DETAILED ACTION
Status of Application
The amendments and response filed 20 February 2026 are acknolweged and have been considered in their entireties. Claim 9 is cancelled, thus, claims 2, 6-7, 14, 17, 32, 42, 63, 70-71, 75-77, 89, 128, 130-132, 135 are pending; Claims 32, 42, 63, 70-71, 75-77, 89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 2, 6-7, 14, 17, 128, 130-132 and 135 are subject to examination on the merits.
Withdrawal of Previous Rejections
The rejection of claim(s) 128, 2, 6, 9, 130-132 and 135 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Savakis et al. (WO 2014/092562 – cited on IDS 02/20/2024) as evidenced by Cui et al. (J. App. Microb., 2014 – cited on IDS 02/20/2024) is withdrawn in view of the amendments requiring the microorganism to be a methanotroph and
The rejection of claims 128, 2, 6, 7, 14, 131 and 132 under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al. (WO 2018/131898 – cited on IDS 02/20/2024 (with an effectively filed date of 10 January 2017) is withdrawn as they do not teach expressing an NADPH-dependent acetoin reductase.
Maintained Rejections
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.
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Non-provisional:
Claims 2, 6-7, 14, 17, 128, 130-132 and 135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11421235. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘235 patent anticipate the instant claims.
The instant claims in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to 2,3-butanediol (2,3-BDO), the microorganism comprising at least one heterologous gene encoding (a) an NADPH-dependent acetoin reductase, (b) an alpha-acetolactate decarboxylase and/or (c) an acetolactate synthase (claim 128). Dependent claim 14 recites the microorganism is a methanotroph; and claim 17 recites it is Methylcoccus capsulatus. Dependent claim 7 recites the heterologous acetolactate synthase has at least 90% identity to SEQ ID NOs: 1 or 19; the heterologous alpha-acetolactate decarboxylase has at least 90% identity to SEQ ID NO: 7 and/or the heterologous acetoin reductase has at least 90% identity to SEQ ID NO: 9.
The claims to the ‘235 patent in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to a multicarbon product, wherein the microorganism is Methylococcus capsulatus and comprises: (a) a heterologous gene encoding an acetolactate synthase (AlsS) comprising the amino acid sequence of SEQ ID NO: 99; and (b) a heterologous gene encoding a ketol-acid reductoisomerase (KARI) comprising the amino acid sequence of SEQ ID NO: 4;
(c) a heterologous gene encoding a dihydroxy-acid dehydratase (DHAD) comprising the amino acid sequence of SEQ ID NO: 6; (d) a heterologous gene encoding a 2-keto acid decarboxylase (KDC) comprising the amino acid sequence of SEQ ID NO: 10; and (e) a heterologous gene encoding an ADH comprising the amino acid sequence of SEQ ID NO: 14. Claim 9 is drawn to methods of making said genetically modified microorganism and dependent claim 10 is drawn to a method of making a useful product such as 2,3-butanediol by contacting said genetically modified microorganism with a C1 carbon source.
The difference between the two sets of claims is the claims to the ‘235 patent is said genetically modified Methylococcus capsulatus requires five heterologous enzymes, including acetolactate synthase for C1 conversion to 2,3-BDO (when claims 1 and 10 are combined). Nonetheless, this will necessarily still anticipate the instant claims because the genetically modified microorganism of the instant claims only requires one of three enzymes, at least one being heterologous, including acetolactate synthase.
Claims 2, 6-7, 14, 17, 128, 130-132 and 135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12234465. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘465 patent anticipate the instant claims.
The instant claims in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to 2,3-butanediol (2,3-BDO), the microorganism comprising at least one heterologous gene encoding (a) an NADPH-dependent acetoin reductase, (b) an alpha-acetolactate decarboxylase and/or (c) an acetolactate synthase (claim 128). Dependent claim 14 recites the microorganism is a methanotroph; and claim 17 recites it is Methylcoccus capsulatus. Dependent claim 7 recites the heterologous acetolactate synthase has at least 90% identity to SEQ ID NOs: 1 or 19; the heterologous alpha-acetolactate decarboxylase has at least 90% identity to SEQ ID NO: 7 and/or the heterologous acetoin reductase has at least 90% identity to SEQ ID NO: 9. Dependent claim 135 recites the heterologous genes are under the control of a switch.
