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 .
FINAL REJECTION
Priority
Instant application 17/794,729 filed on 07/22/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1 -13 and 15-20 are pending.
Response to Arguments/Amendments
The amendment filled on 02/09/2026 has been entered.
Applicant amended claim 10 by adding additional limitations:
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Further, Applicant canceled claim 14.
Regarding to 112(b) rejection, Applicant’s amendment has overcome the rejection. Thus, the 112 rejection is withdrawn.
Further, Applicant traversed the scope of elected claims and submitted that claim 15 should not had been withdrawn.
It should be noted that Applicant elected “physical performance” in the reply filed on 07/02/2025:
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Claim 15 is directed to energy species. Therefore, the claim has been withdrawn. However, after allowable subject matter is identified, examiner will consider claim 15.
Regarding 102 and 103 rejections, Applicant’s amendment has overcome the rejections. Applicant added an additional step “wherein the fatigue of the subject is measured using a Vigilance Task Test”. Therefore, the rejections have been withdrawn.
However, Applicant's amendment necessitated the new ground(s) of rejections presented in this Office action.
The 103 rejection is reapplied with an additional reference. The new reference is addressing the newly added step of measuring fatigue of the subject using a Vigilance Task Test.
Regarding double patenting rejections, Applicant submitted that “Should any claims be allowed in either application, Applicant will address any remaining rejections at that time”. Further, Applicant notified the Office that a terminal disclaimer, listing U.S. Applications 17/875,368, 17/965,754, 18/070,435, and 17/701,349, will be submitted upon allowance of pending claims 10-14 and 16, should it be necessary. Since no arguments are present, the double patenting rejections are withdrawn and reapplied with additional reference related to using a Vigilance Task Test.
Election/Restrictions
Applicant elected Group II in the reply filed on 07/02/2025.
Claims 1-9 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/02/2025.
Regarding species election, Applicant’s elected:
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in the reply filed on 07/02/2025.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/02/2025.
Claim Interpretation
Costentin teaches dose of paraxanthine between 0.5 mg and 20 mg per kg of body weight (paragraph [0039]).
The dose limitation is met, and the populations are overlapping. Therefore, the functional limitations recited in instant claims (e.g. “does not create dependence” recited in instant claim 12, and “decrease fatigue of at least about 6%” recited in instant claim 1) are necessarily met. The properties of the composition naturally flow from the overlapping dose and overlapping populations.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 10-13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costentin (US-20090325984-A1) in view of Basner (Basner et al., Acta Astronautica 69 (2011) 949–959).
Costentin teaches and claims using paraxanthine for the manufacture of a non-anxiogenic psychoanaleptic drug for the treatment of a neuropsychiatric disorder (claim 1) wherein the neuropsychiatric disorder is fatigue, a sleep disorder or an attention disorder (claim 2).
Costentin teaches treating with paraxanthine patients who suffer psychomotor slowing and fatigue:
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Further, Costentin teaches dose between 0.5 mg and 20 mg per kg of body weight (paragraph [0039]):
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Adults usually weight between 50 kg and 100 kg, thus, Costentin teaches a dose within the range recited in instant claim 13.
Regarding the decrease in fatigue of at least about 6 percent wherein the subject experiences a decrease in fatigue of at least about 6 percent relative to fatigue experienced by the subject under administration of a placebo, and wherein the fatigue of the subject is measured using a Vigilance Task Test, the properties of the recited composition naturally flow from the overlapping dose. As such, properties such as “decrease in fatigue of at least about 6 percent “accrue from a process step of administering paraxanthine are considered characteristic features of the claimed method.
Costentin does not teach measuring fatigue using a Vigilance Task Test.
Regarding the Vigilance Task Test also known as Psychomotor Vigilance Test (see instant specification paragraphs [092] and [093], Basner teaches:
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Applying KSR prong (A) it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the steps disclosed by Costentin with psychomotor vigilance test because Costentin teaches using paraxanthine for treatments of a neuropsychiatric disorder (claim 1) wherein the neuropsychiatric disorder is fatigue, a sleep disorder or an attention disorder (claim 2) and Vigilance Task Test is a known test that objectively assesses fatigue-related changes.
Regarding claim 16, Costentin does not teach providing the subject with a composition comprising paraxanthine and caffeine.
However, Costentin teaches that caffeine also shows stimulating effect:
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Applying KSR prong (A) it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine paraxanthine and caffeine and use it for the same purpose with a reasonable expectation of success. The skilled person would have been motivated by the teachings of Costentin and by the fact that paraxantine (1,7-dimethylxanthine) is a known metabolite (breakdown product) of caffeine (1,3,7-trimethylxanthin).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 10-13 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 17/875368 in view of Basner (Basner et al., Acta Astronautica 69 (2011) 949–959).
The claims of 17/875368 recite methods for improving cognitive function (see claim 1), athletic performance (see claim 13) and endurance (claim 15) comprising administering to a subject 2 mg to about 800 mg of paraxanthine:
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Regarding instant claim 16, the claims of 17/875368 recite paraxanthine and caffeine.
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The claims of 17/875368 limit the population to slow caffeine metabolizer (SCM) subject wherein the instant claims are directed to any subject.
MPEP 2131.02 states “A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named.”
The claims of 17/875368 do not recite fatigue is measured using a Vigilance Task Test.
