DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 14-33, in the reply filed on February 12, 2026 is acknowledged. The traversal is on the grounds that the examiner’s exertion that composition of Group II can be used in a different process, such as an assay, is not reasonable, as the claimed compositions are specifically formulated as therapeutic supplement formulations for administration to human (remarks, pg 9). This is not found persuasive for the detailed reasons set forth for the distinctness between Groups I and II in the Restriction mailed on November 13, 2025. Although the composition comprises a pill or capsule, the formulated agent may be reasonably applied to the generic assay indicated by the examiner. Further, a search of both groups within a single application would have been burdensome because each have acquired a separate status in the art, as evidenced by their unique classification.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of the species of one additional agent as cannabidiol is acknowledged.
Claims 1-13, 19-20, 23, 29-30, and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 12, 2026.
Claims 14-18, 21-22, 24-28, and 31-32 are under consideration in this office action.
Claim Objections
Claims 14, 16, 24, and 26 are objected to because of the following informalities: the claims use acronyms without first defining what they represent in the independent claims (i.e. 5-MTHF, P-5-P, HGH, L-DOPA). While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 15-16 and 25-26 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.
Claims 15 and 25 recite the limitation "the hormone extract”. There is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution, the hormone extract is interpreted to be the hormone supplement.
Claims 16 and 26 recite the limitation "the HGH precursor”. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14, 21-22, 24, and 31-32 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated WO 2021216896, published October 28, 2021 (“Scott”; instant PTO-892).
Scott teaches a thyroid hormone thyromimetic composition comprising 5-methyltetrahydrofolate (5-MTHF) and Vitamin B6, wherein the vitamin B6 is pyridoxal 5’-phosphate (P-5-P (pg 33, ln 22-32; pg 43-44), which reads on the composition comprising a hormone supplement, 5-MTHF, and P-5-P of claims 14 and 24. The composition of Scott can be administered orally as tablets and pills (pg 36, ln 16-18), which reads on instant claim 14, or administered topically as a solid or liquid in combination with a dermatologically acceptable carrier (pg 39, ln 24-33), which reads on instant claim 24.
Scott teaches that the compositions comprise 5-MTHF at about 400 mcg to about 15 mg (pg 22, ln 28-30), which reads on the dose of claims 22 and 32, and vitamin B6 can be at about 100 mcg to about 3 mg (pg 29, ln 13-31), which reads on claims 21 and 31.
Scott anticipates claims 14, 21-22, 24, and 31-32.
Claim Rejections - 35 USC § 103
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.
Claims 14-18, 21-22, 24-28, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180169069, published June 21, 2018 (“Bascomb”; instant PTO-892) in view of WO 2021216896, published October 28, 2021 (“Scott”).
Claims 14 and 24 are directed to a composition comprising a hormone supplement, 5-MTHF, and P-5-P. In claims 15-16 and 25-26, the hormone supplement is the growth hormone precursor L-DOPA. In claims 17-18 and 27-28 , the composition further comprise the cannabinoid cannabidiol.
Bascomb teaches a composition comprising a cannabinoid, a vitamin, an anti-oxidant, a beta blocker, an NSAID, a steroid, and an amino acid (Exemplary combination 86, pg 57). According to Bascomb, the cannabinoid may be cannabidiol, vitamins may be pyridoxal-5’-phosphate and methylformate, and the anti-oxidant may be L-DOPA (Table 1, pg 33-37), as in the composition of claims 15-18 and 25-28. The composition may be formulated as a pill or a gel, as in the compositions of claims 14 and 24.
Bascomb does not teach the amount of P-5-P or 5-MTHF in the composition.
Scott teaches that the compositions comprising a thyroid hormone thyromimetic, 5-methyltetrahydrofolate (5-MTHF), and pyridoxal 5’-phosphate (P-5-P (pg 33, ln 22-32; pg 43-44). The composition comprises 5-MTHF at about 400 mcg to about 15 mg (pg 22, ln 28-30), as in dose of claims 22 and 32, and vitamin B6 can be at about 100 mcg to about 3 mg (pg 29, ln 13-31), which reads on the dose of claims 21 and 31.
Given that Bascomb teaches compositions comprising 5-MTHF, P-5-P, HGH precursor L-DOPA (i.e. hormone supplement), and cannabidiol, and further given that Scott teaches a composition comprising 5-MTHF, P-5-P, and a hormone supplement and doses thereof, it would have been obvious to one of ordinary skill in the art to apply the doses of Scott in the composition of Bascomb because a known work in one field of endeavor may prompt variation of it for use in the same field (MPEP 2143.I.F). Such is the case here, where the ordinary artisan would apply doses of 5-MTHF and P-5-P, as determined in the composition of Scott, in a similar composition taught by Bascomb. Furthermore, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses combining prior art elements according to known methods to yield predictable results; the combination is obvious unless its application is beyond that person's skill. It would have been within the technical grasp of the ordinary artisan to use the doses of Scott in the composition of Bascomb for 5-MTHF and P-5-P to obtain predictable results. Such amounts to combining prior art elements according to known methods to achieve predictable outcomes.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675