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 claims priority from Korean application KR10-2023-0192980, with the priority date of 12/27/2023
Status of Claims
Claims 1-2 are pending.
Claims 1-2 are examined herein.
Information Disclosure Document
NPL document “Jong-Du Lee., Antioxidant activity assessment with optimized biomass and elicitor treatment from adventitious root of Hibiscus hamabo Siebold & Zucc, IAPB (International Association for Plant Biotechnology Congress), 2023, P-224” is unclear and the examiner can’t read it. A clearer copy and date the poster was made public is requested. It appears that this document was made public less than one year before the priority date of 12/27/2023 and disclosed by the applicants.
Specification
It appears figure IDs are incomplete in paragraph 39 line 3 and paragraph 51 line 1. The examiner was also unclear about the difference between “extraction amount” and “extract amount” in Table 2. It was also unclear how the charts in figure 3 were generated, what the x-axis and y-axis units were, what concentrations were used, and how the Y axis measured cell viability as referenced in paragraphs 94-95.
Drawings
Figure 1 and 3 referenced in the specification were filed on 12/26/2024 while figures 2 and 4 were filed on 03/04/2025. Figure 1 from drawings document filed on 12/26/2024 lists a hot water extraction at (S124) while the disclosure lists a 50% EtOH extraction in paragraph 51 and teaches room temperature. Graphs in figure 3 are unclear and need clearer axis labels.
Claim Objections
Claim 1 has an incorrect spelling of Skoog.
Claim Rejections-35 USC § 112(b)
Claim 2 refers to a cosmetic composition referenced in preceding claim 1, which is a method claim and not drawn to a cosmetic composition. Thus, there is a lack of antecedent basis for the “cosmetic composition“ limitation in claim 2, and the claim is indefinite. In the interest of compact prosecution, it will be examined as being dependent upon claim 1 and a method claim.
Claim Rejection-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 1 and 2 are rejected over Lee, Jong-Du, et al. "Mass proliferation of Hibiscus hamabo adventitious root in an air-lift bioreactor, and the antioxidant and whitening activity of the extract." Korean Journal of Plant Resources 35.4 (2022): 435-444 in view of KR 102018533 B1 and Lee, Eun Jung, So Young Park, and Kee Yoeup Paek. "Enhancement strategies of bioactive compound production in adventitious root cultures of Eleutherococcus koreanum Nakai subjected to methyl jasmonate and salicylic acid elicitation through airlift bioreactors." Plant Cell, Tissue and Organ Culture (PCTOC) 120.1 (2015): 1-10.1 The claims are listed below for further reference in this document.
Claim 1: A method of cultivating Hibiscus hamabo's adventitious root comprising:
a first culturing step of inoculating Hibiscus hamabo's adventitious root to a culture medium comprising a MS (Murashige & Skog) salt, indole-3-butyric acid as a plant regulator, and sucrose, and adjusted to pH 5.7 to 5.8 and culturing Hibiscus hamabo's adventitious root cells at a temperature of 24 to 26 °C;
a step of supplying methyl jasmonate to the cultured Hibiscus hamabo's adventitious root so that the concentration of methyl jasmonate is maintained at 50 to 200 μM;
a step of extracting cultured Hibiscus hamabo's adventitious root cells by immersing in an alcohol at room temperature and separating the Hibiscus hamabo's adventitious root extract; and
a step of decompression-concentrating and freeze-drying of the separated Hibiscus hamabo's adventitious root extract, wherein the extract comprises at least 2.1 mg/g of N-[4'-hydroxy-cinnamoyl]-aspartic acid as an active ingredient.
Claim 2: The cosmetic composition according to claim 1, wherein the inoculation volume of the Hibiscus hamabo's adventitious root is 3 to 5 g/L.
Lee et al 2022 teaches a method for culturing Hibiscus hamabo's adventitious roots using a bioreactor to produce active ingredients for the production of cosmetics (See abstract). The method for culturing adventitious roots used medium consisting of MS (Murashige & Skoog) salts, sucrose, and indole-3-butyric acid. The medium’s pH and temperature was maintained at pH 5.7-5.8 and 24-26 °C and was described on page 2 paragraph 5. Another method of culturing adventitious roots in suspension flasks is described on page 3 paragraph 1, teaches the same conditions, but doesn’t mention a temperature. Lee et al 2022 also teaches a method of extracting metabolites (i.e. phenolics and flavonoids) using the alcohol, ethanol, on page 3 paragraph 2. Additionally, Lee et al 2022 teaches a method of separating the Hibiscus hamabo's adventitious root tissue from the extract and a step of vacuum concentration (i.e. decompression-concentrating) on page 3 paragraph 2 to page 4 paragraph 1. Regarding claim 2, Lee et al 2022 also teaches the inoculation of 4 grams of adventitious roots per liter into a bioreactor on page 3 paragraph 1.
