DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The amendment filed August 13, 2025 is acknowledged. Claims 23-33 are pending in the application. Claims 1-22 have been cancelled.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 23-26 and 29-31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bunick et al. US 20030017202 (hereinafter “Bunick”) in view of view of Newman US 20060134300 (hereinafter “Newman”).
With respect to claim 23, Bunick teaches a fluid dosage comprising a stimulant (paragraphs [0013], [0014], [0024], [0025], and [0027]).
Regarding the limitation of consisting of caffeine, at least one member selected from the group consisting of citicoline, phosphatidylcholine, and combinations thereof, at least three members selected from the group consisting of vitamin B6, vitamin B12, niacin, N-acetyl-tyrosine, L-phenylalanine, malic acid, citric acid, taurine, glucuronolactone, and combinations thereof, at least one flavorant where the at least one flavorant includes sucralose, and at least one preservative as recited in claim 23, Bunick teaches the dosage contains mixtures of active agents, including caffeine, citric acid, niacin, vitamin B6, and vitamin B12. The dosage may contain conventional excipients, including sucralose, flavor(s), and preservative(s) (paragraphs [0001], [0013], [0015], and [0028]).
However, Bunick does not expressly disclose the dosage comprises citicoline and/or phosphatidylcholine.
Newman teaches an oral energy formulation. The formulation comprises caffeine, cytidine diphosphocholine (citicoline), flavoring agents, sucralose, vitamin B6, vitamin B12, and niacin (Abstract; paragraphs [0006], [0020], [0030]-[0032], [0035], [0039], [0044], [0047], [0048], [0055], [0056], [0062], and [0063]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, given the teachings of Newman, to select citicoline in the composition of Bunick based in its suitability for its intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Bunick and Newman similarly teach compositions comprising similar ingredients, Newman teaches cytidine diphosphocholine (citicoline) increases acetylcholine levels in the brain which is beneficial in controlling mood, improving memory, and stimulating alertness and mental energy (paragraphs [0006], [0007], [0030], [0031], [0035]-[0041], [0055], and [0056]), Bunick teaches nutrients may be included in the composition and the dosage effectively masks the taste of the active agents (paragraphs [0011], [0013], and [0015]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
The claimed composition cannot be “clearly envisaged” from modified Bunick as required to meet the standard of anticipation (cf. MPEP 2131.03). However, in light of the overlap between the claimed edible energy composition and the dosage comprising a stimulant as disclosed by modified Bunick, it is urged that it would have been within the bounds of routine experimentation, as well as the skill level of one of ordinary skill in the art, to select a combination of caffeine, citicoline, vitamin B6, vitamin B12, niacin, citric acid, flavorant, sucralose, and preservative, which is both disclosed by modified Bunick and encompassed within the scope of the present claims and thereby arrive at the claimed invention. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) and MPEP 2144.07.
Regarding the limitation of wherein said composition has a volume from about 10 ml to about 300 ml as recited in claim 23, modified Bunick does not expressly disclose this feature. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize the volume of the composition through routine experimentation with the expectation of successfully preparing a nutritionally and organoleptically desirable product. One of ordinary skill in the art would have been motivated to do so because the quantities of the components are a matter of choice and may be adjusted to obtain the desired nutritional and organoleptic qualities of the dosage, Bunick teaches the formulation comprises a pre-determined volume of components, such as 500 ml (paragraphs [0022] and [0061]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 24, modified Bunick is relied upon for the teaching of the composition of claim 23 as addressed above.
Regarding the limitation of wherein said vitamin B6 is present in an amount from about 0.01 % to about 0.3 %; said vitamin B12 is present in an amount from about 0.0001 % to about 0.003 %; and said niacin is present in an amount from about 0.01 % to about 0.3 % as recited in claim 24, modified Bunick does not expressly disclose the claimed quantities of vitamin B6, vitamin B12, and niacin. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize the quantities of vitamin B6, vitamin B12, and niacin in the composition through routine experimentation with the expectation of successfully preparing a nutritionally desirable product. One of ordinary skill in the art would have been motivated to do so because the quantities of the components are a matter of choice and may be adjusted to obtain the desired nutritional qualities of the dosage, and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 25, modified Bunick is relied upon for the teaching of the composition of claim 23 as addressed above.
