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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/27/2026 has been entered.
1. Claim 6 remains pending and is under consideration
Priority
2. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP 2018-209884, filed on 11/7/2018 and parent Application No. JP 2018-166842 filed on 9/6/2018.
3. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign applications must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Withdrawn Claim Objections/Rejections
4. The objection of claim 1 is rendered moot in view of Applicant’s cancellation of the claim.
5. The rejection of claims 1, 7, and 9 under 35 U.S.C. 112(b) is rendered moot by Applicant’s cancellation of the claim.
6. The rejection of claim 1 under 35 U.S.C. 103 is rendered moot in view of Applicant’s cancellation of the claim.
7. The rejection of claim 6 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to the claim requiring “preparing an adsorption module”.
8. The rejection of claim 7 under 35 U.S.C. 103 is rendered moot in view of Applicant’s cancellation of the claim.
9. The rejection of claim 9 under 35 U.S.C. 103 is rendered moot in view of Applicant’s cancellation of the claim.
Claim Interpretation
10. For the purpose of applying prior art, recitation of “when the lactic acid adsorbent comprises…” in lines 15 – 18 is interpreted as conditional limitations which are not required when the lactic acid adsorbent does not comprise the layered double hydroxide or does not comprise the layered double oxide.
11. For the purpose of applying prior art, “bringing the culture solution comprising cells, lactic acid, and glucose” is interpreted as bringing the culture solution comprising lactic acid and glucose because Applicant’s specification teaches the cells do not contact the lactic acid adsorbent (page 16, lines 10 – 14).
Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
12. Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. 37 CFR 1.118 (a) states that “No amendment shall introduce new matter into the disclosure of an application after the filing date of the application”.
Claim 6 is drawn to a method for removing lactic acid, comprising: preparing an adsorption module comprising: a container packed with a lactic acid adsorbent, and having an inlet and an outlet;
a circulation path connecting the container to a culture vessel, comprising an outward path connecting the culture vessel and the inlet of the container, and a return path connecting the outlet of the container and the culture vessel, wherein the culture vessel contains a culture solution of cells comprising lactic acid and glucose; and a pump disposed in the outward path or the return path; and
bringing the culture solution comprising cells, lactic acid and glucose to the lactic acid adsorbent by operating the pump, wherein the lactic acid adsorbent consists of at least one substance selected from the group consisting of layered double hydroxide and layered double oxide, wherein an amount of addition of the lactic acid adsorbent in the container is equal to or more than 0.025 g/mL and less than 0.2 g/mL, wherein when the lactic acid adsorbent comprises the layered double hydroxide, the lactic
acid adsorbent adsorbs 3.6% - 23% glucose, and wherein when the lactic acid adsorbent comprises the layered double oxide, the lactic acid adsorbent adsorbs 9% - 26% glucose.
The specification provides no implicit or explicit support for the context of “bringing the culture solution comprising cells, lactic acid, and glucose to the lactic acid adsorbent by operating the pump”. The specification provides support for bringing the culture solution comprising lactic acid and glucose to the lactic acid adsorbent by operating the pump but does not provide support for bringing the cells as Applicant’s specification teaches a filter is provided such that the cells are suppressed from flowing towards the adsorption module (page 16, lines 10 – 14). Applicants are reminded that it is their burden to show where the specification supports any amendments to the claims. See 37 CFR 1.121 (b)(2)(iii), the MPEP 714.02, 3rd paragraph, last sentence and also the MPEP 2163.07, last sentence.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure [or point to case law supporting incorporation of such a limitation as in the instant case]” (emphasis added).
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.
13. Claims 6 is 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.
14. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “when the lactic acid adsorbent comprises…”, and the claim also recites “wherein the lactic acid adsorbent consists of…” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
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.
15. Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsao (US5786185A; Filed 06/07/1995; Published 07/28/1998), hereinafter Tsao in view of Lalikoğlu (Lalikoğlu, M. et. al. Journal of Chemical & Engineering Data 2015 60 (11), 3159-3165; previously cited), hereinafter Lalikoğlu which is cited on the IDS filed 05/25/2022 in view of Onda (Onda, Ayumu, et al. Catalysis Communications 9.6 (2008): 1050-1053; previously cited), hereinafter Onda which is cited on the IDS filed 05/24/2024.
