DETAILED ACTION
This office action is in response to applicant’s filing dated October 28, 2025.
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 .
Status of Claims
Claims 1-20 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed October 28, 2025. Acknowledgement is made of Applicant’s amendment of claim 1.
Applicants elected with traverse Group I, drawn to a method for attenuating stress-induced mental fatigue in subject in need thereof, comprising: administering to the subject a composition comprising from about 2 mg to about 800 mg of paraxanthine as the elected invention and a formulation species further comprising L-theanine and psychological stress as the elected stress species in the reply filed on August 24, 2023. The requirement is still deemed proper. Claims 3 and 11-20 remain withdrawn.
Claims 1, 2, and 4-10 are presently under examination as they relate to the elected species: L-theanine and psychological stress.
Priority
The present application claims benefit of US Provisional Application No. 63/166,494 filed on March 26, 2021. The effective filing date of the instant application is March 26, 2021.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
New Objections and/or Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “wherein paraxanthine is present in the composition in amount from about 50 mg to about 400 mg.”
Claim 1 recites “a composition comprising from about 50 mg to about 400 mg of paraxanthine.”
Thus, claim 2 recites the same scope and fails to further limit the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Withdrawn Objections and/or Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 1, 2, and 4-10 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 has been rendered moot in view of the claim amendment deleting the term “intense.” Thus, the rejection has been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 2, 4-6, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Costentin et al (US 2009/0325984 A1, cited in the IDS filed September 30, 2022).
Regarding claims 1 and 4, Costentin teaches the use of paraxanthine for the manufacture of a nonanxiogenic psychoanaleptic drug for the treatment of a neuropsychiatric disorder (claim 1) wherein the neuropsychiatric disorder is anxiety disorder (claim 3). Costentin further teaches anxiety means feelings of imminent and unspecified danger accompanied by general apprehension, helplessness or fear [0007]. Anxiety reads on intense mental exertion as evidence by the Mayo Clinic (https://www.mayoclinic.org/diseases-conditions/anxiety/symptoms-causes/syc-20350961?utm_source=Google&utm_medium=abstract&utm_content=Anxiety&utm_campaign=Knowledge-panel, dated May 4, 2018, obtained from the internet September 3, 2024, cited in a previous Office Action). Mayo Clinic teaches people with anxiety disorders frequently have intense, excessive and persistent worry and fear about everyday situations; often, anxiety disorders involve repeated episodes of sudden feelings of intense anxiety and fear or terror that reach a peak within minutes (panic attacks); these feelings of anxiety and panic interfere with daily activities, are difficult to control, are out of proportion to the actual danger and can last a long time (1st and 2nd paragraph). Thus, anxiety reads on intensive mental exertion.
Moreover, Costentin teaches the disclosed method is useful for treating fatigue (claim 2) and fatigue is a symptom of depression and often associated with anxiety [0027]. Thus, fatigue associated with anxiety reads on psychological stress-induced fatigue. Thus, Costentin teaches a method of treating stress-induced fatigue comprising administering to the subject paraxanthine, wherein the stressor is an intensive mental exertion, anxiety.
Regarding the amounts of paraxanthine of instant claims 1 and 2, Costentin teaches the term “patient” refers to a human or to a non-human mammal affected or potentially affected by a given pathology; preferentially, the patient is human [0018]. Costentin teaches a pharmaceutical composition according to the invention contains paraxanthine in a therapeutically-active quantity; the quantity of paraxanthine required is such that the dose administered is between 0.1 mg and 100 mg per kg of body weight per day, preferably between 0.5 mg and 20 mg per kg of body weight per day [0039]. Assuming the average weight for an adult human is 60 kg, an amount between 0.5 mg and 20 mg per kg of body weight is equivalent to an amount between 30 mg and 1200 mg. MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Taken together, all this would result in the practice of the method of claims 1, 2, and 4 with a reasonable expectation of success.