Regarding the limitation of wherein said sucralose is present in an amount from about 0.001% to about 0.4% as recited in claim 25, modified Bunick does not expressly disclose the amount of sucralose. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize the amount of sucralose present in the composition through routine experimentation with the expectation of successfully preparing an organoleptically desirable product. One of ordinary skill in the art would have been motivated to do so because the quantity of sucralose is a matter of choice and may be adjusted to obtain the desired organoleptic qualities of the dosage, Bunick teaches the dosage effectively masks the taste of the active agents (paragraph [0011]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 26, modified Bunick is relied upon for the teaching of the composition of claim 23 as addressed above.
Regarding the limitation of wherein said glucuronolactone in an amount from about 0.1% to about to about 1.2% as recited in claim 26, Bunick does not expressly disclose the composition comprises glucuronolactone in an amount from about 0.1% to about to about 1.2%.
Newman teaches an oral energy formulation. The formulation comprises caffeine, glucuronolactone, choline related compound, flavoring agents, sucralose, vitamin B6, vitamin B12, and niacin. In one embodiment, 500 to 750 mg of glucuronolactone is mixed with 10-15 mL (.03 - .075 g/mL or 3-7.5%) to 250 mL (.002-.003 g/mL or 0.2-0.3%) of a liquid (Abstract; paragraphs [0006], [0030]-[0032], [0035], [0039], [0044], [0047], [0048], [0055], [0056], [0062], and [0063]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, given the teachings of Newman, to select glucuronolactone in the composition of Bunick based in its suitability for its intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Bunick and Newman similarly teach compositions comprising similar ingredients, Newman teaches additional ingredients, such as glucuronolactone, enhance the nutritional value, functionality, or taste and palatability of the composition (paragraphs [0006], [0007], [0030], [0031], and [0039]), Bunick teaches nutrients may be included in the composition and the dosage effectively masks the taste of the active agents (paragraphs [0011] and [0013]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
Further, it would have been obvious to one of ordinary skill in the art at the time of the invention to select any portions of the disclosed range, including the instantly claimed range of glucuronolactone, from the ranges disclosed in the prior art. One of ordinary skill in the art would have been motivated to do so because Bunick and Newman similarly teach oral compositions comprising similar ingredients, Bunick teaches nutrients may be included in the composition and the dosage effectively masks the taste of the active agents (paragraphs [0011] and [0013]), and Newman teaches additional ingredients, such as glucuronolactone, enhance the nutritional value, functionality, or taste and palatability of the composition (paragraphs [0006], [0007], [0030], [0031], and [0039]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
With respect to claim 29, Bunick teaches a fluid dosage comprising a stimulant (paragraphs [0013], [0014], [0024], [0025], and [0027]).
Regarding the limitation of consisting of caffeine, at least one member selected from the group consisting of citicoline, phosphatidylcholine, and combinations thereof, vitamin B6, vitamin B12, niacin, at least two members selected from the group consisting of N-acetyl-tyrosine, L-phenylalanine, malic acid, citric acid, taurine, glucuronolactone, and combinations thereof, at least one flavorant where the at least one flavorant includes sucralose, and at least one preservative as recited in claim 29, Bunick teaches the dosage contains mixtures of active agents, including caffeine, citric acid, niacin, vitamin B6, and vitamin B12. The dosage may contain conventional excipients, including sucralose, flavor(s), and preservative(s) (paragraphs [0001], [0013], [0015], and [0028]).
However, Bunick does not expressly disclose the dosage comprises citicoline and/or phosphatidylcholine and at least two members of the listed compositions.
