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
Claims 1-6 and 8-12 are pending and under examination. Claim 7 is cancelled.
The claim objections to claims 1-2 and 6 are withdrawn in light of the claim amendment dated 6/18/2026 correcting the informalities.
The rejection of claims 1-12 under 35 U.S.C. 112(b) is withdrawn in light of the claim amendment dated 6/18/2026 cancelling claim 7 and the amendment to claim 1 clarifying that pathways are inhibited in a microorganism.
The rejection of claims 1-3, 6, 9 and 11-12 under 35 U.S.C. 102(a)(1) as being clearly anticipated by Song et al. (“Microbial production of 2,3‑butanediol for industrial applications”, Journal of Industrial Microbiology & Biotechnology, 2019, Vol.46, Issue 11, pp.1583-1601) is withdrawn in light of the claim amendment to claim 1.
The rejection of claims 1, 4-5 and 10 under 35 U.S.C. 102(a)(1) as being clearly anticipated by Elsholz et al. (“Self-regulation of exopolysaccharide production in Bacillus subtilis by a tyrosine kinase”, Genes & Development, 2014, Vol. 28, pp.1710-1720) and evidenced by Song et al. (“Simultaneous and selective production of exopolymers and polyols by metabolically engineered Bacillus licheniformis strains”, Biochemical Engineering Journal, 2022, Vol. 181, Article 108381, 11 pages) is withdrawn in light of the claim amendment to claim 1.
Priority
This application, filed on 4/11/2024, is a 371 of PCT/KR2022/009268 filed 6/28/2022, which claims priority to REPUBLIC OF KOREA 10-2021-0121930 filed 9/13/2021.
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 application 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.
For the prior art purposes, the effective filing date is June 28, 2022.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
New rejection necessitated by amendment: Claims 1-6 and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Song et al. (“Simultaneous and selective production of exopolymers and polyols by metabolically engineered Bacillus licheniformis strains”, Biochemical Engineering Journal, April 2022, Vol. 181, Article 108381, 11 pages; first available online February 25, 2022), referred to as Song 2022.
Regarding claim 1, Song 2022 teaches Bacillus licheniformis for simultaneous and selective production of exopolymers and polyols (abstract). Song 2022 teaches the most efficiently and selectively produced exopolymer and polyol were levan and (2R,3S)-butanediol (abstract). Song 2022 teaches that as epsAB genes encoding tyrosine kinases were identified as essential genes for EPS synthesis, they were removed to increase the metabolic selectivity for levan or polyglutamic acid (i.e. a pathway that converts glucose-6-phosphate to exopolysaccharide is inhibited) (p.2, 1st column last paragraph). Song 2022 further teaches that for simultaneous and selective production of 2,3-butanediol (BDO) isomers, further deletions of both the dgp gene, budC gene encoding (2R,3S)-BDO dehydrogenase and the gdh gene encoding (2R,3R)-BDO dehydrogenase were carried out (i.e. and a pathway that converts acetoin to (2R,3S)-butanediol is inhibited) (p.2, 1st column last paragraph).
Regarding claim 2, Song 2022 teaches Bacillus licheniformis (abstract).
Regarding claim 3, Song 2022 teaches polyols which are glycerol and (2R,3S)-butanediol (abstract).
Regarding claim 4, Song 2022 teaches exopolymers that include polyglutamic acid (PGA), levan and exopolysaccharide (EPS) (abstract).
Regarding claim 5, Song 2022 teaches that EPS commonly contained glucose, galactose, glycerol, acetate and phosphorous (p.6, 1st column 1st paragraph).
Regarding claim 6, Song 2022 teaches that B. licheniformis produces two types of 2,3-BDO stereoisomers and selectivity can be improved by deletion of corresponding genes budC encoding (2R,3S)-butanediol dehydrogenase and gdh encoding glycerol dehydrogenase with function as (2R,3R)-butanediol dehydrogenase (i.e. an ability to produce (2R,3S)-butanediol or (2R,3R)-butanediol is inhibited)9 (p.7, 2nd column last paragraph – p.8, 1st column, top paragraph).
