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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/12/2025 has been entered.
The Amendment filed 09/12/2025, amended claims 7-11 and 13, cancelled claim 12, and added claim 14.
Claims 7-11 and 13-14 are pending and examined on the merits herein.
In view of the definition of dietary supplements, “Dietary supplements are products that are ingested” (pg. 1, Questions and Answers on Dietary Supplements, US FDA, PTO-892), this term provides implicit support for “oral composition,” as recited in the instant claims.
Priority
The instant application does not claim priority to any previously filed applications. Therefore, the effective filing date is the US filing date of 8/29/2023.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Claim Objections
Applicant’s amendment to claim 8 is sufficient to overcome this objection.
35 U.S.C. § 112(b)
Applicant’s deletion to claim 12 is sufficient to overcome this rejection.
35 U.S.C. § 103
Applicant’s amendments to independent claims 7 and 8 that added the limitation “in an amount of about 600 mg” in reference to alpha-glycerylphosphorylcholine, is sufficient to overcome this rejection.
REJECTIONS—MAINTAINED, MODIFIED, & NEW
Applicant’s amendments to independent claims 7 and 8 that adds “in an amount of 600mg” in reference to alpha-glycerylphosphorylcholine (alpha-GPC), and which add claims 14, has resulted in the below new rejections and objections.
Claim Rejections - 35 USC § 112(a)-New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New) Claims 7-11 and 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
-In claims 7-8, and 14 the recitation “about 600mg,” is new matter. While [0008] of the specification provides support for 600mg, it does not provide support for “about 600mg” of alpha-glycerylphosphorylcholine.
-In claim 13, the recitation “wherein a mass of the Alpha-glycerylphosphorylcholine is six times the mass of the phosphatidylserine,” is new matter. While [0006] of the specification provides support for 55-60% of Alpha-GPC and 9-10% phosphatidylserine, and [0010] provides support for 100mg phosphatidylserine, these teachings do not provide support for “a mass of the Alpha-glycerylphosphorylcholine is six times the mass of the phosphatidylserine.”
-In claim 14, the recitation “within about 5% of 140mg” in reference to methylliberine, is new matter. While [009] of the specification recites “methylliberine. . .it produces an unexpected energy boost at precisely 140 mg to potentiate and synergize with caffeine and theacrine. The inventors have discovered that a “+” or “-“ of as little as 5 mg significantly affect the results on the brain,” this teaching does not provide support for “within about 5% of 140mg” in reference to methylliberine.
-In claim 14, the recitation “approximately equivalent” in reference to an amount of theacrine and methylliberine, is new matter. While [0006] of the specification teaches 10-15% theacrine and 10-15% methylliberine, this does not provide support for “approximately equivalent” in reference to these compounds.
-In claim 14, the recitation “approximately half” in reference to an amount of caffeine to methylliberine, is new matter. While [0006] of the specification teaches 6-10% caffeine and 10-15% methylliberine, this does not provide support for “approximately half” in reference to these compounds.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(New) Claims 7-11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0056484 to Farese (published 2010, PTO-892) in view of US 2021/0137928 to Lopez (published 2021, PTO-892), Roberto (Dynamine: A neuroactivating ‘Stimulant’ by Compound Solutions, Priceplow, PTO-892), and US 2023/0115966 to Wells (effectively filed 10/13/2021, PTO-892 of 11/15/2023).
Farese teaches dietary supplement compositions comprising acetyl-L carnitine, phosphatidylserine, L-alpha-glycerylphosphorylcholine, and fish oils, such as decosahexaenoic acid and alpha lipoic acid, for increasing cognitive performance, elevating mood, and decreasing oxidative stress levels in mammals (abstract; pg. 6, claims 1-9).
Farese teaches administering 15-600mg alpha-glycerylphosphorylcholine and 5-200mg phosphatidylserine, and about 100mg phosphatidyl serine (pg. 6, claims 5, 8), thus meeting the mg limitations of alpha-GPC and phosphatidylserine in the claims.
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. The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Farese teaches its compositions in oral dosage forms ([0053]; pg. 6, claim 4).