Newman teaches an oral energy formulation. The formulation comprises caffeine, glucuronolactone, amino acids such as taurine and L-phenylalanine, cytidine diphosphocholine (citicoline), flavoring agents, sucralose, vitamin B6, vitamin B12, and niacin (Abstract; paragraphs [0006], [0020], [0030]-[0032], [0035]-[0041], [0044], [0047], [0048], [0055], [0056], [0062], and [0063]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, given the teachings of Newman, to select citicoline, glucuronolactone, taurine, and L-phenylalanine in the composition of Bunick based in its suitability for its intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Bunick and Newman similarly teach compositions comprising similar ingredients, Newman teaches taurine is an amino acid that has been found to ameliorate and counteract some of the uncomfortable side effects of caffeine, L-phenylalanine is an amino acid that can be used to boost the functionality of caffeine, cytidine diphosphocholine (citicoline) increases acetylcholine levels in the brain which is beneficial in controlling mood, improving memory, and stimulating alertness and mental energy, and additional ingredients, such as glucuronolactone, enhance the nutritional value, functionality, or taste and palatability of the composition (paragraphs [0006], [0007], [0030], [0031], [0035]-[0041], [0055], and [0056]), Bunick teaches nutrients and amino acids may be included in the composition and the dosage effectively masks the taste of the active agents (paragraphs [0011], [0013], and [0015]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
The claimed composition cannot be “clearly envisaged” from modified Bunick as required to meet the standard of anticipation (cf. MPEP 2131.03). However, in light of the overlap between the claimed edible energy composition and the dosage comprising a stimulant as disclosed by modified Bunick, it is urged that it would have been within the bounds of routine experimentation, as well as the skill level of one of ordinary skill in the art, to select a combination of caffeine, citicoline, vitamin B6, vitamin B12, niacin, L-phenylalanine, citric acid, taurine, glucuronolactone, flavorant, sucralose, and preservative, which is both disclosed by modified Bunick and encompassed within the scope of the present claims and thereby arrive at the claimed invention. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) and MPEP 2144.07.
Regarding the limitation of wherein said composition has a volume from about 10 ml to about 300 ml as recited in claim 29, modified Bunick does not expressly disclose this feature. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize the volume of the composition through routine experimentation with the expectation of successfully preparing a nutritionally and organoleptically desirable product. One of ordinary skill in the art would have been motivated to do so because the quantities of the components are a matter of choice and may be adjusted to obtain the desired nutritional and organoleptic qualities of the dosage, Bunick teaches the formulation comprises a pre-determined volume of components, such as 500 ml (paragraphs [0022] and [0061]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 30, modified Bunick is relied upon for the teaching of the composition of claim 29 as addressed above.
Regarding the limitation of wherein said sucralose is present in an amount from about 0.001% to about 0.4% as recited in claim 30, modified Bunick does not expressly disclose the amount of sucralose. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize the amount of sucralose present in the composition through routine experimentation with the expectation of successfully preparing an organoleptically desirable product. One of ordinary skill in the art would have been motivated to do so because the quantity of sucralose is a matter of choice and may be adjusted to obtain the desired organoleptic qualities of the dosage, Bunick teaches the dosage effectively masks the taste of the active agents (paragraph [0011]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 31, modified Bunick is relied upon for the teaching of the composition of claim 29 as addressed above.
Regarding the limitation of wherein said glucuronolactone in an amount from about 0.1% to about to about 1.2% as recited in claim 31, Bunick as modified by Newman teaches this limitation since Newman is relied upon for the teaching of glucuronolactone as addressed above in claim 29, and Newman teaches in one embodiment, 500 to 750 mg of glucuronolactone is mixed with 10-15 mL (.03 - .075 g/mL or 3-7.5%) to 250 mL (.002-.003 g/mL or 0.2-0.3%) of a liquid (Abstract; paragraphs [0006], [0030]-[0032], [0062], and [0063]). It would have been obvious to one of ordinary skill in the art at the time of the invention to select any portions of the disclosed range, including the instantly claimed range of glucuronolactone, from the ranges disclosed in the prior art. One of ordinary skill in the art would have been motivated to do so because Bunick and Newman similarly teach oral compositions comprising similar ingredients, Bunick teaches nutrients may be included in the composition and the dosage effectively masks the taste of the active agents (paragraphs [0011] and [0013]), and Newman teaches additional ingredients, such as glucuronolactone, enhance the nutritional value, functionality, or taste and palatability of the composition (paragraphs [0006], [0007], [0030], [0031], and [0039]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Claims 27 and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bunick et al. US 20030017202 (hereinafter “Bunick”) in view of Newman US 20060134300 (hereinafter “Newman”) as applied to claims 23 and 29 above, and in further view of Gardiner et al. WO 2006096996 (hereinafter “Gardiner”).
