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 .
Status of the Claims
Claims 1-17 are pending.
Claims 1-17 are examined herein.
Claims 1-17 are rejected.
Priority
Application No. 19/403,594 filed on 11/28/2024 is a continuation of Application No. 18/259,319 filed on 06/26/2023 which is a 371 of PCT Application No. PCT/JP2021/048621 filed 12/27/2021 and also claims foreign priority to Japanese Application No. JP2021-206911 filed on 12/21/2021 and Japanese Application No. JP2020-218249 filed on 12/28/2020.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/259,319 filed on 06/26/2023 (see Doc Codes FRPR, dated 06/26/2023)
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date for the following reason(s): No certified translations of the foreign priority documents have been received. As such, any claim to foreign priority is not recognized.
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.
Claim Objections
Claim 7 and 16 are substantial duplicates and both claims depend from claim 1. Applicant is advised that should claim 7 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In claim 17, “P35SIcat” is used as an abbreviation. It is suggested to
insert a definition for P35SIcat without bringing in new matter, immediately before the first appearance of “P35SIcat” in claim 17; and to enclose the appearance of “P35SIcat” in parentheses (in claim 17 only).
Claim 8 appears to have grammatical errors. The Claim recites “8. The method according to claim 1, wherein the expression of the nucleic acid is overexpressing is not driven by expressing BABY BOOM.” Applicant is required to amend the claim and address the grammatical errors. For purposes of examination, the claim is interpreted to require BABY BOOM is not expressed in the cell or plant body.
Claim Rejections - 35 USC § 112
Indefiniteness
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 1-17 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.
Claims 1, 2, 9, and 13 recite “a nucleic acid sequence encoding a polypeptide that includes/ including an amino acid sequence”. It is unclear if the amino acid sequence is from a list that “includes” the sequences, or that the nucleic acid sequence encodes a polypeptide that comprises the sequence. For purposes of examination, the claim(s) is/ are interpreted to require that the nucleotides and/or polypeptides “comprise” the sequences. This interpretation does not relieve Applicant of the duty to amend the claims to address the cited deficiency.
Claims 3-8, 10-12, and 14-15 are further rejected as a function of their dependency.
Claims 1, 7, 9, and 16 recite “ a/the promoter that includes/ including a/the 35S promoter”. It is unclear if the promoter is one selected from a list including the 35S promoter or if the promoter must comprise the structure (“include”) of the 35S promoter. For purposes of examination, the claim is interpreted to mean the promoter is one selected from a list including the 35S promoter. This interpretation does not relieve Applicant of the duty to amend the claims to address the cited deficiency.
Claims 2-6, 8, and 10-15 are further rejected as a function of their dependency.
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.
Claims 1, 2, 8, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ye (WO-2018224001-A1) and Hummel (WO2019122381-A2).
Claim 1 is drawn to a method of reducing abnormality of a phenotype of maize, the method comprising: overexpressing, in a cell or plant body of maize, the following nucleic acid 1) or 2):
1) a nucleic acid encoding an amino acid sequence of SEQ ID NO: 2, or a nucleic acid encoding a polypeptide that includes an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 2, the polypeptide having a function of promoting cell division of maize; or
2) a nucleic acid encoding an amino acid sequence of SEQ ID NO: 15, or a nucleic acid encoding a polypeptide that includes an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 15, the polypeptide having a function of promoting cell division of maize, the overexpressing being controlled by a promoter that includes a 35S promoter sequence of Cauliflower mosaic virus, wherein the method further comprises reducing abnormality of a phenotype of the maize compared to a case in which the nucleic acid is overexpressed in a cell or plant body of maize under the control of a promoter other than the promoter that includes the 35S promoter sequence of the Cauliflower mosaic virus, and wherein a resulting maize plant that is created by the overexpressing exhibits a morphologically normal phenotype and fertility.
Claim 2 is drawn to the method according to claim 1, wherein the nucleic acid 1) is the nucleic acid encoding a polypeptide that includes an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 2, the polypeptide having a function of promoting cell division of maize, and the nucleic acid 2) is the nucleic acid encoding a polypeptide that includes an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 15, the polypeptide having a function of promoting cell division of maize.
