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 .
Status of Application, Amendments and/or Claims
Claims 1-33 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 14-33, drawn to a composition comprising a formulation comprising therapeutically effective amounts of a hormone supplement, a plurality of amino acids, and phosphatidylserine, in the reply filed on 04 February 2026 is acknowledged.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04 February 2026.
Claims 14-33 are under consideration in the instant application.
Claim Objections
1. Claims 16, 19, 23, 26, 29, and 33 are objected to because of the following informalities:
1a. Claims 16 and 26 recite the acronym “HGH” without first defining what it represents. While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym and/or in each independent claim.
1b. Claims 19, 23, 29, and 33 recite the acronym “alpha-GPC” without first defining what it represents. While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym and/or in each independent claim.
1c.
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.
2. Claims 15, 16, 25, and 26 are 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.
2a. Claims 15 and 25 recite the limitation "the hormone extract" in line 1. There is insufficient antecedent basis for this limitation in the claims. Claims 14 and 24, from which claims 15 and 25 respectfully depend, do not recite a “hormone extract”. Rather, claims 14 and 24 recite a “hormone supplement”.
2b. Claims 16 and 26 recite the limitation "the HGH precursor" in line 1. There is insufficient antecedent basis for this limitation in the claims. Claim 14 and 24, from which claims 16 and 26 respectfully depend, do not recite a “HGH precursor”.
Claim Rejections - 35 USC § 102
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 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.
3. Claims 14, 15, 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dushenkov et al. (US 2012/0225053; 24 November 2020).
Dushenkov et al. teach compositions comprising theaflavin in combination with additional agents (page 2, [0015-0016]). Dushenkov et al. disclose that a supplement or food of the invention can comprise the composition described and one or more additional ingredients, including a plurality of amino acids, acetylcarnitine, glutathione, L-theanine, hormones (such as human growth hormone), acetylcarnitine, alpha-GPC, and phosphatidylserine, meeting the limitations of instant claims 14, 15, and 19-22 (page 17, [0160] through the top of page 18). Dushenkov et al. teach that the dosage form of the composition includes capsules and pills, meeting the limitations of instant claim 14 (page 21, [0190]).
4. Claims 24-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fitzsimmons et al. (U.S. Patent 10,842,758; 24 November 2020).
Fitzsimmons et al. teach a transdermal delivery formulation that comprises a cannabidiol and one or more active agents, meeting the limitations of instant claims 27 and 28 (column 2, lines 9-16). Fitzsimmons et al. disclose that the an additional active agent includes Levodopa, meeting the hormone supplement limitations of instant claims 24-26 (column 18, lines 31-35). Fitzsimmons et al. indicate that the transdermal delivery formulation also comprises phosphatidylserine, meeting the limitations of instant claim 24 (column 12, lines 24-30; column 29, lines 62-65). Fitzsimmons et al. also teach that buffers may be utilized in the formulation, such as lysine and histidine buffers, meeting the amino acid limitation of instant claim 24 (column 20, lines 35-39, 47-48). Fitzsimmons et al. disclose that the transdermal delivery formulation may be an aqueous gel, meeting the limitations of instant claim 24 (column 14, lines 10-17).
5. Claims 24-26 and 29-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazed et al. (US 2013/0338039; 19 December 2013).
Mazed et al. teach chemical compositions of bioactive compounds and/or bioactive molecules for lowering the risks of Alzheimer’s, cardiovascular, and diabetes diseases (page 1, [0003]). Mazed et al. teach that the composition may be in the form of a hydrogel, meeting the limitations of instant claim 24 (page 21, [0377]; page 22, [0397, 0419-0420]). Mazed et al. disclose a specific composition for lowering the risks of Alzheimer’s disease in Table 7A at page 9, wherein the composition comprises:
(i) hormone supplement, L-Dopa (see Table, column 2);
(ii) a plurality of amino acids, including arginine and tyrosine (see Table, column 2);
(iii) phosphatidylserine (see Table, column 2);
(iii) L-alpha glycerylphosphorylcholine (alpha-GPC) with dosage range of 100-300 mg (see Table, column 1);
(iv) acetylcarnitine (see Table, column 2);
(v) L-theanine (see Table, column 2); and
(vi) L-glutathione (see Table, column 2).
It is noted that Table 7A is reproduced below with the components of the composition underlined.
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607
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666
420
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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.
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.
6. Claims 24-33 are rejected under 35 U.S.C. 103 as being unpatentable over Mazed et al. (US 2013/0338039; 19 December 2013) and Zou et al. (U.S. Patent 11,497,719).
The teachings of Mazed et al. are set forth directly above.
Mazed et al. do not teach that the composition of bioactive compounds for lowering the risks of Alzheimer’s (as set forth in Table 7A) also comprises a cannabinoid compound, such as cannabidiol.
