DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for priority to Korean Patent Application No. 10-2022-0032842 filed March 16, 2022. Receipt of a Certified Copy of Foreign Priority Application is acknowledged. However, the present application does not yet satisfy the formal requirements to establish entitlement to the benefit of the earlier foreign filing date. Specifically, the following items are required under 37 CFR 1.55 and MPEP § 214:
Certified Copy English Translation of Foreign Application: A certified copy of the foreign application (specification and drawings) upon which the priority claim is based must be submitted. If the foreign application is not in the English language, a verified English translation must also be provided.
Status of the Claims
Amendments dated 09/11/2024 are entered.
Claims 1-24 are canceled.
Claims 25-44 are entered.
Claims 25-44 is/are pending.
Claims 25-44 is/are examined herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/11/2024 is acknowledged and is being considered by the Examiner.
Claim Objections
Claim 25 is objected to for the following informalities:
“linked to a 5' end of the FMM promoter” instead of .linked to the 5' end of the FMM promoter; a typical sequence only has one 5’ end.
Claim Rejections - 35 USC § 112b
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 25-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend. Details are listed below.
Claims 25 and 34, both independent claims, recite “a gene construct for high expression.” It is unclear what the relative term “high expression” refers to. Is it 60%, 80%, or closer to 100% expression, or more? Is this high expression objective or is it relative to some other gene or relative to the expression level of the gene of interest in a wildtype organism? Further, this claim language indicates the lack of a comparative basis.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25-27, 37, 39, 41 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar(cited in IDS; Kumar D, Patro S, Ranjan R, Sahoo DK, Maiti IB, et al. (2011) Development of Useful Recombinant Promoter and Its Expression Analysis in Different Plant Cells Using Confocal Laser Scanning Microscopy. PLOS ONE 6(9): e24627. https://doi.org/10.1371/journal.pone.0024627, published 9/9/2011) in view of Maiti (cited in IDS; U.S. Patent Publication No. 6420547 B1, Assigned to UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, published 16 July 2002), and Mizutani (cited in IDS; MIZUTANI, A. et al. Regions of GAL4 critical for binding to a promoter in vivo revealed by a visual DNA-binding analysis. The EMBO Journal. 2003, vol. 22, no. 9, pp. 2178-2187, published 5/1/2003).
Kumar teaches a plant expression vector carrying a recombinant promoter (MSgt-FSgt) in which a Figwort mosaic virus sub-genomic transcript promoter fragment is coupled with a Mirabilis mosaic virus sub-genomic transcript promoter fragment (i.e., an FMM promoter in which a Figwort subgenomic transcript promoter gene fragment, and a Mirabilis mosaic virus subgenomic transcript promoter gene fragment are sequentially linked)(see abstract and pages 3-4).
Kumar does not explicitly teach Mirabilis mosaic virus full-length transcript fragment and an upstream DNA (UD) having four repeated copies of an upstream activation sequence (UAS), which is a GAL4-binding site of yeast, linked to the 5' end of the FMM promoter.
Maiti is in the field of promoters like Kumar and teaches that the “full-length transcript promoter from mirabilis mosaic caulimovirus (MMV)… functions as a strong and uniform promoter for chimeric genes inserted into plant cells” (i.e., Mirabilis mosaic virus full-length transcript fragment )(abstract).
Mizutani is in the field of promoters like Kumar and teaches that transcription activators are allowed to effectively bind to promoters having four GAL4-binding sites (i.e., an upstream DNA having four repeated copies of an upstream activation sequence (UAS), which is a GAL4-binding site of yeast)(see title, abstract, and figure 1). Mizutani also teaches that the 4 GAL4 copies are located upstream of the coding sequence of a gene of interest, RFP, where the promoter is typically placed and thus would make sense for the 4X GAL4 to be downstream of a promoter sequence like FMM (i.e., linked to the 5' end of the FMM promoter)(Figure 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to modify Kumar’s recombinant promoter with the combined teachings of Maiti’s full-length transcript promoter from mirabilis mosaic caulimovirus and Mizutani’s four copies of GAL4‐binding site to arrive upon the claimed invention. One would have been motivated to this in order to “enhance promoter binding [and] binding of diverse regulatory factors to DNA in vivo” (Mizutani Abstract).