Claim 8 is drawn to the method according to claim 1, wherein the expression of the nucleic acid is overexpressing is not driven by expressing BABY BOOM.
Claim 15 is drawn to the method according to claim 1, wherein the abnormality includes a gross morphology.
Regarding claim 1, Ye teaches in a working example the transformation and overexpression of TaWOX5, or the rice homologue OsWOX5, in maize cells (varieties A188 and B73) under control of the constitutively expressed ubiquitin promoter (p.39, lines 11-23 through p. 40, lines 1-20). Ye teaches regenerating maize plants from the transformed cells and the maize plants were rooted and grown in the greenhouse by transferring to soil (p. 42, lines 2-5)
Regarding claim 8, Ye teaches overexpressing WOX5 and not BBM (p.39, lines 11-23 through p. 40, lines 1-20).
However, Ye does not explicitly teach in a single embodiment a 35S promoter is the promoter that drives expression of the WOX5 gene, and also does not explicitly teach the WOX5 gene has at least 95% sequence identity to SEQ ID NO: 15. Additionally, Ye teaches plants were regenerated and root and grown in the greenhouse, but does not explicitly say the plants had a morphologically normal phenotype and fertility.
Regarding the remaining limitations of claim 1, in an alternative embodiment, Ye teaches an alternative known constitutive promoter that may be used for expressing a nucleic acid in a target plant includes is CaMV35S (p. 20, lines 4-11 and p. 21, lines 23-24). Additionally, in other analogous art, Hummel teaches another known WOX5 gene that is from maize and encodes an amino acid sequence (SEQ ID NO: 242 of Hummel) with 98.2% sequence identity to instant SEQ ID NO: 15 (see alignment below).
ALIGNMENT:
Query Match 98.2%; Score 1135.5; Length 221;
Best Local Similarity 98.6%;
Matches 218; Conservative 0; Mismatches 2; Indels 1; Gaps 1;
Qy 1 MEALSGRVGVKCGRWNPTAEQVKVLTELFRAGLRTPSTEQIQRISTHLSAFGKVESKNVF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MEALSGRVGVKCGRWNPTAEQVKVLTELFRAGLRTPSTEQIQRISTHLSAFGKVESKNVF 60
Qy 61 YWFQNHKARERHHHKKRRRGASSSSPDSGSGRGSNNEEDGRGAASQSHDADADADLVLQP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YWFQNHKARERHHHKKRRRGASSSSPDSGSGRGSNNEEDGRGAASQSHDADADADLVLQP 120
Qy 121 PESKREARSYGHHHRLVTCYVRDVVEQQEASPSWERPTREVETLELFPLKSYGDLEAAEK 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 PESKREARSYGHHHRLVTCYVRDVVEQQEASPSWERPTREVETLELFPLKSYGDLEAAEK 180
Qy 181 VRSYVRGIAATSEQCRELSFFD-VSAGRDPPLELRLCSFGP 220
||||||| ||||||||||||| ||||||||||||||||||
Db 181 VRSYVRGSGATSEQCRELSFFDVVSAGRDPPLELRLCSFGP 221
BGM45912
ID BGM45912 standard; protein; 221 AA.
XX
AC BGM45912;
XX
DT 08-AUG-2019 (first entry)
XX
DE Maize WOX5 protein, SEQ ID 242.
XX
KW CRISPR-Cas9 system; CRISPR-cpf1 system; Genome editing; WOX5 protein;
KW cell culture; gene expression; plant; transcription; transformation.
XX
OS Zea mays.
XX
CC PN WO2019122381-A2.
XX
CC PD 27-JUN-2019.
XX
CC PF 21-DEC-2018; 2018WO-EP086700.
XX
PR 22-DEC-2017; 2017US-0609508P.
PR 28-SEP-2018; 2018US-0738568P.
XX
CC PA (KWSS-) KWS SAAT SE.
XX
CC PI Hummel A, Labs M;
XX
DR WPI; 2019-557521/51.
DR N-PSDB; BGM45891.
XX
CC PT Synthetic transcription factor, or nucleotide sequence encoding same,
CC PT comprises one recognition domain and one activation domain, where
CC PT synthetic transcription factor is configured to modulate expression of
CC PT morphogenic gene.
