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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/04/2025 has been entered.
Status of Claims
Claims 1-26 are pending and under examination in this application. Any objections or rejections not repeated below have been withdrawn.
Claim Rejections - 35 USC § 112
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 1-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 25-26 recite the following, “reducing blending speed.” However, it is unclear what the blending speed is being reduced to. It is also unclear what would constitute a reduced speed when there is no other speed to compare to. For the purpose of examination, the limitation will be interpreted as reducing the blending speed from a high-shear speed to a low-shear speed.
Claims 1 and 25-26 recite the following, “changing to low-shear blades.” However, it is unclear what the blade is being changed from. It is also unclear what would constitute a low-shear blade when there is no other blade type claimed. For the purpose of examination, the limitation will be interpreted as, a first blade was used, which was a high shear blade, and then the blade was changed to a second blade, which is a low-shear blade.
Claims 1 and 25-26 recite the following, “…while adding the NADH component to maintain the encapsulated NADH uniformly dispersed throughout the liquid.” However, it is unclear if “maintain the encapsulated NADH uniformly dispersed throughout the liquid” means maintaining the encapsulation of the NADH, uniformly dispersing the encapsulated NADH and maintaining that dispersion, maintaining some prior uniform dispersion of the encapsulated NADH, or some combination of the three. For the purpose of examination, the limitation will be interpreted as the encapsulated NADH being uniformly dispersed throughout the liquid and maintaining that dispersion.
Claim 2-24 are included in the rejection because they depend from a rejected base claim.
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.
Claims 1-26 are rejected under 35 U.S.C. 103 as being unpatentable over Harkins at el. (WO 2020106746) in view of Meijerink et al. (US 20180140553), Hennis, The Difference between High Shear and Low Shear Mixing, INDCO, and Kamcharov et al. (US 20200077682).
Regarding claims 1-3 and 7-8, Harkins teaches a method for synthesis of a dietary supplement (all natural biologic enhancing beverage; Abstract, pg. 11 Example 1 L5-11), as required by claim 1. Harkins teaches providing a nicotinamide adenine dinucleotide in its reduced form (NADH) component (NAD+ precursor such as the reduced form of nicotinamide adenine dinucleotide (NADH); pg. 4 L32-34) from about 0.01 to 0.05% (pg. 6 L7). This is within the claimed range of 0.000001% to about 3.0%, 0.001% to about 2.0% and 0.01% to about 0.5% by weight, as required by claims 1, 2 and 3, respectively.
Harkins does not teach the NADH component is at least partially microencapsulated nicotinamide, as required by claims 1-3. Meijerink teaches the administration of nicotinamide in a long-acting formulation [0011]. Meijerink teaches the nicotinamide is microencapsulated, which makes it resistant to gastric juice and controls the release of the nicotinamide over the desired period of time [0061], [0064].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins to incorporate the teachings of Meijerink by having the nicotinamide be microencapsulated, making it resistant to gastric juice and controlling the release of the nicotinamide over the desired period of time [0061], [0064].
Harkins teaches blending the NADH (NAD+ precursor) with water (pg. 6 L3-16, pg. 11 L6-7), as required by claim 1. Harkins states the water in the dietary supplement is between 12-16 oz, which is about 340 g to 454 g, and the rest of the dietary supplement which is the supplement component rounds to about 1 g (pg. 11 L5-11). Therefore, Harkins teaches water is about 99% by weight of the dietary supplement. This is within the claimed range for water from about 15% to about 99%, as required by claim 1.
Harkins in view of Meijerink teaches providing the at least partially microencapsulated nicotinamide, as recited above. Meijerink states that the nicotinamide is present in the microencapsulation (suspension) at about 1-95% and the microencapsulation agent (polymers and release controlling agents) is present at about 5-99% (Example 1 [0091]). When this amount of microencapsulation agent (polymers and release controlling agents) is applied to the amount of nicotinamide used in the dietary supplement formulation of Harkins, which is 0.01 to 0.05% (pg. 6 L7), the amount of microencapsulation agent by weight of the dietary supplement formulation is about 0.0104% to about 0.052%. This is within the claimed range of 0.000001-3.0%, as required by claim 1. Meijerink explains that this amount of microencapsulation agent used in their formulation is able to cover the nicotinamide creating insolubility in acid fluids of the stomach and allows for the release of the nicotinamide active ingredient over a desired period of time [0064].
