office action claim 21 list of salts will be interpreted as including the broader version, i.e., a sodium, potassium, magnesium, calcium, and zinc salts of carboxylic acids being present in an additive to reduce bitterness as recited in claim 16.
Claim 21 is also indefinite for the recitation of terms like “sodium gluconic, sodium glucaric, sodium citric, sodium lactic, sodium maleic, sodium tartaric, potassium gluconic, potassium glucaric, potassium citric, potassium lactic, potassium maleic, potassium tartaric”, which include incomplete terms and /or improper nomenclature for one reasonably skilled in the art at the time of the invention to understand. In the instant case it is unclear if the applicant’s recitation of “sodium gluconic”, was intended to be either “sodium salt of gluconic acid” or “sodium gluconate” or something else. Similarly the above mentioned list of chemical names all are unclear for the same reason as provided for “sodium gluconic” in claim 21. Clarification and/or correction is required.
For the purpose of this office action, Claim 21 above cited terms will be interpreted as salts of carboxylic acids listed.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 8, 16, 22, 24-25, 28-29 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Catania et al., (US 5633006 A), hereinafter Catania.
Claim term interpretation: “biochelant” or “chelant” as recited in claims 1-3 and 28 is being interpreted based on the description provided in the current specification in paragraph 14, where “a biochelant” (also termed as a chelator, sequestrant or a chelating agent), refers to a molecule or a chemical that is produced by a biological process, e.g., through the use of an enzyme catalyst and a chemical that capable of bonding a metal.
Term “counter cation” , recited in claim 25 (see 112 second rejection above) is being interpreted as containing any cation from either alkali earth metal group 1, such as, sodium, potassium, or alkaline earth metal group 2, such as, calcium, magnesium, present in an additive to reduce bitterness as recited in claim 16.
Regarding claim 1, Catania teaches a bitter masking agent comprising:
a biochelant; and a salt. Column 3, lines 23-30 of Catania teaches “The present invention is directed to pharmaceutical compositions having reduced bitterness …, a taste-masking component and a pharmaceutically acceptable carrier or diluent. The taste-masking component may consist of said basic compound as recited hereinabove alone or in combination with an aldonic acid or a pharmaceutically acceptable salt of an aldonic acid.” In Column 4, 17-20 Catania elaborates that “aldonic acids used herein are readily available derivatives of sugars such as gluconic acid, mannonic acid, galactonic acid and the like”. Catania also teaches “basic compound of the present invention is an alkaline earth oxide or an alkaline earth hydroxide. Examples of suitable such basic compounds include, but are not limited to, such compounds as sodium hydroxide, potassium methoxide, calcium hydroxide, magnesium oxide, calcium oxide and the like.” (Column 4, lines 9-13) and regarding the salts Catania teaches “salts of said aldonic acids are prepared by reacting the aldonic acid with an appropriate base, …” (Column 4, lines 25-32) and example 2 of Catania teaches combination of magnesium oxide and chelant/ biochelant calcium gluconate (Column 7, lines 32-38). Thus, the taste masking agent comprising a chelant/biochelant and a salt is anticipated by Catania.
Regarding claim 2, Catania teaches agent of claim 1, wherein the biochelant comprises an aldonic acid, uronic acid, aldaric acid, or a combination thereof. Column 3, lines 28-29 of Catania teach aldonic acid, Column 4, 17-20 teach “Said aldonic acids used herein are readily available derivatives of sugars such as gluconic acid, mannonic acid, galactonic acid and the like.”.
Regarding claim 8, Catania teaches a composition comprising the bitter masking agent of claim 1, where gluconate, i.e., salt of aldonic acid with calcium or sodium or potassium or magnesium (as taught by Catania in Column 4, lines 24-30) with See Example 2 of Catania in Column 7, lines 30-40 where Azithromycin Chewable tablet (composition) comprising gluconate salt which is a magnesium oxide, calcium gluconate and sodium starch glycolate is taught , which meets the limitation of composition comprising the bitter masking agent.
Regarding claim 16, Catania teaches a composition for an additive to reduce bitterness (Column 3, lines 23-30 of Catania) comprising: a chelant sodium salt comprising an aldonic, uronic, or aldaric acid (Column 3, lines 28-29). Regarding the limitation of “a chelant sodium salt” Catania teaches “salts of said aldonic acids are prepared by reacting the aldonic acid with an appropriate base, usually one equivalent, in a co-solvent. Typical bases are sodium hydroxide, sodium methoxide, sodium ethoxide, potassium methoxide, magnesium hydroxide, calcium hydroxide, benzathine, choline, diethanolamine, ethylenediamine, meglumine, benethamine, diethylamine, piperazine and tromethamine” (Column 4, lines 25-32), which anticipates the composition of claim 16.