XX
CC PS Disclosure; SEQ ID NO 242; 113pp; English.
XX
CC The present invention relates to a novel synthetic transcription factor
CC (STF) or its encoding nucleotide sequence, useful for modulating
CC expression of a morphogenic gene in a cellular system. The synthetic
CC transcription factor comprises at least one recognition domain and at
CC least one activation domain. The invention further relates to: (1) a
CC method for increasing transformation efficiency in a cellular system; (2)
CC a method for modifying genetic material of a cellular system at a
CC predetermined location using a clustered regularly interspaced short
CC palindromic repeats (CRISPR)-associated protein 9 (Cas9) system and a
CC CRISPR-cpf1 system; (3) a method for producing a haploid or a double
CC haploid organism; (4) a cellular system or a progeny obtained by the
CC method; and (5) the haploid or double haploid organism obtained by the
CC method. The novel STF or its encoding nucleotide sequence of the
CC invention can be used for: modulating transcription of a morphogenic gene
CC of a eukaryote; enhancing transformation frequencies; optimizing
CC successful genome editing approaches; providing haploid or double haploid
CC organisms; and/or providing compositions suitable for general
CC transformation and breeding purposes.
XX
SQ Sequence 221 AA;
Regarding claim 2, Hummel teaches SEQ ID NO: 242 is a ZmWOX5 polypeptide with 98.2% sequence identity to instant SEQ ID NO; 15, and the function of promoting cell division in maize is inherent to the structure of the polypeptide.
It would therefore be obvious to combine the teachings of Ye and Hummel to arrive at the instantly claimed method with a reasonable expectation of success because incorporation of the alternative known constitutive promoter (35S) and alternative known WOX5 gene (ZmWOX5) could be achieved by one of ordinary skill in the art. One of ordinary skill in the art would have been motivated to combine the teachings because it would be obvious to substitute one known constitutive promoter and WOX5 gene and encoded protein with another for the same purpose that is increasing transformation efficiency of the maize plants. Additionally, because the obvious plant (a maize plant with 35S promoter driving expression of a nucleotide encoding an amino acid with at least 95% identity to SEQ ID NO: 15) would be structurally identical to the instantly claimed plant, the maize plant would reasonably be expected to have the normal morphology and fertility as a function of inherency (as required by claim 1). Additionally, the limitations of wherein the method further comprises reducing abnormality of a phenotype of the maize compared to a case in which the nucleic acid is overexpressed in a cell or plant body of maize under the control of a promoter other than the promoter that includes the 35S promoter sequence of the Cauliflower mosaic virus (as required by claim 1) and wherein the abnormality includes a gross morphology (as required by claim 15) would also be obvious as a function of inherency because the limitations are functions that flow directly from the structure of the plant that is obvious in view of Ye and Hummel.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ye and Hummel as applied to claim 1 above, and further in view of Malini (Malini, N., Anandakumar, C. R., Gnanam, R., & Ramakrishnan, S. H. (2018). Effect of harmones on callus induction in Maize (Zea mays L.). Journal of Applied and Natural Science, 10(1), 202-209).
Claim 3 is drawn to the method according to claim 1, wherein the overexpressing, in the cell or plant body of maize, the nucleic acid includes culturing immature embryos of the maize on a MS medium to undergo callus induction.
Regarding claim 3, Ye and Hummel teaches the limitations of claim 1 as set forth in the previous obviousness rejection. The teachings of Ye and Hummel as they are applied to claim 1 are set forth previously herein and are incorporated by reference.
However, Ye and Hummel do not explicitly teach the method according to claim 1, wherein the overexpressing, in the cell or plant body of maize, the nucleic acid includes culturing immature embryos of the maize on a MS medium to undergo callus induction.
In analogous art, Malini teaches the immature embryo has proven to be the best source for establishment of embryogenic callus and plant regeneration in maize (page 203, paragraph 1, sentence 6), and teaches a method of culturing immature maize embryos on an MS-based medium (p. 202, materials and methods, plant materials and preparation of callus induction sections).