The claims to the ‘465 patent in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to a multicarbon product, the microorganism comprising: (a) a gene encoding an acetolactate synthase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 2; (b) a gene encoding a ketol-acid reductoisomerase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 4; (c) a gene encoding a dihydroxy-acid dehydratase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 8; and (d) a gene encoding a 2-keto acid decarboxylase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 12; wherein at least one of the gene(s) is under the control of a rare earth metal switch. Dependent claim 4 recites the microorganism is Methylococcus. Dependent claim 13 is drawn to a method of making a useful product such as 2,3-butanediol by contacting said genetically modified microorganism with a C1 carbon source.
The difference between the two sets of claims is the claims to the ‘465 patent is said genetically modified Methylococcus capsulatus requires four heterologous enzymes, including acetolactate synthase for C1 conversion to 2,3-BDO (when claims 1 and 10 are combined). Nonetheless, this will necessarily still anticipate the instant claims because the genetically modified microorganism of the instant claims only requires one of three enzymes, at least one being heterologous, including acetolactate synthase.
Claims 2, 6-7, 14, 17, 128, 130-132 and 135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11111496. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘496 patent anticipate the instant claims.
The instant claims in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to 2,3-butanediol (2,3-BDO), the microorganism comprising at least one heterologous gene encoding (a) an NADPH-dependent acetoin reductase, (b) an alpha-acetolactate decarboxylase and/or (c) an acetolactate synthase (claim 128). Dependent claim 14 recites the microorganism is a methanotroph; and claim 17 recites it is Methylcoccus capsulatus. Dependent claim 7 recites the heterologous acetolactate synthase has at least 90% identity to SEQ ID NOs: 1 or 19; the heterologous alpha-acetolactate decarboxylase has at least 90% identity to SEQ ID NO: 7 and/or the heterologous acetoin reductase has at least 90% identity to SEQ ID NO: 9. Dependent claim 135 recites the heterologous genes are under the control of a switch.
The claims to the ‘496 patent in their broadest are drawn to a genetically modified microorganism capable of converting a Cl carbon to 2,3-BDO, wherein the microorganism is from the species Methylococcus capsulatus and comprises at least one heterologous gene encoding: i) an acetoin reductase; ii) an alpha-acetolactate decarboxylase; and/or iii) an acetolactate synthase. Dependent claim 4 recites the heterologous acetolactate synthase has at least 90% identity to SEQ ID NOs: 1 or 19; the heterologous alpha-acetolactate decarboxylase has at least 90% identity to SEQ ID NO: 7 and/or the heterologous acetoin reductase has at least 90% identity to SEQ ID NO: 9. Dependent claim 9 recites the heterologous genes are under the control of a switch. Dependent claims 11-18 are drawn to methods of making said 2,3-BDO by contacting a C1 carbon source with the genetically modified Methylococcus capsulatus of claim 1.
Thus, the claims of the ‘496 patent anticipate the instant claims.
Claims 2, 6-7, 14, 17, 128, 130-132 and 135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11198877. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘877 patent render obvious the instant claims.
The instant claims in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to 2,3-butanediol (2,3-BDO), the microorganism comprising at least one heterologous gene encoding (a) an NADPH-dependent acetoin reductase, (b) an alpha-acetolactate decarboxylase and/or (c) an acetolactate synthase (claim 128). Dependent claim 14 recites the microorganism is a methanotroph; and claim 17 recites it is Methylcoccus capsulatus. Dependent claim 7 recites the heterologous acetolactate synthase has at least 90% identity to SEQ ID NOs: 1 or 19; the heterologous alpha-acetolactate decarboxylase has at least 90% identity to SEQ ID NO: 7 and/or the heterologous acetoin reductase has at least 90% identity to SEQ ID NO: 9. Dependent claim 135 recites the heterologous genes are under the control of a switch.
The claims to the ‘877 patent in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to a multicarbon product, the microorganism comprising a heterologous gene under the control of a promoter that is responsive to a rare earth metal. Dependent claim 3 recites the microorganism is a methanotroph. Dependent claim 4 recites wherein the heterologous gene of the genetically modified microorganism encodes acetolactate synthase, alpha-acetolactate decarboxylase, acetoin reductase, or any combination thereof. Dependent claim 5 is drawn to a method of making a useful product such as 2,3-butanediol by contacting said genetically modified microorganism with a C1 carbon source.
Thus, when claims 1, 4 and 5 of the ‘877 patent are combined, it is clear that the recombinant microorganism of the ‘877 patented claims are capable of production of 2,3-BDO from a C1 carbon source, thus rendering obvious the instant claims.
Claims 2, 6-7, 14, 17, 128, 130-132 and 135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12091667. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘667 patent render obvious the instant claims.
