DETALIED 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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to Korean Patent Application No. 10-2023-0180395, filed on December 13, 2023, in the KIPO (Korean Intellectual Property Office). A Certified Copy of the Foreign Priority Application was retrieved by the USPTO from a participating IP Office. However, the present application does not yet satisfy the formal requirements to establish entitlement to the benefit of the earlier foreign filing date. Specifically, the following items are required under 37 CFR 1.55 and MPEP § 214:
1. Certified Copy English Translation of Foreign Application: A certified copy of the foreign
application (specification and drawings) upon which the priority claim is based must be
submitted. If the foreign application is not in the English language, a verified English translation
must also be provided.
Status of the Claims
Claims 1-2 are pending and are examined herein.
Information Disclosure Statement
The information disclosure statements filed 12/13/2024 fail to comply with 37 CFR 1.98(a)(3)(i) because none of the referenced documents are in the English language. Therefore, the information disclosure statements have been placed in the file but have not been considered.
Specification
The specification is objected as failing to comply with 37 CFR § 1.71(a) because it fails to provide a definition for "MPLC” used in Figure 2 and paragraph 0084 of the specification. An abbreviation may be in common use, but if it is not defined within the specification, the term is unclear. Applicant is required to amend the specification to define the ”MPLC” upon its first usage or replace the abbreviation with the full term in, provided such amendment does not introduce new matter.
Claim Interpretation
Regarding claims 1-2, the recitation “extracting the cultured Damnacanthus major callus with hot water” refers to the use of hot water in direct contact with the Damnacanthus major callus as opposed to a hot water bath; see Specification paragraphs 0051 and 0073.
Regarding claims 1-2, the term “decompression-concentrating” refers to the removal of solvents or moisture from samples under reduced pressure where “[t]he decompression concentration step S126 can be performed using various known methods and devices” (specification paragraph 0052). .
Claim Objections
Claim 1 is objected to because of the following informalities:
Line 4 should recite “Murashige & Skoog” instead of “Murashige & Skog”
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.
Claims 1-2 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. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend. Details are listed below.
Claim 1 recites “a step of extracting the cultured Damnacanthus major callus with hot water and separating a Damnacanthus major callus extract.” It is unclear what “separating” means in this context. Separating could mean separating between two layers, separating liquid and solids, separating into two or three instances, separating the components of the Damnacanthus major callus extract. The specification recites “a step of separating a Damnacanthus major callus extract by immersing the Damnacanthus major callus obtained by the culturing method described above in an alcohol having a concentration of 60 to 80%” in paragraph 0017. “FIG. 2 schematically shows the separation of active ingredients” by MPLC (i.e., separating a Damnacanthus major callus extract into components)(paragraph 0025 and figure 2). Because “MPLC” is not defined in the specification, MPLC is being given the broadest reasonable interpretation of referring to Medium Pressure Liquid Chromatography (MPLC). The Specification also recites “[o]nly the filtrate was taken from the sample using a suction filter” after a hot water extraction step 9” the crushed product was immersed in distilled water at 90 °C and leached for 4 hours”) and before a “compression-concentration step” (i.e., separating a Damnacanthus major callus extract from the solid plant mater) (paragraph 0073). In the interest of compact prosecution “separating a Damnacanthus major callus extract” is being given the broadest reasonable interpretation of “separation of active ingredients”.
Claim 2 is further rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), because it recites “[T]he method of claim 1, wherein the pH of the culture medium is adjusted to 5.7 to 5.8.” It is unclear which culture medium is being adjusted; is it for the first culturing step or the second culturing step or both?
In the interest of compact prosecution, the claim is being given the broadest reasonable interpretation of referring to both the culture medium of the first culturing step and the second culturing step.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Publication No. KR-102105001-B1, titled “Method for mass production of whitening functional ingredients using Damnacanthus major cell,” Published 04/28/2020, Translation obtained from Global Dossier, Appears to be a translation of a reference cited in both IDS documents) in view of Derksen (Derksen, Goverdina C. H., and Wageningen Universiteit. Red, Redder, Madder : Analysis and Isolation of Anthraquinones from Madder Roots (Rubia Tinctorum) / Goverdina C.H. Derksen. s.n., 2001., Published 2001) and Kondo (Publication No. JPH07203955A, titled “METHOD FOR TISSUE CULTURE OF RUBIACEOUS PLANT”, Published 08/08/1995, Translation of the description obtained by WIPO Translate). Details are listed below.