It would therefore have been obvious to one of ordinary skill in the art to combine the method taught by Ye and Hummel with the teachings of Malini to arrive at the instantly claimed method with a reasonable expectation of success because the teachings of both Ye and Malini are drawn to methods for corn transformation and regeneration, and the callus induction teachings of Malini could be incorporated into the method of Ye by the ordinary artisan without any special technical obstacles. One having ordinary skill in the art would have been motivated to make the combination because Ye teaches a method of transforming corn, and Malini teaches optimized tissue and media to generate callus that can be used for corn transformation and regeneration (abstract, conclusion).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ye and Hummel as applied to claim 1 above, and further in view of Malini (Malini, N., Anandakumar, C. R., Gnanam, R., & Ramakrishnan, S. H. (2018). Effect of harmones on callus induction in Maize (Zea mays L.). Journal of Applied and Natural Science, 10(1), 202-209) and Zhao (Zhao, C. H., Zhang, L. J., Chao, G. E., & Kai, H. U. (2008). Establishment and optimization of the regeneration system of mature embryos of maize (Zea mays L.). Agricultural Sciences in China, 7(9), 1046-1051).
Claim 4 is drawn to the method according to claim 1, wherein the overexpressing, in the cell or plant body of maize, the nucleic acid includes culturing immature embryos of the maize on a MS medium to undergo callus induction.
Claim 5 is drawn to the method according to claim 1, wherein the overexpressing, in the cell or plant body of maize, the nucleic acid includes culturing immature embryos of the maize on a medium including proline at a concentration higher than 6.1 mM to undergo callus induction.
Claim 6 is drawn to the method according to claim 1, wherein the overexpressing, in the cell or plant body of maize, the nucleic acid includes culturing immature embryos of the maize on a MS medium for 2 weeks or longer and shorter than 8 weeks to undergo callus induction.
Regarding claims 4-6, Ye and Hummel teaches the limitations of claim 1 as set forth in the previous obviousness rejection. The teachings of Ye and Hummel as they are applied to claim 1 are set forth previously herein and are incorporated by reference.
However, Ye and Hummel do not explicitly teach the limitations of claims 4-6 as recited above.
In analogous art, Malini teaches the immature embryo has proven to be the best source for establishment of embryogenic callus and plant regeneration in maize (page 203, paragraph 1, sentence 6), and teaches a method of culturing immature maize embryos on an MS-based medium (page 202, materials and methods, plant materials and preparation of callus induction sections). In other related art, Zhao also teaches maize immature embryos were the most widely explant used in plant regeneration from callus, however there is an inherent difficulty to supplying immature embryos year round (page 1046, introduction section, paragraph 2). For this reason, Zhao uses mature embryos for callus, and teaches callus is induced on an MS-based media for three weeks, and then transferred to an MS-based media supplemented with 12 mM proline for four weeks (i.e. the remaining limitations of claims 4, 5, and 6) (conclusion).
It would therefore have been obvious to one of ordinary skill in the art to combine the method taught by Ye and Hummel with the teachings of Malini to arrive at the instantly claimed method with a reasonable expectation of success because the teachings of Ye, Malini, and Zhao are drawn to methods for corn transformation and regeneration and, although Zhao teaches using mature corn embryos due to limited availability of immature embryos year round, both Malini and Zhao reference immature embryos as the best callus source. The callus induction teachings of Malini and Zhao could be incorporated into the method of Ye by the ordinary artisan without any special technical obstacles. One having ordinary skill in the art would have been motivated to combine the teachings because Ye teaches a method of transforming corn, Malini teaches optimized tissue and media to generate callus that can be used for corn transformation and regeneration (abstract, conclusion) and Zhao teaches supplementing the media with 12mM proline significantly increases embryogenic callus formation (abstract, Fig. 2).
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ye and Hummel as applied to claim 1 above, and further in view of Wang (Wang, M., Li, Z., Matthews, P. R., Upadhyaya, N. M., & Waterhouse, P. M. (1997, September). Improved vectors for Agrobacterium tumefaciens-mediated transformation of monocot plants. In International Symposium on Biotechnology of Tropical and Subtropical Species Part 2 461 (pp. 401-408).).
