DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of Group II (Invention II) in the reply filed on 07/22/2025 is acknowledged. Claims 1, 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 2-12, 20 are under consideration in this Office Action.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
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 2-12, 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 pre-AIA the applicant regards as the invention.
Claim 2 recites the phrase “a derivative thereof (e.g., expressing a heterologous polypeptide such as a glucoamylase and/or alpha-amylase) or a fermenting organism having properties that are about the same as that of Saccharomyces cerevisiae” which renders the claim vague and indefinite since it is unclear if the claim is limited to a strain expressing a heterologous polypeptide including glucoamylase and/or alpha-amylase; and the specific properties that are “about the same as that of Saccharomyces cerevisiae” are not know and not recited in the claim. Dependent claims 3-12, 20 are also rejected because they do not correct the defect.
Claims 4-7 recite the phrase “capable of” which renders the claims vague and indefinite since it is unclear if the recombinant Saccharomyces cerevisiae strain have the properties of higher ethanol yield and production or greater than 95% glucose consumption.
For examination purposes the claims are deemed to encompass any Saccharomyces cerevisiae strains and any derivatives thereof, and are not limited to MBG5151 and MBG5248.
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Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 2 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that the recited Saccharomyces cerevisiae strain MBG5151 and Saccharomyces cerevisiae strain MBG5248 are required to practice the claimed invention. As such the Saccharomyces cerevisiae strains must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC § 112, first paragraph, may be satisfied by a deposit of the Saccharomyces cerevisiae strains.
The process disclosed in the specification to make and/or obtain the Saccharomyces cerevisiae strain MBG5151 and Saccharomyces cerevisiae strain MBG5248 do not appear to be repeatable. It is noted that the claim references deposit accession numbers NRRL Y-67971 and NRRL Y-68015. However, it is not apparent if the source materials to make the Saccharomyces cerevisiae strains are both known and readily available to the public. Thus, all of the conditions of 37 CFR 1.801-1.809 have not been met since there is no indication in the specification as to public availability.
If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by the applicant, or a statement by an attorney of record over his/her signature and registration number, stating that the specific microorganism has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of the patent, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. 1.801-1.809 and MPEP 2402-2411.05, the applicant may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his/her signature and registration number, showing that:
(1) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(2) all restriction upon availability to the public will be irrevocably removed upon granting of the patent;
(3) the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer; and
(4) the deposit will be replaced if it should ever become inviable.
For examination purposes the claims are deemed to encompass any Saccharomyces cerevisiae strains and any derivatives thereof, and are not limited to MBG5151 and MBG5248.
Claims 2-12, 20 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a broad and widely varying genus of recombinant Saccharomyces cerevisiae strains including derivatives and variants of Saccharomyces cerevisiae strain MBG5151 having properties that are about the same as said strain MBG5151, and genus of recombinant Saccharomyces cerevisiae strains including derivatives and variants of Saccharomyces cerevisiae strain MBG5248 having properties that are about the same as said strain MBG5248. According to MPEP 2163:
“For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The reference of Kizer et al. (Appl Environ Microbiol. 2008 May;74(10):3229-41; PTO 892), which teaches that producing complex chemicals using synthetic metabolic pathways in microbial hosts is often complicated by deleterious interactions between pathway intermediates and the host cell metabolism [see p. 3229, abstract], noting that “… embedding a novel biochemical pathway in the metabolic network of a host cell can disrupt the subtle regulatory mechanisms that the cell has evolved over the millennia" [see p. 3229, column 1] and “[w]hile it can be relatively simple to determine that an engineered synthetic biochemical pathway is not functioning in the heterologous host, it is often a far more challenging task to determine exactly what is causing the problem” [p. 3237, column 2]. The reference of Prather et al. (Curr Opin Biotechnol. 2008 Oct;19(5):468-74; PTO 892) teaches numerous challenges associated with constructing de novo metabolic pathways, including selection of the appropriate enzymes in a multi-step pathway, compatibility of the enzymes with the expression host and with each other, and the requirement to engineer one or more of the enzymes to achieve the desired activity on a given substrate [see p. 472, columns 1-2]. Prather et al. specifically teach that “while synthetic biology provides a complementary framework for de novo pathway design, it is unclear how well some of the core principles, for example, Abstraction, can be implemented [see p. 472, column 2, top]. The reference teachings only provide guidance for searching and screening for the claimed genus recombinant Saccharomyces cerevisiae strains including derivatives and variants of Saccharomyces cerevisiae strain MBG5151 having properties that are about the same as said strain MBG5151, and genus of recombinant Saccharomyces cerevisiae strains including derivatives and variants of Saccharomyces cerevisiae strain MBG5248 having properties that are about the same as said strain MBG5248.
