DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the claim set filed July 1, 2024, claims 1-14 are pending in the application.
Claim Objections
Claims 3 and 5-7 are objected to because of the following informalities:
In claim 3 at line 2, it is recommended to insert “one” after “least” and before “member”.
In claim 5 at line 2, it is suggested to replace “ml” with “mL” after “mg/”.
In claim 6 at line 2, it is recommended to replace “ml” with “mL” after “mg/”.
In claim 7 at line 2, it is suggested to replace “ml” with “mL” after “mg/”.
Appropriate correction is required.
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 1-14 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.
Independent claim 1 recites “choline derivative” at line 3. It is unclear what is encompassed by this recitation. More specifically, “derivative” is a relative term, and the specification fails to provide any guidance for its meaning. In the instant case, a derivative of a compound could include its molecular elements, and the metes and bound cannot be readily ascertained by said relative term. Therefore, the scope of claim 1 is indefinite.
For the purpose of the examination, the recitation of “choline derivative” at line 3 of claim 1 (emphasis added) is interpreted as “choline compound” (emphasis added).
Claims 2-4 are not specifically discussed but are rejected due to their dependence on claim 1.
Claim 5 recites “wherein said magnesium is present from about 0.05 mg/ml to about 1.0 mg/ml”, and this claim depends upon claim 1. It is unclear what is intended by this recitation. More specifically, it is uncertain what the magnesium content is based upon (e.g., per ml of the composition). Therefore, the scope of claim 5 is indefinite.
For the purpose of the examination, the recitation of “from about 0.05 mg/ml to about 1.0 mg/ml” in claim 5 is interpreted as “from about 0.05 mg/ml to about 1.0 mg/ml of the composition” (emphasis added).
Claim 6 recites “wherein said magnesium is present from about 0.05 mg/ml to 0.2 mg/ml”, and this claim depends upon claim 1. It is unclear what is intended by this recitation. More specifically, it is uncertain what the magnesium content is based upon (e.g., per ml of the composition). Therefore, the scope of claim 6 is indefinite.
For the purpose of the examination, the recitation of “from about 0.05 mg/ml to 0.2 mg/ml” in claim 6 is interpreted as “from about 0.05 mg/ml to 0.2 mg/ml of the composition” (emphasis added).
Claim 7 recites “wherein said magnesium is present from 0.5 mg/ml to about 1.0 mg/ml”, and this claim depends upon claim 1. It is unclear what is intended by this recitation. More specifically, it is uncertain what the magnesium content is based upon (e.g., per ml of the composition). Therefore, the scope of claim 7 is indefinite.
For the purpose of the examination, the recitation of “from 0.5 mg/ml to about 1.0 mg/ml” in claim 7 is interpreted as “from 0.5 mg/ml to about 1.0 mg/ml of the composition” (emphasis added).
Claims 8-12 are not specifically discussed but are rejected due to their dependence on claim 1.
Claim 13 recites “wherein said at least one preservative comprises sodium benzoate, potassium sorbate and EDTA”. It is unclear what is intended by this recitation. It is uncertain whether all three preservatives are required or if the preservative is at least one of the listed preservatives. Therefore, the scope of the claim is indefinite. Applicant is reminded that if a claim is intended to encompass combinations or mixtures of the alternatives set forth in the Markush grouping, the claim may include qualifying language preceding the recited alternatives (such as "at least one member" selected from the group), or within the list of alternatives (such as "or mixtures thereof"). Id. at 1281. See also MPEP § 2111.03. (MPEP 2173.05(h)).
For the purpose of the examination, the recitation of “wherein said at least one preservative comprises sodium benzoate, potassium sorbate and EDTA” in claim 13 (emphasis added) is interpreted as “wherein said at least one preservative is selected from the group consisting of sodium benzoate, potassium sorbate and EDTA” (emphasis added).
Claim 14 is not specifically discussed but is rejected due to its dependence on claim 1.
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 1 and 5-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krotzer WO 9961038 (hereinafter “Krotzer”) in view of Yu et al. WO 2006036634 (hereinafter “Yu”).
With respect to claim 1, regarding the recitation of comprising at least one methyl xanthine; at least one choline compound; magnesium; at least two members selected from the group consisting of niacin, vitamin B12, and vitamin B6 and combinations thereof; at least three members selected from the group consisting of glucuronolactone, taurine, L-phenylalanine, and N-acetyl-L-tyrosine and combinations thereof; and malic acid in claim 1, Krotzer relates to a composition comprising at least one nutritionally beneficial substituent (A) and at least one additional substituent (B) that provides traditional psychological feedback. Krotzer also discloses the composition additionally comprises at least one additional substituent (C) that provides long term psychological feedback and/or at least one additional substituent (D) that provides short term psychological feedback (P3, L14-P5, L5).
