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 is a 371 of PCT/JP2023/022392 filed 06/16/2023. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on application JAPAN 2022-098493 filed 06/17/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/16/2024 and 01/03/ comply with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Claims
Claims 1-20 are pending (claim set filed 12/16/2024) and are examined on the merits herein.
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 4, 5, 8, 10, 13, 18 and 20 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.
The term “substantially no acetone” in claims 4, 5 and 13 referring to the fermentation liquid and the term “substantially no acetone” in claims 10 and 13 referring to the separated liquid are relative terms which render the claims indefinite. The term “substantially no acetone” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the fermentation liquid the specification describes: “Preferably, the fermented liquid contains no acetone (contains substantially no acetone). Even if it contains acetone, the amount thereof may be a very trace amount. For example, the acetone concentration of the fermented liquid may be 0.05 mass% or less [e.g., from 0 mass% (or the detection limit) to 0.03 mass%], preferably 0.01 mass% or less, and more preferably 0.005 mass% or less” (paragraph 0075). For the separated liquid the specification describes: “The separated liquid preferably contains no acetone (contains substantially no acetone), and, even if it contains acetone, the amount thereof may be a very trace amount. For example, the acetone concentration of the separated liquid may be 0.2 mass% or less, preferably 0.1 mass% or less, and more preferably 0.05 mass% or less” (paragraph 0120). Thus, the specification provides examples for the term “substantially no acetone” in some (preferable) embodiments, however, does not provide definition of the term and hence it is not clear what concentrations of acetone are limited in the scope of the claims. The scope and boundaries of claims 4, 5, 10 and 13 are not certain making claims indefinite.
The term “mainly containing butanol” and “mainly containing water” in claims 8, 13, 18 and 20 are relative terms which render the claims indefinite. The terms “mainly containing butanol” and “mainly containing water” are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the layer containing mainly butanol the specification describes: “In the layer mainly containing butanol the concentration of butanol may be, for example, 70 mass% or more (e.g., from 70 to 90 mass%), preferably 75 mass% or more (e.g., from 75 to 85 mass%), and more preferably about 78 mass% or more (e.g., from 78 to 82 mass%)” (paragraph 0140). For the layer mainly containing water the specification describes: “In the layer mainly containing water, the concentration of butanol may be, for example, 9 mass% or less (e.g., from 6 to 9 mass%), preferably 8.5 mass% or less (e.g., from 6.5 to 8.5 mass%), and more preferably about 8 mass%, or less (e.g., from 7 to 8 mass%)” (paragraph 0141). Thus, the specification provides examples for the terms “mainly containing butanol” and “mainly containing water”, however, does not provide definition of the term and hence it is not clear what concentrations of butanol are limited in the scope of the claims. The scope and boundaries of claims 8, 13, 18 and 20 are not certain making claims indefinite.
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.
Claims 1-5, 11, 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dobashi (US 201600532285 A1 on record in IDS) in view of Ichige (JP 2010161987 A on record in IDS) as evidenced by SensorOne (SensorOne, kPa to Torr Conversion Table [retrieved on 09/01/2026]. Retrieved from the Internet: < https://www.sensorsone.com/kpa-to-torr-conversion-table/>).
Regarding claims 1 and 2, Dobashi teaches producing butanol by butanol fermentation using genetically modified Clostridium saccharoperbutylacetonicum (Abstract). Dobashi describes several modifications of C. saccharoperbutylacetonicum to increase production of butanol, one of which is disruption of a function of an acetone producing enzyme gene involved in a pathway leading to production of acetone from acetoacetyl-CoA (paragraph 0019). The disrupted genes are adc and/or ctfAB genes (paragraph 0020). Dobashi provides working example for the microorganism with deletion of ctfB gene resulting in undetectable amount of acetone in the fermentation step (paragraph 0088, Table 9). Dobashi mentions that: “By disrupting the acetone producing enzyme gene, acetone as a by-product is not produced and a separation/purification step is more simplified” (paragraph 0041). Dobashi describes culturing the microorganism in a medium containing carbon source, nitrogen source and inorganic salts (paragraphs 0023, 0057-0060) and collection of butanol by combining methods such as distillation, gas stripping, solvent extraction and other methods (paragraph 0068).