Regarding claim 8, Song 2022 teaches that after confirming selectivity improvement on exopolymers, further engineering was carried out to try to improve the simultaneous production of specific polyols (p.7, 2nd column – 3.3. Improvement on selectivity of 2,3-BDO for simultaneous production with EPS).
Regarding claim 9, Song 2022 teaches small aliquots were inoculated into flasks containing 100mL of medium containing glucose or sucrose (i.e. a carbon source) (p.3, 2nd column 2.4. Flask cultivation and fed-batch fermentation). Song 2022 teaches a schematic procedure for simultaneous production and separation of polyols and exopolymers (p.2, Fig. 1).
Regarding claim 10, Song 2022 teaches that specific exopolymers could be produced by changing carbon source and temperature (abstract). Song 2022 teaches small aliquots were inoculated into flasks containing 100mL of medium containing glucose or sucrose (i.e. a carbon source) (p.3, 2nd column – 2.4. Flask cultivation and fed-batch fermentation).
Regarding claim 11, Song 2022 teaches small aliquots were inoculated into flasks containing 100mL of medium containing glucose or sucrose (i.e. a carbon source) (p.3, 2nd column – 2.4. Flask cultivation and fed-batch fermentation).
Regarding claim 12, Song 2022 teaches flask cultivations were conducted in a 500 mL Erlenmeyer flask containing 100 mL of working volume at 30–45°C (p.3, 2nd column – 2.4. Flask cultivation and fed-batch fermentation).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 6, 9, and 11-12 as being anticipated by Song et al. and claims 1, 4-5 and 10 as being anticipated by Elsholz et al. (See Remarks dated 6/18/2026, p.5) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
New rejection necessitated by amendment: Claims 1-4, 6, 8, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Elsholz et al. (“Self-regulation of exopolysaccharide production in Bacillus subtilis by a tyrosine kinase”, Genes & Development, 2014, Vol. 28, pp.1710-1720; previously cited) in view of Song et al. (“Microbial production of 2,3‑butanediol for industrial applications”, Journal of Industrial Microbiology & Biotechnology, 2019, Vol.46, Issue 11, pp.1583-1601; previously cited), referred to as Song 2019.
Regarding claim 1, Elsholz teaches that the first two genes (epsA and epsB) of the 15-gene eps operon encode conserved two-component bacterial tyrosine kinases, that may function in the production of EPS (p.1711, 2nd column – 2nd full paragraph). Elsholz further teaches constructing single and double mutants of the two genes and tested their ability to form an extracellular matrix (p.1711, 2nd column – 2nd full paragraph).
Elsholz does not teach inhibiting a pathway that converts acetoin to (2R,3S)-butanediol.
Song 2019 teaches that gram-positive bacteria belonging to Bacillus and Paenibacillus are capable of producing 2,3-Butanediol (2,3-BD) (p.1589, 2nd column last sentence – p.1590, 1st column top 2 lines). Song 2019 teaches that several strains including B. licheniformis and B. amyloliquefaciens have shown good performance, and a newly isolated B. licheniformis strain 10-1-A could thermo-stably produce 115.7 g/L of 2,3-BD with high productivity and yield (p.1590, 1st column 1st paragraph). Song 2019 teaches that when the gdh gene was deleted, optically pure (2R,3S)-BD isomer can be produced with a titer of 90.1 g/L in B. licheniformis (p.1590, 1st column, 2nd paragraph). Song 2019 further teaches that B. subtilis can be engineered for production of (2R,3S)-BD, and systematic engineering strategies include inactivation of (2R,3R)-BD dehydrogenase (p.1590, 1st column 2nd paragraph). Song 2019 teaches tyrosine kinases are involved in the pathway that converts glucose-6-phosphate to exopolysaccharide (Figure 3).
