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 .
Priority
This application claims benefit of priority to Republic of Korea Patent Application No. KR10-2019-0129324 filed on 10/17/2019. This application is also a 371 of PCT/KR2020/012364 filed on 10/17/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, a translation of the certified copy of the Korean patent document was not provided. As such, the priority date of the instant application is the PCT date, 10/17/2019.
Information Disclosure Statement
The Information Disclosure Statement filed 03/16/2026 has been acknowledged and considered.
Amendments and Claim Status
In the reply filed 05/13/2026, Applicant amended claims 1-2, 10 and 17, canceled claim 9 and added new claim 19. Claims 5-7 were previously canceled by Applicant.
Claims 1-4, 8 and 10-19 are currently pending and under examination.
Examiner’s Suggestions
Claim 1 recites “culturing a microorganism that produces 5’-inosinic acid to obtain a microorganism culture broth” in lines 3-4 and goes on to recite “concentrating a microorganism culture broth to a primary concentration” in line 5. It appears a microorganism culture broth in line 5 is the same as in lines 3-4 and thus the examiner suggests amending to ‘concentrating the microorganism culture broth.’ This appears to be a typographical error and thus the claim is not rejected under 112b.
Claim 17 recites the limitation “removing cell bodies from the microorganism culture before concentrating the culture broth to the primary concentration” in lines 2-3. As stated above, the Examiner suggests amending all instances of ‘culture broth’ and ‘microorganism culture’ to be consistent with the first recitation in claim 1, being ‘microorganism culture broth.’
Claim 18 recites the limitation “adding NaOH to the culture broth after the removing of the cell bodies and before the concentrating of the culture broth” in lines 2-3. As stated above, the Examiner suggests amending all instances of ‘culture broth’ and ‘microorganism culture’ to be consistent with the first recitation in claim 1, being ‘microorganism culture broth.’
Maintained Rejections (with modification as necessitated by amendment)
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 1-4, 8 and 10-19 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 the limitation “5’-inosinic acid in the culture broth” in line 6, “concentrated culture broth” in line 7 and “pH-adjusted culture broth” in lines 8 and 9. It is unclear if the ‘culture broth’ being concentrated and pH adjusted is the ‘microorganism culture broth’ as recited in lines 3 and 4 of the claim or a different broth is produced after the microorganism culture broth is concentrated. It appears ‘the culture broth’ is referring to the ‘microorganism culture broth.’ However, terminology should be confluent throughout the claims. Moreover the dependent claims appears to remove the cell bodies from the microorganism culture broth and refer to the broth as ‘culture broth” so it is unclear if ‘microorganism culture broth’ and ‘culture broth’ are intended to be two different broths in claim 1, i.e. a broth with microorganism and a broth without the microorganism cell bodies). If applicant is intending to claim the same broth in all the steps, the Examiner suggests amending all instances of ‘culture broth’ and ‘microorganism culture’ to be consistent with the first recitation in claim 1, being ‘microorganism culture broth.’
Claim 17 recites the limitation “removing cell bodies from the microorganism culture before concentrating the culture broth to the primary concentration” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 1, the claim from which claim 17 depends, has been amended to recite “concentrating a microorganism culture broth to a primary concentration until a concentration of the 5’-inosinic acid in the culture broth …” in lines 5-6. The recitation of ‘culture broth’ first occurs in line 5 of claim 1, after the concentrating occurs. Thus, the limitation lacks proper antecedent basis because the limitation of claim 17 refers to the ‘culture broth’ preceding the concentrating step, however, claim 1 does not recite ‘culture broth’ until after the concentrating has already occurred.
Claim 18 recites the limitation “adding NaOH to the culture broth after the removing of the cell bodies and before the concentrating of the culture broth” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim for the same reasons stated above in regard to claim 17, being the recitation of ‘culture broth’ prior to the concentrating step while ‘culture broth’ is not recited in claim 1 until after the concentrating step. Thus, claim 18 lacks proper antecedent basis.
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.
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 1-4, 8, 10-15, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (CN 101918576 A, 12/15/2010) (IDS Reference of 06/22/2023) (New translation provided).
Regarding claims 1 and 17, Hong et al. disclose a method of preparing disodium 5’-inosinate from 5’-inosinic acid via a method that uses only a small amount of organic solvent (See entire document, Abstract). Using a large amount of hydrophilic organic solvent causes impurities to be extracted which results in reduced inosinic acid content, negatively affecting the crystallization process (Page 2, Sentence 8). Therefore, Hong et al. experimented on how to increase the yield and purity of crystals while also minimizing the amount of organic solvent used.