Regarding “preparing an adsorption module”, Tsao teaches preparation of a lactic acid adsorbent container (resin columns in Figure 1 and 5) having an inlet and an outlet, a circulation path connecting the container to a culture vessel (fermentor in Figure 1; 3 in Figure 5) and the inlet of the container, and a return path connecting the outlet of the container and the culture vessel and a pump (recycle pump in Figure 1) in the outward and return path (Figure 1; col. 6, lines 1 – 21; col. 8, lines 64 – 67; col. 9, lines 1 – 12). Tsao teaches the culture vessel contains a culture of either Lactobacillus delbrueckii NRRL-B-445, glucose, and lactic acid (col. 6, lines 25 – 67; col. 7, lines 1 – 18) or Rhizopus oryzae, glucose and lactic acid (col. 8, lines 55 – 62; col. 9, lines 14 – 61).
Regarding “bringing the culture solution comprising cells, lactic acid and glucose to the lactic acid adsorbent by operating the pump”, Tsao teaches the pump circulates the fermentation broth from the fermentor to the resin columns containing the lactic acid adsorbent (col. 6, lines 1 – 20 and lines 61 – 67; col. 7, lines 1 – 18; col. 9, lines 33 – 61).
Regarding “more than 0.025 g/mL and less than 0.2 g/mL” of lactic acid adsorbent in the container, Tsao teaches 65 grams of adsorbent was packed in the column and the working volume in the fermentor was 1.1 L (col. 6, lines 16 – 18 and 45). Therefore, Tsao teaches 65 g/1100 mL or 0.059 mg/mL lactic acid adsorbent in each container.
Regarding “adsorbs 3.6% - 23% glucose” and “adsorbs 9% - 26% glucose”, Tsao teaches the amount of glucose decreased by 17% after 5.25 hours in Table 1 and Figure 3.
Tsao does not teach the lactic acid adsorbent is a layered double hydroxide or a layered double oxide but teaches the adsorbent is an anion exchange resin (col. 4, line 53; col. 6, line 18; col. col. 8, line 66). Tsao teaches lactic acid has long been used in the food industry, in the preparation of pharmaceuticals, cosmetics, agrichemicals, and for producing biodegradable plastics (col. 1, lines 18 – 25). Tsao teaches lactic acid is produced by synthetic and fermentation processes and in fermentation, the growth and lactic acid-producing capacity of lactic-acid producing microorganisms are inhibited by lactic acid itself and by low pH (col. 1, lines 28 – 40). Tsao teaches lactate has proven difficult to effectively extract with no solvent or adsorbent having yet been found which avoids significant harm to lactic acid bacteria (col. 1, lines 55 – 59). Tsao teaches there exists a continued need for a more effective and competitive microbial route to lactic acid and such a microbial route would achieve high productivity and facilitate recovery of the final lactic acid product (col. 2, lines 1 – 5).
Regarding “layered double hydroxide”, Lalikoğlu teaches a method for removing lactic acid from a solution of lactic acid using a layered double hydroxide (LDH) adsorbent where 0.05 – 1 g of LDH was added to 5 mL of lactic acid solution (0.20 g/5 mL = 0.04 g/mL) (page 3160, left col. last para.; page 3161, left col. paragraph 5; Table 2). Lalikoğlu teaches increasing concentrations of LDH increase the amount of lactic acid adsorbed where 1 gram of LDH removes 66.49% of lactic acid (Abstract; page 3161, left col. last para; and right col. para. 1). Lalikoğlu teaches nanoclays have attracted attention for their inexpensive costs, large surface area, high sorption capacities, reusability, and easy recovery (page 3161, left col. para. 1). Lalikoğlu teaches researchers have drawn their attention to fermentation to produce carboxylic acid from renewable resources (page 3159, left col. para. 1). Lalikoğlu teaches some of the important carboxylic acids that are produced by fermentation technology include lactic acid because it is widely used in food, beverages, cosmetic, pharmaceutical, leather, and textile industries (page 3159, left col. para. 1). Lalikoğlu teaches polylactic acid is used in drug release systems, in the production of certain medical devices, and for designing scaffolds in tissue engineering is synthesized from lactic acid (page 3159, left col. para. 2). Lalikoğlu teaches LDH is also called anionic clays that intercalate anionic biomolecules through anion exchange (page 3159, right col. para. 2). Lalikoğlu teaches lactic acid adsorption onto LDH is spontaneous and LDH is a suitable adsorbent for the removal of lactic acid from aqueous solutions (page 3164, left col. paragraph 4). One would have been motivated to combine the teachings of Tsao and Lalikoğlu because both teach the adsorption of lactic acid from solutions using lactic acid adsorbents that are anion exchangers.