However, regarding the Vigilance Task Test also known as psychomotor vigilance test (see instant specification paragraphs [092] and [093], Basner teaches:
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Applying KSR prong (A) it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use psychomotor Vigilance Task Test because Vigilance Task Test is a known test that objectively assesses fatigue-related changes.
This is a provisional nonstatutory double patenting rejection.
Claims 10-13 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-29, 31-34 and 37-46 of copending Application No. 17/965754 in view of Basner (Basner et al., Acta Astronautica 69 (2011) 949–959).
The claims of 17/965754 recite methods for improving physical performance, comprising providing a subject with a composition comprising about 50 mg to about 800 mg of paraxanthine (see claim 28):
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Regarding instant claim 16, the claims of recite paraxanthine and caffeine (see claim 32).
Regarding claims 12 and 14, the properties of the recited composition comprising paraxanthine naturally flow from the overlapping dose and overlapping populations. Since the dose limitation is met and the populations are overlapping, the functional limitations recited in instant claims are necessarily met.
The claims of 17/965754 do not recite fatigue is measured using a Vigilance Task Test.
Regarding the Vigilance Task Test also known as psychomotor vigilance test (see instant specification paragraphs [092] and [093], Basner teaches:
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Applying KSR prong (A) it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use psychomotor Vigilance Task Test because Vigilance Task Test is a known test that objectively assesses fatigue-related changes.
This is a provisional nonstatutory double patenting rejection.
Claims 10-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, 11 and 19 of copending Application No. 18/070435 in view of Basner (Basner et al., Acta Astronautica 69 (2011) 949–959).
The claims of Application No. 18/070435 recite:
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Since the dose limitation is met and the populations are overlapping, the functional limitations recited in instant claims are necessarily met.
The claims of 18/070435 do not recite fatigue is measured using a Vigilance Task Test.
Regarding the Vigilance Task Test also known as psychomotor vigilance test (see instant specification paragraphs [092] and [093], Basner teaches:
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Applying KSR prong (A) it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use psychomotor Vigilance Task Test because Vigilance Task Test is a known test that objectively assesses fatigue-related changes.
This is a provisional nonstatutory double patenting rejection.
Claims 10-13 and 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, 11 and 19 of copending Application No. 18/070435 in view of Costentin (US-20090325984-A1) and in view of Basner (Basner et al., Acta Astronautica 69 (2011) 949–959).
Although claims 10-14 have been rejected above, alternative reasoning is provided below.
The claims of Application No. 18/070435 recite:
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The claims of Application No. 18/070435 do not explicitly recite improving physical performance or fatigue. Further, the claims of 18/070435 do not recite fatigue is measured using a Vigilance Task Test.
However, one of ordinary skill would expect that improvement of muscle function results in reduction of fatigue. Stronger, more efficient muscles require less effort to perform the same tasks, leading to less perceived fatigue.
In addition, Costentin teaches treating with paraxanthine patients who suffer psychomotor slowing and fatigue:
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Regarding the Vigilance Task Test also known as psychomotor vigilance test (see instant specification paragraphs [092] and [093], Basner teaches:
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Applying KSR prong (A) it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use psychomotor Vigilance Task Test because Vigilance Task Test is a known test that objectively assesses fatigue-related changes.
Regarding claim 16, the claims of 18/070435 do not recite providing the subject with a composition comprising paraxanthiene and caffeine.
However, Costentin teaches that caffeine also shows stimulating effect:
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Applying KSR prong (A) it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine paraxanthine and caffeine and use it for the same purpose with a reasonable expectation of success. The skilled person would have been motivated by the teachings of Costentin and by the fact that paraxantine (1,7-dimethylxanthine) is a known metabolite (breakdown product) of caffeine (1,3,7-trimethylxanthin).
This is a provisional nonstatutory double patenting rejection.
Claims 10-13 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13-14, 16-23 and 25-26 of copending Application No. 17/701349 in view of Vgontzas (VGONTZAS, A.N., BIXLER, E.O. and CHROUSOS, G.P. (2006), Obesity-Related Sleepiness and Fatigue. Annals of the New York Academy of Sciences, 1083: 329-344) and in view of Basner (Basner et al., Acta Astronautica 69 (2011) 949–959).
The claims of Application No. 17/701349 recite a method for promoting weight loss in a subject comprising administering to the subject the seme compound as recited in the instant claims.
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Further, regarding instant claim 16, the claims of Application No. 17/701349 recite composition comprising paraxanthine and caffeine (see claim 5).
The claims of Application No. 17/701349 do not explicitly recite improving physical performance or fatigue, and the claims of 17/701349 do not recite fatigue is measured using a Vigilance Task Test.
However, the properties of the recited composition naturally flow from the overlapping dose.
In addition, Vgontzas teaches that obesity led to sleepiness and fatigue (see title).
Regarding the Vigilance Task Test also known as psychomotor vigilance test (see instant specification paragraphs [092] and [093], Basner teaches:
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Applying KSR prong (A) it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Vgontzas and the recitations of claims of 17/701349 and use the composition to reduce fatigue with a reasonable expectation of success. The skilled person would expect that weight loss will result in reduction of fatigue and increased energy levels because a subject with a higher mass requires more energy to perform the same activities. Further, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use psychomotor Vigilance Task Test because Vigilance Task Test is a known test that objectively assesses fatigue-related changes.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is 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 IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621