Regarding their specific method, Hong et al. disclose:
A method for preparing 5'-disodium inosinate, wherein the method comprises: The first step is to separate and remove fungal cells from the fermentation broth of the inosinic acid-producing strain; In the second step, concentrating the fermented liquid; In the third step, the pH value of the concentrated fermented liquid is adjusted to 6-10; The fourth step is to heat the fermented liquid after adjusting the pH so that the pre-crystallized 5'-disodium inosinate is completely dissolved; Step 5, cooling the fermentation broth containing dissolved disodium 5'-inosinate crystals; and In the sixth step, a hydrophilic organic solvent is added to the cooled fermented liquid to crystallize disodium 5'-inosinate (Claim 1 of Hong et al.).
Hong et al. further disclose the second step of condensing stops when the concentration of inosinic acid is 200-300 g/L (Claim 2 of Hong et al.). This condensing step occurs before the pH is adjusted and reads on the second part of instant claim 1 which states “concentrating a culture broth to a first concentration of the 5’-inosine acid in the culture broth is from 150 g/L to 360 g/L, and the adjusting the pH of the concentrated culture broth to be from 7.4 to 8.0.”
Regarding the limitation of concentrating the pH-adjusted culture broth to a concentration of 5’-inosinic acid from 400 g/L to 550 g/L to provide a slurry containing disodium 5’-inosinate crystals, it is noted the instant Specification states:
The concentrating of the pH-adjusted culture broth may be to reduce the amount
of moisture in the culture broth. The concentrating may be to evaporate moisture by applying heat to the culture broth. The concentrating may be performed on the culture broth at a temperature of 50 °C or more, 60 °C or more, 70 °C or more, 80 °C or more, 90 °C or more, 50 °C to 90 °C, 50 °C to 80 °C, 50 °C to 70 °C, 50°C to 60 °C, 60 °C to 90 °C, 60 °C to 80 °C, 60 °C to 70 °C, or 60 °C to 65 °C. The concentrating may be to perform concentration under reduced pressure. The concentrating may be performed until disodium 5'-inosinate crystals are formed by increasing the concentration of 5'-inosinic acid in the culture broth (Specification, Paragraph [17]).
Hong et al. disclose the heating in the fourth step, after the pH has been adjusted, is carried out at 55-77°C (Claim 3 of Hong et al.). Thus, though Hong et al. do not explicitly state the fourth step is a ‘concentrating’ step, it appears, absent evidence to the contrary, that the fourth step of warming the pH adjusted fermentation broth step of Hong et al. would necessarily concentrate the fermentation broth because the liquid is being heated which would result in a reduction of moisture in the broth, meaning the broth is more concentrated, as evidenced by the citation from the instant Specification discussed immediately above. Hong et al. further state the cooling of the fifth step is carried out at a rate of 5-10°C an hour and cooled to 20-30°C (Claim 4 of Hong et al.). Then, in step 6, once the fermented liquid is at a temperature of 20°C, the organic solvent is added (Claim 5 of Hong et al.). This indicates organic solvent is not added until after the warming step, wherein the warming step is the second concentrating step as discussed above. Therefore, Hong et al. disclose concentrating the pH adjusted culture broth in the absence of an organic solvent. Additionally, the 5th step of cooling, occurring after the warming step, where the fermentation broth is slowly cooled reads on a providing a slurry containing disodium 5’-inosinate crystals because as the fermentation broth begins to cool, the crystals naturally begin to precipitate, as evidenced by Hong et al. warming the fermentation broth to thoroughly dissolve the pre-crystallized 5'-disodium inosinate in step 4. Then, in step 6, the organic solvent is added, reading on washing the 5'-disodium inosinate by contacting the crystals with a hydrophilic organic solvent.
Hong et al. do not disclose a concentration of 5’-inosinic acid in the pH adjusted culture broth of 400 g/L to 550 g/L.