Dobashi does not teach a separation step by pervaporation membrane separation.
Regarding claims 1 and 2, Ichige teaches method of production of butanol by fermentation (Abstract). Method includes fermentation of bacteria and further performing the separation recovery of the 1-butanol by a pervaporation separation membrane method (Abstract). Ichige indicates the preferable thickness of the membrane (40-200 µm) (paragraph 0014), material (silicone, zeolite) (paragraph 0015) and optimal temperature (30-40°C) (paragraph 0021) and provides examples of recovery of butanol from the fermentation medium by pervaporation method (Example 2, paragraph 0033). Ichige describes continuous fermentation and butanol separation by pervaporation for more than 400 hours with recovery of 480 g of butanol and indicates that pervaporation enables long-term stable production of butanol at a lower cost (paragraphs 0038, 0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add separation of butanol by pervaporation method from Ichige teaching to method of production of butanol by genetically modified C. saccharoperbutylacetonicum in Dobashi teaching. One would have been motivated to do so since Ichige provides instructions for butanol separation by pervaporation and describes that pervaporation enables long-term stable production of butanol at a lower cost. A skilled artisan would have reasonably expected success in that combination because Dobashi and Ichige teach production of butanol by fermentation. Thus, Dobashi and Ichige teachings render claims 1 and 2 obvious.
Regarding claim 3, Dobashi teaches genetic modifications of C. saccharoperbutylacetonicum to increase butanol production, including disruption of the acetone producing enzyme gene (adc and/or ctfAB), butyric acid producing enzyme gene (ptb and/or buk) and acetic acid producing enzyme gene (pta and/or ack) (paragraphs 0015-0020). Dobashi provides example of butanol production by fermentation of ∆ctfB∆pta∆ptb C. saccharoperbutylacetonicum variant including disruption of all 3 recited pathways (Example 5, paragraph 0088). Thus, Dobashi and Ichige teachings render claim 3 obvious.
Regarding claims 4 and 5, Dobashi teaches Example 5 of butanol fermentation by ∆ctfB∆pta∆ptb C. saccharoperbutylacetonicum variant and provides results of the products concentration after fermentation in Table 9. The acetone is undetectable, the concentrations of butanol and ethanol are: 164-168 mM and 16-19 mM, respectively. That corresponds to 1.21-1.24 mass% of butanol and 0.74-0.88 mM of ethanol that reads on claims 4 and 5 limitations. Thus, Dobashi and Ichige teachings render claims 4 and 5 obvious.
Regarding claim 16, Dobashi teaches collection of butanol by combining methods such as distillation, gas stripping, solvent extraction and other methods. Dobashi mentions that preferably butanol is collected by gas stripping or solvent extraction followed by purification via distillation (paragraph 0068).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute gas stripping or solvent extraction of butanol in Dobashi teaching with separation of butanol by pervaporation method from Ichige teaching and add distillation for butanol purification as describe by Dobashi. One would have been motivated to do so with reasonably expected success since Dobashi and Ichige teach production of butanol by fermentation and Ichige describes that pervaporation enables long-term stable production of butanol at a lower cost. Thus, Dobashi and Ichige teachings render claim 16 obvious.
Regarding claim 6 and 11, Ichige teaches pervaporation for separation of butanol using silicone rubber membrane, pressure reduction at 10-20 torr that corresponds to 1.3-2.6 kPa as evidenced by SensorOne and liquid temperature of 35°C (paragraphs 0004, 0031).