Claim 22 depends from claim 16 and recites “wherein the chelant comprises glucaric acid, gluconic acid, glucuronic acid, glucose oxidation products, or gluconic acid oxidation products”. Catania as applied above to claim 16 teaches gluconic acid (Column 4, 17-20 Catania elaborates that “aldonic acids used herein are readily available derivatives of sugars such as gluconic acid, mannonic acid, galactonic acid and the like”), therefore claim 22 is also rejected for the same reason as provided above for claim 16.
Claim 24 depends from claim 16 and recites, “wherein the chelant comprises gluconic acid, glucaric acid, glucuronic acid, n-keto-acids and C2-C6 diacids”. Catania as applied above to claims 1 and 16 teaches gluconic acid, (Column 4, 17-20, where Catania teaches aldonic acid and “aldonic acids used herein are readily available derivatives of sugars such as gluconic acid, mannonic acid, galactonic acid and the like)” therefore claim 24 is also anticipated by Catania.
Note: Also see the rejection of claim 24 under 35 USC 112 (second paragraph) and its interpretation for this office action.
Claim 25 also depends from claim 16 and recites ”wherein the counter-cation comprises of an alkali earth metal of group 1 and group 2”, this limitation is also anticipated by Catania as applied above where it is clearly taught that salts of said aldonic acids are prepared by reacting the aldonic acid with an appropriate base, usually one equivalent, in a co-solvent. Typical bases are sodium hydroxide, sodium methoxide, sodium ethoxide, potassium methoxide, magnesium hydroxide, calcium hydroxide, benzathine, choline, diethanolamine, ethylenediamine, meglumine, benethamine, diethylamine, piperazine and tromethamine” (Column 4, lines 25-32), where sodium potassium are group 1 or alkali earth metal salts of gluconic acid and calcium, magnesium which are group 2 or alkaline earth metal salts of gluconic acid.
Note: Also see the rejection of claim 25 under 35 USC 112 (second paragraph) and its interpretation for this office action.
Regarding claim 28, Catania teaches a method of preparing a composition, the method comprising:
combining a bitter masking agent comprising a biochelant and a salt with an edible material; and forming an edible composition based on the combining. (Catania , Column 3, lines 23-25, and Example 2 where “The present invention is directed to pharmaceutical compositions having reduced bitterness …, a taste-masking component and a pharmaceutically acceptable carrier or diluent. The taste-masking component may consist of said basic compound as recited hereinabove alone or in combination with an aldonic acid or a pharmaceutically acceptable salt of an aldonic acid.”).
Regarding the edible material and combining the bitter masking agent in the edible material, reference is made to Example 2, Catania (especially Column 7, lines 30-40 and 55-62 ), where Azithromycin Chewable tablet is taught by combining and mixing the bitter taste masking agent with pharmaceutical chewable product before compressing into tablets.
Regarding claim 29, Catania as applied above to the method of claim 28, further comprising: reducing a bitterness of the edible material based on combining the bitter masking agent with the edible composition, see Example 2, Column 7 of Catani and also see Column 3, lines 1-4 where Catania teaches “a method of reducing the bitterness of a bitter pharmaceutical comprising formulating said bitter pharmaceutical agent as a pharmaceutical composition as recited hereinabove”
Claim(s) 1-2, 16, 22, 24-25 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Nakamura et al., (EP 1163852A1), hereinafter Nakamura.
Regarding claims 1-2 and 16, Nakamura teaches a composition for an additive to reduce bitterness comprising: a chelant sodium salt comprising an aldonic, uronic, or aldaric acid (see para 1, 14 and 24, Example 1) Nakamura teaches “a masking agent comprising a nontoxic salt of gluconic acid as an active ingredient, an oral ingestible product added with the masking agent, and a method of masking flavor or odor of an oral ingestible product by adding the masking agent” is taught in para 1. Gluconic acid is an easily available aldonic acid. Further Nakamura para 14 clarifies that “nontoxic salts of gluconic acid include alkali metal salts of gluconic acid such as sodium gluconate, potassium gluconate and the like, and alkali earth metal salts of gluconic acid such as calcium gluconate, magnesium gluconate and the like” and specific utility of reduction of bitterness in a bitter gourd drink by using sodium gluconate is taught in Example 1 of Nakamura (para 24).