With respect to claim 27, modified Bunick is relied upon for the teaching of the composition of claim 23 as addressed above.
Regarding the limitation of wherein N-acetyl L- tyrosine is present in an amount from about 0.1% to about 0.8 %, L- phenylalanine in an amount from about 0.1 to about 0.8 % and taurine in an amount from about 0.1 % to about 0.8 % as recited in claim 27, Bunick does not expressly disclose the presence of L-phenylalanine and taurine in the composition.
Newman teaches an oral energy formulation. The formulation comprises caffeine, amino acids such as taurine and L-phenylalanine, choline related compound, flavoring agents, sucralose, vitamin B6, vitamin B12, and niacin. In one embodiment, 500 to 1500 mg of taurine is mixed with 250 mL of a beverage (.002-.006 g/mL or 0.2-0.6%) (Abstract; paragraphs [0006], [0020], [0030]-[0032], [0035]-[0041], [0044], [0047], [0048], [0055], [0056], [0062], and [0063]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, given the teachings of Newman, to select taurine and L-phenylalanine in the composition of Bunick based in its suitability for its intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Bunick and Newman similarly teach compositions comprising similar ingredients, Newman teaches taurine is an amino acid that has been found to ameliorate and counteract some of the uncomfortable side effects of caffeine, L-phenylalanine is an amino acid that can be used to boost the functionality of caffeine, and additional ingredients enhance the nutritional value, functionality, or taste and palatability of the composition (paragraphs [0006], [0007], [0030], [0031], and [0035]-[0041]), Bunick teaches nutrients and amino acids may be included in the composition (paragraphs [0013] and [0015]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
Also, it would have been obvious to one of ordinary skill in the art at the time of the invention to select any portions of the disclosed range, including the instantly claimed range of taurine, from the ranges disclosed in the prior art. One of ordinary skill in the art would have been motivated to do so because Bunick and Newman similarly teach compositions comprising similar ingredients, Newman teaches amino acids can be used as nutritional additives that boosts functionality of the caffeine containing foodstuff and additional ingredients enhance the nutritional value, functionality, or taste and palatability of the composition (paragraph [0040]), and Bunick teaches nutrients and amino acids may be included in the composition (paragraphs [0013] and [0015]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Additionally, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the amount of L-phenylalanine in the composition of Bunick through routine experimentation to obtain desirable compositions with nutritional properties. One of ordinary skill in the art would have been motivated to do so because Bunick teaches nutrients and amino acids may be included in the composition (paragraphs [0013] and [0015]), Newman teaches L-phenylalanine is an amino acid that can be used to boost the functionality of caffeine and additional ingredients enhance the nutritional value, functionality, or taste and palatability of the composition (paragraphs [0006], [0030], [0031], and [0039]-[0041]), the content of L-phenylalanine may be adjusted to obtain desirable functional and nutritional properties of the final product, and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Further, Bunick does not expressly disclose the composition comprises N-acetyl-L-tyrosine.
