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
This Office Action is in response to Applicant’s Arguments and Amendment filed, 5/15/2026, wherein the Amendment amended claims 7-8, and 13-14.
Claims 7-11 and 13-14 are pending and examined on the merits herein.
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REJECTIONS WITHDRAWN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.
35 U.S.C. § 112(a)-New Matter
Applicant’s amendment to claims 7-8 and 13-14 are sufficient to overcome these rejections.
REJECTIONS—MAINTAINED & MODIFIED
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.
(Slightly Modified) 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 of 11/19/2025) in view of US 2021/0137928 to Lopez (published 2021, PTO-892 of 11/19/2025), Roberto (Dynamine: A neuroactivating ‘Stimulant’ by Compound Solutions, Priceplow, PTO-892 of 11/19/2025), 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 (i.e., caffeine, theacrine, and methylliberine) with cholinergics for a synergistic effect (pg. 9).
Roberto teaches administering methylliberine in a dosage 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).
Wells teaches caffeine, theacrine and methylliberine as paraxanthine congeners or analogs (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]).
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 an addition 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 specifically teach 135-145mg methylliberine, 125-150mg theacrine, and 70mg caffeine.
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]).
Lopez exemplifies administration of 125 mg theacrine ([0028]-[0036]), and generally teaches administering 5-800mg theacrine with 25-650mg caffeine ([0087]).
Roberto teaches administration of 100-200mg methylliberine (“Stacking Dynamine”).
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, the mass ratio of alpha-GPC to phosphatidylserine, and the mg amounts of methylliberine, theacrine, and caffeine, to arrive at the instantly claimed ratios and mg amounts. 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,
-Lopez exemplifies administration of 125 mg theacrine ([0028]-[0036]), and generally teaches administering 5-800mg theacrine with 25-650mg caffeine ([0087]),
- Roberto teaches administration of 100-200mg methylliberine, 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
On pgs. 5-6, Remarks, Applicant argues that to arrive at the presently claimed composition from Farese, a person of ordinary skill would be required to 1) remove three of Farese’s five core ingredients, 2) add three entirely new stimulant-class ingredients, and 3) retain only two of Farese’s five original ingredients. Applicant argues that this is impermissible hindsight.
This argument has been fully considered, but is not found persuasive. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Moreover, the instant rejection does not remove three of Farese’s five core ingredients. As discussed above, 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.
As discussed above, 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 an addition to predictably arrive at a composition that synergistically enhances cognition, and which elevates mood, without adversely affecting heart rate or blood pressure.
On pg. 6, Remarks, Applicant argues that the motivation to combine the references is a generalized and sweeping statement of purpose that is insufficient to establish a motivation to combine and that numerous compositions improve mood and cognition through vastly different mechanisms.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that the motivation to combine the references is not based on a generalized and sweeping statement of purpose that provides insufficient motivation to combine. While Farese, Lopez, and Roberto are all directed toward oral compositions that elevate mood and cognition, Lopez further teaches that combining theacrine with a nutritional cholinergic ingredient such as alpha-GPC, provides a synergistic effect of increased psychometric measures for attention, focus, and concentration, Roberto teaches caffeine, theacrine, and methylliberine as having synergistic effects with cholinergics, i.e., alpha-GPC, Wells teaches improving cognitive function, such as memory and learning, by administering compositions consisting of paraxanthine compounds, i.e., methylliberine, caffeine, and theacrine, and cholinergic acid compounds, such as alpha-GPC and phosphatidylserine, and Wells teaches paraxanthine-cholinergic compositions as providing synergistic effects in energy and cognition. Thus, it is known in the art to combine caffeine, theacrine, and methylliberine with cholinergic compounds such as alpha-GPC and phosphatidylserine, to arrive at compositions that enhance cognition and elevate mood without adversely affecting heart rate or blood pressure.
On pg. 7, Remarks, Applicant argues that while Lopez teaches that theacrine may be combined with a nutritional cholinergic, this is a passing reference made in the context of listing numerous possible additives, and that neither Farese nor Lopez provide working examples or clinical studies limited to caffeine, theacrine, and methylliberine with alpha GPC or phosphatidylserine. Applicant additionally argues that Roberto provides no experimental data, no specific guidance on combining these stimulants with alpha-GPC or phosphatidylserine, and no suggested amounts for such a combination.