Claim 22 depends from claim 16 and recites “wherein the chelant comprises glucaric acid, gluconic acid, glucuronic acid, glucose oxidation products, or gluconic acid oxidation products”. Nakamura as applied above to claim 16 teaches gluconic acid (Para 1 and 14), therefore claim 22 is also rejected for the same reason as provided above for claim 16.
Claim 24 depends from claim 16 and recites, “wherein the chelant comprises gluconic acid, glucaric acid, glucuronic acid, n-keto-acids and C2-C6 diacids”. Nakamura as applied above to claim 16 teaches gluconic acid, Nakamura para 14 clarifies that “nontoxic salts of gluconic acid include alkali metal salts of gluconic acid such as sodium gluconate, potassium gluconate and the like, and alkali earth metal salts of gluconic acid such as calcium gluconate, magnesium gluconate and the like” therefore claim 24 is also anticipated by Nakamura.
Claim 25 also depends from claim 16 and recites ”wherein the counter-cation comprises of an alkali earth metal of group 1 and group 2”, this limitation is also anticipated by Nakamura para 1 and 14 where it is clearly taught that a nontoxic salts of gluconic acid include alkali metal salts of gluconic acid such as sodium gluconate, potassium gluconate and the like which are group 1 or alkali earth metal salts of gluconic acid and calcium gluconate, magnesium gluconate which are group 2 or alkaline earth metal salts of gluconic acid.
Also see the rejection of claim 25 under 35 USC 112 (second paragraph) and its interpretation as provided above.
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:
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Catania et al., (US 5633006 A), hereinafter Catania.
Regarding claim 5, Catania teaches an agent of claim 1 as applied above, a bitter masking agent comprising a biochelant; and a salt. Column 3, lines 23-30 of Catania.
Regarding the recitation of claim 5 please refer to rejection under 35 USC 112 and interpretation, wherein “the salt comprises any one of zinc sulfate, tripotassium phosphate, calcium chloride, magnesium chloride. potassium chloride , sodium chloride, sodium, potassium, magnesium, calcium, and zinc salts of carboxylic acids such as: gluconic, glucaric, citric, lactic, maleic, tartaric or a combination thereof”, reference is made to Column 3, lines 23-30 of Catania teaches “a taste-masking component and a pharmaceutically acceptable carrier or diluent. … aldonic acid or a pharmaceutically acceptable salt of an aldonic acid”. Catania teaches of including a diluent or bulking agents including sodium chloride and potassium chloride (Column 5, lines 60-66) as well as salts of aldonic acids with calcium gluconate are taught (Example 2, Column 7, lines 32-38), where calcium gluconate is a calcium salt of a carboxylic acid; and similarly other calcium sodium, potassium, and magnesium salts of aldonic acids also taught in Column 4, lines 24-30. Therefore, including a salt as recited in claim 5 with a bitterness masking agent composition would have been a matter of routine determination for one of ordinary skill in the art at the time of the effective filing date of the invention. The ordinary artisan would have been motivated to modify Catania at least for the purpose of adding a diluent or a bulking agent in the form of sodium or potassium chloride, to facilitate inclusion of bitterness masking agent in a desirable form, which may be a powder, granular solid or pellet/ tablet form, as taught by Catania in (Column 4, lines 66- Column 5, line 5 and column 5, lines 61-66).
Claims 3, 6-7, and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Catania et al., (US 5633006 A), hereinafter Catania, as applied above further in view of IDS reference to Eisenstadt (US 3875311A), hereinafter Eisenstadt.
Claim term interpretation:
Claims 10-12 depend from claim 7 directly or indirectly and recite “ An ingestible composition comprising the composition of claim 7.” (claim 10), claim11 depends from claim 10 and further limits that the “ingestible composition of claim 10 that is edible” and claim 12 further limits claim 10 in that the “ingestible composition of claim 10 that is inedible”.