Additionally, when looking at the amount of nicotinamide present in the microencapsulation (suspension), which is at about 1-95%, and the amount of microencapsulation agent (polymers and release controlling agents), which is present at about 5-99%, in Meijerink (Example 1 [0091]), this gives a ratio range of nicotinamide to microencapsulation agent of about 1:99 to about 19:1. This encompasses the ratio of about 1:1, required by claim 1. 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).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins to incorporate the teachings of Meijerink by having the amount of microencapsulation agent be within the claimed range and the ratio of nicotinamide to microencapsulation agent be within the claimed ratio because using this amount of microencapsulation agent to cover the nicotinamide creates insolubility in acid fluids of the stomach and allows for the release of the nicotinamide active ingredient over a desired period of time, as recognized by Meijerink [0064].
The supplement component of Harkins is 1 g of supplement component in 12-16 oz of water, which is from about 0.2% to about 0.3% by weight of the dietary supplement (pg. 11 L5-11). This is within the claimed range for the supplement component from about 0.000001% to about 36% by weight, as required by claim 1.
Harkins teaches forming a mixed component by mixing the NADH component with the supplement component at ambient conditions, the mixed component being a liquid at the ambient conditions (pg. 3 L29-30, pg. 11 L5-11). Harkins also teaches the NADH component is uniformly dispersed throughout the liquid (at least one niacinamide adenine dinucleotide precursor is dissolved or suspended in a liquid carrier (pg. 3 L27-32), as required by claim 1.
Harkins does not disclose the blending speed being reduced to a low-shear speed or blade type being changed to a low-shear blade for uniformly dispersing the encapsulated NADH and to maintain the uniform dispersion of the encapsulated NADH, as required by claim 1. Hennis teaches the difference between high shear and low shear mixing, with the goal of mixing being to achieve a process result of a homogeneous fluid product (pg. 1 Title and [0001]). Hennis discloses using high shear mixing, which requires higher blending speed (requires more horsepower; [0005]) and a sharp-edged blade, for dispersing particles and ingredients that resist blending easily, solids that need to be broken down, or ingredients that require vigorous action to evenly distribute [0004-0005]. Hennis also discloses using low shear mixing, which requires a reduced blending speed (minimum horsepower input; [0003]) and a low-shear blade (a hydrofoil; [0003]), that provides the gentlest agitation with the least shear and is effective for materials that can be damaged by a high speed and higher shear impeller, while still achieving the goal of a homogeneous fluid product [0001], [0003].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Meijerink to incorporate the teachings of Hennis by reducing the blending speed and changing to a low-shear blade while adding the NADH component to uniformly disperse the encapsulated NADH and to maintain the uniformly dispersed encapsulated NADH throughout the liquid, because this provides the gentlest agitation with the least shear and is effective for materials that can be damaged by a high speed and higher shear impeller, like a microencapsulated nicotinamide, while still achieving the goal of a homogeneous fluid product, as recognized by Hennis [0001], [0003].
Harkins discloses the pH is between 2.5-9.5 (pg. 4 L5, Claim 6). This encompasses the claimed pH of about 2.5 to about 5.0, about 2.5 to about 4.5 and 2.5 to about 4.0, as required by claims 1, 7 and 8, 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).
Harkins teaches wherein the at least partially micro-encapsulated nicotinamide is homogeneously dispersed throughout the mixed component, as required by claim 1 (dissolving or suspending the at least one niacinamide adenine dinucleotide precursor throughout a liquid carrier; pg. 3 L27-32).
Harkins is silent on subjecting the mixed component to a cold fill production process, as required by claim 1. Kamcharov teaches a method for making a dietary supplement (a beverage comprising a collagen hydrolysate; abstract). Kamcharov discloses subjecting the mixed component (the beverage) to a cold fill production process (clean fill), where the filling of the beverage happens in a sterile environment [0088], which ensures microbial safety of the dietary supplement. It is noted that Kamcharov discusses several filling processes one of them being a clean fill and one being a hot fill [0088-0091]. Since the clean fill occurs after a product is pasteurized and cooled in the pasteurization system, it is considered a cold fill, meaning the product is not hot, or around room temperature during the filling process.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Meijerink and Hennis to incorporate the teachings of Kamcharov by subjecting the mixed component to a cold fill production process, where the filling of the beverage happens in a sterile environment, as recognized by Kamcharov [0088], ensuring microbial safety of the dietary supplement.