This argument has been fully considered, but is not found persuasive. First, it is respectfully pointed out that patents are relevant as prior art for all they contain and “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments, In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971), MPEP 2123. Second, in [0081] of Lopez, Lopez does not make a passing reference in the context of listing numerous possible additives. Lopez specifically teaches combining theacrine with a cholinergic ingredient, such as alpha-GPC, which is one of five cholinergic compounds recited, for combination with theacrine to produce a synergistic effect. And regarding Roberto, 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).
On pgs. 7-8, Remarks, Applicant argues that Wells does not bridge the gap between references. Applicant specifically argues that Wells’ working examples combine only two ingredients at a time, and that no working examples in Wells combine caffeine, theacrine, methylliberine with alpha-GPC or phosphatidylserine. Applicant further argues that Wells teaches paraxanthine as having distinct advantages over caffeine.
These arguments have been fully considered, but are not found persuasive. It is first respectfully pointed out that the instant rejection is a obviousness type rejection and not an anticipatory rejection, and Wells is therefore not relied upon to teach a combination of caffeine, theacrine, methylliberine with alpha-GPC and phosphatidylserine. Moreover, Wells is not relied upon solely to provide motivation to add a combination of caffeine, theacrine, and methylliberine to the composition of Farese. Lopez and Roberto are specifically utilized to teach a combination of caffeine, theacrine, and methylliberine. Wells is specifically relied upon to teach that it is known in the art to combine paraxanthine compounds, such as instantly claimed caffeine, theacrine, and methylliberine, with cholinergic compounds to improve cognitive function and provide a synergistic effect.
On pgs. 8-9, Remarks, Applicant argues that the claimed amounts and ratios are not the product of routine optimization. Applicant specifically argues that one cannot optimize a ratio that the prior art has never identified as a meaningful variable and points to In re Antonie. Applicant further argues that in each of the references, the stimulant ingredient dominates the formulation and that the claimed composition reverses this hierarchy. Applicant argues that the present application disclose a sensitivity window that is inconsistent with routine optimization and points to [0014] of the specification.
This argument has been fully considered, but is not found persuasive. Lopez exemplifies administration of 125 mg theacrine ([0028]-[0036]), and generally teaches administering 5-800mg theacrine with 25-650mg caffeine ([0087]). Roberto teaches administration of 100-200mg methylliberine. 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 further teaches that the chemical compounds and mixtures may be used to provide a variety of benefits that are varied by concentration. Thus, the prior art clearly teaches the dosage amounts of methylliberine, theacrine, and caffeine that are instantly claimed, and clearly teaches that amounts of methylliberine, theacrine, and caffeine can be modified to arrive at specific benefits. As such, the prior art does teach methylliberine, theacrine, and caffeine as result effective variables.
Regarding Applicant’s arguments regarding the inverse of the conventional approach of the prior art, it is not clear what prior art teaches this conventional approach, wherein in a composition comprising a cholinergic and methylliberine, theacrine, and/or caffeine, the cholinergic compound is always in an amount less than that of methylliberine, theacrine, and/or caffeine.
Regarding [0014] of the specification, this paragraph recites the following:
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It is not clear how this paragraph discloses a “sensitivity window.”
While [0013] of the specification states that “The present invention has some of the most effective and unique ingredients that are highly sensitivity to the most subtle of adjustments, working powerfully together in a very narrow therapeutic window,” it is respectfully pointed out that this statement is not substantiated by supporting evidence, see MPEP 2107.02, and is therefore not persuasive.
Lastly regarding the claimed amount, Applicant is respectfully reminded that to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range, see MPEP 716.02(d).
On pg. 10, Remarks, Applicant argues that “consisting essentially of” has independent exclusionary force and that the addition of Farese’s other ingredients would materially alter the claimed composition’s pharmacodynamic profile and therapeutic characteristics.
This argument has been fully considered, but is not found persuasive. Applicant has provided no evidence to substantiate this assertion. Applicant is respectfully reminded that the arguments of counsel cannot take the place of evidence in the record, see MPEP 716.01(c).
For these reasons, Applicant’s arguments are not persuasive to overcome the rejections of record.
Conclusion
No claims are allowed.
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.
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
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