Regarding Claim 26, which depends from claim 25, Kumar teaches the “Mirabilis mosaic virus sub-genomic transcript (MS8, -306 to +27) and TATA containing core domains of Figwort mosaic virus sub-genomic transcript promoter (FS3, −271 to +31)(Table 1) and primers used for amplifying the fragments (Table 2). The Figwort subgenomic transcript promoter gene comprising a nucleotide sequence of SEQ ID NO: 1 and the Mirabilis mosaic virus subgenomic transcript promoter gene comprising a nucleotide sequence of SEQ ID NO: 2 could easily have been derived by one of ordinary skill in the art before the filing of the claimed invention due to the teachings of Kumar and the availability of the genomic and subgenomic annotated sequences of both viruses on public and routinely used databases. Maiti’s SEQ ID NO: 4 teaches the MMV full length transcript promoter DNA sequence and is a 100 percent match of SEQ ID NO: 3. (i.e., the Mirabilis mosaic virus full-length transcript promoter gene comprises a nucleotide sequence of SEQ ID NO: 3).
Regarding claim 27, given that Kumar teaches “Mirabilis mosaic virus sub-genomic transcript (MS8, -306 to +27) and TATA containing core domains of Figwort mosaic virus sub-genomic transcript promoter (FS3, −271 to +31) and Maiti’s SEQ ID NO: 4 teaches the MMV full length transcript promoter DNA sequence (see claim 26), one of ordinary skill in the art before the filing of the claimed invention would have been motivated and able use standard procedures in art recombine the sequences into a Binary vector plasmid, like pINDEX1, that comprises at least a 93 percent match to SEQ ID NO: 4 (i.e., : the gene construct of claim 25, FMM-UD promoter gene comprises a nucleotide sequence of SEQ ID NO: 4) in order to ascertain enhanced “high-level constitutive expression of transgenes in a wide variety of plant cells” (Kumar Abstract).
Regarding claims 37 and 39, which depend from claim 25 and are listed below for reference within this document, Kumar teaches “promoter-GUS vectors” where the GUS gene encodes the reporter protein GUS and can be replaced by other genes encoding proteins of interest like GFP (i.e., the protein of interest is a reporter gene)( page 2, col 2, last 3 para). Maiti teaches “a chimeric gene construct containing… multiple enhancer domains… and a coding sequence for a protein of interest” (see column 1 lines 7-23).
37. (new): A recombinant expression vector for high expression of a gene of a protein of interest, comprising:
the gene construct according to claim 25; and
a gene encoding a protein of interest.
39. (new): The recombinant expression vector of claim 37, wherein the protein of interest is at least any one protein selected from the group consisting of human interleukin 6, a transcription factor, a toxic protein, a hormone, a hormone analog, a cytokine, a movement protein, an enzyme, an enzyme inhibitor, a transport protein, a structural protein, a receptor, a receptor fragment, a biological defense inducer, a storage protein, an exploitative protein, a reporter protein, an antigen, an antibody and an antibody fragment.
Regarding claims 41 and 43, which depend from claim 37 and ultimately depend from claim 24, Mason teaches a plant expression vector and Agrobacterium transformed with the vector (i.e., A transformant for high expression of a gene of a protein of interest, transformed with the recombinant expression vector of claim 37)(see claims 1 and 45-47) and that “the plant or plant part is transformed by the plant expression vector of claim 1 via agroinfiltration” (i.e., A plant, into which the transformant of claim 41 is introduced)(see claims 1, 45-47, and 49).
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar, Maiti, and Mizutani as applied to claim 25 above in view of Limphong (cited in IDS; U.S. Patent Application Publication No. 20190002906A1, assigned to ARCTURUS THERAPEUTICS, INC., published 1/3/2019). The claims are listed below for reference within this document.
