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
Claims 1-22 are pending in the instant application.
Claims 13-22 are withdrawn from consideration.
Claims 1-12 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 63226113, filed on 27 July 2021, and U.S. Provisional Application No. 63331732, filed on 15 April 2022. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 27 July 2021.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 20 October 2022, 03 February 2023, 18 March 2025, 20 August 2025, and 20 August 2025, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Election/Restrictions
Applicant’s election of Group I, claims 1-12, without traverse, in the reply filed on 02 October 2025 is acknowledged. Claims 13-22 are withdrawn for not reading on the elected group.
If the elected group is not identified in the art, the search will be expanded to additional groups per MPEP 802.03.
Claim Objections
Claim 1 recites “providing” the SCM subject with a composition comprising paraxanthine. “Providing” is not defined in the specification and can be interpreted as supplying a patient with a composition and not administering it. For the purposes of art “providing” is interpreted as “administering.” Examiner suggests amendment of “providing” to “administering” to make claim language consistent with claims 11 and 12.
Claim 5 is objected to because of the following informalities:
Claim 5 recites dependence on claim 2 wherein the SCM subject is identified by an assessment. Claim 2 recites the SCM subject is identified by genotyping. Either claim 5 should be dependent on claim 1, or claim 5 should recite “…wherein the subject is further identified…”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in claim 1 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim. While the specification sets forth a definition in paragraph [025] it does not provide a standard for ascertaining the requisite degree for the endpoints of a recited range, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The dependent claims 2-12 do not remedy the issue and are therefore subject to the rejection.
The term “about” in claim 10 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim. While the specification sets forth a definition in paragraph [025] it does not provide a standard for ascertaining the requisite degree for the endpoints of a recited range, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “about” in claim 11 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim. While the specification sets forth a definition in paragraph [025] it does not provide a standard for ascertaining the requisite degree and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 11 recites the limitation "…the method of claim 1, wherein the administration of the composition…" There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite the administration of the composition, but its provision.
Claim 12 recites the limitation, “wherein the composition further comprises at least one ingredient selected from the group consisting of tyrosine,… paraxanthine…” This is unclear as the composition of claim 1 already comprises paraxanthine.
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.
Claim(s) 1-4 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carswell et al. (European Journal of Applied Physiology.2020;120:1495–1508) in view of Costentin et al. (US20090325984A1; cited by Applicant on 1449 IDS).
Regarding claim 1, Carswell teaches identifying a subject as a slow metabolizer (page 1500) and administering caffeine to improve cognitive function.
Carswell monitors paraxanthine levels but does not teach administering the caffeine metabolite directly.
Costentin teaches administering paraxanthine to treat a cognitive disorder (claim 3) in an amount ranging from 0.1 mg/kg to 100 mg/kg, which is 8.5 mg to 8500 mg for an average 85 kg male.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. Substitution for paraxanthine, as taught by Costentin, for caffeine, as taught by Carswell, would be prima facie obvious to one of ordinary skill in the art. Carswell teaches that caffeine improves cognitive function in SCM subjects albeit at a slower rate than fast caffeine metabolizers. Knowing paraxanthine is the main metabolite of caffeine, one skilled in the art, guided by the work of Costentin, would expect to see improved cognition from paraxanthine and apply the method to SCM subjects, thereby avoiding the slower metabolism of caffeine and supplying the subject directly with the main metabolite.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claim 2, Carswell teaches genotyping the subjects (page 1500).
Regarding claim 3, Carswell teaches the genetic variants in the ADORA2A gene and CYP1A2 gene (page 1500).
Regarding claim 4, Carswell teaches the genetic variant is in the CYP1A2 gene and the genotype is AC or CC (page 1500).
Regarding claim 7, Carswell teaches measuring the subjects rate of caffeine metabolism.
Regarding claim 8, Carswell teaches improved attention (page 1498). Costentin teaches improvement in attention and memory (paragraph [0032]).
Regarding claim 11, the combination of Costentin and Carswell teach administering paraxanthine to a slow caffeine metabolizer to improve cognitive function. As the combination teaches the claimed composition and the claimed patient population the claimed limitation of increasing serum brain derived neurotropic factor concentration of at least 10% does necessarily occur. MPEP 2112.01:I states:
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”
Claim(s) 1-8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carswell et al. (cited above) in view of Costentin et al. (cited above) and in further view of Pierre (Precision Nutrition. All about coffee. 2012. https://www.precisionnutrition.com/all-about-coffee).
The teachings of Carswell and Costentin are disclosed above and incorporated by reference herein.
Regarding claims 5 and 6, the combined references do not teach administering the subject a questionnaire or administering paraxanthine to a self-diagnosed SCM.
Pierre teaches characteristics of fast and slow metabolizers so one can self-diagnose as an SCM.
It would be prima facie obvious to one of ordinary skill in the art to administer paraxanthine to a patient that has self-diagnosed as a SCM, as the physical effects of being a SCM are readily available to the general public., as shown by Pierre. Or if a patient has not asked themselves if they exhibit these characteristics it would be prima facie obvious to one of ordinary skill in the art to administer a questionnaire.
Claim(s) 1-4 and 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carswell et al. (cited above) in view of Costentin et al. (cited above) and in further view of Müller et al. (Handb Exp Pharmacol. 2011;200:1-59).
The teachings of Carswell and Costentin are disclosed above and incorporated by reference herein.
Regarding claim 9, the combined references do not teach administering an additional therapeutic agent.
Müller teaches that 1-methylxanthine as one of the major metabolites of caffeine (page 1) and demonstrates the binding affinity of 1-methylxanthine and 7-methyxanthine for the adenosine receptors A1, A2A, A2B, and A3 (Table 1), the same receptors caffeine and paraxanthine antagonize.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong A of KSR applies – combining known compounds for the same purpose of antagonizing adenosine receptors.
It would be prima facie obvious to one or ordinary skill in the art to combine paraxanthine and 1-methylxanthine and/or 7-methylxanthine to improve cognition of a slow caffeine metabolizer. The combination of Carswell and Costentin teach the administration of paraxanthine to improve cognitive function of a SCM. Müller teaches paraxanthine, 1-methylxanthine and 7-methyxanthine bind with A1, A2A, A2B, and A3 receptors. Therefore all three compounds are antagonists of the same receptor(s) and would be expected to exhibit the same properties and be utilized for the same purpose.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claim 10, a dosage amount for the additional agent(s) is not taught. However, in the absence of criticality, this would be considered routine optimization. See MPEP 2144.05.II.A.
Claim(s) 1-4, 7-8, and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carswell et al. (cited above) in view of Costentin et al. (cited above) and in further view of Schuster et al. (Progress in Neuropsychopharmacology & Biological Psychiatry.2019;89:263–274).
The teachings of Carswell and Costentin are disclosed above and incorporated by reference herein.
Regarding claim 12, the combined references do not teach administering an additional therapeutic agent.
Schuster teaches cognitive effect of administering caffeine with theobromine (page 265) and L-theanine (page 266).
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. Substitution of caffeine, as taught by Schuster, for paraxanthine for slow caffeine metabolizers, as taught by the combination of Carswell and Costentin, results in the instant invention. This substitution would be prima facie obvious to the skilled artisan as paraxanthine is the main metabolite of caffeine and the work of Constentin and Carswell demonstrate both caffeine and paraxanthine improve cognition, therefore they share utility and substitution of one for the other would be expected to demonstrate the same properties.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Conclusion
Claims 1-12 are rejected.
Claims 1 and 5 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton 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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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621