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 Bacillus subtilis strain taught by Elsholz to further inactivate the pathway of (2R,3R)-butanediol as taught by Song 2019 to obtain a Bacillus subtilis strain that has the ability to produce polyol or exopolymer. Each of Elsholz and Song 2019 teach recombinant Bacillus subtilis microorganisms genetically modified to inhibit a pathway. One of ordinary skill in the art would reasonably expect that combining a modification to increase exopolysaccharide production taught by Elsholz with a modification to increase production of (2R,3S)-butanediol taught by Song in the same recombinant bacterial host cell would predictably result in a single Bacillus subtilis strain that could produce either polyol (2R,3S)-butanediol or exopolysaccharide, because it would amount to a combination of known elements in a predictable way, and it was known in the art at the time of invention that Bacillus subtilis species could be modified to produce each of (2R,3R)-butanediol and exopolysaccharide.
Regarding claim 2, Elsholz teaches transformation of B. subtilis was performed by a two-step protocol (p.1717, 1st column – General methods).
Regarding claim 3, claim 3 depends from claim 1, which further limits “polyol”. However, claim 3 does not limit the method to a microorganism with controlled ability to produce polyol. As such, claim 3 is being interpreted as if the recombinant microorganism is one with controlled ability to produce polyol, then the limitations of claim 3 apply.
Since Elsholz teaches a recombinant microorganism with controlled ability to produce exopolysaccharide (i.e. exopolymer), the limitations of claim 3 are considered met.
Song 2019 teaches production of (2R,3R)-butanediol and (2R,3S)-butanediol isomer (p.1590, 1st column 2nd paragraph).
Regarding claim 4, Elsholz teaches gram-positive Bacillus subtilis is capable of forming biofilms, with cells in biofilms held together by an extracellular matrix consisting of amyloid-like fibers and exopolysaccharide (EPS) (p.1710, 2nd column).
Regarding claim 6, claim 6 depends from claim 1, which is directed to the production of polyol or exopolymer. However, claim 6 does not limit the method to a microorganism with controlled ability to produce polyol. As such, claim 6 is being interpreted as if the recombinant microorganism is one with controlled ability to produce polyol, then the limitations of claim 6 apply.
Since Elsholz teaches a recombinant microorganism with controlled ability to produce exopolysaccharide (i.e. exopolymer), the limitations of claim 6 are considered met.
Song 2019 teaches most B. licheniformis and B. subtilis strains produce (2R,3R)-BD and (2R,3S)-BD at a close ratio of 1:1; however, when the budC gene was deleted, optically pure (2R,3R)-BD isomer can be produced in B. licheniformis with a titer of 123.7 g/L and when the gdh gene was deleted, optically pure (2R,3S)-BD isomer can be produced with a titer of 90.1 g/L in B. licheniformis (p.1590, 1st column, 2nd paragraph).
Regarding claim 8, Elsholz teaches that the first two genes (epsA and epsB) of the 15-gene eps operon encode conserved two-component bacterial tyrosine kinases, that may function in the production of EPS (p.1711, 2nd column – 2nd full paragraph). Elsholz further teaches constructing single and double mutants of the two genes and tested their ability to form an extracellular matrix (p.1711, 2nd column – 2nd full paragraph).
Elsholz does not teach the production of (2R,3S)-butanediol.
Song 2019 teaches that B. subtilis can be engineered for production of (2R,3S)-BD, and systematic engineering strategies include inactivation of (2R,3R)-BD dehydrogenase (p.1590, 1st 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 modify the Bacillus subtilis strain taught by Elsholz to further inactivate the pathway of (2R,3R)-butanediol taught by Song 2019 to obtain a Bacillus subtilis strain that has the ability to simultaneously produce polyol and exopolymer. Each of Elsholz and Song 2019 teach recombinant Bacillus subtilis microorganisms genetically modified to inhibit a pathway. One of ordinary skill in the art would reasonably expect that combining a modification to increase exopolysaccharide production taught by Elsholz with a modification to increase production of (2R,3S)-butanediol taught by Song 2019 in the same recombinant bacterial host cell would predictably result in a single Bacillus subtilis strain that could produce both polyol (2R,3S)-butanediol and exopolysaccharide, because it would amount to a combination of known elements in a predictable way, and it was known in the art at the time of invention that Bacillus subtilis species could be modified to produce each of (2R,3R)-butanediol and exopolysaccharide.