Regarding claims 4-6, Harkins in view of Meijerink teaches providing an NADH component that is at least partially microencapsulated nicotinamide, as taught in claim 1. Meijerink discloses providing a microencapsulation agent (release controlling polymers) being selected from derivatives of celluloses (hydrophilic cellulose derivatives; [0064]), alginates, and a combination thereof (or a mixture of at least two release controlling polymers; [0064], as required by claims 4-6. Meijerink uses derivatives of celluloses and/or alginates due to their insolubility in acid fluids of the stomach and their ability to release active ingredients over a desired period of time [0064]. Additionally, Meijerink states that the nicotinamide is present in the microencapsulation (suspension) at about 1-95% and the cellulose is present at about 5-99%. When this amount of microencapsulation agent (polymers and release controlling agents) is applied to the amount of nicotinamide used in the dietary supplement formulation of Harkins, which is 0.01 to 0.05% (pg. 6 L7), the amount of microencapsulation agent by weight of the dietary supplement formulation is about 0.0104% to about 0.052%. This is within the claimed ranges of 0.01-2.0% and 0.01-0.5%, as required by claims 5 and 6, respectively.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins to incorporate the teachings of Meijerink by having the microencapsulation agent be celluloses and within the claimed about because using celluloses within this amount to cover the nicotinamide creates insolubility in acid fluids of the stomach and allows for the release of the nicotinamide active ingredient over a desired period of time, as recognized by Meijerink [0064].
Regarding claims 9-11, Harkins teaches the inclusion of sweeteners (pg. 4 L6-7) and that the composition comprises of at least one of sucrose, glucose and fructose (pg. 4 L1). However, Harkins is silent as to the Brix value of the mixed component. Kamcharov teaches a Brix value of between 1-16°Bx, which may vary and be adjusted based on the desired degree of sweetness [0102]. This is within the claimed range of Brix value of about 1 to about 85, as required by claim 9, and overlaps the claimed ranges of Brix value of about 3 to about 30 and 5 to about 15, as required by claims 10 and 11, 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).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Meijerink and Hennis to incorporate the teachings of Kamcharov by having the mixed component have a Brix value within the claimed ranges of claims 9-10 since the Brix value may vary and be adjusted based on the desired degree of sweetness [0102], as recognized by Kamcharov.
Regarding claims 12-14, Harkins in view of Meijerink, Hennis and Kamcharov teach a mixed component, specifically a beverage, as recognized by Harkins (pg. 1 L8-9), that is substantially identical to the claimed product. Therefore, it is considered to possess the property of a viscosity when measured in centipoise at 21.1 °C, within the range of about 0.05-300,000, 0.05-250,000 and 0.05-100,000, as required by claims 12, 13 and 14, respectively. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claims 15-17, Harkins does not teach collagen as a supplement component. Kamcharov teaches a supplement component of collagen, which is a major protein of human connective tissue and vital importance for muscle function [0003]. Kamcharov discloses that collagen is in the range of about 0.01 grams per liter to 40 grams per liter and 40 grams per liter or more [0068], which is 0.001% to 4% and 4% or more. This encompasses the claimed ranges of 0.5% to 10%, 1.5% to 7% and 2% to 5%, as required by claims 15, 16 and 17, 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).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Meijerink and Hennis to incorporate the teachings of Kamcharov by providing the supplement component of collagen within the claimed ranges of claims 15-17 since collagen is a major protein of human connective tissue and has vital importance for muscle function [0003], as recognized by Kamcharov.
Regarding claim 18-20, Harkins teaches providing the supplement component of Coenzyme Q10 (CoQ10) in the range of 0.01-0.05% by weight (pg. 3 L27-28; pg. 6 L11-13). This is within the claimed ranges of 0.000001-3%, 0.001-2% and 0.01-1.0%, as required by claims 18, 19 and 20, respectively.