Claim 7 is drawn to the method according to claim 1, wherein the promoter that includes the 35S promoter of the Cauliflower mosaic virus is a sequence that includes the 35S promoter of the Cauliflower mosaic virus and a castor bean catalase intron placed downstream of the 35S promoter.
Claim 16 is drawn to the method according to claim 1, wherein the promoter that includes the 35S promoter of the Cauliflower mosaic virus is a promoter having a sequence that includes the 35S promoter of the Cauliflower mosaic virus and a castor bean catalase intron placed downstream of the 35S promoter.
Regarding claims 7 and 16, Ye and Hummel teaches the limitations of claim 1 as set forth in the previous obviousness rejection. The teachings of Ye and Hummel as they are applied to claim 1 are set forth previously herein and are incorporated by reference.
However, Ye and Hummel do not explicitly teach method according to claim 1, wherein a castor bean catalase intron placed downstream of the 35S promoter.
In analogous art, Wang teaches the 35S promoter can have leaky expression in A. tumefaciens that is used for plant transformation, and by placing an intron in the coding region of a gene that is downstream the 35S promoter, expression in A. tumefaciens is prevented while expression in monocot plants is still conferred and in many instances is increased (p. 402, results, ¶1; p. 403, ¶2; p. 404, ¶2; and Fig. 1 on p. 407).
It would therefore have been obvious to one of ordinary skill in the art to modify the invention of Ye and Hummel to include the limitation as taught by Wang to arrive at the instantly claimed method with a reasonable expectation of success because inclusion of the castor bean catalase intron (cat-1) into a coding region downstream the 35S promoter to prevent leaky expression of a gene in bacteria can be achieved by one of ordinary skill in the art without encountering any special technical difficulties. One of ordinary skill in the art would have been motivated to combine the teachings because Wang teaches inclusion of the intron controls gene expression so that it is only expressed in targeted genes, and it would be prima facie obvious to include a known intron downstream the 35S promoter as taught by Wang to inhibit expression in bacteria (of which the gene expression is not intended to be expressed) and allow and increase gene expression in plants of which the gene is intended to be expressed.
Claims 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ye (WO-2018224001-A1) and Hummel (WO2019122381-A2).
Claim 9 is drawn to a nucleic acid construct for reducing abnormality of a phenotype of maize, comprising:
1) a nucleic acid encoding an amino acid sequence of SEQ ID NO: 2, or a nucleic acid encoding a polypeptide that includes an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 2, the polypeptide having a function of promoting cell division of maize, or
2) a nucleic acid encoding an amino acid sequence of SEQ ID NO: 15, or a nucleic acid encoding a polypeptide that includes an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 15, the polypeptide having a function of promoting cell division of maize; and a promoter that includes a 35S promoter sequence of Cauliflower mosaic virus for producing a nucleic acid in maize, wherein a polypeptide that includes the amino acid sequence of SEQ ID NO: 2 reduces abnormality of a phenotype of the maize compared to a case in which the nucleic acid is overexpressed in a cell or plant body of maize under the control of a promoter other than the promoter that includes the 35S promoter sequence of the Cauliflower mosaic virus, wherein the polypeptide that includes an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 2 reduces the abnormality of the phenotype of the maize compared to a case in which the nucleic acid is overexpressed in the cell or plant body of maize under the control of the promoter other than the promoter that includes the 35S promoter sequence of the Cauliflower mosaic virus, wherein a polypeptide that includes the amino acid sequence of SEQ ID NO: 15 reduces the abnormality of the phenotype of the maize compared to a case in which the nucleic acid is overexpressed in the cell or plant body of maize under the control of a promoter other than the promoter that includes the 35S promoter sequence of the Cauliflower mosaic virus, and wherein the polypeptide that includes an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 15 reduces the abnormality of the phenotype of the maize compared to a case in which the nucleic acid is overexpressed in the cell or plant body of maize under the control of the promoter other than the promoter that includes the 35S promoter sequence of the Cauliflower mosaic virus, and wherein a resulting maize plant that is created by overexpressing the nucleic acid exhibits a morphologically normal phenotype and fertility.
Claim 10 is drawn to a method of introducing a nucleic acid into a cell or plant body of maize, the method comprising: introducing the nucleic acid construct according to claim 9 and a predetermined nucleic acid into a cell or plant body of maize.