Regarding claim 10, Elsholz teaches B. subtilis cells were cultured from a 1-d-old colony in LB broth at 37°C (p.1717, 2nd column, Biofilm assay). Elsholz teaches the LB broth comprises tryptone and yeast extract (i.e. carbon sources) (p.1717, 1st column last paragraph).
Regarding claim 12, Elsholz teaches cultures were routinely grown in 500-mL Erlenmeyer flasks at 37°C (p.1717, 2nd column top paragraph).
Modified rejection necessitated by amendment: Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Elsholz et al. (“Self-regulation of exopolysaccharide production in Bacillus subtilis by a tyrosine kinase”, Genes & Development, 2014, Vol. 28, pp.1710-1720; previously cited) in view of Song et al. (“Microbial production of 2,3‑butanediol for industrial applications”, Journal of Industrial Microbiology & Biotechnology, 2019, Vol.46, Issue 11, pp.1583-1601; previously cited), referred to as Song 2019, and further evidenced by Song et al. (“Simultaneous and selective production of exopolymers and polyols by metabolically engineered Bacillus licheniformis strains”, Biochemical Engineering Journal, 2022, Vol. 181, Article 108381, 11 pages); referred to as Song 2022.
Regarding claim 5, Elsholz or Song 2019 does not identify the exopolysaccharide composition.
However, as evidenced by Song 2022, (analysis of exopolysaccharide from B. licheniformis strain (4071)), EPS commonly contains glucose, galactose, glycerol, acetate and phosphate as monomers (p.6, 1st column 1st paragraph). Thus, the exopolysaccharide of Elsholz would necessarily contain at least one of glucose, galactose, phosphate and glycerol.
New rejection necessitated by amendment: Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (“Microbial production of 2,3‑butanediol for industrial applications”, Journal of Industrial Microbiology & Biotechnology, 2019, Vol.46, Issue 11, pp.1583-1601; previously cited), referred to as Song 2019, in view of Elsholz et al. (“Self-regulation of exopolysaccharide production in Bacillus subtilis by a tyrosine kinase”, Genes & Development, 2014, Vol. 28, pp.1710-1720; previously cited).
Regarding claim 9, Song 2019 teaches that gram-positive bacteria belonging to Bacillus and Paenibacillus are capable of producing 2,3-Butanediol (2,3-BD) (p.1589, 2nd column last sentence – p.1590, 1st column top 2 lines). Song 2019 teaches that several strains including B. licheniformis and B. amyloliquefaciens have shown good performance, and a newly isolated B. licheniformis strain 10-1-A could thermo-stably produce 115.7 g/L of 2,3-BD with high productivity and yield (p.1590, 1st column 1st paragraph). Song 2019 teaches that when the gdh gene was deleted, optically pure (2R,3S)-BD isomer can be produced with a titer of 90.1 g/L in B. licheniformis (p.1590, 1st column, 2nd paragraph). Song 2019 further teaches that B. subtilis can be engineered for production of (2R,3S)-BD, and systematic engineering strategies include inactivation of (2R,3R)-BD dehydrogenase (p.1590, 1st column 2nd paragraph). Song 2019 teaches tyrosine kinases are involved in the pathway that converts glucose-6-phosphate to exopolysaccharide (Figure 3).
Song 2019 teaches newly isolated B. licheniformis X10 strain possessing high tolerance to fermentation inhibitors such as furfural, vanillin, formic acid, and acetic acid was used for fed-batch fermentation, and 74 g/L of 2,3-BD was produced from corn stover hydrolysate (i.e. a carbon source) with a productivity of 2.1 g/L/h (p.1592, 2nd column, last paragraph).
