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
In a preliminary amendment filed on 07/14/2025, claims 20-22 are canceled. Claims 1-19 are pending and examined.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/15/2024 is acknowledged and has been considered.
Drawings
The drawings are objected to because “FIGURE” should be replaced with “FIG.”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 recites “pH in the range of from about” in lines 2 and 4. The phrase is convoluted. Applicant may consider amending the claim to recite “pH ranging from about”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-19 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.
Claim 1 recites in lines 6 and 9 “incubating the culture broth”. The claim is indefinite because it is not clear if the culture broth that is incubated comprises the fresh growth medium. It is not clear if the new mixture, which comprises culture broth and fresh growth medium, is incubated for a second and third periods of time, or if only the culture broth that is transferred is incubated.
Claim 2 recites “the culture broth of the first culture stage to incubation”. The claim is indefinite because it is not clear which broth the claim requires. Applicant may consider amending the claim to recite “wherein the growth medium of the first culture stage has a pH ranging from about 2.8 to about 3.7 prior to inoculation and incubation, and a pH ranging from about 5 to about 5.5 after inoculation and incubation for a first period of time” in order to obviate the rejection.
Claims 4, 8 and 12 recite the limitations "the first time period " in line 1”, "the second time period " in line 1, and "the third time period" in line 1, respectively. There is insufficient antecedent basis for these limitation in the claims. Applicant may consider amending the claims to recite “the first period of time”, “the second period of time”, and “the third period of time”, respectively, to obviate the rejection.
Claims 3, 5-7, 9-11, and 13-19, which depend from claim 1, do not cure the indefiniteness, and are also rejected.
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.
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 and 3-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wan (Journal of Industrial Microbiology and Biotechnology 32.6 (2005): 227-233)
Regarding claims 1, 3, 5, and 14-15, Wan teaches multi-stage cultivation of Aspergillus oryzae to produce kojic acid using fed-batch culture or repeated-batch culture methods (title, Abstract, Materials and Methods). Wan teaches first stage comprises inoculating spores of A. oryzae into a growth medium and incubating at 30oC for 8 days in an Erlenmeyer flask (i.e., aerobically) (page 228 para. “Shake-flask cultures”). Wan teaches this culture is then used to inoculate a second culture which is incubated for 6 days at 30oC (i.e., second stage culture comprising transferring the culture broth obtained from the first culture stage to a volume of fresh growth medium and incubating the culture broth for a second period of time) (Fig. 6, pages 231-232 para. “Repeated-batch culture in shake-flasks and modified stirred-tank fermenter”). Wan teaches that following 6 days, a part of the growth medium in the second culture was replaced with fresh medium and incubated for at least 2 days (repeated batch culture method), or a fresh medium was added to the second culture (fed-batch culture) (i.e., a third culture stage comprising the culture broth from the second culture stage to a volume of fresh growth medium and incubating the culture broth for a third period of time) (Fig. 5-7, pages 231-232 para. “Repeated-batch culture in shake-flasks and modified stirred-tank fermenter”). Wan teaches that the fresh medium is added to the culture broth. Wan does not teach transferring the culture broth to the fresh medium.
However, MPEP 2144.04 IV(C) states that selection of any order of mixing ingredients is prima facie obvious. It is obvious for one of ordinary skill in the art to change the sequence of adding ingredients, and to add the culture broth of the second cultivation stage to the fresh medium. There is no indication that adding fresh medium to the culture broth or transferring the culture broth to the fresh medium would result in a different outcome. Both orders would result in a culture broth mixed with fresh medium.
Regarding claim 4, Wan teaches the duration of the first incubation is 8 days (para. Shake-flask cultures). One of ordinary skill in the art would be motivated to optimize the first period of time in order to ensure the germination and formation of mycelium depending on the incubation temperature, agitation speed, and size of initial inoculum.
Regarding claims 6-7 and 10-11, Wan teaches that the second and third cultures have a pH ranging from about 4 to about 5.5 (Fig 7A), and that they are grown at a temperature of 30oC (Figs 5-6, para “Repeated-batch culture in shake-flasks and modified stirred-tank fermenter”).
Regarding claims 8 and 12, Wan teaches growing the second and third stage cultures for 2 days before adding fresh medium (Fig 7A, page 232 left column second para.).
Regarding claims 9 and 13, Wan teaches that the fed-batch and the repeated-batch culture methods comprise 300 rpm agitation and 1 vvm aeration (i.e., aerobic) (Fig. 5 and 7 legends).
Regarding claims 16-17, Wan teaches growing A. oryzae in carbon and nitrogen sources including sugars and inorganic nitrogen (NH4)2SO4 (Abstract, Fig. 1, Fig. 3).
Regarding claim 18-19, Wan teaches collecting the medium to test for kojic acid production and teaches that the culture samples were filtered on a pre-weighed filter paper (para “Analytical methods”, Fig. 7).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wan as applied to claim 1 above, and further in view of Daba (Bioresources and Bioprocessing 8.1 (2021): 52).
Regarding claim 2, Wan teaches that the pH of the medium of the second and third cultures is between 4 and 5 (Fig. 7A). Wan does not teach the pH of the growth medium of the first culture is from about 2.8 to about 3.7.
However, Daba teaches A. oryzae spores can germinate at pH 2 to 8 and that the microorganism has an optimal growth in pH ranging between 5 and 6 (page 2 right column first para.).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the pH of the germination medium and of the growth medium, as suggested by Daba. One of ordinary skill in the art would be motivated to do so to ensure the germination of the spores and the subsequent growth of the cells. Since Wan teaches a desire to germinate the spores of A. oryzae and grow the cells for production of kojic acid, there is a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/ Examiner, Art Unit 1657
/THANE UNDERDAHL/ Primary Examiner, Art Unit 1699
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