Gardiner teaches consumables comprising caffeine and N-acetyl L-tyrosine (Abstract; and P3, bottom – P4, top; P5, bottom; and P6-P7, Examples 1 and 2).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, given the teachings of Gardiner, to select N-acetyl L-tyrosine in the composition of Bunick based in its suitability for its intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Bunick and Gardiner similarly teach compositions comprising caffeine and amino acids, Bunick teaches nutrients and amino acids may be included in the composition (paragraphs [0013] and [0015]), Gardiner teaches the composition increases the metabolic rate (Abstract; and P1), and said combination would amount to the use of known elements for their intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the amount of N-acetyl-tyrosine in the composition of Bunick through routine experimentation to obtain desirable compositions with nutritional properties. One of ordinary skill in the art would have been motivated to do so because Bunick teaches nutrients and amino acids may be included in the composition (paragraphs [0013] and [0015]), Gardiner teaches the composition increases the metabolic rate and the amounts may vary depending on the desired effect (Abstract; P1 and P4, bottom), the content of N-acetyl-tyrosine may be adjusted to obtain desirable functional and nutritional properties of the final product, and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 32, modified Bunick is relied upon for the teaching of the composition of claim 29 as addressed above.
Regarding the limitation of wherein N-acetyl L- tyrosine is present in an amount from about 0.1% to about 0.8 %, L- phenylalanine in an amount from about 0.1 to about 0.8 % and taurine in an amount from about 0.1 % to about 0.8 % as recited in claim 32, Bunick as modified by Newman teaches the presence of L-phenylalanine and taurine in the composition as well as the claimed quantity of taurine since Newman is relied upon for the teaching of the composition comprising L-phenylalanine and taurine as addressed above in claim 29. Additionally, Newman teaches 500 to 1500 mg of taurine is mixed with 250 mL of a beverage (.002-.006 g/mL or 0.2-0.6%) in one embodiment (paragraphs [0006], [0030]-[0032], [0035]-[0041], [0062], and [0063]). It would have been obvious to one of ordinary skill in the art at the time of the invention to select any portions of the disclosed range, including the instantly claimed range of taurine, from the ranges disclosed in the prior art. One of ordinary skill in the art would have been motivated to do so because Bunick and Newman similarly teach compositions comprising similar ingredients, Newman teaches amino acids can be used as nutritional additives that boosts functionality of the caffeine containing foodstuff and additional ingredients enhance the nutritional value, functionality, or taste and palatability of the composition (paragraph [0040]), and Bunick teaches nutrients and amino acids may be included in the composition (paragraphs [0013] and [0015]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Additionally, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the amount of L-phenylalanine in the composition of modified Bunick through routine experimentation to obtain desirable compositions with nutritional properties. One of ordinary skill in the art would have been motivated to do so because Bunick teaches nutrients and amino acids may be included in the composition (paragraphs [0013] and [0015]), Newman teaches L-phenylalanine is an amino acid that can be used to boost the functionality of caffeine and additional ingredients enhance the nutritional value, functionality, or taste and palatability of the composition (paragraphs [0006], [0030], [0031], and [0039]-[0041]), the content of L-phenylalanine may be adjusted to obtain desirable functional and nutritional properties of the final product, and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Further, modified Bunick does not expressly disclose the composition comprises N-acetyl-L-tyrosine.
Gardiner teaches consumables comprising caffeine and N-acetyl L-tyrosine (Abstract; and P3, bottom – P4, top; P5, bottom; and P6-P7, Examples 1 and 2).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, given the teachings of Gardiner, to select N-acetyl L-tyrosine in the composition of modified Bunick based in its suitability for its intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Bunick and Gardiner similarly teach compositions comprising caffeine and amino acids, Bunick teaches nutrients and amino acids may be included in the composition (paragraphs [0013] and [0015]), Gardiner teaches the composition increases the metabolic rate (Abstract; and P1), and said combination would amount to the use of known elements for their intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the amount of N-acetyl-tyrosine in the composition of modified Bunick through routine experimentation to obtain desirable compositions with nutritional properties. One of ordinary skill in the art would have been motivated to do so because Bunick teaches nutrients and amino acids may be included in the composition (paragraphs [0013] and [0015]), Gardiner teaches the composition increases the metabolic rate and the amounts may vary depending on the desired effect (Abstract; P1 and P4, bottom), the content of N-acetyl-tyrosine may be adjusted to obtain desirable functional and nutritional properties of the final product, and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bunick et al. US 20030017202 (hereinafter “Bunick”) in view of Newman US 20060134300 (hereinafter “Newman”) as applied to claim 23 above, and in further view of Ferruzzi US 20040096547 (hereinafter “Ferruzzi”).