However, Hong et al. do disclose the precipitation of crystals was based on the supersaturation of inosinic acid in the culture concentrate (Page 3, Embodiment 1, Sentence 3). Thus, supersaturation, being when a solute concentration exceeds its solubility in a given solution, drives the precipitation of crystals. Hong et al. disclose in order to establish the optimal crystallization conditions of disodium 5’-inosinate, the solubility of disodium 5’-inosinate was determined by temperature and organic solvent (Page 3, Embodiment 1, Sentence 1). Figure 1 of Hong et al. is a graph showing the solubility of inosinic acid in concentrated fermented broth based on % of methanol added and Figure 2 of Hong et al. is a graph showing a supersaturation curve of crystals based on the added organic solvent methanol (Page 3, Description of Drawings, Sentences 1-2). Figure 2 of Hong et al. shows supersaturation is reached at a higher concentration (g/L) of inosinic acid when there is 0 methanol present in the concentrated fermented broth. Similarly, Figure 1 of Hong et al. shows the solubility of inosinic acid is higher when 0 methanol is present in the concentrated fermented broth.
“Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05(II)(A). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the optimal concentrations of inosinic acid because inosinic acid is an art-recognized result-effective variable wherein the concentration of inosinic acid in a fermentation broth must be high when no organic solvent is present to promote natural crystallization as disclosed by the prior art above. Therefore, the concentration of inosinic acid would have been routinely and predictably optimized to promote the formation of the desired product, disodium 5’-inosinate crystals. Although the prior art does not disclose the specific concentration of 5’-inosinic acid claimed, it would have been conventional and within the skill level of an ordinary artisan to modify the concentration of 5’-inosinic acid in a fermentation broth, via further concentrating, motivated by the desire to reach supersaturation so disodium 5’-inosinate crystals would precipitate.
Regarding claims 2 and 3, Hong et al. disclose the microbial fermented liquid of the invention is cultivated by inoculating inosinic acid producing strains wherein the bacterial strains used for cultivation can be any bacterial strain capable of producing inosinic acid, preferably Corynebacterium sp. (Page 2, Sentence 13). Coryneform bacteria are preferably cultured for production of about 5% - 10% inosinic acid in the fermentation broth (Page 2, Sentence 13). 5% - 10% inosinic acid falls within the claimed range.
Regarding claim 4, Hong et al. disclose the filtered fermented liquid was concentrated by drying under reduced pressure at a vacuum degree of 680 mmHg and a container temperature of 55°C so that the concentration of inosinic acid became 230-260 g/L (Page 3, Step 2: Concentration of the filtered broth).
Hong et al. do not disclose the concentrating of the pH-adjusted culture broth is performed under reduced pressure.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed the concentrating of the pH-adjusted culture broth under reduced pressure as Hong et al. do disclose the first concentrating step being performed under reduced pressure. Thus, it would have been obvious to one of ordinary skill in the art to perform the second concentration step, the warming step, under reduced pressure as well motivated by the desire to effectively concentrate the fermentation broth to the desired concentration of inosinic acid.
Regarding claim 8, Hong et al. disclose the filtered fermented liquid was concentrated by drying under reduced pressure at a vacuum degree of 680 mmHg and a container temperature of 55°C so that the concentration of inosinic acid became 230-260 g/L (Page 3, Step 2: Concentration of the filtered broth).
Regarding claim 10, Hong et al. disclose wherein the 5th step of cooling wherein the fermentation broth is cooled to the temperature of 20-30°C (Claim 4 of Hong et al.). The fermentation broth being cooled to the temperature of 20-30°C spans the entirety of the claimed range of 25°C to 30°C.
Regarding claims 11 and 12, Hong et al. disclose wherein the lower alcohol is methanol (Claim 8 of Hong et al.).
Regarding claim 13, Hong et al. disclose methanol, ethanol, propanol and isopropanol are all organic solvents which can be used in the invention (Page 3, Step 5: Addition of organic solvent).
Regarding claim 14, Hong et al. disclose wherein the concentration of the methanol is 70-95% (v/v) (Claim 9 of Hong et al.).
Regarding claim 15, Hong et al. disclose the sixth step is carried out by adding a hydrophilic organic solvent when the concentrated fermentation broth is at 20ׄ°C wherein the hydrophilic organic solvent is added in an amount of 30-60 (v/v)% of the total amount of the fermentation broth (Page 2, Sentence 10 under ‘Contents of the Invention’).
Regarding newly added claim 19, Hong et al. disclose the sixth step is carried out by adding a hydrophilic organic solvent when the concentrated fermentation broth is at 20ׄ°C wherein the hydrophilic organic solvent is added in an amount of 30-60 (v/v)% of the total amount of the fermentation broth (Page 2, Sentence 10 under ‘Contents of the Invention’).
Claims 1-4, 8 and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (CN 101918576 A, 12/15/2010) (IDS Reference of 06/22/2023) (New translation provided) and further in view of Han et al. (CN 101109017 A, 01/23/2008) (IDS Reference of 01/24/2023).