Claim 11 is drawn to the method according to claim 10, wherein a nucleic acid encoding BABY BOOM is not introduced into the maize.
Claim 12 is drawn to the nucleic acid construct according to claim 9, further comprising: a predetermined nucleic acid.
Claim 13 is drawn to the nucleic acid construct according to claim 12, wherein 1) the nucleic acid encoding an amino acid sequence of SEQ ID NO: 2, or the nucleic acid encoding a polypeptide including an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 2, the polypeptide having the function of promoting cell division of maize, or
2) the nucleic acid encoding an amino acid sequence of SEQ ID NO: 15, or the nucleic acid encoding a polypeptide including an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 15, the polypeptide having the function of promoting cell division of maize; and the predetermined nucleic acid are directly bonded or bonded via an amino acid linker.
Claim 14 is drawn to a method of introducing a nucleic acid into a cell or plant body of maize, the method comprising: introducing the nucleic acid construct according to claim 12 into a cell or plant body of maize.
Regarding claim 9, Ye teaches in a working example the transformation and overexpression of TaWOX5, or the rice homologue OsWOX5, in maize cells (varieties A188 and B73) under control of the constitutively expressed ubiquitin promoter (p.39, lines 11-23 through p. 40, lines 1-20). Ye teaches regenerating maize plants from the transformed cells and the maize plants were rooted and grown in the greenhouse by transferring to soil (p. 42, lines 2-5).
Regarding claim 10, Ye teaches a nucleic acid encoding GUS (i.e. a predetermined nucleic acid) is also introduced into the maize plant cell and regenerated plant (p. 41, lines 9-10).
Regarding claim 11, Ye teaches overexpressing WOX5 and not BBM (p.39, lines 11-23 through p. 40, lines 1-20).
Regarding claims 12 and 14, Ye teaches a nucleic acid encoding GUS is also in the construct and introduced into the maize plant cell and regenerated plant (i.e. the nucleic acid further comprises a predetermined nucleic acid and introducing the nucleic acid construct into the maize cell) (p. 41, lines 9-10).
Regarding claim 13, Ye teaches in an alternative embodiment the WOX protein may be fused/ bonded directly or via a linker to a desired nucleic acid to obtain a chimeric fusion protein (p. 27, line 9-17).
However, Ye does not explicitly teach in a single embodiment a 35S promoter is the promoter that drives expression of the WOX5 gene, and also does not explicitly teach the WOX5 gene has at least 95% sequence identity to SEQ ID NO: 15. Additionally, Ye teaches plants were regenerated and root and grown in the greenhouse, but does not explicitly say the plants had a morphologically normal phenotype and fertility. Ye also does not explicitly teach the method according to claim 1, wherein the abnormality includes a gross morphology (claim 15).
Regarding the remaining limitations of claim 9, in an alternative embodiment, Ye teaches an alternative known constitutive promoter that may be used for expressing a nucleic acid in a target plant includes is CaMV35S (p. 20, lines 4-11 and p. 21, lines 23-24). Additionally, in other analogous art, Hummel teaches another known WOX5 gene that is from maize and encodes an amino acid sequence (SEQ ID NO: 242 of Hummel) with 98.2% sequence identity to instant SEQ ID NO: 15 (see alignment previously herein), and the function of promoting cell division in maize is inherent to the structure of the polypeptide.