Regarding claims 21-22, Harkins teaches providing the supplement component of vitamins, as required by claim 21, wherein the vitamins are selected from vitamin B1, vitamin B2, vitamin B3, vitamin B12, vitamin E and biotin, as required by claim 22 (pg. 9 L7-13).
Regarding claims 23-24, Harkins discloses the supplement component comprises minerals, as required by claim 23, wherein the minerals are selected from selenium and zinc, as required by claim 24 (pg. 9 L 14).
Regarding claims 25-26, Harkins teaches a method for synthesis of, or mixing of, a dietary supplement (all natural biologic enhancing beverage; Abstract, pg. 11 Example 1 L5-11). Harkins discloses providing an NADH component having nicotinamide (NAD+ precursor such as the reduced form of nicotinamide adenine dinucleotide (NADH); pg. 4 L32-34) from about 0.01 to 0.05% (pg. 6 L7). This is within the claimed range of 0.001-2.0% and 0.01-0.5%, as required by claims 25 and 26, respectively.
Harkins does not teach the NADH component is at least partially microencapsulated nicotinamide, as required by claims 25-26. Meijerink teaches the administration of nicotinamide in a long-acting formulation [0011]. Meijerink teaches the nicotinamide is microencapsulated, which makes it resistant to gastric juice and controls the release of the nicotinamide over the desired period of time [0061], [0064].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins to incorporate the teachings of Meijerink by having the nicotinamide be microencapsulated, making it resistant to gastric juice and controlling the release of the nicotinamide over the desired period of time [0061], [0064].
Harkins teaches blending the NADH (NAD+ precursor) with water (pg. 6 L3-16, pg. 11 L6-7). Harkins states the water in the dietary supplement is between 12-16 oz, which is about 340 g to 454 g, and the rest of the dietary supplement which is the supplement component rounds to about 1 g (pg. 11 L5-11). Therefore, Harkins teaches water is about 99% by weight of the dietary supplement. This is within the claimed ranges for water from about 25-99% and 50-99%, as required by claims 25 and 26, respectively.
Meijerink discloses providing a microencapsulation agent (release controlling polymers) being selected from celluloses (hydrophilic cellulose derivatives; [0064]). Meijerink uses celluloses due to their insolubility in acid fluids of the stomach and their ability to release active ingredients over a desired period of time [0064]. Additionally, Meijerink states that the nicotinamide is present in the microencapsulation (suspension) at about 1-95% and the cellulose is present at about 5-99%. When this amount of microencapsulation agent (polymers and release controlling agents) is applied to the amount of nicotinamide used in the dietary supplement formulation of Harkins, which is 0.01 to 0.05% (pg. 6 L7), the amount of microencapsulation agent by weight of the dietary supplement formulation is about 0.0104% to about 0.052%. This is within the claimed ranges of 0.01-2.0% and 0.01-0.5%, as required by claims 25 and 26, respectively.
Additionally, when looking at the amount of nicotinamide present in the microencapsulation (suspension), which is at about 1-95%, and the amount of microencapsulation agent (polymers and release controlling agents), which is present at about 5-99%, in Meijerink (Example 1 [0091]), this gives a ratio range of nicotinamide to microencapsulation agent of about 1:99 to about 19:1. This encompasses the ratio of about 1:1, required by claims 25 and 26. 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).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins to incorporate the teachings of Meijerink by having the microencapsulation agent be celluloses and within the claimed amount and within the claimed range for nicotinamide to microencapsulation agent because using celluloses within this amount to cover the nicotinamide creates insolubility in acid fluids of the stomach and allows for the release of the nicotinamide active ingredient over a desired period of time, as recognized by Meijerink [0064].
Harkins discloses providing a supplement component (see all ingredients listed in Example 1 pg. 11 L5-11), where the supplement component of Harkins is 1 g in 12-16 oz of water, which is from about 0.2% to about 0.3% by weight of the dietary supplement (pg. 11 L5-11). This is within the claimed ranges for the supplement component from about 0.000001-24% and 0.000001-11% by weight, as required by claims 25 and 26, respectively.
Harkins does not teach collagen as a supplement component. Kamcharov teaches a supplement component of collagen, which is a major protein of human connective tissue and vital importance for muscle function [0003].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Meijerink to incorporate the teachings of Kamcharov by providing the supplement component of collagen since collagen is a major protein of human connective tissue and has vital importance for muscle function [0003], as recognized by Kamcharov.