The specification as originally filed does not disclose a representative number of species encompassed by the claimed genus by actual reduction to practice. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict the specific genetic modifications and nucleic acids encoding heterologous enzymes and/or proteins that can be performed on the genus of recombinant Saccharomyces cerevisiae strains which will allow the genus of recombinant Saccharomyces cerevisiae strains to use xylose as carbon source for production of ethanol.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed broad and widely varying genus of recombinant Saccharomyces cerevisiae strains including derivatives and variants of Saccharomyces cerevisiae strain MBG5151 having properties that are about the same as said strain MBG5151, and genus of recombinant Saccharomyces cerevisiae strains including derivatives and variants of Saccharomyces cerevisiae strain MBG5248 having properties that are about the same as said strain MBG5248.
For examination purposes the claims are deemed to encompass any Saccharomyces cerevisiae strains and any derivatives thereof, and are not limited to MBG5151 and MBG5248.
Claim Rejections - 35 USC § 102
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 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 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.
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2016045569 (03/31/2016; IDS filed 03/03/2023).
For the reasons stated above and for examination purposes the claim is deemed to encompass any Saccharomyces cerevisiae strains and any derivatives thereof, and are not limited to MBG5151 and MBG5248.
WO2016045569 teaches Saccharomyces cerevisiae strain CIBTS1260 modified with recombinant genes for ethanol production from cellulosic material and its properties with respect to ethanol yield or xylose consumption in Table 3, wherein said strain CIBTS1260 was used in the instant application as reference and basis for further evolution to obtain the deposited strains (see entire publication and claims especially Table 3, claims 10-25). WO2016045569 teaches the following in the claims:
[Claim 12]
A recombinant fermenting organism having properties that are the same as that of Saccharomyces cerevisiae CIBTS1260 (deposited under Accession No. NRRL Y-50973 at the Agricultural Research Service Culture Collection (NRRL) , Illinois 61604 U.S.A.) or a fermenting organism having properties that are about the same as that of Saccharomyces cerevisiae CIBTS1260.
[Claim 13]
The fermenting organism of claim 12, wherein the fermenting organism having properties that are about the same as that of Saccharomyces cerevisiae CIBTS1260 has one or more, such as all, of the following properties:
- higher xylose consumption compared to BSGX001 after 48 hours fermentation at 1 g DWC/L, 35℃, pH 5.5；
- higher glucose consumption compared to BSGX001 after 48 hours fermentation at 1 g DWC/L, 35℃, pH 5.5；
- higher ethanol production compared to BSGX001 after 48 hours fermentation at 1 g DWC/L, 35℃, pH 5.5.
[Claim 14]
The fermenting organism of claim 12 or 13 having properties that are about the same as that of Saccharomyces cerevisiae CIBTS1260 provides full xylose consumption by 48 hours fermentation under the process conditions in Example 3, i.e., 1 g DCW/L, 35℃, pH 5.5.
[Claim 15]
The fermenting organism of any of claims 12-14 having properties that are about the same as that of Saccharomyces cerevisiae CIBTS1260 provides full glucose consumption by 24 hours fermentation.
[Claim 16]
The fermenting organism of any of claims 12-15 having properties that are about the same as that of Saccharomyces cerevisiae CIBTS1260 provides more than 30 g/L ethanol, such as more than 40 g/L ethanol, such as more than 45 g/L ethanol, such as approximately 47 g/L ethanol after 48 hours fermentation.
[Claim 17]
The fermenting organism of any of claims 12-16 is Saccharomyces cerevisiae CIBTS1260 (deposited under Accession No. NRRL Y-50973 at the Agricultural Research Service Culture Collection (NRRL) , Illinois 61604 U.S.A.) .