Regarding claim 5, Costentin teaches paraxanthine exerts a dose-dependent stimulating effect [0018]; paraxanthine stimulated locomotor activity from the first measurement period and for 30 minutes thereafter; at higher doses, the effect was more marked and more long-lasting (at least one hour); paraxanthine demonstrate a stimulating effect that is at least as great as that of caffeine, while remaining non-anxiogenic [0024]. It would have been prima facie obvious to one of ordinary skill in the art to modify the method of treating anxiety and fatigue associated with anxiety taught by Costentin to treat acute anxiety and fatigue in a subject suffering from anxiety and fatigue with a reasonable expectation of success, since the prior art teaches paraxanthine is a stimulant that has stimulating effects from the first measurement period to 30 min-1hr after treatment while remaining non-anxiogenic.
Regarding claim 6, Costentin teaches paraxanthine Is useful for treating chronic fatigue [0029]. It would have been prima facie obvious to one of ordinary skill in the art to modify the method of treating anxiety and fatigue of a patient affected by depression taught by Costentin to treat chronic fatigue in a subject suffering from anxiety and fatigue associated with anxiety of a patient affected by depression with a reasonable expectation of success, since the prior art teaches paraxanthine is useful for treating chronic fatigue.
Taken together, all this would result in the practice of the method of claims 5 and 6 with a reasonable expectation of success.
Regarding claim 9, Costentin teaches the term treatment means preventing or inhibiting the occurrence or progression of the disorder to which the term is applied or of one or more of the symptoms thereof [0015]. Thus, it would have been prima facie obvious to modify the method of treating anxiety and fatigue associated with anxiety taught by Costentin to administer the composition prior to onset of fatigue or anxiety symptoms with a reasonable expectation of success in view of the teachings of the prior art.
Taken together, all this would result in the practice of the method of claim 9 with a reasonable expectation of success.
Regarding claim 10, Costentin teaches administering a composition comprising paraxanthine is compared to the effects of administering a composition comprising caffeine (See Examples 1-4). Thus, Costentin teaches administering a composition comprising paraxanthine that does not include caffeine. Costentin does not explicitly teach that the subject abstains from consuming caffeine during the steps of the method. However, Costentin teaches caffeine is reputed to induce anxiety states and can sometimes cause panic attacks; administration of high doses of caffeine produces increases in anxiety measurements in healthy volunteers; the anxiogenic effects of caffeine are more intense in patients prone to panic attacks; a panic attack, according to DSM-III-R criteria can be caused experimentally by administering caffeine; and in another experimental study with adolescents, the subjects stated that caffeine made them anxious [0004]. Thus, it would have been prima facie obvious for the subject to abstain from caffeine in a method of treating anxiety and fatigue associated with anxiety comprising administering paraxanthine since caffeine is known to induce anxiety.
Taken together, all this would result in the practice of the method of claim 10 with a reasonable expectation of success.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Costentin et al (US 2009/0325984 A1, cited in the IDS filed September 30, 2022) as applied to claims 1, 2, 4-6, 9 and 10 above, and further in view of Patel et al (US 2015/0320814 A1, cited in a previous Office Action).
Costentin teaches all the limitations of claims 7 and 8 (see above 103 rejection), except wherein the composition further comprises the elected additional active agent, L-Theanine.
However, Patel teaches a method of treating anxiety and/or depression in a mammal in need comprising administering a composition comprising L-theanine (claim 5), wherein the method increases the activity of neurotransmitter pathways (claim 12); wherein said increased activity of neurotransmitter pathways results in amelioration of anxiety, amelioration of depression, and improvement of sleep.
As such, since Costentin teaches a method of treating anxiety and fatigue associated with anxiety comprising administering paraxanthine, and since Patel teaches that a composition comprising L-theanine is useful for treating anxiety and depression, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to administer a composition comprising paraxanthine to treat anxiety and fatigue associated with anxiety to further administer a composition comprising L-theanine with an expectation of success. One would have been motivated to do so because of each of the compounds have been individually taught in the prior art to be suitable to treat anxiety and depression. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining paraxanthine with a composition comprising L-theanine, one would have achieved a composition useful for treating anxiety and depression.
Taken together, all this would result in the practice of the method of claim 7 and 8 with a reasonable expectation of success.
