DETAILED 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 .
Election/Restrictions
Applicant's election with traverse of group II, claims 4-15 in the reply filed on 12/1/25 is acknowledged. The traversal is on the ground(s) that there is common subject matter between the groups. This is not found persuasive because Hong, Metwaly and KR 20090106303 teach the claimed steps. See the restriction requirement mailed 10/3/25 for detail.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 12/9/22 and 3/22/32 have been fully considered except where references have been lined through.
Claim Objections
Claim 15 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim 15 not been further treated on the merits.
Claim Rejections - 35 USC § 112
Claims 4-15 are rejected under 35 U.S.C. 112, first paragraph, as containing 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 invention appears to employ novel biological materials, Aspergillus niger KHNT-1. Since the biological materials are essential to the claimed invention they must be obtainable by a reproducible method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
From the specification it is not apparent if the biological materials are readily available to the public. It is noted that Applicant has deposited Aspergillus niger KHNT-1 strain under the Budapest treaty ([0016]), but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
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.
Claim 7, 10, and 12-14 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.
Regarding claim 7, the claim requires emission of far-infrared rays upon heating. The source of the far-infrared rays cannot be determined. The rays could be emitted by the pottery, the ginseng, the heating source, or possibly some external mechanism or sunlight among other possibilities. For examination purposes, the emission of the rays is considered an inherent property upon the heating of the ginseng.
Regarding claim 10, the claim requires a “medical LED”. This term is not defined and it is unclear what the differences between a medical LED and a regular LED would be. For examination purposes any LED source will be interpreted to meet the “medical” limitation.
Regarding claim 12-14, the claim requires the application of wavelengths of solar radiation excluding ultraviolet rays to the LED. It is unclear if the wavelengths are applied to the LED device itself or if the LED device is supposed to emit the wavelengths of solar radiation.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-6, 9, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over KR20090106303A (hereafter 303, of record), Metwaly (of record) and Hong (of record).
Regarding claim 4, 303 teaches a method of producing black ginseng (title). 303 teaches fresh ginseng is washed and dried (claim 1). 303 teaches the dried ginger is fermented with soil microbes (claim 1). 303 teaches that A. niger can be used (example 4).
303 do not explicitly teach the steaming and drying 9 times.
Metwaly teaches that traditional black ginseng is prepared by steaming and drying 9 times (“2. preparation”).
303 and Metwaly do not teach the claimed A. niger.
Hong teaches fungus associated with meju (abstract). As evidenced by instant specification [0086], the claimed Aspergillus niger KHNT-1 strain was isolated from meju. Hong teaches that A. niger can be isolated from the meju (abstract). As instant specification does not detail any modifications made to the claimed KHNT-1 strain, only that it was isolated from meju, Hong therefore teaches the claimed strain without the KHNT-1 nomenclature.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the preparation method of 303 by steaming 9 times as taught by Metwaly and use the A. niger of Hong. One of ordinary skill in the art would be motivated to do so because Metwaly teaches this is how black ginseng is traditionally prepared and this would be a simple substitution of known strains of A. niger. There would be a reasonable expectation of success as Metwaly, 303, and Hong are in the same field of endeavor of black ginseng and A. niger. Further, MPEP 2144.04 states that “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”
Regarding claim 5, Metwaly teaches that the drying can be 50oC (p3 second full paragraph).
Regarding claim 6, 303 teaches that the ginseng is immersed and fermented in the bacterial culture for 1-4 hours to ensure that the bacteria penetrate the ginseng (p8 “1. Immersion Process” section). This is close to the claimed ranges, and one of ordinary skill in the arts could easily allow the ginseng to ferment longer to ensure that the bacteria has penetrated the ginseng as taught by 303.
Regarding claim 9, 303 teaches that repeated fermentation can be conducted (example 4). MPEP 2144.04 states that “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”
Regarding claim 15, neither Metwaly, 303, or Hong teach that benzopyrene is part of the black ginseng and therefore, one of ordinary skill in the arts would understand this compound is not present in the black ginseng.
Claims 7, 8, and 11, are rejected under 35 U.S.C. 103 as being unpatentable over KR20090106303A (hereafter 303, of record), Metwaly (of record) and Hong (of record). as applied to claims 4-6, 9, and 15 above, and further in view of Song (WO2007133054A1).
Regarding claim 7, 303, Metwaly, and Hong do not explicitly teach the use of pottery
for steaming the ginseng.
Song teaches a novel production for shortening the time needed to create black ginseng and increasing ginseng saponin (abstract, applying heat to raise internal temperature and therefore the water contained in the ginseng). Song teaches that pottery is used to steam the ginseng ([74]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use pottery to steam the ginseng as taught by Song in the method of 303, Hong and Metwaly above. One of ordinary skill in the art would be motivated to do so because Song teaches their method is faster and increases saponin. Further, one of ordinary skill in the art would be motivated to do so because pottery has been successfully used to make black ginseng and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as 303, Metwaly and Song are in the same field of endeavor of black ginseng.
Regarding claim 8, Song teaches that steaming is performed at 60-120 degrees C for 3-9 hours (claim 1). This overlaps the claimed range and therefore the claimed range is obvious.
Regarding claim 11, Song teaches that the drying 50 to 700C for the period ranging from 9 to 15 hours (claim 5). This overlaps the claimed range and therefore the claimed range is obvious.
Claims 10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over KR20090106303A (hereafter 303, of record), Metwaly (of record), Song (WO2007133054A1). and Hong (of record) as applied to claims 7, 8, and 11, above, and further in view of Park ("Increase in the contents of ginsenosides in raw ginseng roots in response to exposure to 450 and 470 nm light from light-emitting diodes." Journal of Ginseng Research 36.2 (2012): 198). Claim 14 is further evidenced by Li ( Anti-obesity Effects of Fermented Ginseng Root and Berry in Mice Fed a High-Fat Diet. Diss., 2017).
Regarding claim 10, Metwaly, 303, and Hond do not teach the use of an LED light for drying. Metwaly teaches that ginseng can be sun dried (2. Preparation section).
Park studies the effects of lights on ginseng (title). Park teaches that different wavelengths of LED lights can increase the amount of ginsenosides found in the roots (abstract). Park teaches that LED lights can increase pharmacological components in ginseng and further research is needed (p203 left column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the sun drying step of Metwaly with the LED lights of Park. One of ordinary skill in the art would be motivated to do so because Park teaches this increases pharmacological components. There would be a reasonable expectation of success as both Metwaly and Park are in the same field of endeavor of ginseng.
Regarding claim 12, Park teaches that UV light can trigger stress responses in plants and the mechanism of action of LED lights should be further studied in regards to this (p201-202). Therefore, one of ordinary skill in the arts would be motivated to experiment with the exclusion and inclusion of UV rays.
Regarding claim 13, Park teaches that the wavelengths of dark-660 wavelengths all have different effects on the amount of ginsenosides produced (table 1). Therefore, this is a result effective variable and one of ordinary skill in the arts would be motivated to experiment with the wavelengths applied to the plant.
Regarding claim 14, Song teaches that Rg5, Rg3, and Rk1 among other compounds are produced ([10]). As evidenced by Li, the compounds found in ginseng are transformed into compound K naturally by A. niger (abstract).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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/TREVOR KANE/ Examiner, Art Unit 1657
/ROBERT J YAMASAKI/ Primary Examiner, Art Unit 1657