Onda teaches the layered double hydroxide (LDH) hydrotalcite contains Bronsted-base sites that can convert glucose to lactic acid (page 1050, right col. para. 2; Scheme 1; page 1052, left col. last para.). Onda teaches synthesis of the layered double oxide (LDO) version of hydrotalcite and this version (HT723rehydr) contained the highest percentage of Bronsted-base sites (page 1051, left col. para. 1; page 1052, left col. para. 1; page 1052, left col. last para.). Onda teaches the LDH/LDO could produce lactic acid from adsorbed glucose (Table 2; page 1053, left col. para. 1). Thus, Onda teaches LDH/LDO can adsorb 10% glucose to produce ~20% lactic acid because Onda teaches heating increases the Bronsted-base sites with hydrotalcites (Table 1; page 1052, left col. para. 3; page 1053, left col. para. 1) and because Onda teaches one glucose molecule can be converted into two lactic acid molecules (page 1053, right col. para. 3). Onda teaches hydrotalcites can be used as a base catalyst for the production of lactic acid from glucose in aqueous solution (page 1053, right col. para. 1). Onda teaches lactic acid is a commodity chemical used in the food and pharmaceutical industries and in the manufacture of polylactic acid, but the supply of lactic acid is not enough (page 1050, left col. para. 1).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of Tsao regarding a method of removing lactic acid from a bacterial or fungal culture comprising glucose and lactic acid by circulating (by a pump) the culture through a column containing an anion exchange resin that adsorbs lactic acid with the teachings of Lalikoğlu regarding a method for removing lactic acid from a solution of lactic acid using a layered double hydroxide with the teachings of Onda regarding a layered double hydroxide that can be configured to adsorb glucose and convert it to lactic acid to arrive at the method for removing lactic acid, comprising: preparing an adsorption module comprising: a container packed with a lactic acid adsorbent, and having an inlet and an outlet; a circulation path connecting the container to a culture vessel, comprising an outward path connecting the culture vessel and the inlet of the container, and a return path connecting the outlet of the container and the culture vessel, wherein the culture vessel contains a culture solution of cells comprising lactic acid and glucose; and a pump disposed in the outward path or the return path; and bringing the culture solution comprising cells, lactic acid and glucose to the lactic acid adsorbent by operating the pump, wherein the lactic acid adsorbent consists of at least one substance selected from the group consisting of layered double hydroxide and layered double oxide, wherein an amount of addition of the lactic acid adsorbent in the container is equal to or more than 0.025 g/mL and less than 0.2 g/mL, wherein when the lactic acid adsorbent comprises the layered double hydroxide, the lactic acid adsorbent adsorbs 3.6% - 23% glucose, and wherein when the lactic acid adsorbent comprises the layered double oxide, the lactic acid adsorbent adsorbs 9% - 26% glucose. One would have been motivated to combine the teachings of Tsao, Lalikoğlu, and Onda in a method of removing lactic acid from microorganism cultures to provide large quantities of lactic acid for industrial uses as Tsao teaches there exists a continued need for a more effective and competitive microbial route to lactic acid and such a microbial route would achieve high productivity and facilitate recovery of the final lactic acid product and Lalikoğlu teaches nanoclays have attracted attention for their inexpensive costs, large surface area, high sorption capacities, reusability, and easy recovery, and Onda teaches lactic acid is a commodity chemical used in the food and pharmaceutical industries and in the manufacture of polylactic acid, but the supply of lactic acid is not enough and Onda teaches LDH can adsorb glucose and convert it to lactic acid. One would have a reasonable expectation of success in combining the teachings as Tsao teaches the lactic acid adsorbent is an anion exchange resin and Lalikoğlu teaches LDH adsorbs molecules through anion exchange and Onda teaches LDH and LDO can adsorb glucose and convert it to lactic acid.
Applicant’s Arguments/ Response to Arguments
16. Applicant Argues: Applicant argues that Jinescu is silent regarding an external adsorption module recited in amended claim 6 in the remarks filed 03/27/2026. No Applicant arguments have been provided in the Remarks dated 04/01/2026.
Response to Arguments: Applicant's arguments filed 03/27/2026 have been fully considered but they are not persuasive. Tsao teaches an adsorption module comprising all recited limitations of amended claim 6 for removing lactic acid from cultures of bacteria or fungi containing glucose and lactic acid. Therefore, the limitations of amended claim 6 are obvious in view of the combined teachings of Tsao, Lalikoğlu, and Onda.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZANNA M BEHARRY whose telephone number is (571)270-0411. The examiner can normally be reached Monday - Friday 8:45 am - 5:45 pm.
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/ZANNA MARIA BEHARRY/Examiner, Art Unit 1632
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