Zou et al. teach a cannabinoid composition comprising cannabidiol and cannabigerol, wherein the composition is administered to treat Alzheimer’s disease (column 2, lines 34-67; column 14, lines 44-67 through column 16). Zou et al. disclose that the cannabinoid composition promotes viability and secretion capacity of dopaminergic neurons (Examples 1-2). Zou et al. indicate that the dosage form of the composition includes table, capsule, pill, and gel (column 3, lines 1-3; column 5, lines 48-50).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the composition of bioactive compounds for lowering the risks of Alzheimer’s (that comprises L-Dopa, amino acids, and phosphatidylserine) as taught by Mazed et al. by including cannabinoids (such as cannabidiol and cannabigerol) as taught by Zou et al. The person of ordinary skill in the art would have been motivated to make that modification because dopamine, as a neurotransmitter, participates in the course of Alzheimer’s disease and decreased levels of dopamine, L-DOPA, and metabolites are found in parts such as striatum, amygdala and substantia nigra of AD patients (Zou et al. column 1, lines 34-44). Zou et al. also teach that their cannabidiol and cannabigerol composition (i) produces little side effects and therapeutic effect is not degraded and (ii) may be co-administered with medicines to achieve a better therapeutic effect or defer the side effects of long-term administration (column 1, lines 62-62; column 3, lines 34-47). Additionally, one skilled in the art would have expected success because both Mazed et al. and Zou et al. separately teach their respective compositions treat Alzheimer’s disease. Additionally, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) and MPEP § 2144.06. Therefore, the claimed invention as a whole was clearly prima facie obvious over the prior art.
7. Claims 14, 15, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dushenkov et al. (US 2012/0225053; 24 November 2020) and Mechoulam et al. (WO 01/95899; 20 December 2001).
The teachings of Dushenkov et al. are set forth above under 35 U.S.C. 102(a)(1).
Dushenkov et al. do not teach that the composition comprising theaflavin and additional agents further comprises a cannabinoid compound, such as a cannabidiol.
Mechoulam et al. teach that cannabidiol (CBD) inhibits inflammatory response in animals (page 1, bottom of 3rd paragraph). Mechoulam et al. disclose the preparation of CBD metabolites and determine that several are anti-inflammatory (pages 20-23). Mechoulam et al. also teach pharmaceutical compositions comprising the CBD metabolites and that such can be formulated into a tablet or capsule (page 3, 2nd full paragraph).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the composition comprising theaflavin and one or more additional ingredients, including a plurality of amino acids, acetylcarnitine, glutathione, L-theanine, hormones (such as human growth hormone), acetylcarnitine, alpha-GPC, and phosphatidylserine as taught by Dushenkov et al. by including a cannabidiol as taught by Mechoulam et al. The person of ordinary skill in the art would have been motivated to make that modification and would have expected success because both Dushenkov et al. and Mechoulam et al. separately teach their respective compositions treat inflammation (see Dushenkov et al. page 1, [0011-0012]; page 2, [0013]; Mechoulam et al., (page 1, bottom of 3rd paragraph; pages 20-23)). Additionally, one skilled in the art would have expected success because “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) and MPEP § 2144.06. Therefore, the claimed invention as a whole was clearly prima facie obvious over the prior art.
8. Claims 14, 15, 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Dushenkov et al. (US 2012/0225053; 24 November 2020) and Kellermann et al. (US 2011/0015154).
The teachings of Dushenkov et al. are set forth above under 35 U.S.C. 102(a)(1).
Dushenkov et al. do not teach that the composition comprising theaflavin and additional agents, such as alpha-GPC, comprises alpha-GPC in an amount between 300 mg and 1200 mg.
Kellermann et al. teach a composition to regulate one or more inflammatory pathways, wherein the composition comprises a choline compound (such as alpha-GPC) (page 4, [0045, 0048]). Kellermann et al. disclose that alpha-GPC is in an amount ranging from 10 mg to 10,000 mg, meeting the limitations of instant claim 23 (page 2, [0012]; page 6, [0065]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the composition comprising theaflavin and one or more additional ingredients, including alpha-GPC, as taught by Dushenkov et al. by including alpha-GPC in an amount ranging from 10 mg to 10,000 mg as taught by Kellermann et al. The person of ordinary skill in the art would have been motivated to make that modification in order to improve upon what is already known in Duschenkov et al., thus determining the optimum concentration of alpha-GPC. The person of ordinary skill in the art reasonably would have expected success because optimization of conditions/concentrations is routine in the art. See In re Aller 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. See In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). See also In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). Additionally, a person of ordinary skill has good reason to pursue the known options within his or her grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
Conclusion
No claims are allowable.
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BEB
Art Unit 1647
05 March 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647