It would therefore be obvious to combine the teachings of Ye and Hummel to arrive at the instantly claimed method with a reasonable expectation of success because incorporation of the alternative known constitutive promoter (35S) and alternative known WOX5 gene (ZmWOX5) could be achieved by one of ordinary skill in the art. One of ordinary skill in the art would have been motivated to combine the teachings because it would be obvious to substitute one known constitutive promoter and WOX5 gene and encoded protein with another for the same purpose that is increasing transformation efficiency of the maize plants. It would also be obvious to combine the WOX and GUS proteins taught by Ye into a chimeric protein because Ye teaches the WOX protein may be fused/ bonded directly or via a linker to a desired nucleic acid (in this case the GUS reporter gene is the desired protein) to obtain a chimeric fusion protein (p. 27, line 9-17). Additionally, because the obvious plant (a maize plant with 35S promoter driving expression of a nucleotide encoding an amino acid with at least 95% identity to SEQ ID NO: 15) would be structurally identical to the instantly claimed plant, the maize plant would reasonably be expected to have the normal morphology and fertility as a function of inherency (as required by claim 9). Additionally, the limitation of wherein the polypeptide that includes an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 15 reduces abnormality of the phenotype of the maize compared to a case in which the nucleic acid is overexpressed in the cell or plant body of maize under the control of the promoter other than the promoter that includes the 35S promoter sequence of the Cauliflower mosaic virus (as required by claim 9) would also be obvious as a function of inherency because the limitation is functions that flow directly from the structure of the plant that is obvious in view of Ye and Hummel.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ye and Hummel as applied to claim 1 above, and further in view of Vain (Vain, P., Finer, K. R., Engler, D. E., Pratt, R. C., & Finer, J. J. (1996). Intron-mediated enhancement of gene expression in maize (Zea mays L.) and bluegrass (Poa pratensis L.). Plant cell reports, 15(7), 489-494.).
Claim 17 is drawn to the method according to claim 1, wherein the promoter that includes the 35S promoter of the Cauliflower mosaic virus is a sequence that includes the 35S promoter of the Cauliflower mosaic virus and a castor bean catalase intron placed downstream of the 35S promoter..
Regarding claim 17, Ye and Hummel teaches the limitations of claim 1 as set forth in the previous obviousness rejection. The teachings of Ye and Hummel as they are applied to claim 1 are set forth previously herein and are incorporated by reference. Additionally, Ye teaches a ubiquitin intron is placed between the promoter and the Wox5 gene (p. 40, lines 16-23) (i.e. an intron is downstream the promoter and is implicitly used as an enhancer). Ye also teaches the construct further comprises a GUS reporter gene that is expressed under control of the 35S promoter (p. 40, lines 16-23) (i.e. wherein the nucleic acid construct further includes a selectable marker gene that is expressed under control of a promoter different from the P35SIcat promoter).
However, Ye and Hummel do not explicitly teach method according to claim 1, wherein the overexpressing is controlled by a promoter comprising a P35SIcat sequence derived from Cauliflower mosaic virus; and wherein the abnormal morphology rate is statistically significantly lower compared to a maize plant transformed with the same nucleic acid under control of a maize ubiquitin promoter or a phospholipid transfer protein promoter.
In analogous art, Vain teaches various monocot and dicot-derived introns can be inserted in the 5' untranslated leader between the CaMV 35S promoter and a gene, to enhance gene expression in maize (title, abstract, p. 492, section titled A dicot intron-containing fragment can also enhance gene expression in monocots, ¶3). Vain also teaches the known Cat1 intron from castor bean (inserted in the coding sequence of the gene) has previously been shown to greatly increase gene expression in transgenic monocots (p. 492, section titled A dicot intron-containing fragment can also enhance gene expression in monocots, ¶1).
It would therefore be obvious to combine the teachings of Ye and Hummel with the teachings of Vain, and into a single embodiment, with a reasonable expectation of success because Vain teaches various introns from both monocots and dicots can be inserted in the 5' untranslated leader between the CaMV 35S promoter and a gene to enhance gene expression and one of ordinary skill in the art could do so, including specifically with the catI intron, without encountering any special technical difficulties. One of ordinary skill in the art would have been motivated to combine the teachings because it would be prima facie obvious to include an intron immediately downstream the 35S promoter for the purpose of enhancing gene expression as taught by Vain. It would further be obvious to select the castor bean catalase intron to be placed downstream the 35S promoter as opposed to those used in examples taught by Vain because it would be prima facie obvious to substitute one known intron for another for the same purpose that is enhancing gene expression. Additionally, the limitation of wherein the abnormal morphology rate is statistically significantly lower compared to a maize plant transformed with the same nucleic acid under control of a maize ubiquitin promoter or a phospholipid transfer protein promoter would also be obvious as a function of inherency because the limitation is a functions that flow directly from the structure of the plant that is obvious in view of Ye, Hummel, and Vain.
Conclusion
No claims are allowed.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
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