The instant claims in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to 2,3-butanediol (2,3-BDO), the microorganism comprising at least one heterologous gene encoding (a) an NADPH-dependent acetoin reductase, (b) an alpha-acetolactate decarboxylase and/or (c) an acetolactate synthase (claim 128). Dependent claim 14 recites the microorganism is a methanotroph; and claim 17 recites it is Methylcoccus capsulatus. Dependent claim 7 recites the heterologous acetolactate synthase has at least 90% identity to SEQ ID NOs: 1 or 19; the heterologous alpha-acetolactate decarboxylase has at least 90% identity to SEQ ID NO: 7 and/or the heterologous acetoin reductase has at least 90% identity to SEQ ID NO: 9. Dependent claim 135 recites the heterologous genes are under the control of a switch.
The claims to the ‘667 patent in their broadest are drawn to a vector comprising (a) genes encoding the following polypeptides: (i) an acetolactate synthase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 1; (ii) an alpha-acetolactate decarboxylase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 9; and (iii) an acetoin reductase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 11; and (b) a promoter driving the expression of such genes, the promoter being pMxAF or pXoxF. Dependent claim 3 recites the methods of making a genetically modified methanotroph capable of converting a C1 carbon to a multicarbon product, wherein said methanotroph, including Methylcoccus, has been transformed with the vector above. Dependent claim 4 recites wherein a method of making a multicarbon product by making a genetically modified methanotroph capable of converting a C1 carbon to a multicarbon product, wherein said methanotroph, including Methylcoccus, has been transformed with the vector above and growing said methanotroph to produce the multicarbon product, wherein dependent claim 5 recites the multicarbon product that is made is 2,3-butanediol.
Thus, when claims 1, 4 and 5 of the ‘667 patent are combined, it is clear that the vector comprising the recombinant genetically modified methanotroph of the ‘667 patented claims are capable of production of 2,3-BDO from a C1 carbon source, thus rendering obvious the instant claims.
Claims 2, 6-7, 14, 17, 128, 130-132 and 135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-10 of U.S. Patent No. 10876137. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘137 patent render obvious the instant claims.
The instant claims in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to 2,3-butanediol (2,3-BDO), the microorganism comprising at least one heterologous gene encoding (a) an NADPH-dependent acetoin reductase, (b) an alpha-acetolactate decarboxylase and/or (c) an acetolactate synthase (claim 128). Dependent claim 14 recites the microorganism is a methanotroph; and claim 17 recites it is Methylcoccus capsulatus. Dependent claim 7 recites the heterologous acetolactate synthase has at least 90% identity to SEQ ID NOs: 1 or 19; the heterologous alpha-acetolactate decarboxylase has at least 90% identity to SEQ ID NO: 7 and/or the heterologous acetoin reductase has at least 90% identity to SEQ ID NO: 9.
The claims to the ‘137 patent in their broadest are drawn to a genetically modified methanotroph capable of converting methane to a multi-carbon product comprising a heterologous nucleic acid encoding for a ketoacid decarboxylase (KDC), wherein the KDC has ketoacid decarboxylase activity and comprises an amino acid sequence having at least 90% sequence homology to SEQ ID NO: 8, wherein said methanotroph is capable of converting formaldehyde to pyruvate through a type I RuMP pathway or a type II serine pathway. Dependent claim 2 recites the genetically modified methanotroph further comprises a nucleic acid encoding one or more enzymes selected from four different enzymes, including acetolactate synthase. Dependent claim 3 recites wherein the one or more nucleic acids are heterologous. Dependent claim 7 recites the methanotroph is Methylcoccus capsulatus. While the patented claims do not recite multi-carbon product is 2,3-BDO, it is clear when construing the scope of the patented claims in understanding the context and meaning of “multi-carbon product” as defined in the specification (See MPEP 804(II)(B)(1)), “multi-carbon product” is defined as including 2,3-BDO – See Col. 17, lines 31-42).
Thus, when claims 1-3 and 5 of the ‘137 patent are combined, it is clear that the recombinant microorganism of the ‘137 patented claims are capable of production of 2,3-BDO from a C1 carbon source, thus rendering obvious the instant claims.
Provisional:
Claims 2, 6-7, 14, 17, 128, 130-132 and 135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 91-107 and 110 of copending Application No. 18379079 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘079 application render obvious the instant claims.