Farese teaches that one skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the claims [0056]).
Regarding claims 7, 8, and 14 while Farese teaches a composition comprising 600 mg alpha-glycerylphosphorylcholine and phosphatidylserine, it does not teach methylliberine, caffeine, and theacrine.
Lopez teaches an enhanced caffeinated beverage composition that provides increased mood, energy, alertness, focus, motivation, and/or decreased fatigue without adversely affecting heart rate or blood pressure (abstract).
Lopez teaches its caffeinated beverage composition as comprising 1-65mg/oz caffeine, 1.5-15mg/oz theacrine, and 3-30mg/oz methylliberine (pg. 15, claim 1; [0053]; [0056]-[0057], [0059]; pg. 12, Example 5; Figs 13-14).
The instantly claimed mg/oz amounts fall within the instantly claimed ratios of caffeine to methylliberine and theacrine, and methylliberine and theacrine, recited in instant claims 8, 10, and 14, and in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, MPEP 2144.05. The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Lopez further teaches that theacrine may be combined with a nutritional cholinergic ingredient such as alpha-GPC, and that one of skill in the art will recognize that these are merely examples of cholinergic ingredients and that other such cholinergic ingredients not listed are also contemplated. Lopez further teaches that the combination of a nutritional cholinergic ingredient with theacrine results in a synergistic effect of increased psychometric measures for attention, focus, and concentration beyond either the theacrine alone or cholinergic ingredient alone ([0081]).
Roberto teaches a supplement combination of caffeine, theacrine, and methylliberine that provides immediate and long lasting energy, mood, focus, and alertness (pg. 9). Roberto further teaches combining this combination with cholinergics for a synergistic effect (pg. 9).
Roberto teaches administering methylliberine in a dosage falling of 100-200mg (pgs. 7-8).
Regarding the amount of methylliberine (i.e. dynamine) recited in claim 14, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, MPEP 2144.05. The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Wells teaches paraxanthine based bioactive compositions comprising a cholinergic agent for promoting cognitive function, energy, athletic performance and providing neuroprotective anti-oxidative effects (see title and abstract).
The paraxanthine is selected from caffeine, theacrine, methylliberine, other compounds, and combinations thereof (Wells, pg. 15, claim 8).
Alpha-GPC and phosphatidylserine are taught as cholinergic agents (Wells, pg. 15, claims 3, 10, 15-18, paragraph 96).
The paraxanthine-cholinergic agent compositions have the advantage over compositions containing comparable doses of caffeine, in that paraxanthines a) have substantially lower toxicity, b) are more potent wake-promoting agents, c) enhance striatal dopaminergic tone, d) do not produce sleep rebound, and e) do not enhance anxiety (Wells, paragraph 54).
Paraxanthine-cholinergic agent compositions are combined with much lesser amounts of caffeine in order to modulate the excessive stimulatory effects of caffeine, thereby stabilizing heart rate and other metabolic activity. That is, a combination of paraxanthine and caffeine may result in a composition that imparts the increased focus and energy induced by caffeine, but without the higher heart rate and blood pressure due to modulation of caffeine’s effects by paraxanthine. Thus, the combination may result in heightened awareness and calmness without the jitters caffeine may cause (Wells, paragraph 56).
Exemplified is a composition consisting of paraxanthine and A-GPC (Wells, [0180]-[0185]), wherein the combination of paraxanthine and alpha-GPC shows synergistic effects on increasing cognitive performance and neurotransmitter levels in young and in old, in mood, in neuroplasticity, and in brain protection (Wells, [0221]).