Song 2019 does not teach a microorganism wherein a pathway that converts glucose-6-phosphate to exopolysaccharide is inhibited.
However, Elsholz teaches that the first two genes (epsA and epsB) of the 15-gene eps operon encode conserved two-component bacterial tyrosine kinases, that may function in the production of EPS (p.1711, 2nd column – 2nd full paragraph). Elsholz further teaches constructing single and double mutants of the two genes and tested their ability to form an extracellular matrix (p.1711, 2nd column – 2nd full paragraph).
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 Bacillus subtilis strain taught by Song 2019 to further inactivate the pathway that converts glucose-6-phosphate to exopolysaccharide taught by Elsholz to obtain a Bacillus subtilis strain that has the ability to produce polyol or exopolymer. Each of Song 2019 and Elsholz teach recombinant Bacillus subtilis microorganisms genetically modified to inhibit a pathway. One of ordinary skill in the art would reasonably expect that combining a modification to increase production of (2R,3S)-butanediol taught by Song 2019 with a modification to increase exopolysaccharide production taught by Elsholz in the same recombinant bacterial host cell would predictably result in a single Bacillus subtilis strain that could produce either polyol (2R,3S)-butanediol or exopolysaccharide, because it would amount to a combination of known elements in a predictable way, and it was known in the art at the time of invention that Bacillus subtilis species could be modified to produce each of (2R,3R)-butanediol and exopolysaccharide.
Regarding claim 11, Song 2019 teaches B. subtilis cultivation in glucose and LB based medium (carbon source is glucose) (p.1587, Table 1 continued, lines 1 and 2). Song 2019 also teaches in S. marcescens a yield of 152 g/L of 2,3-BD with yield and productivity of 0.41 g/g sucrose and 2.67 g/L/h (carbon source is sucrose) (p.1589, 2nd column 2nd paragraph).
Response to Arguments
Applicant argues that one of ordinary skill in the art would have no motivation to combine the teachings of Elsholz and Song, because Elsholz and Song address entirely different technical problems and objectives, and one of ordinary skill in the art would have had little motivation to combine these disparate teachings to achieve the unique objective of an industrial-scale production system for simultaneous production of both polyol and exopolymer (See remarks dated 6/18/2026, p.6, paragraph 4). Applicant further argues that the simultaneous inhibition of at least two pathways, as recited in amended claim 1, produces unpredictable results that could not have been anticipated from the cited references, and refers to paragraph [141] of the specification to identify data that demonstrates modifications to polyol pathway can have a negative impact on exopolymer production, an outcome that could not have been predicted from the cited references (See Remarks dated 6/28/2026, p.6, last paragraph – p.7, top sentence). Applicant argues that despite these complex metabolic interconnections, the recombinant microorganism of the present application achieves both high selectivity and high productivity for simultaneous production of polyol and exopolymer, as described in Examples 7 and 8, paragraphs 145 and 162 of the specification (See Remarks dated 6/18/2026, p. 7, 1st paragraph). Applicant argues that the cited references provide no teaching or suggestion that the simultaneous inhibition of both the exopolysaccharide pathway and a polyol pathway would result in a microorganism capable of simultaneously producing both products with such high selectivity and productivity (See Remarks dated 6/18/2026, p.7, 2nd paragraph).
Applicant's arguments filed June 18, 2026 have been fully considered but they are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the simultaneous production of both a polyol and exopolymer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 1 requires a microorganism with controlled ability to produce a polyol or exopolymer, but not both.