Claim 28: The gene construct of claim 25, TATA box sequence is comprised at a 3' end of the FMM-UD promoter, and a 5' UTR gene is linked to a 5' end of the FMM-UD promoter.
Claim 29: The gene construct of claim 28, wherein the 5' UTR gene comprises a nucleotide sequence of SEQ ID NO: 5.
Maiti teaches “a 3′ untranslated region downstream of the promoter's TATA box” ( claim 2)(i.e., the TATA box sequence is comprised at a 3' end of the promoter).
Kumar, Maiti, nor Mizutani do not explicitly teach a 5' UTR gene is linked to a 5' end of the FMM-UD promoter.
Limphong is in the field of target gene expression like Kumar and teaches expression of a target plant gene using an mRNA construct comprising a 5' UTR represented by SEQ ID NO: 10 which is identical to SEQ ID NO: 5 in the present application (i.e., the 5' UTR gene comprises a nucleotide sequence of SEQ ID NO: 5). Regarding the positioning of the 5' UTR gene being linked to the 5' end of the FMM-UD promoter, a person having ordinary skill in the art would be recognize the need to put the 5’ UTR downstream of the promoter region and any gene insertion region when constructing an expression vector.
Claims 30 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar, Maiti, and Mizutani as applied to claim 25 above in view of Mason (cited in IDS; U.S. Patent Application Publication No. 20200407741A1, assigned to ARIZONA BOARD OF REGENTS ON BEHALF OF ARIZONA STATE UNIVERSITY, published 8/31/2020). The claim is listed below for reference within this document.
Claim 30. (new): The gene construct of claim 25, further comprising a 3PR terminator in which a cauliflower mosaic virus 35S terminator gene, a 3' region of a potato proteinase inhibitor II gene, and a gene of an RB7 scaffold attachment site are sequentially linked.
The claim is drawn to a vector with a promoter, FMM-UD promoter, and a terminator, 3PR terminator.
Kumar, Maiti, and Mizutani teach the limitations of claim 25, which includes the FMM-UD promoter but do not explicitly teach a further comprised 3PR terminator in which a cauliflower mosaic virus 35S terminator gene, a 3' region of a potato proteinase inhibitor II gene, and a gene of an RB7 scaffold attachment site are sequentially linked.
Mason is in the field of recombinant expression vectors for protein production in plants and teaches that “an expression cassette comprises three components: a promoter sequence (part of the 5′ untranslated region, 5′ UTR), an open reading frame, and a 3′ untranslated region (3′ UTR) [where] regulatory sequences are found in the 5′ UTR and the 3′ UTR.” (para 39). Regulatory sequences include promoters and terminators meaning Expression cassettes or vectors comprise a promoter and a terminator regions.
Mason also teaches a vector carrying a terminator region, “35S-Pin2”, in which a cauliflower mosaic virus 35S terminator is fused to the 3' UTR region of potato proteinase inhibitor II (Pin2) and adds that “in some aspects, the vector further comprises a chromatin scaffold/matrix attachment region (MAR)” (Abstract) and that the MAR is Rb7 (i.e., a terminator in which a cauliflower mosaic virus 35S terminator gene, a 3' region of a potato proteinase inhibitor II gene, and a gene of an RB7 scaffold attachment site are linked)(see claims 1-5 and 14 and paragraphs [0044] and [0108]).
Mason teaches that the terminators are linked sequentially in the following order 35S-Pin2” and RB7( see paragraph 0010), but Applicants recite the terminators are sequentially linked where the list begins with Pin2, then 35S, and then RB7. Absent evidence to the contrary, the order of terminators does not appear to be to a matter of criticality nor would it produce an unexpected result.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the filing of the claimed invention to combine the enhanced promoter teachings of Kumar, Maiti, and Mizutani with the optimized terminator teachings of Mason arriving at the claimed invention because the art clearly recognizes that gene expression is controlled by both 5’UTR/promoter strength (Kumar, Maiti, and Mizutani) and 3' UTR/terminator efficiency (Mason). The Supreme Court in KSR Int'l Co. v. Teleflex Inc. held that combining prior art elements (Promoter + Terminator) according to known methods to yield predictable results is generally considered prima facie obvious. A person of ordinary skill in the art motivated to maximize expression of a gene of interest would look optimize both regulatory ends of the cassette5’UTR/promoter strength and 3' UTR/terminator regions.