Regarding claim 12, Ichige teaches that fermentation step and separation step can be carried out simultaneously as continuous fermentation (paragraph 0019) and provides working example of continuous fermentation for more than 400 hours providing 480 g of butanol (Example 3, paragraphs 0035, 0038, 0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Ichige teaching and separate of butanol produced by fermentation as taught by Dobashi by pervaporation method with parameters including type of membrane, pressure and temperature as described by Ichige and carry fermentation and separation continuously. One would have been motivated to do so since Ichige provides instructions for butanol separation by pervaporation and shows continuous fermentation for more than 400 hours providing 480 g of butanol indicating stability of production. A skilled artisan would have reasonably expected success in that combination because Dobashi and Ichige teach production of butanol by fermentation. Thus, Dobashi and Ichige teachings render claims 6, 11 and 12 obvious.
Regarding claims 7, 9 and 10, the recitation in the wherein clause of claim 7: “the separation is performed so that a concentration factor of butanol is 15 times or more, and a ratio (X/Y) of a concentration factor X of butanol to a concentration factor Y of ethanol is 1.5 or more”, the recitation in the wherein clause of claim 9: “a separated liquid having a butanol concentration of 6 mass% or more” and the recitation in the wherein clause of claim 10: “having a butanol concentration of 6.5 mass% or more and a concentration of a non-aqueous component other than butanol of 1 mass% or less” are interpreted as recitations of intended use. MPEP 2111.04 states: “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003))”. In instant case, the prior art renders the instantly claimed method steps obvious, Dobashi teaches production of butanol by fermentation with C. saccharoperbutylacetonicum deficient in acetone-producing enzyme gene resulting in undetectable amount of acetone in the fermentation step (paragraph 0088, Table 9) and Ichige provides separation step to recovery of butanol after fermentation using pervaporation. Therefore, the method described in prior art is capable of achieving a concentration factor of butanol of 15 times or more, and a ratio X/Y) of 1.5 or more, a butanol concentration of 6 and 6.5 mass% or more and a concentration of a non-aqueous component other than butanol of 1 mass% or less. Thus, Dobashi and Ichige teachings render claims 7, 9 and 10 obvious.
Claims 8, 13, 14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dobashi (US 201600532285 A1 on record in IDS) in view of Ichige (JP 2010161987 A on record in IDS) as evidenced by SensorOne (SensorOne, kPa to Torr Conversion Table [retrieved on 09/01/2026]. Retrieved from the Internet: <https://www.sensorsone.com/kpa-to-torr-conversion-table/>) as applied to claim 1 above, and further in view of Wyk (Wyk et al. Chem Engin. & Process.: Process Intensif., 2018, 130, 148-159).
The teachings of Dobashi and Ichige have been set forth above.
Dobashi and Ichige do not teach the separated liquid to be phase-separated, removing carbon dioxide from the fermentation liquid, distillation of layer 1 and layer 2 of the phase-separated liquid and recovery of an azeotropic mixture 1 and azeotropic mixture 2 to the separated liquid.
Regarding claims 8 and 13, Wyk teaches pervaporation separation and downstream recovery of acetone-butanol-ethanol (ABE) by distillation (Abstract). Wyk describes adding pervaporation as a pre-treatment step to concentrate ABE before distillation (p. 149, right column, 1st paragraph). Wyk teaches that pervaporation can be integrated with fermentation process so that the inhibitory products, ABE which are toxic to microorganisms, can be removed continuously, thereby enhancing the productivity of the fermentation process (p. 148, right column, last paragraph). The whole process was simulated with AspenPlus (Abstract) and presented on Fig. 10b and Fig. 12. Wyk describes that the feed stream from the fermentation unit and containing ABE is directed to the pervaporation unit, the retentate is recycled to the fermenter and the permeate is concentrated enough to provide liquid-liquid separation between butanol rich phase and water rich phase (p. 156, left column, 2nd paragraph, Figure 10b).
