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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Status of 18/123,143
Claims 6-10, 14-15, and 27-31 are currently pending.
Priority
Instant application 18/123,143, filed 3/17/2023, claims priority as follows:
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Receipt of the foreign priority documents is acknowledged.
Information Disclosure Statement
All references in the IDS’s filed on 6/12/2023, 1/22/2025, 6/25/2025, and 12/18/2025 have been considered unless marked with a strikethrough. In the IDS of 12/18/2025, the Examiner notes the references struck through under foreign references did not contain an English translation, and the reference struck through under non-patent literature was not provided.
Oath/Declaration
No Oath or Declaration has been filed as of 5/8/2025. See the 06/15/2023 misc. communication from the USPTO for example.
Response to Arguments/Amendments
The amendment filed 12/18/2025 has been entered. Applicant has amended claims 28 and 29, and has cancelled claims 21-24. Claims 30 and 31 have been added but are not considered new matter.
Claims 6-10, 14-15, and 27-29 were rejected under 35 U.S.C. 103 in the Final dated 8/18/2025. In response, Applicant argues that the cited combination of references provides no rationale, in the absence of hindsight, as to why a person of ordinary skill in the art would select only urolithin A, niacinamide, trehalose, and caffeine from the combinations thereof when the combinations contain additional elements. Applicant also argues that there is no motivation to remove the cannabinoid from the compositions of Ilera, as the composition of Ilera without a cannabinoid did not provide the purported synergistic effect.
Furthermore, Applicant has provided an affidavit demonstrating the unexpected and superior results of the compositions of the instant claims. Specifically, Applicant has highlighted the superior effect of the combination of urolithin A and trehalose compared to the individual ingredients alone in increasing P62 expression in human keratinocytes. Upregulation of P62 is relevant to the instant disclosure because it is known in the art to improve mitochondrial function and mitigate age-related health decline. Additionally, Applicant has demonstrated the superior effect of the combination of urolithin A and niacinamide in decreasing IL-6 concentration, a pro-inflammatory cytokine, when compared to the individual ingredients alone in normal human dermal fibroblasts. Applicant has also demonstrated an element of criticality with respect to the concentration of urolithin A in the composition as figure 18 of the instant disclosure demonstrates the inactivity of a 0.5% urolithin A cream. Applicants above arguments have been considered, and are fully persuasive. Thus, the rejection of claims 6-10, 14-15, and 27-29 under 35 U.S.C. 103 is overcome and withdrawn.
Election/Restriction
Applicant’s election of Group II (claims 9, 10, and 14-19) without traverse, in the reply filed on 1/22/2025 is acknowledged. Subsequent addition and amendment of claims 6-8 and 27-31 over the course of prosecution is acknowledged, and these claims are added to Group II.
Applicant’s election of species, a composition comprising urolithin A, trehalose, and niacinamide, in the reply filed on 1/22/2025 is also acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the election of species requirement, the election of species has been treated as an election without traverse. See MPEP § 818.01(a).
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
In the Non-Final dated 2/25/2025, the elected species was searched and prior art was identified. Additionally, compositions comprising caffeine, as recited in claims 10, 14, and 15, were identified and an obviousness rejection was made. The 103 rejection in Non-Final dated 2/25/2025 and the Final dated 8/18/2025 has been overcome. The full scope of claims has been searched and no additional prior art was identified. However, additional rejections have been identified and thus, claims 6-10, 14-15, and 27-31 are the subject of this Office Action.
NEW OBJECTIONS AND REJECTIONS
Objection to Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application. Figures 2 and 4 contain minor grammatical informalities, with the misspellings “enrichement” and “chenge”, respectively. Figures 5 and 16A are not able to be interpreted as they are in black and white, but are heat maps and require color to comprehend. Additionally, Figure 15 is not able to be interpreted as it is pixelated and illegible. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Objection to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix, such as http:// or other browser executable code. In this instance, the link (http://www.geneontology.org/) is present on page 86 line 2. See MPEP § 608.01.
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 7 and 10 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.