Claims 31 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar, Maiti, Mizutani, and Mason as applied to claim 30 above in view of Islam (Islam et al (2020). In Vivo Removal of N-Terminal Fusion Domains From Recombinant Target Proteins Produced in Nicotiana benthamiana. Front. Plant Sci. 11:440. doi: 10.3389/fpls.2020.00440, published 4/8/2020) and Hwang (U.S. Patent Application Publication No. 20200354737A1, Assigned to BIOAPPLICATIONS INC., Published 11/12/2020). The claim is listed below for reference within this document.
Claim 31. (new): The gene construct of claim 30, wherein the gene construct comprises an expression cassette comprising a chaperone binding protein (BiP) gene, a mannosylated peptide region (MP) gene, a cellulose-binding module 3 (CBM3) gene, a small ubiquitin-related modifier (SUMO) gene, a gene encoding a protein of interest and a gene encoding His-Asp-Glu-Leu (HDEL) between the FMM-UD promoter and the 3PR terminator.
The specification states that the mannosylated peptide region (MP) recited in claim 31 is “a fragment consisting of 60 amino acid residues from alanine at position 231 to aspartic acid at position 290 of protein tyrosine phosphatase, receptor type, C (PTPRC), and these are for increasing the level of protein expression” (para 75). Glycosylation includes the addition of mannose sugars or mannosylation.
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Islam teaches an expression cassettes comprising BiP, M domain, CBM3, SUMO, human leukemia inhibitory factor (hLIF), and HDEL between an enhanced promoter region and a terminator region (see snippet of Figure 2A above) where the M domain is “a highly glycosylated domain derived from human CD45 which is a known protein tyrosine phosphatase receptor type C (PTPRC)” (page 7 col2, last para) and hLIF is the gene encoding the protein of interest (i.e., an expression cassette comprising a chaperone binding protein (BiP) gene, a mannosylated peptide region (MP) gene, a cellulose-binding module 3 (CBM3) gene, a small ubiquitin-related modifier (SUMO) gene, a gene encoding a protein of interest and a gene encoding His-Asp-Glu-Leu (HDEL) between the FMM-UD promoter and the 3PR terminator).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to combine and modify the teachings of Kumar, Maiti, Mizutani, and Mason with the expression cassettes thought by Islam and Hwang arriving at the claimed invention. One would have been motivated to this in order to enhance translation, increase the solubility of the recombinant protein, and increase targeting to the ER (Islam page 7, col 2, first partial para; Hwang para 0034).
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar, Maiti, Mizutani, Mason, Islam and Hwang as applied to claim 31 above in view of Lee (United States Publication No. 20200087351A1, Assigned to BIOAPPLICATIONS INC., Published 4/3/2019). The claim is listed below for reference within this document.
Claim 32. (new): The gene construct of claim 31, wherein an amino acid sequence of the BiP comprises an amino acid sequence of SEQ ID NO: 11, an amino acid sequence of the MP comprises an amino acid sequence of SEQ ID NO: 13, an amino acid sequence of the CBM3 comprises an amino acid sequence of SEQ ID NO: 17, and an amino acid sequence of the SUMO comprises an amino acid sequence of SEQ ID NO: 19.
Islam teaches: “the BiP leader sequence (BAA13947; amino acid positions 1 to 34)” ( page 3, col 1. para 2) which is 100% identical to SEQ ID NO: 11 of the instant application, and “SUMO domain (amino acids 21-97) of bdSUMO (XP_003564931.1)” (page 2 col 2 last para) which is 100% identical to SEQ ID NO: 19 of the instant application.
Islam does not explicitly teach an amino acid sequence of the MP comprises an amino acid sequence of SEQ ID NO: 13 and , an amino acid sequence of the CBM3 comprises an amino acid sequence of SEQ ID NO: 17.