In order to understand what is encompassed in the term “ingestible”, “edible” and “inedible”, examiner refers to paragraphs 22 and 25 of applicant’s disclosure, which discloses BMA or Bitter Masking Agent and its use in ingestible products as “In an aspect, a BMA … is included in an edible composition such as a food product. Herein “edible” refers to a material that is fit to be eaten as food.” (Para 22)
“In an aspect, a BMA … is included in a non-edible ingestible product. Herein, “non-edible products” refer to supplements, nutraceuticals, functional food products (e.g., any fresh or processed food claimed to have a health-promoting and/or disease-preventing properties beyond the basic nutritional function of supplying nutrients), pharmaceutical and over the counter products, oral care products such as dentifrices and mouthwashes, cosmetic products such as sweetened lip balms and other personal care products that use sucralose and/or other sweeteners.” (Para 25).
Based on applicant’s disclosure, all products taken by mouth are being treated as ingestible, all functional foods and pharmaceutical products etc., as outlined in para 25 by the applicant will be treated as inedible and when the bitter masking agent is mixed with a food products, as addressed in para 22, which like cereal , beverages, drinks, ice-cream, etc., then it will be regarded as edible.
Regarding claim 3, Catania as applied to claims 1-2 teaches a bitter masking /suppressing agent comprising:
a biochelant; and a salt. Column 3, lines 23-30, also “aldonic acid or a pharmaceutically acceptable salt of an aldonic acid.” In Column 4, 17-20 Catani elaborates that “aldonic acids used herein are readily available derivatives of sugars such as gluconic acid, mannonic acid, galactonic acid and the like”.
Regarding the recitation of “glucose oxidation product”, aldonic acids in general are formed as a result of glucose oxidation and specifically gluconic and mannonic acids are formed as a result of glucose oxidation, i.e., Catania teaches glucose oxidation products as recited in claim 3.
Catania also teaches “basic compound of the present invention is an alkaline earth oxide or an alkaline earth hydroxide. Examples of suitable such basic compounds include, but are not limited to, such compounds as sodium hydroxide, potassium methoxide, calcium hydroxide, magnesium oxide, calcium oxide and the like.” (Column 4, lines 9-13) and regarding the salts Catania teaches “salts of said aldonic acids are prepared by reacting the aldonic acid with an appropriate base, …” (Column 4, lines 25-32). Thus, the bitter taste masking agent comprising a chelant/biochelant and a sodium, potassium, magnesium, calcium, calcium salt thereof, such as sodium gluconate and /or calcium gluconate, is taught by Catania. Thus creating a salt of glucose oxidation product was known and taught by Catania.
Although Catania is silent regarding the buffered version of glucose oxidation product as recited in claim 3, at the time of the effective filing date of the invention one of ordinary skill had knowledge of buffer system is known to be included in foods where the pH is was desired to be maintained within a specific range. Addition of buffer or a Ph adjusting agent along with a glucose oxidation product was known in the art at the time of the effective filing date of the invention as taught by Eisenstadt, Abstract, Column 1, lines 50-62 and Column 2, lines 9-17). Eisenstadt teaches an artificial calorie free sweetener with glucono-delta-lactone (hereinafter GDL) and gluconate salt, e.g. “sodium gluconate or potassium gluconate”, where both gluconate and GDL are glucose oxidation products. Eisenstadt also teaches including “cream of tartar and/or a bicarbonate (sodium bicarbonate or potassium bicarbonate)” which are both buffers “in order to improve the sweetening properties of composition and give the same the more natural sweetness of ordinary sugar while still providing a calorie free product” (abstract) and a sweetener composition “which can be used on all types of foods for providing a sweetening effect which is akin to that of natural sugar, and which does not provide any carbohydrates or calories” (Column 2, lines 14-17). Thus, inclusion of a buffer in combination with a taste masking /improving agent which is a glucose oxidation product like sodium or potassium gluconate, would have been a matter of routine determination for one of ordinary skill in the art at the time of the effective filing date of the invention based on the teaching of Eisenstadt where such buffered composition is utilized to improve the taste of a calorie free artificial sweetener. The ordinary artisan would have been motivated to modify Catania at least for the purpose of improving the taste/ flavor of a food/ edible/ ingestible composition and “give the same a more natural sweetness of ordinary sugar while still providing a calorie free product”. One of ordinary skill would be further motivated to include a taste masking agent that can be used on all types of foods for providing an improved “sweetening effect which is akin to that of natural sugar, and which does not provide any carbohydrates or calories” (Column 2, lines 14-17 of Eisenstadt)
Regarding claims 6-7, the limitation of “sweetener comprising a sweetening agent and the bitter masking agent of claim 1” Catania teaches a composition comprising a bitter masking agent, in combination with a sweetener (column 4, lines 66 to Column 5, line 3) where sweeteners are taught. Catania in Column 5, lines 6-11 also teaches that “Sweeteners are sometimes used to impart a pleasant flavor to the taste-masked composition. The sweet flavor imparted by said sweeteners is not altered or reduced by the taste-masking component. Said taste-masking component is specific for the taste-masking of bittering agents.” Catania teaches combination of sweeteners and bitter taste masking agents (Column 5 of Catania) and also teaches artificial sweeteners like aspartame saccharine etc. (Column 5, lines 10-18), but Catania is silent regarding the composition being a “a sweetener” comprising a sweetening agent and the bitter masking agent of claim 1 (as recited in claim 6) and wherein the sweetening agent comprises “acesulfame potassium, alitame, aspartame, cyclamate, saccharin, sucralose, monk fruit, stevioside and thaumatin; maple syrup, honey, molasses, glucose, fructose, erythritol, mannitol, xylitol, sorbitol, tagatose, or combinations thereof” (as recited in claim 7).