As discussed in the rejection above, each of Song 2019 et al. and Elsholz et al. teach the genetic modification of B. subtilis strains to produce a desired substance. Additionally, Wang et al. (“Simultaneous production of poly-γ-glutamic acid and 2,3-butanediol by a newly isolated Bacillus subtilis CS13”, Applied Microbiology and Biotechnology, 2020, Vol. 104, pp.7005-7021) discloses that Bacillus subtilis naturally produce large amounts of 2,3-butanediol (i.e. polyol) as a main by-product during poly-γ-glutamic acid (i.e. exopolymer) production (abstract). Thus, one of ordinary skill in the art would reasonably expect that engineering a recombinant microorganism to inhibit pathways involved in exopolymer and polyol synthesis would predictably result in further improving the production of the desired molecules.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
New rejection necessitated by amendment: Claims 1, 3-4, and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9, and 13 of copending Application No. 18/285,340 in view of Song et al. (“Microbial production of 2,3‑butanediol for industrial applications”, Journal of Industrial Microbiology & Biotechnology, 2019, Vol.46, Issue 11, pp.1583-1601; previously cited), referred to as Song 2019.
Claim 1 of ‘340 is drawn to a recombinant microorganism for producing 2,3-butanediol, wherein the microorganism has a 2,3-butanediol biosynthetic pathway, wherein at least one selected from a group consisting of a polyglutamate biosynthetic pathway, a levan biosynthetic pathway, a lactate biosynthetic pathway, and a glycerol biosynthetic pathway is inhibited (relevant to instant claim 1).
Claim 1 of ‘340 does not teach a pathway that converts acetoin to (2R,3R)-butanediol is inhibited.
However, Song 2019 teaches that gram-positive bacteria belonging to Bacillus and Paenibacillus are capable of producing 2,3-Butanediol (2,3-BD) (p.1589, 2nd column last sentence – p.1590, 1st column top 2 lines). Song 2019 teaches that several strains including B. licheniformis and B. amyloliquefaciens have shown good performance, and a newly isolated B. licheniformis strain 10-1-A could thermo-stably produce 115.7 g/L of 2,3-BD with high productivity and yield (p.1590, 1st column 1st paragraph). Song 2019 teaches that when the gdh gene was deleted, optically pure (2R,3S)-BD isomer can be produced with a titer of 90.1 g/L in B. licheniformis (p.1590, 1st column, 2nd paragraph). Song 2019 further teaches that B. subtilis can be engineered for production of (2R,3S)-BD, and systematic engineering strategies include inactivation of (2R,3R)-BD dehydrogenase (p.1590, 1st 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 modify the recombinant microorganism of ‘340 to inactivate the pathway producing (2R,3R)-butanediol taught by Song 2019 to obtain a microorganism that produced optically pure (2R,3S)-butanediol with a high titer. One of ordinary skill in the art would have found it beneficial to inactivate the pathway that produces (2R,3R)-butanediol to produce higher titers of the desired (2R,3S)-butanediol isomer.
Claim 7 of ‘340 is drawn to a recombinant microorganism for producing 2,3-butanediol of wherein the recombinant microorganism has a production ability of 2,3-butanediol higher than a production ability of 2,3-butanediol of a wild-type microorganism (relevant to instant claim 3).
Claim 9 of ‘340 is drawn to a recombinant microorganism for producing 2,3-butanediol of wherein at least one selected from a group consisting of a path for converting glutamate to polyglutamate, a path for converting sucrose to levan, a path for converting pyruvate to lactate, and a path for converting glycerophosphate to glycerol is inhibited (relevant to instant claim 4).
Claim 13 of ‘340 is drawn to a method for producing 2,3-butanediol, the method comprising: culturing the recombinant microorganism for producing 2,3-butanediol of claim 1; and recovering 2,3-butanediol from the culturing product (relevant to instant claims 9-10).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues claim 1 has been amended to incorporate the features of original claim 7; thus the amended claims are patentably distinct from the claims of the reference application (See Remarks dated 6/19/2026, p.8).
Applicant's arguments filed June 18, 2026 have been fully considered but they are not persuasive. As discussed above, the claims of the reference application in view of Song 2019 render the instant claims obvious. A terminal disclaimer is required to overcome a non-statutory double patenting rejection. See MPEP §804.02.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEEPA MISHRA whose telephone number is (571) 272-6464. The examiner can normally be reached Monday - Friday 9:30am - 3:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise W. Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/DEEPA MISHRA/Examiner, Art Unit 1657
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