Harkins teaches providing the supplement component of Coenzyme Q10 (CoQ10), vitamins and minerals (pg. 9 L7-14).
Harkins teaches forming a mixed component by mixing the NADH component with the supplement component at ambient conditions, the mixed component being a liquid at the ambient conditions (pg. 3 L29-30, pg. 11 L5-11). Harkins also teaches the NADH component is uniformly dispersed throughout the liquid (at least one niacinamide adenine dinucleotide precursor is dissolved or suspended in a liquid carrier (pg. 3 L27-32), as required by claims 25-26.
Harkins does not disclose the blending speed being reduced to a low-shear speed or blade type being changed to a low-shear blade for uniformly dispersing the encapsulated NADH and to maintain the uniform dispersion of the encapsulated NADH, as required by claims 25-26. Hennis teaches the difference between high shear and low shear mixing, with the goal of mixing being to achieve a process result of a homogeneous fluid product (pg. 1 Title and [0001]). Hennis discloses using high shear mixing, which requires higher blending speed (requires more horsepower; [0005]) and a sharp-edged blade, for dispersing particles and ingredients that resist blending easily, solids that need to be broken down, or ingredients that require vigorous action to evenly distribute [0004-0005]. Hennis also discloses using low shear mixing, which requires a reduced blending speed (minimum horsepower input; [0003]) and a low-shear blade (a hydrofoil; [0003]), that provides the gentlest agitation with the least shear and is effective for materials that can be damaged by a high speed and higher shear impeller, while still achieving the goal of a homogeneous fluid product [0001], [0003].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Meijerink and Kamcharov to incorporate the teachings of Hennis by reducing the blending speed and changing to a low-shear blade while adding the NADH component to uniformly disperse the encapsulated NADH and to maintain the uniformly dispersed encapsulated NADH throughout the liquid, because this provides the gentlest agitation with the least shear and is effective for materials that can be damaged by a high speed and higher shear impeller, like a microencapsulated nicotinamide, while still achieving the goal of a homogeneous fluid product, as recognized by Hennis [0001], [0003].
Harkins discloses the pH is between 2.5-9.5 (pg. 4 L5, Claim 6). This encompasses the claimed pH of about 2.5 to about 4.5 and 2.5 to about 4.0, as required by claims 25 and 26, 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).
Harkins in view of Meijerink, Kamcharov and Hennis teach a mixed component as disclosed above, specifically a beverage, as recognized by Harkins (pg. 1 L8-9), that is substantially identical to the claimed product. Therefore, it is considered to possess the property of a viscosity when measured in centipoise at 21.1 °C, within the range of about 0.05-250,000 and 0.05-100,000, as required by claims 25 and 26, respectively. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Harkins teaches wherein the at least partially micro-encapsulated nicotinamide is homogeneously dispersed throughout the mixed component, as required by claims 25-26 (dissolving or suspending the at least one niacinamide adenine dinucleotide precursor throughout a liquid carrier; pg. 3 L27-32).
Harkins is silent on subjecting the mixed component to a cold fill production process, as required by claims 25-26. Kamcharov discloses subjecting the mixed component (the beverage) to a cold fill production process (clean fill), where the filling of the beverage happens in a sterile environment [0088], which ensures microbial safety of the dietary supplement. It is noted that Kamcharov discusses several filling processes one of them being a clean fill and one being a hot fill [0088-0091]. Since the clean fill occurs after a product is pasteurized and cooled in the pasteurization system, it is considered a cold fill, meaning the product is not hot, or around room temperature during the filling process.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Meijerink, Kamcharov and Hennis to further incorporate the teachings of Kamcharov by subjecting the mixed component to a cold fill production process, where the filling of the beverage happens in a sterile environment, as recognized by Kamcharov [0088], ensuring microbial safety of the dietary supplement.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Applicant argues, on pgs. 14-17 of their remarks, that the Harkins obviousness rationales do not teach the claimed method with the limitation, “the at least partially micro-encapsulated nicotinamide is homogenously dispersed throughout the mixed component.” Applicant argues that the secondary reference Meijerink teaches the microencapsulated nicotinamide surrounds a solid floating-dosage form (FDDS) tablet, with the objective of retaining the tablet in the stomach for several hours so the drug is released slowly. Applicant asserts Meijerink seeks prolonged gastric residence via an impervious enteric shell but the claimed invention seeks brief gastric residence while preserving the NADH during refrigerated storage, insisting the teachings point in opposite directions. Applicant continues, contending that the amended claims now require the microcapsules be homogenously dispersed throughout an acidified beverage that exits the stomach in minutes. Applicant states Meijerink teaches the microencapsulated nicotinamide is insoluble in Harkins’ pH of 2.5-5; thus, the microcapsules would not release the nicotinamide but would agglomerate and settle, forming sediment, defeating the purpose of the drink formulation. Applicant contends, because of this sedimentation the art is considered to teach away and that a skilled artisan would expect failure if they were to combine the coating process of Meijerink with cold-fill conditions. However, the Office disagrees for the following reasons.