Regarding claim 13, as described above, Dobashi teaches fermentation of C. saccharoperbutylacetonicum deficient in the function of an acetone producing enzyme gene, a butyric acid producing enzyme gene and an acetic acid producing enzyme gene for production of butanol (paragraphs 0015-0020, 0088) providing fermentation broth with no detectable acetone, 164-168 mM of butanol and 16-19 mM of ethanol that corresponds to 1.21-1.24 mass% of butanol and 0.74-0.88 mM (Table 9).
Regarding claim 13, as described above, Ichige teaches separation of continuous process of butanol production (paragraphs 0038, 0039), recovery of butanol by pervaporation on a silicone rubber membrane, pressure reduction at 10-20 torr that corresponds to 1.3-2.6 kPa as evidenced by SensorOne and liquid temperature of 35°C (paragraphs 0004, 0031).
First, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to expect that continuous process of fermentation of genetically modified of C. saccharoperbutylacetonicum as taught by Dobashi followed by separation step by pervaporation as described by Ichige will result in phase separated liquid permeate separated into butanol rich and water rich phases as taught by Wyk. One would have been motivated to do so with reasonably expected success since Dobashi, Ichige and Wyk teach production of butanol, Dobashi provides bacterial strain modified for fermentation and increased butanol production, Ichige provides instructions for butanol separation by pervaporation and describes that pervaporation enables long-term stable production of butanol at a lower cost and Wyk describes simulated process of butanol production by fermentation and pervaporation followed by further purification by distillation of separate phases of the permeate.
Second, the recitation: “the separation is performed so that a concentration factor of butanol is 20 times or more, and a ratio (X/Y) of a concentration factor X of butanol to a concentration factor Y of ethanol is 1.8 or more” and the recitation: “having a butanol concentration of 7 mass% or more and a concentration of a non-aqueous component other than butanol of 0.5 mass% or less” are interpreted as recitations of intended use. MPEP 2111.04 states: “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003))”. In instant case, the prior art renders the instantly claimed method steps obvious, Dobashi teaches production of butanol by fermentation with C. saccharoperbutylacetonicum deficient in acetone-producing enzyme gene resulting in undetectable amount of acetone in the fermentation step (paragraph 0088, Table 9) and Ichige provides separation step to recovery of butanol after fermentation using pervaporation. Therefore, the method described in prior art is capable of achieving a concentration factor of butanol of 20 times or more, and a ratio X/Y) of 1.8 or more, a butanol concentration of 7 mass% or more and a concentration of a non-aqueous component other than butanol of 0.5 mass% or less.
Thus, Dobashi, Ichige and Wyk teachings render claims 8 and 13 obvious.
Regarding claim 14, Wyk teaches that fermentation produces non-condensable gases, H2 and CO2 that affect the energy cost for the production (p. 157, right column, 2nd paragraph). Wyk describes that in the suggested pervaporation-distillation scheme certain amount of produced CO2 will dissolve in water and the remaining CO2 and H2 are removed from the top of the fermenter prior to separation by evaporation step (p. 156, left column, 2nd paragraph, Figure 10b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add step of removing carbon dioxide from the fermentation liquid prior to subjecting it to separation step as described by Wyk in the process of butanol production based on Dobashi, Ichige and Wyk teachings. One would have been motivated to do so because Wyk teaches that CO2 is non-condensable gas that can affect the energy cost of butanol production. A skilled artisan would have reasonably expected success in that since Dobashi, Ichige and Wyk teach production of butanol. Thus, Dobashi, Ichige and Wyk teachings render claim 14 obvious.