However, at the time of the effective filing date of the invention sweetening agents containing a taste/flavor masking agent as recited in claim 1 were known to be included in sweeteners in order to improve the taste of artificial or high intensity sweetening agents as taught by Eisenstadt. Eisenstadt teaches an artificial calorie free dipeptide sweetener in accordance with claim 6, wherein the dipeptide sweetener is “aspartyl phenylalanine methyl ester” (Column 2, lines 21-22), which is also known as aspartame, and is included in the list of sweeteners recited in claim 7. Eisenstadt includes a composition glucono-delta-lactone (hereinafter GDL) and gluconate salt, e.g. “sodium gluconate or potassium gluconate”, ( where both gluconate and GDL are glucose oxidation products and chelating agents and meet the limitation of claim 1), to provide improved sweetening properties, and a more natural sweetness like that of ordinary sugar, without any bitter after taste, while being calorie free dipeptide sweetener (“aspartyl phenylalanine methyl ester”, hereinafter aspartame, see abstract and Column 2, lines 38-42). Eisenstadt also teaches that the aspartame sweetener with taste improving agents results in a sweetener composition “which can be used on all types of foods for providing a sweetening effect which is akin to that of natural sugar, and which does not provide any carbohydrates or calories” (Column 2, lines 14-17).
Thus, inclusion of a sweetener in combination with a taste masking /improving agent as taught by Eisenstadt, would have been a matter of routine determination for one of ordinary skill in the art at the time of the effective filing date of the invention to improve the taste of a calorie free artificial sweetener. The ordinary artisan would have been motivated to modify Catania and include the bitter masking agent in a dipeptide sweetener, aspartame, at least for the purpose of providing a sweetener that is calorie free but has bitter aftertaste with a “same a more natural sweetness of ordinary sugar while still providing a calorie free product” (abstract). One of ordinary skill would be further motivated to include a taste masking agent that can be used on all types of foods for providing an improved “sweetening effect which is akin to that of natural sugar, and which does not provide any carbohydrates or calories” (Column 2, lines 14-17 of Eisenstadt)
Regarding claim 9, the recitation of “A composition comprising the sweetener of claim 7” is rejected over Catania for the same reason as claim 7 for the purpose of providing a desired level of pleasant flavor to the taste masking composition.
Claims 10-12 depend from claim 7 directly or indirectly and recite “ An ingestible composition comprising the composition of claim 7.” (claim 10), claim 11 depends from claim 10 and further limits that the “ingestible composition of claim 10 that is edible” and claim 12 further limits claim 10 in that the “ingestible composition of claim 10 that is inedible”.
Please refer to details of claim term interpretation for “ingestible”, “edible” and “inedible” provided above. In summary, based on applicant’s disclosure, all products taken by mouth are being treated as ingestible, all functional foods and pharmaceutical products etc., as outlined in para 25 by the applicant will be treated as inedible and when the bitter masking agent is mixed with a food products, as addressed in para 22, which like cereal , beverages, drinks, ice-cream, etc., then it will be regarded as edible.
Regarding “An ingestible composition comprising the composition of claim 7”, Catania teaches an ingestible composition that is administered either as a chewable tablets or a liquid suspension (Column 3, lines 11-14). Catania also teaches that “The tablets may be ground up and mixed with, placed in or sprinkled on cereal, ice cream or other foods or drinks and then ingested…when a reconstitutable form of the composition is administered as a liquid suspension, …said suspension may be mixed with foods and drinks (Column 6, lines 48-59). The bitter masking agent containing chewable tablets of Catania meet the limitations of claims 10 and 12 as the tablets are ingestible and inedible. Further, as per teaching of Catania from Column 6, where the ground up tablets are mixed with food or drink, thereby also meeting the limitations of claims 10 and 11 as the tablets are ingestible and upon mixing with food or drink become edible.