Response to Arguments
Applicant argues:
The Office failed to support a prima facie case of obviousness when rejecting claims 1, 2, 4-6, 9 and 10. The Application-as-filed, defines "mental fatigue" as "the temporary decrease in cognitive function and/or physical performance that accompanies a period
of intense exertion. In certain embodiments, the period of intense exertion involves performing a cognitively taxing task (e.g., taking a timed examination)." Costentin, which is generally directed to treatment of psychiatric/neurological disorders, teaches that "fatigue" and "anxiety" may each be symptoms of depression and/or co-occur with depression and that paraxanthine may be effective at treating depression without increasing anxiety. But this disclosure does not suggest that anxiety is causative of fatigue, only that they frequently cooccur in depression. Furthermore, Costentin neither teaches or suggests any effect of paraxanthine on "the temporary decrease in cognitive function and/or physical performance that accompanies a period of intense exertion" as the term "mental fatigue" is explicitly defined in the present application. Furthermore, claim 1 has been amended to recite that "the stressor inducing mental fatigue in the subject is a period of intense mental exertion." Thus, Costentin fails to teach or reasonably suggest use of paraxanthine for treatment of stress-induced mental fatigue as claimed in instantly amended claim 1.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The instant specification discloses "mental fatigue" refers to the temporary decrease in cognitive function and/or physical performance that accompanies a period of intense exertion; and in certain embodiments, the period of intense exertion involves performing a cognitively taxing task (e.g., taking a timed examination). In further embodiments, the period of intense exertion involves performing a physically taxing task. The instant specification teaches intense exertion involving performing a cognitively taxing tax as a possible embodiment. Thus, this does not constitute a definition.
As set forth above, Costentin teaches fatigue is often associated with anxiety. Moreover, as set forth above, Costentin teaches the use of paraxanthine for treating both anxiety and fatigue. As set forth above, Costentin further teaches anxiety means feelings of imminent and unspecified danger accompanied by general apprehension, helplessness or fear and Mayo Clinic teaches people with anxiety disorders frequently have intense, excessive and persistent worry and fear about everyday situations; often, anxiety disorders involve repeated episodes of sudden feelings of intense anxiety and fear or terror that reach a peak within minutes (panic attacks); these feelings of anxiety and panic interfere with daily activities, are difficult to control, are out of proportion to the actual danger and can last a long time (1st and 2nd paragraph). Thus, anxiety reads on intensive mental exertion. Thus, as set forth above, Costentin teaches a method of treating stress-induced fatigue comprising administering to the subject paraxanthine, wherein the stressor is an intensive mental exertion, anxiety. Moreover, as set forth above, Costentin teaches paraxanthine is useful for treating both anxiety and fatigue. The skilled artisan would have been motivated to treat fatigue in a subject suffering from anxiety with a reasonable expectation of success, since the prior art teaches paraxanthine is useful for treating both anxiety and fatigue.
Moreover, Costentin teaches considering that the absence of anxiogenic effects, and even the induction of anxiolytic effects, associated with the stimulating effects of paraxanthine can have only favorable effects on attention and memory, the inventors also propose the use of paraxanthine to treat cognitive deficits [0031]. Cognitive deficits reads on decrease in cognitive function. The skilled artisan would have been recognized that a decrease in cognitive function would be improved in the method of treating fatigue in a subject suffering from anxiety suggested by Costentin, since Costentin teaches the absence of anxiogenic effects, and even the induction of anxiolytic effects, associated with the stimulating effects of paraxanthine can have only favorable effects on attention and memory.
Applicant argues:
Claims 2, 4-6, 9 and 10 depend directly or indirectly from claim 1 and incorporate all the limitations thereof, the above remarks apply equally to those claims.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicant has not independently argued the merits of this rejection. Arguments regarding Costentin have been addressed above. Therefore, the rejection is maintained for the reasons set forth on the record and for those set forth in the response to the arguments above.
Conclusion
Claims 1, 2, and 4-10 are rejected. No claim is allowed.
THIS ACTION IS MADE FINAL. 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 RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/Primary Examiner, Art Unit 1628