It is noted that Claim 1 teaches an alcohol extraction at room temperature while Lee et al 2022 teaches an extraction at 80 °C. According to MPEP § 2144.05 II “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” The criticality of temperature to the success of extracting N-[4'-hydroxy-cinnamoyl]-aspartic acid has not been demonstrated. Thus, the difference in temperature is considered routine optimization and would have been prima facie obvious to one of ordinary skill in the art at the time of filing.
Lee et al 2022 does not explicitly teach an extraction at room temperature in an alcohol or freeze drying extracts as recited in claim 1. Descriptions of Hibiscus hamabo extractions in methanol at room temp prior to a vacuum concentration and freeze drying steps can be seen in KR 102018533 B1 in Example 1. “15 L of methanol was added to 700 g of dried humus root (presumably Hibiscus hamabo), and extracted three times at room temperature for 72 hours. The extracted extract was filtered and then the solvent was removed using a vacuum concentrator, and freeze-dried to prepare a methanol extract of yellow root.”
Additionally, Lee et al 2022 does not explicitly teach the incubation of the adventitious root cultures with methyl jasmonate to increase the production of the phenolic, N-[4'-hydroxy-cinnamoyl]-aspartic acid. However, it does mention the concept of using methyl jasmonate to increase the production of phenolic compounds on page 7 paragraph 1.
Lee et al 2015 teaches that incubating adventitious roots with methyl jasmonate is already known to be an elicitation strategy on page 2 paragraph 3. This document also demonstrates that culturing the adventitious roots with 50 to 200 μM methyl jasmonate led to an increase in the amount of synthesized phenolics (See Figure 1 and Tables 2 and 3).2 Additionally, the recited active method steps of claim 1, which are already well known in the art, will produce the claimed 2.1 mg/g of N-[4'-hydroxy-cinnamoyl]-aspartic acid regardless if it was reported (i.e. latent properties).
It would have been prima facie obvious to combine and to modify the teachings of Lee et al 2022, KR 102018533 B1, and Lee et al 2015 to generate a method for culturing Hibiscus hamabo's adventitious roots in media with MS salts, sucrose, indole-3-butyric acid, maintaining a pH of 5.7-5.8 and temperature of 24-26 °C, and using 50 to 200 μM methyl jasmonate for the production of active ingredients (i.e. N-[4'-hydroxy-cinnamoyl]-aspartic acid) for cosmetics. One would have been motivated to use these growth conditions because they have already been demonstrated to be successful in culturing Hibiscus hamabo's adventitious roots. A person wanting to increase the amount of phenolics synthesized by the cultured roots would also have been motivated to use methyl jasmonate as it is already known to elicit the production of secondary metabolites, like phenolics.3 A person of ordinary skill in the art would also have been motivated to isolate N-[4'-hydroxy-cinnamoyl]-aspartic acid as it is a conjugate of the phenylpropanoid (phenolic), p-coumaric acid and aspartic acid. The compound, p-coumaric acid, is also an ingredient already known to the cosmetic industry.
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to Applicants’ disclosure:
Boo, Yong Chool. "p-Coumaric acid as an active ingredient in cosmetics: A review focusing on its antimelanogenic effects. " Antioxidants 8.8 (2019): 275: this reference teaches that p-coumaric acid is also an ingredient already known to the cosmetic industry.
Conclusion
No claims are allowed.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W MEYER whose telephone number is (571)272-3733. The examiner can normally be reached Monday - Friday 8:00 am- 5:00 pm.
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/GEORGE W MEYER/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662
1 NOTE: A translated document of Lee et al 2022 was generated and is attached with this office action for reference. The “Phellodendron amurense” referenced in the translated copy is believed to be “Hibiscus hamabo”. A similar issue was seen in KR 102018533 B1 where the names of species in translated document were not translated to “Hibiscus hamabo”.
2 The claimed metabolite, N-[4'-hydroxy-cinnamoyl]-aspartic acid, is a known phenolic/amino acid conjugate found in plants (see table 2, figure 1, and page 22 paragraph 2 in Oracz, Joanna, et al. "Bioavailability and metabolism of selected cocoa bioactive compounds: A comprehensive review." Critical reviews in food science and nutrition 60.12 (2020): 1947-1985).
3 This was taught in the review article, Jeyasri, Rajendran, et al. "Methyl jasmonate and salicylic acid as powerful elicitors for enhancing the production of secondary metabolites in medicinal plants: an updated review." Plant Cell, Tissue and Organ Culture (PCTOC) 153.3 (2023): 447-458 (see IDS filed 12/26/2024). Jevasri et al 2023 teaches “Medicinal plants are an incredible source for producing pharmaceutically important novel bioactive compounds to reform medicines in the future and also these are all used for industrial and other food materials. Elicitation is one of the effective methods to enhance the synthesis of therapeutic metabolite production in medicinal plants to maintain their resilience and survival” on page 9 paragraph 2 and gives more example of methyl jasmonate’s ability to elicit the biosynthesis of phenolics on page 8 paragraph 1 and table 3.