Regarding claims 17-20, Wyk teaches that the permeate after evaporation is concentrated and provides liquid-liquid separation between butanol rich phase (instant layer 1) and water rich phase (instant layer 2) (p. 156, left column, 2nd paragraph, Figure 10b). Wyk describes separation of phases by decanting followed by separate distillation of butanol rich layer (instant distillation 1) and of water rich layer (instant distillation 2) (Figure 12). Thus, in distillation of butanol the water rich layer (instant layer 2) is removed (purged). The method does not comprise step of preliminary separating a non-aqueous component other than butanol before distillation. The process described by Wyk includes recovery step of returning the azeotropic mixtures after distillation of butanol and azeotropic mixture after final distillation of water rich layer (ethanol distillation) to the separate liquid prior to decanting (Figure 12). Wyk discloses that the suggested scheme provides 5 t/h of butanol with 99.9 wt% purity (p. 156, left column, 2nd paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Wyk teaching and add distillation of the separated by evaporation butanol rich layer and water rich layer step including recovery step of returning the azeotropic mixtures after distillation to the separate liquid as described by Wyk in the process of butanol production based on Dobashi and Ichige teachings. One would have been motivated to do so because Wyk teaches detailed scheme for the purification of butanol by distillation of the fermentation broth separated and concentrated by evaporation that provides production of 5 t/h of butanol with 99.9 wt% purity. A skilled artisan would have reasonably expected success in that since Dobashi, Ichige and Wyk teach production of butanol. Thus, Dobashi, Ichige and Wyk teachings render claims 17-20 obvious.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dobashi (US 20160053285 A1 on record in IDS) in view of Ichige (JP 2010161987 A on record in IDS) as evidenced by SensorOne (SensorOne, kPa to Torr Conversion Table [retrieved on 09/01/2026]. Retrieved from the Internet: <https://www.sensorsone.com/kpa-to-torr-conversion-table/>) as applied to claim 1 above, and further in view of Barr (US 20170298393 A1 on record in IDS).
The teaching of Dobashi and Ichige have been set forth above.
Dobashi and Ichige do not teach circulating vapor passed through the perforation membrane to the fermentation step.
Regarding claim 15, Barr teaches recovering butanol from a fermentation process using ethanol producing plant that can be reversibly retrofitted for butanol production (Abstract). Barr discloses that fermentation broth proceeds through a separation unit forming butanol-rich and butanol-lean stream and the butanol-lean stream is returned to the fermentation unit for continued production of butanol (paragraph 0086). In one of the embodiments Barr describes that butanol is separated from the fermentation broth utilizing vaporization under vacuum in a series of flash units (paragraph 0120, Figure 2D). Figure 2G demonstrates that the fermentation broth 212 comprising butanol is conducted to pre-flash 226 operating at a reduced pressure to degas much of the carbon dioxide dissolved in fermentation broth 212 and form vapor stream 208. The degassed fermentation broth 221 is then conducted to flash unit 227 operating at a further reduced pressure to volatilize a portion of the dissolved butanol forming vapor stream 239. Stream 207 that has been evaporatively cooled and at least partially depleted of butanol relative to fermentation broth 212 is recycled back to fermentation 100. The vapor stream 239 is liquified in a condenser unit 228 forming liquid stream and vapor stream which proceeds through additional condensers (paragraph 0120). The combined liquid stream containing butanol is further separated through a decanter into aqueous and organic phase from which butanol is purified (paragraph 0123). Thus, the stream 207 partially depleted of butanol and which was not condensed to liquid and not separated is recycled into fermentation unit. Although Barr does not teach separation by pervaporation, Barr describes separation of butanol by similar process of evaporation under reduced pressure followed by condensation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Barr teaching and add recycling to the fermentation unit of the butanol depleted vapor stream obtained after passing of the fermentation broth through a pervaporation membrane but not condensed into liquid and not separated to the method based on Dobashi and Ichige teachings. One would have been motivated to do so because Barr describes recycling of the butanol-lean stream to the fermentation unit for continued production of butanol and recycling of the that vapor stream will prevent losses of residual butanol and increase efficiency of production. A skilled artisan would have reasonably expected success in that since Dobashi, Ichige and Barr teach production of butanol including steps of fermentation and separation of butanol-rich stream. Thus, Dobashi, Ichige and Barr teachings render claim 15 obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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