[Claim 18]
The fermenting organism of any of claims 12-17, wherein the fermenting organism comprises a gene (e.g., SEQ ID NO: 20 herein) encoding the amino acid sequence having xylose isomerase activity shown in SEQ ID NO: 13 herein, or an amino acid sequence being at least 80％, such as at least 90％, such as at least 95％, such as at least 96％, such as at least 97％, such as at least 98％, such as at least 99％, such as 100％ identical to SEQ ID NO: 13 herein.
[Claim 19]
The fermenting organism of any of claims 12-18, wherein the fermenting organism comprises a pentose transporter gene.
[Claim 20]
The fermenting organism of any of claims 12-19, wherein the pentose transporter gene is a GFX gene, in particular GFX1 from Candida intermedia, in particular the one shown in SEQ ID NO: 18 herein.
[Claim 21]
The fermenting organism of any of claims 12-20, wherein the fermenting organism overexpresses a xylulokinase gene (XKS) , in particular from a type strain of Saccharomyces cerevisiae.
[Claim 22]
The fermenting organism of any of claims 12-20, wherein the fermenting organism overexpresses a ribulose 5 phosphate 3-epimerase gene (RPE1) , in particular from a type strain of Saccharomyces cerevisiae.
[Claim 23]
The fermenting organism of any of claims 12-22, wherein the fermenting organism overexpresses a ribulose 5 phosphate isomerase gene (RKI1) , in particular from a type strain of Saccharomyces cerevisiae.
[Claim 24]
The fermenting organism of any of claims 12-23, wherein the fermenting organism overexpresses a transketolase gene (TKL1) and overexpresses a transaldolase gene (TAL1) , in particular from a type strain of Saccharomyces cerevisiae.
[Claim 25]
The fermenting organism of any of claims 12-24, wherein the fermenting organism has one or more, such as all, of the following genetic modifications:
- xylose isomerases gene (Ru-XI) obtained from bovine rumen fluid, in particular the one shown in SEQ ID NO: 20 herein, encoding the xylose isomerase shown in SEQ ID NO: 13 herein；
- optionally a pentose transporter gene (GXF1) from Candida intermedia, in particular the one shown in SEQ ID NO: 18 herein；
- xylulokinase gene (XKS) , in particular from a type strain of Saccharomyces cerevisiae；
- ribulose 5 phosphate 3-epimerase gene (RPE1) , in particular from a type strain of Saccharomyces cerevisiae；
- ribulose 5 phosphate isomerase gene (RKI1) , in particular from a type strain of Saccharomyces cerevisiae；
- transketolase gene (TKL1) and transaldolase gene (TAL1) , in particular from a type strain of Saccharomyces cerevisiae.
Since the claim recite a fermenting organism having properties that are about the same as that of Saccharomyces cerevisiae MBG5151 or MBG5248, then the taught strain CIBTS1260 is deemed to have properties that are about the same as that of Saccharomyces cerevisiae MBG5151 or MBG5248 and anticipates the claimed invention.
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 of this title, 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.
Claims 2-12, 20 are rejected under 35 U.S.C. 103 as being unpatentable over WO2016045569 (03/31/2016; IDS filed 03/03/2023) in view of US20060216804 (09/28/2006; PTO 892), US20100035306 (02/11/2010; PTO 892).
For the reasons stated above and for examination purposes the claim is deemed to encompass any Saccharomyces cerevisiae strains and any derivatives thereof, and are not limited to MBG5151 and MBG5248.
The teachings of WO2016045569 have been stated above in the rejection of claim 2 under 35 U.S.C. 102(a)(1).
The teachings of the reference differ from the claims in that the reference does not teach that the recombinant Saccharomyces cerevisiae higher ethanol fermentation kinetics compared to Saccharomyces cerevisiae CIBTS1260, higher xylose consumption compared to Saccharomyces cerevisiae CIBTS1260, and/or higher glucose consumption compared to Saccharomyces cerevisiae CIBTS1260.