Claim 1 is drawn to a method of cultivating callus of Damnacanthus major, a member of the Rubiaceae plant family, and extracting from the Damnacanthus major callus comprising:
a first culturing step on a culture medium comprising MS (Murashige & Skoog) salt, a mixture of α-naphthalene acetic acid and kinetin as plant growth regulators, and sucrose, and the modified wood callus cell line is cultured at a temperature of 24 to 26°C.
a second culturing step a second culturing step of sequentially treating the callus of Damnacanthus major with methyl jasmonate as an elicitor so that the concentration of the methyl jasmonate in the culture medium is maintained at 70 to 150 μM; and
a step of extracting the cultured Damnacanthus major callus with hot water and separating a Damnacanthus major callus extract; and
a step of decompression-concentrating and freeze-drying the separated callus extract,
wherein the Damnacanthus major callus extract comprises at least 1.8 mg/g of digiferruginol-11-O-β-primeveroside as an active ingredient.
Lee teaches a research project titled “Development of whitening functional cosmetics using callus derived from domestic plant genetic source” (page 4) and that “Damnacanthus major is an evergreen broadleaf shrub belonging to the rubiaceae [family], and it has been reported [to contain] anthraquinone and the like” (paragraph 0004). Lee also teaches “a photograph of fertilized wood cells induced and selected in a solid medium according to an embodiment of the present invention” wherein four calli are visible in the bottom-most image (paragraph 0070; see image below which is figure 2 of Lee). Cumulatively, this reads on a “method of cultivating… callus of Damnacanthus major.
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Lee teaches that the “cell culture…is carried out by (1) using 1×ms (murashige & [skoog]) medium containing 30 g/l of sucrose and 3 mg/l of naa (1-naphthylacetic acid)[i.e., MS (Murashige & Skoog) salt, a mixture of α-naphthaleneacetic acid and sucrose], (2) adjusting the ph of the medium to 5.8, (3) adjusting the inoculum amount of the cells to 20.0 g/l [i.e., inoculating the callus of Damnacanthus major to a culture medium] , (4) adjusting the air supply amount to 0.1 vvm, (5) culturing at a culturing temperature of 20±1° c., and (6) harvesting after 15 days of culturing, but is not limited thereto, and it is possible to allow some changes as long as the culture conditions can be changed by those skilled in the art within the scope of maintaining the same effect” (paragraph 0077).
Lee teaches that “[i]n order to simultaneously maximize the growth of cells and the accumulation of useful components, a two-stage culture was performed in a bioreactor. The cells were cultured in a bioreactor for 10 days to achieve a certain level of growth, and after 10 days, the cells were treated with eliciters (methyljasmonate, salicylic acid, and yeast extract) at various concentrations and further cultured for 5 days” (i.e., a second culturing step of sequentially treating the callus of Damnacanthus major with Methyl jasmonate as an elicitor)(paragraph 0094).
Lee further teaches that “the cells were treated with methyl jasmonate at concentrations of 50, 100, 200, 300, and 400 μM” (i.e., so that the concentration of the methyl jasmonate in the culture medium is maintained at 70 to 150 μM) (paragraph 0116; see table 4; note that the translation erroneously recites “μm” instead of “μM” found in the original patent publication document ).
Lee teaches that, regarding extraction, “60% alcohol (the ratio of alcohol to water:6:4)” is preferably used, and that “the extraction is preferably performed at 25° c. to 80° c. for 1 hour to 4 hours, but is not limited thereto” (i.e., extracting the cultured Damnacanthus major callus with hot water) (paragraph 0084, 0098).
Lee teaches that “rubiadin content was analyzed by hplc for the extract” and “chromatograms” (i.e., separating a Damnacanthus major callus extract) (paragraph 0098).