The object of Meijerink is to provide a method for treatment of ADHD, ADD, autism spectrum disorders as well as other symptoms associated with a deficiency in essential amino acid absorption, which method, relies on the administration of nicotinamide, typically in a long-acting formulation [0011]. The microencapsulation of the nicotinamide is seen as providing this long-acting formulation. Meijerink states that the nicotinamide formulation on an FDDS tablet is one preferred embodiment within the invention [0052] but there are other preferred embodiments as well, such as the daily oral administration of the nicotinamide in a total daily dosage specified in Meijerink [0033]. Thus, the beverage of modified Harkins would be seen as providing this dosage. Therefore, Meijerink is not seen as teaching away from the claimed method.
Moreover, a prior art reference that "teaches away" from the claimed invention is a significant factor to be considered in determining obviousness; however, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) MPEP 2145(X)(D)(1).
While, Meijerink does not disclose all the features of the present claimed invention, Meijerink is used as teaching reference to show how nicotinamide can be microencapsulated and then used in preparations. Therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely, microencapsulation of nicotinamide and the amount and ratio of microencapsulation agent to nicotinamide that can be present.
Regarding the amount of time it takes for the composition to exit the stomach, it is noted that this is not a feature that is claimed and the composition of modified Harkins is a beverage and is substantially identical to the claimed product. Thus, the composition made by the substantially identical method to the claimed method, is considered to exit the stomach at the same rate. Additionally, modified Harkins teaches the microencapsulated nicotinamide is homogenously dispersed throughout the acidified beverage, as shown in the rejection above. Harkins teaches wherein the at least partially micro-encapsulated nicotinamide is homogeneously dispersed throughout the mixed component (dissolving or suspending the at least one niacinamide adenine dinucleotide precursor throughout a liquid carrier; pg. 3 L27-32).
The Applicant’s argument on the microencapsulated nicotinamide of Meijerink being insoluble in Harkins’ pH of 2.5-5, thus not releasing the nicotinamide within the drink and settling and agglomerating at the bottom is unconvincing. It is noted that the purpose of microencapsulation is to protect active substances from degradation and control their release to a specific target site or at a desired time. As stated in the instant specification, the acidic pH of the dietary supplement acts as a stabilizing mechanism enabling the dietary supplement to avoid deterioration in the stomach and have high absorption in the intestines [0013]. The dietary supplement, which includes the microencapsulated nicotinamide, avoids deterioration in the stomach and preserves the NADH during refrigerated storage. In other words, the microencapsulation stays intact at low pH, such as at the low pH of the claimed dietary supplement, which is between about 2.5 and about 5 [0013], and also the low pH of the stomach. This enables high absorption of the nicotinamide in the intestines [0013]. This is also the case for the microencapsulated nicotinamide of modified Harkins, since the microencapsulation agent of modified Harkins and the claimed microencapsulation agent (see claim 4), are both selected from the group consisting of derivatives of celluloses and alginates, and combinations thereof. As stated in the rejection above, Meijerink discloses providing a microencapsulation agent (release controlling polymers) being selected from derivatives of celluloses (hydrophilic cellulose derivatives; [0064]), alginates, and a combination thereof (or a mixture of at least two release controlling polymers; [0064]). Thus, the microencapsulation of the nicotinamide in the composition of modified Harkins would have a substantially identical effect as the claimed microencapsulated nicotinamide
Additionally, even though the microencapsulation of modified Harkins and the claimed invention stays intact within low pH solutions, that does not mean that the microcapsules would agglomerate and settle, forming sediment. As the amended claim language states and the amended rejection above teaches, a low-shear blending speed and blade are used to maintain the uniform dispersion of the NADH component throughout the liquid until it is subjected to a cold fill production process. This would ensure that the microencapsulated nicotinamide stays homogenously dispersed throughout the mixed component until bottling. Moreover, the microencapsulated agent that covers the nicotinamide can be a cellulose derivative as stated in claim 4 and taught by Meijerink. The cellulose derivatives of Meijerink, such as a hydrophilic cellulose derivative [0064] would allow the nicotinamide to be suspended within the drink matrix. A hydrophilic cellulose derivative would be suspended in water, rather than settling. Thus, with the continued blending and a hydrophilic cellulose derivative microencapsulating the nicotinamide, the microencapsulated nicotinamide of modified Harkins is viewed as being homogenously dispersed throughout the mixed component.