Hwang is in the field of recombinant vectors for expressing target protein in plant cells and teaches the amino acid sequence of the M domain comprises an amino acid sequence of SEQ ID NO: 2 which is 100% identical to SEQ ID NO: 13 of the instant application.
Lee is in the field of recombinant vectors for expressing target protein in plant cells and teaches the amino acid sequence for CBM3 comprises an amino acid sequence of SEQ ID NO: 14 which is 100% identical to SEQ ID NO: 17 of the instant application.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to combine and modify the teachings of Kumar, Maiti, Mizutani, Mason, Islam, and Hwang with the teachings of Lee arriving at the claimed invention. One would have been motivated to this in order to increase the solubility of the recombinant protein (Islam page 7, col 2, first partial para).
Regarding claim 33, which depends from Claim 31 and is listed below for reference within this document Hwang teaches that a nucleotide sequence Recombinant vector BiP:Leptin:M comprises a nucleotide sequence of SEQ ID NO: 10 which is 100% identical to SEQ ID NO: 10 of the instant application and a nucleotide sequence M domain coding nucleic acid sequence comprises a nucleotide sequence of SEQ ID NO: 1 which is 100% identical to SEQ ID NO: 12 of the instant application (i.e., the BiP gene comprises a nucleotide sequence of SEQ ID NO: 10, and the MP gene comprises a nucleotide sequence of SEQ ID NO: 12).
33. (new): The gene construct of claim 31, wherein the BiP gene comprises a nucleotide sequence of SEQ ID NO: 10, the MP gene comprises a nucleotide sequence of SEQ ID NO: 12, the CBM3 gene comprises a nucleotide sequence of SEQ ID NO: 16, and the SUMO gene comprises a nucleotide sequence of SEQ ID NO: 18.
Lee teaches a nucleotide sequence of DNA sequence for CBM3 comprises a nucleotide sequence of SEQ ID NO: 13 which is 100% identical to SEQ ID NO: 16 of the instant application (i.e., the CBM3 gene comprises a nucleotide sequence of SEQ ID NO: 16).
Regarding claim 33’s limitation that the SUMO gene comprises a nucleotide sequence of SEQ ID NO: 18, Islam teaches the NCBI amino acid accession XP_003564931.1 which is derived from Brachypodium distachyon, has a corresponding nucleotide sequence and then teaches codon optimization of the nucleotide sequence based on the codon usage of the plant into which the gene will be transformed (page 2 col 2 last para). It is noted that the Applicant also stated that “the SUMO gene may be derived from Brachypodium distachyon” (para 72). Even though Islam does not recite the exact sequence of SEQ ID NO: 18, SEQ ID NO: 18 is interpreted as being codon optimized for the would be transformed plant (i.e., the SUMO gene comprises a nucleotide sequence of SEQ ID NO: 18).
Claims 34-36, 38, 40, 42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Mason (U.S. Patent Application Publication No. 20200407741A1, assigned to ARIZONA BOARD OF REGENTS ON BEHALF OF ARIZONA STATE UNIVERSITY, published 8/31/2020). Claim 34 is listed below for reference within this document.
34. (new): A gene construct for high expression of a gene of a protein of interest, comprising a 3PR terminator in which a cauliflower mosaic virus 35S terminator gene, a 3' region of a potato proteinase inhibitor II gene, and a gene of an RB7 scaffold attachment site are sequentially linked.
Mason is in the field of recombinant expression vectors for protein production in plants and teaches that “an expression cassette comprises three components: a promoter sequence (part of the 5′ untranslated region, 5′ UTR), an open reading frame, and a 3′ untranslated region (3′ UTR) [where] regulatory sequences are found in the 5′ UTR and the 3′ UTR.” (para 39). Regulatory sequences include promoters and terminators meaning Expression cassettes or vectors comprise a promoter and a terminator regions.