Wells teaches caffeine, theacrine and methylliberine as paraxanthine congeners or analogs (pg. 15-claim 8).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add the caffeine, theacrine, methylliberine combination of Lopez or Roberto, to that of Farese, to arrive at instant claims 7-8 and 14. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Farese, Lopez, and Roberto are all directed toward oral compositions that elevate mood and cognition,
-Lopez specifically teaches that combinations of caffeine, methylliberine, and theacrine increase mood, energy, motivation, alertness, focus, creativity, and concentration, while decreasing fatigue, and not adversely affecting blood pressure or heart rate,
- Lopez teaches that combining theacrine with a nutritional cholinergic ingredient such as alpha-GPC, or any other cholinergic ingredient, provides a synergistic effect of increased psychometric measures for attention, focus and concentration,
-Roberto teaches the combination of caffeine, theacrine and methylliberine as providing immediate and long-lasting energy, mood, alertness, and focus, and as having synergistic effects with cholinergics,
-Wells teaches methods of improving cognitive function, such as memory and learning, by administering compositions comprising and consisting of paraxanthine compounds, such as methylliberine, caffeine, and theacrine, and cholinergic acid compounds, such as A-GPC and phosphatidylserine,
-Wells teaches paraxanthine-cholinergic compositions as providing synergistic effects in energy and cognition ([0190]; [0203]; [0221]), and
-"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), MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such a combination to predictably arrive at a composition that synergistically enhances cognition, and which elevates mood, without adversely affecting heart rate or blood pressure.
Further regarding claims 8 and 14, and regarding claims 9-11, and 13, while the combination of Farese, Lopez, Roberto, and Wells teach a composition comprising 600mg alpha-GPC, methylliberine, theacrine, 100mg phosphatidylserine, and caffeine, and the instantly claimed ratios of caffeine to methylliberine and theacrine, it does not teach the instantly claimed ratios of caffeine to alpha-GPC or phosphatidylserine, or the mass ratio of alpha-GPC to phosphatidylserine.
Farese teaches that one skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the claims [0056]).
Wells teaches that the paraxanthine is present in amounts from 2 mg to about 800 mg ([0028], [0045], [0093]-[0095], pg. 15-claim 1) and 50-400mg (pg. 15-claim 12), wherein caffeine, theacrine and methylliberine are taught as paraxanthine congeners or analogs (pg. 15-claim 8).
Wells further teaches the cholinergic agent as present in amounts ranging from about 1 to about 1000mg([0031]), wherein phosphatidylcholine and alpha-GPC are cholinergic agents ([0030]).
By altering the dosage of paraxanthine and/or chemical compounds it is combined with, various physiological effects may be selected for. The compositions may provide primarily a single benefit, or may provide multiple benefits simultaneously (Wells, [0050]).
The chemical compounds and mixtures may be used to provide a variety of benefits, varying by concentration (Wells, paragraph 8).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the ratio of caffeine to alpha-GPC, the ratio of caffeine to phosphatidylserine, and the mass ratio of alpha-GPC to phosphatidylserine, to arrive at the instantly claimed ratios. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Farese teaches that the amounts of its composition can be modified,
-Wells teaches that the cholinergic compounds, such as A-GPC and phosphatidyl choline are present in amount of 1-1000 mg,
-Wells teaches that paraxanthine compounds, such as caffeine, theacrine and methylliberine, are present in amounts from 2-800 mg,
-Wells teaches that by altering the dosage of paraxanthine (caffeine, methylliberine and theacrine) and/or chemical compounds it is combined with, various physiological effects may be selected for, and teaches that the compositions may provide primarily a single benefit, or may provide multiple benefits simultaneously,
-Wells teaches that the chemical compounds and mixtures may be used to provide a variety of benefits that are varied by concentration, and
- "[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." MPEP 2144.05(II).
Thus, an ordinary skilled artisan would have been motivated to make such modifications, to predictably arrive at the most therapeutically effective composition that synergistically improves cognition and mood, with minimal adverse effects on heart rate and blood pressure.
The optimization of result effect parameters (e.g., amounts of active ingredients) is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art; it has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPT 215 (CCPA 1980).
Further regarding claim 7, the transitional phrase “consisting essentially of” is interpreted as comprising since the instant specification does not teach any limitations that would “materially affect the basic and novel characteristic(s)” of the claimed composition. See MPEP 2111.03.
Response to Arguments
In view of the new rejections, the Arguments filed 09/12/2025, are not directed toward the above rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622