The teachings of Hong et al. are disclosed above.
Regarding claim 16, Hong et al. disclose the product created from the method of preparing disodium 5’-inosinate contains colored substances, sugars, amino acids, organic acids and inorganic that must be removed through purification in order to obtain a product with a quality that can be used as a food additive (Page 2, Sentence 4).
Hong et al. do not disclose contacting the washed crystals with activated carbon in an aqueous solvent to remove a coloring material.
However, Han et al. disclose a method of making 5’-disodium inosinate via microbial fermentation (See entire document, Abstract). Han et al. further disclose utilizing active carbon in a decoloring step (Page 2, Last Paragraph).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized activated carbon in the method of Hong et al. motivated by the desire to remove colored substances and purify the product because activated carbon is a known and effective decoloring agent as taught by Han et al. as this amounts to utilizing a known technique to improve similar products in the same way. Exemplary rationales that may support a conclusion of obviousness include use of a known technique to improve similar products in the same way. See MPEP 2143(I)(C).
Claims 1-4, 8, 10-15 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (CN 101918576 A, 12/15/2010) (IDS Reference of 06/22/2023) (New translation provided) and further in view of Fujinawa et al. (US 4958017 A, 09/18/1990) (IDS Reference of 06/22/2023).
The teachings of Hong et al. are discussed above.
Regarding claim 18, Hong et al. do not disclose adding NaOH to the culture broth after removing the cell bodies and before concentrating the culture broth. It is noted the step being referred to is adjusting the pH.
However, Fujinawa et al. disclose a method for purifying inosine (See entire document, Title). Fujinawa et al. further disclose a mixture containing inosine and guanosine as a starting material, where the mixture is suspended in water at a specific pH range (Column 3, Lines 44-51). For adjusting the pH, an appropriate alkali can be used, preferably sodium hydroxide (Column 3, Lines 55-56).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used NaOH (sodium hydroxide) as a pH adjusting agent in the method of Hong et al. since the method does not require a specific pH adjusting agent and NaOH is a known and effective pH adjusting agent as taught by Fujinawa et al.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive.
Applicant argued Hong does not teach the step of “washing the disodium 5’-inosinate crystals by contacting the crystals with a hydrophilic organic solvent” which is an essential element of the present invention (Top of Page 7).
The Examiner respectfully disagrees. It is the Examiner’s position that Hong does teach washing the disodium 5’-inosinate crystals by contacting the crystals with a hydrophilic organic solvent as discussed above on Page 7. To reiterate, the 5th step of cooling, occurring after the warming step, where the fermentation broth is slowly cooled reads on a providing a slurry containing disodium 5’-inosinate crystals because as the fermentation broth begins to cool, the crystals naturally begin to precipitate, reading on the crystals separating from the slurry, as evidenced by Hong et al. warming the fermentation broth to thoroughly dissolve the pre-crystallized 5'-disodium inosinate in step 4. Then, in step 6, the hydrophilic organic solvent is added, reading on washing the 5'-disodium inosinate by contacting the crystals with a hydrophilic organic solvent. Thus, as this is the only step where Hong et al. disclose the use of a hydrophilic organic solvent, the disclosure of Hong et al. reads on the hydrophilic organic solvent only being used in the washing step. Additionally, it is noted that Hong et al. do not have to explicitly state the use of the hydrophilic organic solvent is for ‘washing the disodium 5’-inosinate crystals,’ rather, Hong et al. must only disclose the actual step, being, contacting the crystals with a hydrophilic organic solvent.
Applicant further argued the method of instant claim 1 provides an unexpected superior result with a higher purity and transmittance than not washing or washing with water provides. Applicant goes on to state Hong corresponds to control 1 of the instant invention which does not include a washing process (Top of Page 8).
The Examiner respectfully disagrees. As stated immediately above, it is the Examiner’s position that Hong et al. do disclose washing the crystals with a hydrophilic organic solvent. Thus, control 1 as pointed to by Applicant would not be consistent with the process disclosed by Hong et al. Additionally, it is the Examiner’s position that unexpected results are not shown. When looking at table 1, the experimental group, which represents the method of the instant claims, only shows about a 1% increase in purity and a 14% increase in transmittance when compared to control 2. This does not show unexpected superior results. It is noted unexpected results should be compared to the closest prior art.
Conclusion
Claims 1-4, 8 and 10-19 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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