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
The amendment of 11 June 2026 has been entered in full. Claims 14, 15, 19, 24-26, and 29 are amended. Claim 16 is cancelled.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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, 15, and 17-33 are under consideration in the instant application.
Withdrawn Objections and/or Rejections
1. The objections to claims 16, 19, 23, 26, 29, and 33 as set forth at pages 2-3 of the previous Office Action of 18 March 2026 are withdrawn in view of the amended and cancelled clams (11 June 2026).
2. The rejections of claims 15, 16, 25, and 26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph as set forth at page 3 of the previous Office Action of 18 March 2026 are withdrawn in view of the amended and cancelled clams (11 June 2026).
3. The rejection of claims 14, 15, 19-22 under 35 U.S.C. 102(a)(1) as being anticipated by Dushenkov et al. (US 2012/0225053; 24 November 2020) as set forth at page 4 of the previous Office Action of 18 March 2026 is withdrawn in view of the amended claim 14 (11 June 2026). Specifically, Dushenkov et al. do not teach a composition comprising a hormone supplement comprising L-DOPA.
4. The rejection of claims 24-28 under 35 U.S.C. 102(a)(1) as being anticipated by Fitzsimmons et al. (U.S. Patent 10,842,758; 24 November 2020) as set forth at page 5 of the previous Office Action of 18 March 2026 is withdrawn in view of amended claim 24 (11 June 2026). Specifically, Fitzsimmons et al. do not teach a formulation comprising a penetration enhancer (eucalyptol provided as eucalyptus oil) and menthol (provided as peppermint oil).
5. The rejection of claims 24-26 and 29-33 under 35 U.S.C. 102(a)(1) as being anticipated by Mazed et al. (US 2013/0338039; 19 December 2013) as set forth at pages 5-7 of the previous Office Action of 18 March 2026 is withdrawn in view of amended claim 24 (11 June 2026). Specifically, Mazed et al. do not teach a formulation comprising a penetration enhancer (eucalyptol provided as eucalyptus oil) and menthol (provided as peppermint oil).
6. The rejection of claims 24-33 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) as set forth at pages 8-9 of the previous Office Action of 18 March 2026 is withdrawn in view of amended claim 24 (11 June 2026). Specifically, Mazed et al. and Zou et al. do not teach a formulation comprising a penetration enhancer (eucalyptol provided as eucalyptus oil) and menthol (provided as peppermint oil).
7. The rejection of claims 14, 15, 17-22 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) as set forth at pages 10-11 of the previous Office Action of 18 March 2026 is withdrawn in view of amended claim 14 (11 June 2026). Specifically, Dushenkov et al. and Mechoulam et al. do not teach a composition comprising a hormone supplement comprising L-DOPA.
8. The rejection of claims 14, 15, 19-23 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) as set forth at pages 11-12 of the previous Office Action of 18 March 2026 is withdrawn in view of amended claim 14 (11 June 2026). Specifically, Dushenkov et al. and Kellermann et al. do not teach a composition comprising a hormone supplement comprising L-DOPA.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
9. Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14, from which claim 15 depends, recites a composition for oral supplementation, comprising: an ingestible pill comprising, or a capsule containing, therapeutically effective amounts of:
a hormone supplement comprising L-DOPA;
a plurality of amino acids; and
phosphatidylserine.
Claim 15 recites the composition of claim 14, wherein the hormone supplement further comprises human growth hormone (HGH) or a precursor or analog thereof.
However, the instant specification teaches that the HGH precursor is L-DOPA (page 89, [0249]). Therefore, the alternative limitation of claim 15 wherein the hormone supplement further comprises a HGH precursor fails to further limit the subject matter of claim 14. The HGH precursor (L-DOPA) is already recited as being comprised in the hormone supplement of claim 14.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
New 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.
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.
10. Claims 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzsimmons et al. (U.S. Patent 10,842,758; 24 November 2020; cited on the PTO-892 of 18 March 2026) and Le Devedec et al. (US 2023/0025693).
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 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).
Fitzsimmons et al. do not teach that the transdermal delivery formulation comprises a penetration enhancer comprising eucalyptol provided as eucalyptus oil in an amount between 0.5% and 1.5% by weight and menthol provided as peppermint oil in an amount between 2% and 3% by weight.
Le Devedec et al. teach that the cannabinoid (such as cannabidiol) or combination of cannabinoids comprised in compositions, upon topical application, is available at the site of administration in a mammal in a therapeutically effective amount and is absorbed in the deeper layers of skin in a therapeutically effective concentration (page 2, [0052], [0058]). Le Devedec et al. state that the compositions also comprise the combinations of humectants and penetration enhancers, which are selected such that these ingredients not only improve penetration of cannabinoids into the epidermis, but they also enter the subepidermal layers (such as they dermis and hypodermis layers) quickly with resulting effects that transportation/diffusion of cannabinoids through the subepidermal layers of the skin is enhanced (page 2, [0052]).