Claim 7 recites the limitations “for example” and “such as”, which render the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required.
Claim 10 recites an instance of parentheses. This renders the claim indefinite because it is exemplary language, and it is not clear if the contents of the parentheses are required, or just examples of what is required. Appropriate correction is required.
Claim Objections
Claim 6 is objected to for a minor grammatical informality. Specifically, claim 6 recites, “a soaps” and “a mousses”, but should read, “a soap” and “a mousse”, respectively. Appropriate correction is required.
Claim 9 is objected to for minor grammatical informalities. Specifically, the genus and species names of the plants should be italicized. The limitation “Nicotiana sylvestris” should read “Nicotiana sylvestris” and the limitation “Opuntia ficus-indica” should read “Opuntia ficus-indica”. Appropriate correction is required.
Claim 10 is objected to for minor grammatical informalities. The claim recites both “saccharide isomerate” and “Saccharide isomerate”. To ensure continuity, Applicant is required to amend the “s” to be both lower case or both capitalized. Appropriate correction is required.
Claims 14 and 15 are objected to because they recite, “(w/w)”, in reference to the concentration of ingredients in the formulation, but should read “w/w” to eliminate the parentheses. This is to ensure continuity with “w/w” recited in claim 7 and obviate a potential rejection under 35 U.S.C. 112(b). Appropriate correction is required.
Claims 8 and 27-29 are objected to as being dependent upon a non-allowable base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Allowable Subject Matter
Claims 30 and 31 are allowed.
Close Prior Art Not Cited
Close prior art identified during the search is Ilera Derm LLC (WO 2021/237214 A1, herein after “Ilera”), which is drawn to compositions for treatment of mitochondrial ATP deficit disorders, acne, and dermatological conditions (abstract and title). Specifically, Ilera teaches a composition of Formulation P (page 132, para [0386] and table 8):
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where the cofactor or precursor thereof is niacinamide in a concentration of 10mg/mL and the mitophagy stimulant is urolithin A in a concentration of 1 w/w%. Further, in the same table, Ilera teaches varying concentrations of niacinamide ranging from 10 mg/mL to 30mg/mL, and extensive tables 11, 13, 15, and 17-19 teach varying concentrations of niacinamide and urolithin A, indicating they are result effective variables in the composition.
However, Ilera fails to teach the presence of trehalose and with respect to instant claims 10, 14, 15, and 27-29, fails to teach the presence of caffeine in the composition. Ilera also teaches that there is no synergistic effect observed between urolithin A and niacinamide in ATP metabolism assays (page 139, para [0399] and page 144, Table 15).
Additional close prior art not cited is W Skincare, LLC (US 2018/0296464 A1, herein after “W Skincare”), which is drawn to compositions comprising caffeine and trehalose to generate an autophagy activating nutrient complex for improving skin integrity (abstract). Specifically, W Skincare teaches a day cream (page 8, para [0110]):
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Which contains caffeine and trehalose in concentrations of 0.25-0.75 w/w% and 0.15-0.35 w/w%, respectively. W Skincare also teaches a booster cream (page 8, para [0116]):
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Which contains caffeine and trehalose in concentrations of 0.25-1.00 w/w%, independently. However, W Skincare fails to teach the composition with the additional elements of urolithin A and niacinamide.
Initially, the Examiner made an obviousness argument with the references Ilera and W Skincare. However, Applicants arguments regarding the lack of motivation for a person of ordinary skill to only select urolithin A, niacinamide, trehalose, and caffeine from the cited references when the combinations contain additional elements and arguments that there is no motivation to remove the cannabinoid from the compositions of Ilera, as the composition of Ilera without a cannabinoid did not provide the purported synergistic effect (page 139, para [0399] and page 144, Table 15) have been considered, and are persuasive. Additionally, the affidavit demonstrating superior effects of the combination of ingredients over the individual ingredients are also considered persuasive.
Conclusion
Claims 30 and 31 are allowed. Claims 7 and 10 are rejected. Claims 6, 8, 9, 14, 15, and 27-29 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 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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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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