US20060216804 teaches the construction of xylose utilizing Saccharomyces cerevisiae strains for fermenting ethanol expressing xylose isomerase (XI), overexpressing xylulokinase (XK), overexpressing the pentose phosphate pathway (PPP), and non-expressing aldose reductase (AR) and being adapted to growth in mineral defined medium with xylose as sole carbon source (see entire publication and claims especially paragraphs [0018]- [0020]). US20060216804 teaches the following in the claims:
1. A saccharomyces cerevisiae strain utilizing xylose for fermenting ethanol expressing xylose isomerase (XI), overexpressing xylulokinase (XK), overexpressing the pentose phosphate pathway (PPP), and non-expressing aldose reductase (AR) and being adapted to growth in mineral defined medium with xylose as sole carbon source.
2. A saccharomyces cerevisiae strain according to claim 1, wherein the strain expresses xylose isomerase derived from a Thermus thermophilus xylA gene, overexpresses xylulokinase by an addition of a plasmid YIpXK (Lönn et al. 2003) linearized with NdeI coding for xylulokinase, overexpresses the pentose phosphate pathway by adding the genes TAL1, TKL1, RPE1, RKI1, and non-expresses aldose reductase by deletion of the gene GRE3 and being adapted to growth in mineral defined medium with xylose as sole carbon source.
3. A saccharomyces cerevisiae strain according to claim 1, wherein the strain exhibits a growth rate of at least 0.12 h−1, and a xylose uptake rate of at least 0.10 g xylose/g cells/h.
4. A Saccharomyces cerevisiae strain according to claim 1, wherein the strain is TMB3050 deposited at Deutsche Sammlung von Mikroorganismen und Zellkulturen under deposition number DSM 15834.
US20100035306 teaches the introduction of a functional xylose isomerase into Saccharomyces cerevisiae and mentions the involvement of the endogenous xylulokinase and the enzymes of the non-oxidative part of the pentose phosphate pathway, which includes RPE1, RKI1, TKL1, and TAL1 (see entire publication and claims especially paragraphs [0009]-[0044]). US20100035306 teaches the following in the claims:
11. A cultured yeast or filamentous fungal cell transformed with a nucleic acid expression construct which construct comprises:
(a) a nucleotide sequence that encodes xylose isomerase protein, the amino acid sequence of which is at least 70% identical with SEQ ID NO:1, and
(b) operative linked to the nucleotide sequence of (a), a promoter that drives active expression of the xylose isomerase coding sequence in the transformed cell,
wherein, said expression construct is expressible in said cell and expression thereof confers on the cell the ability to directly isomerize xylose to xylulose.
12. The cell according to claim 11, wherein the nucleotide sequence encodes a xylose isomerase the amino acid sequence of which is SEQ ID NO:1.
13. The cell according to claim 11, wherein the cell is a yeast cell.
14. The yeast cell of claim 13 that is a member of a genus selected from the group consisting of Saccharomyces, Kluyveromyces, Candida, Pichia, Schizosaccharomyces, Hansenula, Kloeckera, Schwanniomyces, and Yarrowia.
15. The yeast cell according to claim 14 that is a member of a species selected from the group consisting of S. cerevisiae, S. bulderi, S. barnetti, S. exiguus, S. uvarum, S. diastaticus, K. lactis, K. marxianus, and K. fragilis.
16. The cell according to claim 11, wherein the cell is a filamentous fungus.
17. The filamentous fungus cell of claim 16 that is a member of a genus selected from the group consisting of Aspergillus, Trichoderma, Humicola, Acremonium, Fusarium, and Penicillium.
18. The cell according to claim 11, wherein the promoter is insensitive to catabolite repression in the cell.
19. The cell according to claim 11 that has been further genetically modified to confer on the cell one or more of the following properties:
(1) increased transport of xylose into the host cell;
(2) increased xylulose kinase activity;
(3) increased flux of the pentose phosphate pathway;
(4) decreased sensitivity to catabolite repression;
(5) increased tolerance to ethanol, osmolarity or organic acids; or
(6) decreased production of by-products,
in comparison to a similar cell that has not undergone said genetic modification.
20. The cell according to claim 19, wherein the nucleotide sequence encodes a xylose isomerase the amino acid sequence of which is SEQ ID NO:1.
21. The cell according to claim 19, wherein the genetic modification that results in said properties (1)-(6) is
(A) overexpression of an endogenous gene,
(B) expression of a heterologous gene, or
(i) a pentose transporter;
(ii) a xylulose kinase;
(iii) an enzyme from the pentose phosphate pathway,
(iv) a glycolytic enzyme, or
(v) an ethanologenic enzyme.