Le Devedec et al. disclose a topical composition comprising: (a) a cannabinoid, (b) a humectant, (c) a penetration enhancer at 1-5% (w/w), and (d) water (page 3, [0072-0076]; page 5, [0103-0105]). Le Devedec et al. indicate that the topical composition is provided as a gel (page 4, [0092-0095]). Le Devedec et al. also teach that topical composition may comprise a second penetration enhancer at about 0.1% to about 3% (w/w) which may be an essential oil, such as eucalyptus oil, peppermint oil, and any combination thereof, meeting the limitations of instant claim 24 (page 5, [0113]; page 6, [01124-0115]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the transdermal delivery formulation that comprises a cannabidiol and one or more active agents as taught by Fitzsimmons et al. by including penetration enhancers (eucalyptus oil and peppermint oil) in an amount between about 0.1% to about 3% (w/w) as taught by Le Devedec et al. The person of ordinary skill in the art would have been motivated to make that modification to enhance the transportation/penetration of the cannabidiol formulation into the epidermis and subepidermal (dermis and hypodermis) layers of the subject (see Le Devedec et al., page 2, [0052, 0054]). Furthermore, the composition would have less frequency and severity of side effects that is typically associated with oral and systemic cannabinoid administration (see Le Devedec et al., page 2, [0055]). The person of ordinary skill in the art reasonably would have expected success because Fitzsimmons et al. and Le Devedec et al. both successfully generate transdermal formulations comprising a cannabinoid to treat conditions, such as pain and inflammation (Fitzsimmons et al., column 17, lines 34-41; Le Devedec et al., pages 6-7, [0134-0137]). 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. 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)). Therefore, the claimed invention as a whole was clearly prima facie obvious over the prior art.
11. Claims 24-33 are rejected under 35 U.S.C. 103 as being unpatentable over Mazed et al. (US 2013/0338039; 19 December 2013; cited on the PTO-892 of 18 March 2026), Zou et al. (U.S. Patent 11,497,719; cited on the PTO-892 of 18 March 2026), and Le Devedec et al. (US 2023/0025693).
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
426
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666
420
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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. Mazed et al. also do not teach that the composition comprises a penetration enhancer comprising eucalyptol provided as eucalyptus oil in an amount between 0.5% and 1.5% by weight and menthol provided as peppermint oil in an amount between 2% and 3% by weight.
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).
Le Devedec et al. teach that the cannabinoid (such as cannabidiol) or combination of cannabinoids comprised in compositions, upon topical application, is available at the site of administration in a mammal in a therapeutically effective amount and is absorbed in the deeper layers of skin in a therapeutically effective concentration (page 2, [0052], [0058]). Le Devedec et al. state that the compositions also comprise the combinations of humectants and penetration enhancers, which are selected such that these ingredients not only improve penetration of cannabinoids into the epidermis, but they also enter the subepidermal layers (such as they dermis and hypodermis layers) quickly with resulting effects that transportation/diffusion of cannabinoids through the subepidermal layers of the skin is enhanced (page 2, [0052]).
Le Devedec et al. disclose a topical composition comprising: (a) a cannabinoid, (b) a humectant, (c) a penetration enhancer at 1-5% (w/w), and (d) water (page 3, [0072-0076]; page 5, [0103-0105]). Le Devedec et al. indicate that the topical composition is provided as a gel (page 4, [0092-0095]). Le Devedec et al. also teach that topical composition may comprise a second penetration enhancer at about 0.1% to about 3% (w/w) which may be an essential oil, such as eucalyptus oil, peppermint oil, and any combination thereof, meeting the limitations of instant claim 24 (page 5, [0113]; page 6, [01124-0115]).
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 (i) cannabinoids (such as cannabidiol and cannabigerol) as taught by Zou et al. and Le Devedec et al. and (ii) penetration enhancers (eucalyptus oil and peppermint oil) in an amount between about 0.1% to about 3% (w/w) as taught by Le Devedec et al. The person of ordinary skill in the art would have been motivated to make those modifications 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). Furthermore, one skilled in the art would have been motivated to include penetration enhancers of eucalyptus oil and peppermint oil in the topical gel composition to enhance the transportation/penetration of the composition into the epidermis and subepidermal (dermis and hypodermis) layers of the subject (see Le Devedec et al., page 2, [0052, 0054]). The inclusion of penetration enhancers also would reduce the frequency and severity of side effects that is typically associated with oral and systemic cannabinoid administration (see Le Devedec et al., page 2, [0055]). T
One skilled in the art would have expected success because Mazed et al., Zou et al., and Le Devedec et al. separately teach their respective compositions treat conditions such as Alzheimer’s disease, pain, or inflammation. 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)). Therefore, the claimed invention as a whole was clearly prima facie obvious over the prior art.
Conclusion
Claims 15 and 24-33 are rejected.
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.
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BEB
Art Unit 1647
08 September 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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