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 .
Priority
This Application filed on 05/24/2023 is a 371 of PCT/KR2020/013508 filed on 10/05/2020 which claims foreign priority to KOREA, REPUBLIC OF 10-2019-0155901 filed on 11/28/2019.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed March 16, 2026 to the restriction requirement made on April 10, 2025.
Applicant's election with traverse of Group II, claims 15-21, and the species FORMULA 2 (ferulic acid) in the reply filed on March 16, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 5/27/22 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
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.
Claims 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murray et al. (A topical antioxidant solution containing vitamins C and E with ferulic acid protects human skin from sunlight damage and DNA mutations associated with skin cancer, J. Am. Acad. Dermatol. 2008, Vol. 59:418-425).
Murray et al. teaches a topical antioxidant solution containing vitamins C and E with ferulic acid protects human skin from sunlight damage and DNA mutations associated with skin cancer. The recitation of “ferulic acid or analog thereof increases the expression of keratin 6a protein” “suppressing the function of a gene encoding at least one keratin” “ regulates the expression of beta catenin protein” are inherit because they are parts of the pathway which ferulic acid acts on and products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
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.
Claims 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Lo et al. (Ferulic acid altered IL-17A/IL-17RA interaction and protected against imiquimod-induced psoriasis-like skin injury in mice. Food Chem Toxicol. 2019 Jul;129:365-375. doi: 10.1016/j.fct.2019.04.060. Epub 2019 May 3. PMID: 31054998.) in view of Wang et al., 2018 (Gain-of-Function Mutation of Card14 Leads to Spontaneous Psoriasis-like Skin Inflammation through Enhanced Keratinocyte Response to IL-17A Immunity, 49 (2018), pp. 66-79.e5).
Lo et al. teaches “we newly identified that oral administration of ferulic acid (FA) protected against IMQ-induced psoriatic skin injury in mice. “ (abstract) Further, the reference teaches “in addition to the regulation of cytokine production, FA might interact with IL-17A, prevent IL-17A from binding to IL-17RA, and consequently improve psoriasis-like skin inflammation. FA is a safety food additive, with the oral lethal dosage at 50% (LD50) of approximately 2 g/kg in rats, equivalent to 4 g/kg in mice. Our data showed that FA ameliorated IMQ-induced psoriasis-like lesions at 100 mg/kg, a dosage below LD50. Therefore, our findings suggested that FA was a bioactive compound against psoriasis-like skin inflammation with low toxicity.” (conclusion)
The reference does not specify the psoriasis-like skin inflammation is caused by a genetic mutation.
Wang et al. teaches dorsal skin from Card14−/− mice expressed higher level of Keratin 10 (K10) but lower level of Keratin 14 (K14) in epidermal layers than wild-type mice. The mRNA expression of K10 and loricrin were also relatively higher in IMQ-treated Card14−/− mice.
It would have been obvious to one of ordinary skill in the art at the time of filing to treat a psoriasis-like skin inflammation having high levels of K10 expression with ferulic acid. The motivation to treat psoriasis-like skin inflammation with increased K10 expression with ferulic acid is because IMQ-induced psoriatic skin injury in mice and mRNA expression of K10 are relatively higher in IMQ-treated Card14−/− mice. Therefore, a skilled artisan would have had reasonable expectation of successfully achieving treatment of psoriasis-like skin inflammation having high levels of K10 expression with ferulic acid.
Claims 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over El-Gammal et al. (Apitherapy as a New Approach in Treatment of Palmoplantar Psoriasis. Open Access Maced J Med Sci. 2018 Jun 10;6(6):1059-1061. doi: 10.3889/oamjms.2018.135. PMID: 29983801; PMCID: PMC6026437.) in view of Mellet et al. (CARD14 Gain-of-Function Mutation Alone Is Sufficient to Drive IL-23/IL-17–Mediated Psoriasiform Skin Inflammation In Vivo. Journal of Investigative Dermatology
Volume 138, Issue 9, September 2018, Pages 2010-2023).
El Gammal et al. teaches patients who have palmoplantar psoriasis, who were treated with a topically applied mixture of propolis (50%) and aloe vera (3%), have shown noteworthy improvement thus proving the efficiency of propolis and aloe vera in the treatment of mild to moderate psoriasis. The principal components of propolis are flavonoids of group 5 (betulinol, quercetin, isovanillin), cafeic acids, unsaturated aromatic acid, and ferulic acids.
The reference does not specify the palmoplantar psoriasis is caused by a genetic mutation.
Mellet et al. teaches are autosomal dominant mutations in the gene encoding the keratinocyte signaling molecule CARD14, have been associated with an increased susceptibility to psoriasis.
It would have been obvious to one of ordinary skill in the art at the time of filing to treat autosomal dominant mutations of psoriasis with ferulic acid. The motivation to treat autosomal dominant mutations of psoriasis with ferulic acid is because Mellet et al. teaches autosomal dominant mutations in the gene encoding the keratinocyte signaling molecule CARD14, have been associated with an increased susceptibility to psoriasis. Therefore, a skilled artisan would have had reasonable expectation of successfully achieving treatment of psoriasis having autosomal dominant mutations.
Relevant art:
CN 104621568 A teaches ferulic acid is an excellent free radical scavenger, plays an important role in the prevention of cancer.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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