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 .
Claim Status
Claims 1-13, 19-20, 23, 29-30, and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking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.
Claims 14-18, 21-22, 24-28, and 31-32 are under consideration in this office action.
Modified Objections/Rejections Necessitated by Amendment
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, 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 are included in this rejection because they are dependent on a rejected base claim and fail to correct the indefiniteness.
Maintained Rejections
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”; PTO-892 from 3/23/2026).
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.
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”; PTO-892 from 3/23/2026) 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.
Response to Arguments
Applicant's arguments filed June 11, 2026 have been fully considered but they are not persuasive.
Regarding the rejection of claims 15-16 and 25-26 under 35 U.S.C. 112(b) as being indefinite, applicant has failed to amend claims 15 and 25 to correct the lack of antecedent basis issue. “[T]he hormone extract” lacks antecedent basis because, claims 14 and 24, from which claim 15 and 25 depend, respectively, do not recite a “hormone extract” limitation. The rejection of these claims for being indefinite are maintained.
With respect to the rejection of claim 14, 21-22, 24, and 31-32 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated Scott, applicant argues that the examiner has interpreted “a hormone supplement” in a manner that is unreasonably broad (remarks, pg 8) and that Scott does not disclose a thyroid hormone supplement, only a thyromimetic (remarks, pg 7). Applicant states that a hormone supplement, as claimed, “requires a hormone, or a precursor or analog thereof, that supplements hormone levels within the body” (remarks, pg 7). This definition, however, does not appear within the specification; rather the specification only provides the exemplary embodiment wherein “the hormone supplement may comprise human growth hormone or a precursor or analogue thereof.” Given this lack of guidance, the term “hormone supplement” was given its broadest reasonable interpretation consistent with the specification. The examiner has interpreted “hormone supplement” to be any pharmaceutical that increases hormone activity. As understood by an ordinary artisan, a thyromimetic compound, which are thyroid-hormone receptor agonists designed to mimic the biological effects of thyroid hormone, would constitute a hormone supplement. Thyromimetics are thyroid-hormone receptor agonists, designed to mimic the biological effects of thyroid hormone; thyromimetics are thyroid hormone analogs.
In support of the argument that the examiner has inappropriately interpreted the scope of “hormone supplement”, applicant asserts that none of ordinary skill in the art would describe the epinephrine mimic albuterol as a hormone supplement (remarks, pg 8). If, as purported by the applicant, the hormone supplement of the claims is interpreted to be limited to hormones and hormone precursors or analogs that supplement hormone levels within the body, then the L-DOPA limitations of claims 16 and 26 fall beyond the hormone supplement scope of claims 14 and 24, as L-DOPA is not a hormone or hormone precursor/analog. Human growth hormone is a polypeptide and L-DOPA is a small molecule that is a precursor for the neurotransmitter dopamine; there is no evidence that L-DOPA is a precursor for the synthesis of human growth hormone.
Applicant asserts that “Scott does not disclose such a hormone supplement” and that “Scott separately distinguishes thyroid hormone thyromimetics from thyroid hormone drugs, thyroid hormone analogs, thyroid hormone chaperones, and thyroid hormone gene therapies, demonstrating that a thyromimetic is recognized as a distinct category of compound rather than a hormone or hormone supplement” (remarks, pg 7). Notably, Scott also teaches compositions comprising thyroid hormone analog or thyroid hormone chaperone and 5-MTHF and vitamin B6 (pg 31, ln 6-22; pg 32, ln 6-22); suggesting that Scott recognized that the pharmaceutical composition comprising 5-MTHF and P-5-P was broadly applicable to hormone supplement compositions. The rejection under35 U.S.C. 102(a)(1) is maintained.
With respect to Bascomb, applicant argues that the species of folate and vitamin B6 are from separate portions of the disclosure, and that the claimed composition requires a pick and choose situation from disparate parts of the disclosure (pg 7-8). Applicant is directed to pg 33, ln 22-32 of Scott (which is applied in the rejection with Bascomb), which discloses a thyromimetic composition comprising 5-MTHF and Vitamin B6; the vitamin B6 is selected from a limited group that includes pyridoxal 5’-phosphate (P-5-P) (pg 33, ln 22-32; pg 43-44). Scott clearly names the claimed species; see MPEP 2131.02, which states that a reference anticipates a claim no matter how many other species are named.
Also, applicant asserts that Bascomb does not disclose the recited composition in any one embodiment and that combination cited by the examiner, combination 86, of Bascomb does not recite cannabidiol or folate (pg 8) and that combination 86 includes species that are substituted by different species drawn from other sections of Bascomb (pg 8). It is the examiner’s position, however, that it would have been obvious to the ordinary artisan to adapt the composition 86 of Bascomb to include the ingredients from elsewhere in the disclosure, this is because these ingredients, e.g., cannabidiol and folate, were already known in the art at the time the invention was made to generate hormone supplementation compositions. A person of ordinary skill in the art would have been motivated to substitute modalities of the composition known to be useful for the same conditions and would have expected the combination formulation to be at least as good as either formulation alone (see MPEP §2144.06). The determination of the ingredients claimed requires only routine experimentation for one of ordinary skill in the art. The instant formulation comprises components that are routinely used and are at concentrations that are typical of those routinely used in the art for preparation hormone supplements. Scott teaches doses that fall squarely within the claimed range. Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to select the recited ingredients of Bascomb and Scott to produce a stable pharmaceutical composition for the hormone supplement. One of ordinary skill in the art at the time the invention was made would have been motivated to do so, in view of the art-recognized need to optimize formulations of therapeutics, and have a reasonable expectation of success, based on the knowledge and skill in the art and in view of the routine nature of the experimentation involved.
Applicant also argues that the examiner has failed to provide a motivation for why one would have selected from Bascomb’s broad and separate lists the specific combination of L-DOPA, 5-MTHF, and P-5-P. Bascomb’s breadth weighs against the obviousness of the particular composition recited in claims 14 and 24 (remarks, pg 9). The examiner agrees that Bascomb expressly contemplates numerous combinations selected from multiple ingredient groups. The rejection, however, was made over Bascomb in view of Scott, which teaches compositions comprising a hormone supplement and 5-MTHF and P-5-P. The additional limitations directed to the growth hormone supplement L-DOPA and cannabidiol are taught by Bascomb in a similar formulation, demonstrating that these specific ingredients are not only known in the art but are also known to be used together in pharmaceutical formulations for hormone supplements.
Applicant is reminded that the test for obviousness is not whether the features of the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). Applicant’s arguments do not show how the combined teachings of the cited references and the knowledge/skills contained therein cannot render the rejected claims obvious. The rejection under 35 U.S.C. 103 is maintained.
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 JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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