Applicant argues on pgs. 17-18 of their remarks, that the specification only discloses one polymer to nicotinamide ratio of about 1:1 and repeats that ratio in every working embodiment. Applicant contends that the 1:1 ratio links directly to the required homogenous dispersion and the functional goal of stable, sediment-free suspension. The Applicant asserts the claimed ratio is a critical feature and not an arbitrary point within Meijerink’s 1:99 to 19:1 ratio span. Applicant state the prior art does not identify or prefers this 1:1 ratio for acidic ready-to-drink beverages and thus, the overlap doctrine cannot support the rejection. However, the Office disagrees for the following reasons.
The instant specification paragraphs [0015-0016] discusses the amount of microencapsulation agent used to surround the nicotinamide. While the specification does say the microencapsulation agent “may” by present at “about” a 1:1 ratio with the nicotinamide, that does not mean that other ratios could not be contemplated by the inventors. This is especially seen in the wording choice of “may” and “about” instead of using words like “is” or “must.” Based on the ranges in the specification for the microencapsulation agent and the nicotinamide, it would not be unreasonable to have a ratio of 1:5 to 5:1, using about 0.1% to about 0.5% microencapsulation agent and about 0.1% to about 0.5% nicotinamide [0016].
Additionally, in paragraphs [0015-0016] of the specification, which discuss the microencapsulation agent, there is no discussion on the criticality of the ratio. No discussion in the specification links the 1:1 ratio of the microencapsulation agent and nicotinamide to being a critical feature that is tied to the functional goal of having a sediment-free suspension. In paragraph [0012] of the specification it discusses how blending is sufficiently maintained to achieve encapsulated NADH uniformity and prevent bottom sediment throughout the bottling process. However, it does not state that this is due to the specific 1:1 ratio or that the ratio is critical. The specification also does not state that having a sediment-free suspension is a critical feature. Thus, the specification has not shown criticality of the claimed ratio and the rejection outlined above still applies, see MPEP 2144.05.
Applicant argues on pg. 18 of their remarks, that Meijerink is silent on cold-fill technology. Applicant contends that Meijerink teaches away from cold fill by relying on hot-melt or fluid-bed spraying at elevated temperatures that would degrade NADH. Applicant asserts the references fail to supply the missing process step. However, the Office disagrees for the following reasons.
The Meijerink reference does not teach away from the cold fill process. Meijerink teaches the method of forming the ingredient of the microencapsulated nicotinamide which is used as an ingredient in the claimed method. As stated above, while Meijerink does not disclose all the features of the present claimed invention, Meijerink is used as a teaching reference to show how nicotinamide can be microencapsulated and then used in preparations. Therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely, microencapsulation of nicotinamide and the amount and ratio of microencapsulation agent to nicotinamide that can be present.
Moreover, a prior art reference that "teaches away" from the claimed invention is a significant factor to be considered in determining obviousness; however, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) MPEP 2145(X)(D)(1).
Applicant’s arguments with respect to the newly added claim limitation of a “low-shear blending” process on pgs. 18-21 have been considered but are moot because the new ground of rejection does not rely on any teaching or matter specifically challenged in the argument.
Conclusion
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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