With respect to claim 28, modified Bunick is relied upon for the teaching of the composition of claim 23 as addressed above.
Regarding the limitation of wherein said preservative is selected from the group consisting of sodium benzoate, potassium sorbate, and EDTA and combinations thereof as recited in claim 28, Bunick does not expressly disclose the claimed preservatives.
Ferruzzi teaches food and/or beverage compositions comprising caffeine, choline bitartrate, vitamin B6, vitamin B12, citric acid, flavoring and preservative(s). The preservatives include potassium sorbate, sodium benzoate, EDTA, and mixtures thereof (paragraphs [0018], [0021], [0031], [0033], [0037], [0039], [0040], [0045], [0046], [0058], [0060], and [0064]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, given the teachings of Ferruzzi, to select potassium sorbate, sodium benzoate, and/or EDTA as the preservative in the composition of Bunick based in its suitability for its intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Bunick and Ferruzzi similarly teach compositions comprising similar ingredients, Ferruzzi teaches the preservatives stabilize the components of the composition (paragraphs [0040], [0046], and [0064]), Bunick is not limited to the particular preservative selected (paragraph [0028]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bunick et al. US 20030017202 (hereinafter “Bunick”) in view of Newman US 20060134300 (hereinafter “Newman”) as applied to claim 29 above, and in further view of Ferruzzi US 20040096547 (hereinafter “Ferruzzi”).
With respect to claim 33, modified Bunick is relied upon for the teaching of the composition of claim 29 as addressed above.
Regarding the limitation of wherein said preservative is selected from the group consisting of sodium benzoate, potassium sorbate, and EDTA and combinations thereof as recited in claim 33, modified Bunick does not expressly disclose the claimed preservatives.
Ferruzzi teaches food and/or beverage compositions comprising caffeine, choline bitartrate, vitamin B6, vitamin B12, citric acid, flavoring and preservative(s). The preservatives include potassium sorbate, sodium benzoate, EDTA, and mixtures thereof (paragraphs [0018], [0021], [0031], [0033], [0037], [0039], [0040], [0045], [0046], [0058], [0060], and [0064]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, given the teachings of Ferruzzi, to select potassium sorbate, sodium benzoate, and/or EDTA as the preservative in the composition of modified Bunick based in its suitability for its intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Bunick and Ferruzzi similarly teach compositions comprising similar ingredients, Ferruzzi teaches the preservatives stabilize the components of the composition (paragraphs [0040], [0046], and [0064]), Bunick is not limited to the particular preservative selected (paragraph [0028]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
Response to Arguments
Applicant’s remarks filed August 13, 2025 are acknowledged.
Due to the amendments to the claims, the 35 USC 112 rejection in the previous Office Action has been withdrawn (P5).
Applicant’s arguments have been fully considered, but they are unpersuasive.
Applicant reiterates that Bunick teaches a solid form of a composition. That is, the oral dosage form is a solid that must be chewed not drunk. The Bunick disclosure makes clear that the brittle coating is central to the composition. Bunick teaches that the brittle shell is added during panning, and materials used in panning are some form of carbohydrates. Applicant suggests that carbohydrates are excluded from the current claims. Both independent claims recite a composition having a volume from about 10 ml to about 300 ml. Applicant suggests that this limitation teaches away from the Bunick disclosure. A person of ordinary skill in the art would realize that a solid composition having a volume of even only 10 ml would be too large for an oral dosage form for delivering an active agent in solid form (P5-P7).
Examiner disagrees. While Bunick teaches a brittle coating may be added to the cores in the examples, Bunick is not limited to this embodiment since the reference also teaches the dosage may be a fluid (e.g., liquid) in another embodiment. However, “Applicant must look to the whole reference for what it teaches. Applicant cannot merely rely on the examples and argue that the reference did not teach others.” In re Courtright, 377 F.2d 647, 153 USPQ 735,739 (CCPA 1967).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793