Mason also teaches a vector carrying a terminator region, “35S-Pin2”, in which a cauliflower mosaic virus 35S terminator is fused to the 3' UTR region of potato proteinase inhibitor II (Pin2) and adds that “in some aspects, the vector further comprises a chromatin scaffold/matrix attachment region (MAR)” (Abstract) and that the MAR is Rb7 (i.e., A gene construct for high expression of a gene of a protein of interest, comprising a 3PR terminator in which a cauliflower mosaic virus 35S terminator gene, a 3' region of a potato proteinase inhibitor II gene, and a gene of an RB7 scaffold attachment site are linked)(see claims 1-5 and 14 and paragraphs [0044] and [0108]).
Mason teaches that the terminators are linked sequentially in the following order 35S-Pin2” and RB7( see paragraph 0010), but Applicants recite the terminators are sequentially linked where the list begins with Pin2, then 35S, and then RB7. Absent evidence to the contrary, the order of terminators does not appear to be to a matter of criticality nor would it produce an unexpected result.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to recombine and modify the teachings of Mason, in order to optimize the terminator region of a gene expression vector (Mason, abstract).
Regarding claim 35-36, which depend from claim 34 and are listed below, Mason teaches the nucleotide sequences of 35S terminator gene, Pin2 gene, and RB7 gene are SEQ ID NOS: 2 (7-217 region, 100% identical to SEQ ID NO: 6 of the instant application), 3 (20-57 4 region, 99 .6% identical to SEQ ID NO:7 of the instant application), and 16 (713-1174 region, 100% identical to SEQ ID NO:8 of the instant application), respectively (see paragraphs [0054] and [0064]-[0066]).
35. (new): The gene construct of claim 34, wherein the cauliflower mosaic virus 35S terminator gene comprises a nucleotide sequence of SEQ ID NO: 6, the 3' region of the potato proteinase inhibitor II gene comprises a nucleotide sequence of SEQ ID NO: 7, and the gene of the RB7 scaffold attachment site comprises a nucleotide sequence of SEQ ID NO: 8.
36. (new): The gene construct of claim 34, wherein the 3PR terminator comprises a nucleotide sequence of SEQ ID NO: 9.
In light of the teachings of Mason, one of ordinary skill in the art before the filing of the claimed invention could easily derive the 3PR terminator comprising a nucleotide sequence of SEQ ID NO: 9. One would have been motivated to this in order to “[improve] protein production in plants” by optimizing the gene terminator and surrounding regions (Mason paragraph [0004]).
Regarding claims 38 and 40, which depend from claim 34 and are listed below, Mason teaches a “recombinant protein” (see claim 45) and a “gene of interest” (i.e., gene encoding a protein of interest)(FIGS. 1A and 1B description) wherein the gene of interest encodes a reporter protein like GFP or GUS (i.e., the protein of interest is a reporter gene).
38. (new): A recombinant expression vector for high expression of a gene of a protein of interest, comprising:
the gene construct according to claim 34; and
a gene encoding a protein of interest.
40. (new): The recombinant expression vector of claim 38, wherein the protein of interest is at least any one protein selected from the group consisting of human interleukin 6, a transcription factor, a toxic protein, a hormone, a hormone analog, a cytokine, a movement protein, an enzyme, an enzyme inhibitor, a transport protein, a structural protein, a receptor, a receptor fragment, a biological defense inducer, a storage protein, an exploitative protein, a reporter protein, an antigen, an antibody and an antibody fragment.
Regarding claims 42 and 44, which depend from claim 38 and ultimately depend from claim 34 Mason teaches that “vectors were separately introduced into Agrobacterium tumefaciens” (i.e., A transformant for high expression of a gene of a protein of interest, transformed with the recombinant expression vector of claim 38), and that the vector transforms the plant or plant part using agrobacterium, for example, Agrobacterium tumefaciens” (i.e., a plant, into which the transformant of claim 42 is introduced) (paragraphs [0152] and [0012]).
Conclusion
Claims 25-44 are rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YVETTE B TAMUKONG whose telephone number is (571)272-1040. The examiner can normally be reached M-Th 830-5 EST.
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/YVETTE BIH TAMUKONG/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662