Regarding (A), Krotzer teaches choline, magnesium, niacin, vitamin B12, vitamin B6, taurine, methylxanthine, and L-Phenylalanine.
Regarding (B), Krotzer teaches methylxanthine and malic acid. Krotzer also teaches the use of methylxanthine as a vehicle for oral formulation.
Regarding (C), Krotzer teaches magnesium, methylxanthine, and L-Phenylalanine.
In the instant case, Krotzer teaches a composition comprising: methylxanthine, choline, magnesium, niacin, vitamin B12, vitamin B6, taurine, L-Phenylalanine and malic acid (P3, L14-P5, L4; P12, Table A; P21, Table A; P22, L1-13; P23, Table B; P24, L8-13; P26, Table C; P29, Table C; and P38, L21-26).
However, Krotzer does not expressly disclose the composition comprises glucuronolactone and N-acetyl-L-tyrosine.
Yu relates to a composition comprising N-acetylamino acid for oral mammal consumption. The N-acetyl-amino acid can be N-acetyl-L-tyrosine. The composition may also comprise caffeine (methyl xanthine), glucuronolactone, malic acid, vitamin B6, and vitamin B12 (paragraphs [0002], [0019], [0020], [0028], [0032], [0033], [0035], [0037], [0044], [0048], and [0069]).
It would have been obvious to one of ordinary skill in the art at the time of the claimed invention, given the teachings of Yu, to select N-acetyl-L-tyrosine and glucuronolactone in the composition of Krotzer based in their suitability for their 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 Krotzer and Yu similarly teach compositions comprising similar ingredients, Yu teaches therapeutic effects of the N-acetylamino acid (N-acetyl-L-tyrosine), such as improving cognition and memory performance, are complemented or enhanced synergistically with caffeine (methyl xanthine), glucuronolactone, malic acid, pharmaceutical agents, vitamins, and amino acids (paragraphs [0002], [0019], [0028], [0035], and [0048]), Krotzer teaches the composition comprises nutritionally beneficial substituents that improve or repair brain function (e.g., memory, learning, etc.) (P2, L28-29; and P10, L17-27), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. 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).
With respect to claims 5-7, modified Krotzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding wherein said magnesium is present from about 0.05 mg/ml to about 1.0 mg/ml of the composition in claim 5, wherein said magnesium is present from about 0.05 mg/ml to 0.2 mg/ml of the composition in claim 6, and wherein said magnesium is present from 0.5 mg/ml to about 1.0 mg/ml of the composition in claim 7, Krotzer does not expressly disclose these limitations. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize the concentration of magnesium in the composition of modified Krotzer through routine experimentation with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Krotzer teaches the preferred concentration of magnesium is a maximum of 1-1990 mg per day, the daily intake amount of magnesium may be obtained by a single serving or by multiple servings of the composition, and magnesium can be present in an amount sufficient to provide a nutritional benefit to the human recipient, such as restoring magnesium deficit (P3, L14-P4, L2; P10, L29-P11, L3; and P18, Table A), 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 8, modified Krotzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of wherein said methyl xanthine is caffeine in claim 8, modified Krotzer teaches this limitation since Krotzer teaches the methyl xanthine is caffeine (P3, L14-18 and 22; P4, L3-5; P23, Table B; P24, L9-12; P25, L3-7; and P38, L21-24).
With respect to claim 9, modified Krotzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of comprising of glucuronolactone, taurine, L-phenylalanine, and N-acetyl-L-tyrosine in claim 9, Krotzer as modified by Yu teaches this limitation since Krotzer teaches the composition comprises taurine and L-phenylalanine (P3, L14-32) and Yu is relied upon for the teaching of glucuronolactone and N-acetyl-L-tyrosine as addressed above in claim 1 (paragraphs [0002], [0019], [0020], [0032], [0033], [0035], and [0044]).
With respect to claim 10, modified Krotzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of comprising niacin, vitamin B12, and vitamin B6 in claim 10, modified Krotzer teaches this limitation since Krotzer teaches the composition comprises niacin, vitamin B12, and vitamin B6 (P3, L14-32; P21, Table A; P22, L1-13; and P40, L24).
With respect to claim 11, modified Krotzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of further comprising at least one artificial sweetener in claim 11, modified Krotzer teaches this limitation since Krotzer teaches the composition may comprise sweeteners such as aspartame (and its derivatives), saccharin, cyclamates, etc. (P24, Table B).
With respect to claim 12, modified Krotzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of further comprising at least one preservative in claim 12, modified Krotzer teaches this limitation since Krotzer teaches the composition may comprise a preservative (P40, L32).
With respect to claim 13, modified Krotzer is relied upon for the teaching of the composition of claim 12 as addressed above.