Claim 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Catania and Eisenstadt as applied above, further in view of Victor et al. (US 20160324777 A1), hereinafter Victor.
Catania as applied to claims 1-7, teaches a composition comprising bitter masking agent of claims 1-6) further comprising a sweetener (claim 7, see rejection under 35 USC 112 second paragraph).
See, Column 3, lines 23-30, also “aldonic acid or a pharmaceutically acceptable salt of an aldonic acid.” Are taught and Column 4, 17-20 and 24-30 where it is taught that aldonic acids are derivatives of sugars such as gluconic acid, mannonic acid, galactonic acid and the like and salts thereof. Thus, the bitter taste masking agent comprising a chelant/biochelant as a sodium , calcium salt thereof, such as sodium gluconate and /or calcium gluconate, is taught by Catania.
Further, regarding the limitation of ingestible composition, Catania as applied above to claim 10, addresses the limitation of teaches an ingestible composition that is administered either as a chewable tablets or a liquid suspension (Column 3, lines 11-14). Catania also teaches that “The tablets may be ground up and mixed with, placed in or sprinkled on cereal, ice cream or other foods or drinks and then ingested…when a reconstitutable form of the composition is administered as a liquid suspension, …said suspension may be mixed with foods and drinks (Column 6, lines 48-59). Thus, the incorporation of calcium or sodium gluconate, as bitter taste masking/ suppressing agent or factor in foods, pharmaceuticals or ingestible was known in the art at the time of effective filing date of the invention as taught by Catania.
Although inclusion of calcium or sodium gluconate as bitter taste masking/ suppressing agents in foods and beverages was known, such inclusion in tea, coffee , cocoa containing and other caffeinated beverages and /or compositions known to have bitter element is not taught by Catatnia. However, bitterness masking/ suppressing effect of sodium, potassium, calcium or magnesium gluconate for a caffeine containing product, including “A caffeinated beverage”, such as tea, coffee was also known in the art at the time of the effective filing date of the invention as taught by Victor (abstract, para 8, 15, 30, 66, examples in para 183-185 and claims 48, 56 and 65 ).Victor also recognizes the bitter masking effect of sodium gluconate especially in tea, “the tea composition can have sodium gluconate which can inhibit bitterness” (para 41). Based on the teaching of Victor, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention that sodium gluconate, a gluconic acid salt (aldonic acid salt as taught by Catania, columns 3-4), is effective when utilized as a bitterness masking / suppressing agent in foods and beverages containing caffeine. The ordinary artisan would have been motivated to modify Catania at least for the purpose of reducing the bitterness and enhancing the acceptability of caffeine containing foods and/or beverages and/or pharmaceutical compositions in the intended consumer, as taught by Victor, in para 41.
Note: Claims 14-15 are directed to bitter masking agent in ingestible containing cannabinoid products (claim 14) wherein the cannabinoid can be chosen from a list “comprising tetrahydrocannabinol, tetrahydrocannabinolic acid, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabicyclol, cannabivarin, tetrahydrocannabivarin, tetrahydrocannabiphorol, cannabidivarin, cannabichromevarin, cannabigerovarin, cannabigerol monomethyl ether, cannabielsoin, acannabicitran, or a combination thereof” (claim 15).
Regarding claims 14-15, Catania as applied to claims 1-7, teaches a composition comprising bitter masking agent of claims 1-6) further comprising a sweetener (claim 7, see rejection under 35 USC 112 second paragraph), see above under rejection of claim 13 for detailed citation of Catania). Although inclusion of calcium or sodium gluconate as bitter taste masking/ suppressing agents in ingestible products was known in the art at the time of effective filing date of the invention, such inclusion in cannabinoid-containing ingestible product of claims 14 and 15 is not taught by Catatnia. However, bitterness masking/ suppressing effect of sodium gluconate for a cannabis containing product, including “cannabinoid-containing ingestible product” was known in the art at the time of the effective filing date of the invention as taught by Victor (para 80, 182, 185 and claim 65 ), where a tea composition comprising cannabis , tea and sodium gluconate is taugh