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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/27/2026 has been entered.
Status of Claims
The amendments and arguments filed on 05/27/2026 are acknowledged and have been fully considered. Claims 1-8 are now pending. Claim 1 is amended; claims 5-8 are withdrawn.
Claims 1-4 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite the limitation of “wherein the tocopherol and carnosine are present in amounts effective to synergistically reduce oxidative stress and glycation in skin tissue” however the specification and overall disclosure do not teach this limitation. The instant specification teaches:
“Carnosine has a number of antioxidant properties including both scavenging free radicals as well as unsaturated aldehydes produced by cellular lipid membranes during oxidative stress via the process of lipid auto-peroxidation. It also has anti-glycation properties, reducing the formation of glycation end-products that contribute to premature aging effects and a variety of degenerative disorders such as Alzheimer’s and diabetes…These properties make carnosine a useful adjunct in combination with silymarin and tocopherols, where their respective antioxidant and anti-aging benefits work synergistically to complement each other. In test studies, topical applications of this synergistic mixture have been shown to improve skin health and reduce age-related wrinkles by as much as 27%” (instant specification, paragraph 0034).
This excerpt does not teach the synergistic relationship between carnosine and tocopherol, rather it discusses the synergistic relationship between silymarin and tocopherols. Further, even if it was read as discussing the synergistic relationship between carnosine, silymarin, and tocopherols, the claims do not mention silymarin. The combination of carnosine and tocopherol in a synergistic relationship on their own is not taught in the instant specification as filed. Also, while the reduction of oxidative stress and glycation in skin tissue are taught as benefit of carnosine use, there is nothing in the specification as filed that teaches that the combination of carnosine with tocopherol is a synergistic relation that has an effect on the reduction of oxidative stress and glycation in skin tissue. It is also noted that in paragraph 0014 of the instant specification as filed, there is a mention of the combination of tocopherols and carnosine having a synergistic relationship, however it is not drawn to the benefits of reducing oxidative stress and glycation of the skin. As the specification as filed is silent on the synergy of carnosine and tocopherol in regard to their combined effect on reducing oxidative stress and glycation in skin tissue, this amendment is considered new matter.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The claims recite the limitation of “wherein the tocopherol and carnosine are present in amounts effective to synergistically reduce oxidative stress and glycation in skin tissue.” The specification and overall disclosure, however, do not enable one with ordinary skill in the art to make or use the invention as claimed as there are no amounts disclosed for the carnosine and tocopherol in order to produce desired reduction of oxidative stress and glycation of skin tissue. There is no guidance for one with ordinary skill in the art to make the instant invention as claimed because of the lack of examples and amounts of the compositions disclosed and as such would have to undergo undue experimentation to understand what amounts of tocopherol and carnosine would be synergistic or not.
To highlight the need of amounts/examples, it is known in the art that the combination of peppermint oil and alpha-tocopherol destabilizes the oxidative stress benefits of the tocopherols derived from soybean oil (see Kim (2019), introduction, paragraph 2). Without data and support, it is not clear how the combination of peppermint oil and alpha-tocopherol would be expected to lower oxidative stability when the art teaches that the combination increases it (see Kim, abstract). As such, without a recitation of amounts, ranges, or data to support the claims, one with ordinary skill in the art would not be enabled to make or use the instant invention as filed using the specification as filed.
Response to Arguments
Claim Rejections - 35 USC § 103
Applicant's arguments filed 05/27/2026 have been fully considered.
The amendments of 05/27/2026 do overcome the prior art rejections as the amendments recite the limitation of a synergistic relationship between the eucalyptus oil and peppermint oil in specific amounts (i.e., eucalyptus oil in 0.1%-3% and peppermint oil in 1%-4% by weight of the composition. As written these amendments seem to be free of the art at this time.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