Lee teaches “vacuum drying, and lyophilization” (paragraph 0036) and “stored in a freeze-dried (freeze-dried) state” (paragraph 0035). The instant application reads “The decompression concentration
step Sl26 and the freeze-drying step Sl28 can be performed using various known methods and devices” (specification paragraph 0052). Thus, Lee’s teachings read on “decompression-concentrating and
freeze-drying the separated callus extract” limitation of claim 1.
Lee does not explicitly teach the use of kinetin as a plant growth regulator in the culture medium or culturing Damnacanthus major callus cells at a temperature of 24 to 26° C. However, Lee does teach that those skilled in the art can change the conditions of the culturing while maintaining the same effect (paragraph 0077).
Lee also does not explicitly teach water alone for extraction.
Although Lee does not explicitly teach that the extract comprises at least 1.8 mg/g of digiferruginol-11-O-β-primeveroside, Lee does teach using “methyl jasmonate…as an elicitor to increase the content of rubiadin, which is a…useful component” (paragraph 0079] with the preface that “in the culture method…,the useful component… may be anthraquinone, damnacanthal, damnacanthol, or damnidin, preferably anthraquinone, and more preferably rubiadin, but is not limited thereto” (i.e., the genus of anthraquinones which includes anthraquinone glycosides like digiferruginol-11-O-β-primeveroside)(paragraph 0076). Lee also teaches that “[w]hen extracted at 40° c., the rubiadin content was 2.9-fold higher on average than when extracted at 25° c.” (paragraph 112).
Regarding the use of hot water for extraction, Derksen recites the following on page 10 in the first paragraph: “[A]nthraquinone glycosides… should be extracted by using water, ethanol, methanol or water-ethanol mixtures. The extraction can be performed at different temperatures. During the extraction of anthraquinones from plant material with hot methanol or ethanol artefacts can be formed… This reaction is highly temperature-dependent. Thus for the extraction of anthraquinones the use of hot methanol or ethanol should be avoided.” Derksen teaches the use of water for extracting anthraquinone glycosides especially when using heat in order to prevent the formation of artifacts that would otherwise occur if using use of hot methanol or ethanol.
The combination of Lee’s teachings of methyl jasmonate treatment of Damnacanthus major calli and hot extractions with Derksen’s teachings of water for the extraction of anthraquinone glycosides and against hot alcohols for the extraction of anthraquinones would result in greater yield of anthraquinone glycosides including digiferruginol-11-O-β-primeveroside of the instant application, absent evidence to the contrary.
Kondo, in the analogous field of culture medium and cell culture of Rubiaceae plants teaches that “alpha-naphthalene acetic acid (hereinafter abbreviated as NAA),… and cytokinins such as N-furfural aminopurine (hereinafter abbreviated as kinetin), can be used as plant hormones” in culture medium (paragraph 0010). This reads on the “mixture of α-naphthaleneacetic acid and kinetin as a plant growth regulator” limitation of claim 1.
Kondo also teaches that “the culture [of the callus rubiaceous plants (i.e., Damnacanthus major callus)] is continued at a constant temperature of 20 to 30° C, preferably 24 to 26° C” (paragraph 0011). This reads on the “culturing Damnacanthus major callus cells at a temperature of 24 to 26° C” limitation of claim 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine and modify the α-naphthaleneacetic acid and kinetin plant hormones of Lee and Kondo, the methyl jasmonate treatment of Lee, and the hot water extraction of Lee and Derksen. Such a combination, intended to maximize anthraquinone yield, would have been a routine optimization with a reasonable expectation of success and would have yielded predictable results, specifically in enhancing production and extraction, that would be characterized as a difference in degree rather than a difference in kind.
Regarding claim 2, Lee teaches “adjusting the p[H] of the medium to 5.8” (paragraph 0077).
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YVETTE B TAMUKONG whose telephone number is (571)272-1040. The examiner can normally be reached M-Th 730-5 EST.
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/YVETTE BIH TAMUKONG/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
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