Regarding wherein said at least one preservative is selected from the group consisting of sodium benzoate, potassium sorbate, and EDTA in claim 13, modified Krotzer teaches this limitation since Krotzer teaches preservative such as sodium benzoate may be used (P40, L32).
Claims 2-4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krotzer WO 9961038 (hereinafter “Krotzer”) in view of Yu et al. WO 2006036634 (hereinafter “Yu”) as applied to claim 1 above, and in further view of Umbdenstock WO 9529668 (hereinafter “Umbdenstock”).
With respect to claims 2-4, modified Krotzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of wherein said magnesium is provided by a magnesium salt in claim 2, wherein said magnesium is provided by at least one member selected from the group consisting of magnesium glycinate, magnesium chloride, magnesium lactate, magnesium malate, magnesium oxide, magnesium taurate, and combinations thereof in claim 3, and comprising magnesium glycinate in claim 4, Krotzer teaches the composition comprises magnesium (P3, L14-18 and 29) but does not expressly disclose these claimed limitations.
Umbdenstock relates to a nutritional supplement. The nutritional supplement comprises magnesium such as magnesium glycinate, vitamin B6, vitamin B12, niacin, choline, and at least one amino acid such as phenylalanine (P5, L16-19; P13, L25-37; P14, L23-27; P17, L11-15; and P16, L29; P17, L5).
It would have been obvious to one of ordinary skill in the art at the time of the invention, given the teachings of Umbdenstock, to select magnesium glycinate as the magnesium in the composition of Krotzer 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 Krotzer and Umbdenstock similarly teach compositions comprising similar ingredients, Umbdenstock teaches the synergistic combination of magnesium glycinate, vitamin B6, niacin, vitamin B12, and other nutrients are provided to effect beneficial changes at the cellular level (P14, L23-27; P15, L4-6), Krotzer teaches the composition comprises nutritionally beneficial substituents (P2, L28-29; and P3, L14-P4, L9), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. 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 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krotzer WO 9961038 (hereinafter “Krotzer”) in view of Yu et al. WO 2006036634 (hereinafter “Yu”) as applied to claims 1 and 12 above, and in further view of Ferruzzi US 20040096547 (hereinafter “Ferruzzi”).
With respect to claim 13, modified Krotzer is relied upon for the teaching of the composition of claims 1 and 12 as addressed above.
Regarding wherein said at least one preservative is selected from the group consisting of sodium benzoate, potassium sorbate, and EDTA in claim 13, Krotzer teaches preservative such as sodium benzoate may be used (P40, L32).
However, Krotzer does not expressly disclose the preservative also includes potassium sorbate and EDTA.
Ferruzzi relates to compositions that provide nutrition to consumers. The composition comprises methylxanthines, vitamin B3 (niacin), vitamin B6, vitamin B12, choline, malic acid, magnesium, EDTA, and preservative comprising mixtures of sodium benzoate and potassium sorbate (paragraphs [0018], [0021], [0031], [0036], [0037], [0039], [0040], [0044]-[0046], [0051], and [0064]).
It would have been obvious to one of ordinary skill in the art at the time of the invention, given the teachings of Ferruzzi, to select potassium sorbate and EDTA in the preservative of Krotzer based in their suitability for their 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 Krotzer and Ferruzzi similarly teach compositions comprising similar ingredients, Ferruzzi teaches preservatives may be included to enhance the performance of the composition and EDTA serves to stabilize the components of the composition (paragraphs [0040] and [0046]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. As stated in MPEP 2144.06 ““It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.)”
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krotzer WO 9961038 (hereinafter “Krotzer”) in view of Yu et al. WO 2006036634 (hereinafter “Yu”) as applied to claim 1 above, and in further view of Newman US 20060134300 (hereinafter “Newman”).
With respect to claim 14, modified Krotzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding wherein said choline derivative is citicoline, Krotzer does not expressly disclose this limitation.
Newman relates to a composition. The composition comprises caffeine (methylxanthine), taurine, L-phenylalanine, vitamin B6, vitamin B12, niacin, magnesium, and bioactive nutrients such as choline and/or cytidine diphosphocholine (citicoline) (Abstract; paragraphs [0002], [0020], [0036], [0039]-[0041], [0047]-[0049], [0055], and [0056]).
It would have been obvious to one of ordinary skill in the art at the time of the invention, given the teachings of Newman, to select cytidine diphosphocholine (citicoline) in the composition of Krotzer 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 Krotzer and Newman similarly teach compositions comprising similar ingredients, Newman teaches cytidine diphosphocholine, a choline related compound, is thought to be another way of increasing acetylcholine levels in the brain which is beneficial in controlling mood, improving memory and stimulating alertness and mental energy (paragraph [0056]), Krotzer teaches the composition comprises nutritionally beneficial substituents that improve or repair brain function (e.g., memory, learning, etc.) (P2, L28-29; and P10, L17-27), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. 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).
Conclusion
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