22. The cell according to claim 19 wherein the genetic modification that results in said properties (1)-(6) is one that causes inactivation of one of the following endogenous genes:
(a) a gene encoding a hexose kinase
(b) Saccharomyces MIG1 gene;
(c) Saccharomyces MIG2 gene; or
(d) a gene homologous to (a), (b) or (c) and which hybridizes thereto.
23. The cell according to claim 11, that further expresses one or more enzymes that confers on the cell the ability to produce a non-ethanolic fermentation product.
24. The cell according to claims 23 which is a yeast cell.
25. The cell according to claim 25 wherein said fermentation product is selected from the group consisting of lactic acid, acetic acid, succinic acid, amino acids, 1,3-propanediol, ethylene, and glycerol.
26. The cell according to claim 23, wherein the cell is a filamentous fungus.
27. The cell according to claim 23 wherein said fermentation product is a β-lactam antibiotic or a cephalosporin.
28. The cell according to claim 23 in which alcohol dehydrogenase activity is genetically decreased to reduce ethanol production by said cell.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by using the methods of constructing recombinant Saccharomyces cerevisiae taught by US20060216804 and US20100035306 on the recombinant Saccharomyces cerevisiae of WO2016045569 to express heterologous genes encoding any of the recited enzymes and enzyme combinations stated in the claims including heterologous gene encoding xylose isomerase, heterologous gene encoding pentose transporter gene, heterologous gene encoding xylulokinase, and combination of RPE1, RKI1, TKL1, and TAL1; search and screen for the recombinant Saccharomyces cerevisiae higher ethanol fermentation kinetics compared to Saccharomyces cerevisiae CIBTS1260, higher xylose consumption compared to Saccharomyces cerevisiae CIBTS1260, and/or higher glucose consumption compared to Saccharomyces cerevisiae CIBTS1260; and forming a composition comprising the recombinant Saccharomyces cerevisiae in aqueous solution comprising other components including buffer and culture media. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to obtain the recombinant Saccharomyces cerevisiae having the recited properties that can be used to produce ethanol from xylose as a carbon source. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because constructing recombinant Saccharomyces cerevisiae strains for producing ethanol from xylose are known in the art as shown by the reference teachings. Hence, the claimed invention as a whole is prima facie obvious.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 2-12, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-6 of US Patent 11473109 (10/18/2022; PTO 892).
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons. For the reasons stated above and for examination purposes the claim is deemed to encompass any Saccharomyces cerevisiae strains and any derivatives thereof, and are not limited to MBG5151 and MBG5248.
The claims and/or specification of the patent teach a Saccharomyces yeast strain selected from: Saccharomyces cerevisiae strain MBG5038 (deposited under Accession No. NRRL Y67549 at the Agricultural Research Service Patent Culture Collection (NRRL), Northern Regional Research Center, 1815 University Street, Peoria, IL., USA); and Saccharomyces cerevisiae strain MBG5012 (deposited under Accession No. NRRL Y67700 at the Agricultural Research Service Patent Culture Collection (NRRL), Northern Regional Research Center, 1815 University Street, Peoria, IL., USA).
Thus, the teachings anticipate the claimed recombinant Saccharomyces cerevisiae strain or a derivative thereof.
Claims 2-12, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11 of US Patent 10889836 (01/12/2021; PTO 892)
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons. For the reasons stated above and for examination purposes the claim is deemed to encompass any Saccharomyces cerevisiae strains and any derivatives thereof, and are not limited to MBG5151 and MBG5248.
The claims and/or specification of the patent teach a Saccharomyces cerevisiae yeast strain, wherein the strain is Saccharomyces cerevisiae strain MBG4985 (deposited under Accession No. NRRL Y67342 at the Agricultural Research Service Patent Culture Collection (NRRL), Northern Regional Research Center, 1815 University Street, Peoria, Ill., USA), and composition comprising said Saccharomyces cerevisiae yeast strain.
Thus, the teachings anticipate the claimed recombinant Saccharomyces cerevisiae strain or a derivative thereof.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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