The instant claims in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to 2,3-butanediol (2,3-BDO), the microorganism comprising at least one heterologous gene encoding (a) an NADPH-dependent acetoin reductase, (b) an alpha-acetolactate decarboxylase and/or (c) an acetolactate synthase (claim 128). Dependent claim 14 recites the microorganism is a methanotroph; and claim 17 recites it is Methylcoccus capsulatus. Dependent claim 7 recites the heterologous acetolactate synthase has at least 90% identity to SEQ ID NOs: 1 or 19; the heterologous alpha-acetolactate decarboxylase has at least 90% identity to SEQ ID NO: 7 and/or the heterologous acetoin reductase has at least 90% identity to SEQ ID NO: 9.
The claims to the ‘079 application are drawn to a genetically modified methanotroph comprising a heterologous polynucleotide encoding for an acetolactate synthase (ALS), wherein the acetolactate synthase can catalyze the conversion of pyruvate to acetolactate and comprises an amino acid sequence having at least 90% sequence homology to SEQ ID NO: 2, and wherein said genetically modified methanotroph is capable of converting formaldehyde to pyruvate through a type I RuMP pathway or a type II serine pathway. Dependent claim 104 recites wherein the genetically modified methanotroph is Methylcoccus capsulatus. Dependent claim 106 recites a method of making a multi-carbon compound by (a) contacting a genetically modified methanotroph with a multi-carbon product precursor comprising a heterologous polynucleotide encoding for an acetolactate synthase (ALS), wherein the ALS can catalyze the conversion of pyruvate to acetolactate and comprises an amino acid sequence having at least 90% sequence homology to SEQ ID NO: 2, and wherein said methanotroph is capable of converting formaldehyde to pyruvate through a type I RuMP pathway or a type II serine pathway; and (b) growing said methanotroph in conditions to produce a multi-carbon compound. While the applications claims do not recite multi-carbon product is 2,3-BDO, it is clear when construing the scope of the patented claims in understanding the context and meaning of “multi-carbon product” as defined in the specification (See MPEP 804(II)(B)(1)), “multi-carbon product” is defined as including 2,3-BDO – See paragraph 0075 of PG-Pub.
Thus, when claims 91 and 106 of the ‘079 application are combined, it is clear that the genetically modified methanotroph of the ‘079 application claims are capable of production of 2,3-BDO from a C1 carbon source, thus rendering obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 6-7, 14, 17, 128, 130-132 and 135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 70-75, 85, 87-88, 92, 94-96, 103, 107-108, 128-131 of copending Application No. 18805099 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘099 application render obvious the instant claims.
The instant claims in their broadest are drawn to a genetically modified microorganism capable of converting a C1 carbon to 2,3-butanediol (2,3-BDO), the microorganism comprising at least one heterologous gene encoding (a) an NADPH-dependent acetoin reductase, (b) an alpha-acetolactate decarboxylase and/or (c) an acetolactate synthase (claim 128). Dependent claim 14 recites the microorganism is a methanotroph; and claim 17 recites it is Methylcoccus capsulatus. Dependent claim 7 recites the heterologous acetolactate synthase has at least 90% identity to SEQ ID NOs: 1 or 19; the heterologous alpha-acetolactate decarboxylase has at least 90% identity to SEQ ID NO: 7 and/or the heterologous acetoin reductase has at least 90% identity to SEQ ID NO: 9. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims to the ‘099 application in their broadest are drawn to a vector comprising (a) genes encoding the following polypeptides: (i) an acetolactate synthase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 5; (ii) an alpha-acetolactate decarboxylase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 9; and (iii) an acetoin reductase comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 11; and (b) a promoter driving the expression of such genes, said promoter being responsive to rare earth metals and active in a methanotroph (claim 70). Dependent claim 85 recites the methods of making a genetically modified methanotroph capable of converting a C1 carbon to a multicarbon product. Dependent claim 87 recites wherein a method of making a multicarbon product by making a microorganism with a vector of claim 70, thereby making a genetically modified microorganism, contacting said genetically modified microorganism with a C1 carbon, and growing the methanotroph to produce multicarbon product, wherein dependent claim 88 recites the multicarbon product that is made is 2,3-butanediol.
Thus, when claims 70, 87-88 of the ‘099 application are combined, it is clear that the vector comprising the recombinant genetically modified methanotroph of the ‘667 patented claims are capable of production of 2,3-BDO from a C1 carbon source, thus rendering obvious the instant claims.
APPLICANT’S RESPONCE & EXAMINERS REBUTTAL:
Applicant’s indicate they may file terminal disclaimers, as appropriate, when allowable subject matter has been identified.
It is noted, the Non-Statutory Double Patenting rejections of record are the only rejections of record remaining.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 06 March 2026