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 .
Election/Restrictions
Applicant's election without traverse of species of SEQ ID NO:71 as the polypeptide sequence from claims 1 and 65 subsection (c); SEQ ID NO:69 as the nucleotide sequence from claims 1 and 65 subsection (a) and claims 2 and 73; SEQ ID NO:79 as the nucleotide sequence from claim 1 subsection (b) and claim 73; SEQ ID NO:87 as the polypeptide sequence from claim 1 subsection (d); SEQ ID NO:108 as the polypeptide sequence from claims 15 and 75; and SEQ ID NO:79 as the nucleotide sequence from claim 84 in the reply filed on 08/11/2025 is acknowledged.
Therefore claims 1, 2, 6, 8, 12, 15-17, 23, 65, 69, 72, 73, 75, 76, 79, 84, 94, 97, and 98 are pending and the claims along with elected species of SEQ ID NOs: 69, 71, 79, 87 and 108 are examined in this office action.
Claim Interpretation
Claims 1 is interpreted where it recites “mutation”, mutation is not given any weight whether it is natural or not. Since the claims are directed to products (plants or plant parts comprising a mutation) rather than methods, therefore, there is no weight given to how the mutation is made (see MPEP 2113 for discussion of “product by process” claims).
Rejection that are withdrawn
35 USC § 101 over claims 1, 8, 12, 17, 23 and 97-98 rejection has been withdrawn in light of applicant’s amendment of claims 1 and 97 to recite mutation is in the Ethylene-responsive element binding factor-associated Amphiphilic Repression (EAR) motif. The cited prior arts does not show the mutation are in the EAR motif.
35 USC § 102 (a)(1) rejection over claims 12 and 17 are withdrawn in light of applicant’s amendment of claims 1 and 97 to recite mutation is in the Ethylene-responsive element binding factor-associated Amphiphilic Repression (EAR) motif. The cited art Xie et al. does not disclose limitation of their sequence has mutation in an EAR motif.
Following 35 USC § 112 - Written Description Requirement has been modified to analyze the new limitation of “wherein the target site comprises a sequence having at least 80% identity to any one or more of the nucleotide sequences of SEQ ID NO:79” in claim 65.
Claim Rejections - 35 USC § 112 - Written Description Requirement
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1, 2, 6, 8, 12, 15-17, 23, 65, 69, 72, 73, 75, 76, 79, 84, 94, 97, and 98 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Analysis of Breadth of Claims
Claims encompass genus of polynucleotides comprising 80% sequence identity to SEQ ID NOs: 69 and 79 (claims 1, 65, 73, and 84).
Claims encompass genus of polypeptide comprising 80% sequence identity to SEQ ID NO:71 (claims 1, 65).
Claims encompass genus of polypeptide and polynucleotides comprising 90% sequence identity to SEQ ID NOs:87, 115, 113 (claims 1, 23, 65, 75, 79, 94 and 97).
The mutation altering function would encompass any mutations including any numbers of deletion, substitutions and additions (claims 1 and 72).
What is Described in the Specification
Applicant describes:
for alte1ing the activity of the transcription factor HD-Zip17-1 (Glyma.20g014400, SEQ ID N0:69) by generating edits in the EAR domain of the HD HDZip17-1 polypeptide (SEQ ID N0:71) (page 102, lines 30-33).
An editing construct was designed with spacers PWsp1537 (SEQ ID NO:109) and PWsp1539 (SEQ ID NO:110) and regenerating soybean plants were evaluated for edits in the target gene.
Soybean plants with edited alleles of the HD-Zip17-1 gene showed one of the edited alleles contained a 21 bp deletion (AAGTAGCTCCTCAAACTTGGA; SEQ ID NO:114) starting at position 2190 of SEQ ID NO:69 giving rise to the edited allele sequence of SEQ ID NO:113 (page 103, lines 7-12).
The 21 bp deletion is in-frame and results in the deletion of the amino acids "SSSSNLE" (SEQ ID NO:116) at amino acids 6-12 of SEQ ID NO:71 giving rise to the amino acid sequence of SEQ ID NO:115 (page 103, lines 12-14)
at the R6 growth stage plant architectural features that may be indicative of an increase in yield, as well as assed counts which are a direct indication of plant yield were measured (page 103, lines 17-21).
Tale 6 showed increased pods per plant in deletion mutant compared to control plants and decreased seeds per plant (Table 7), decreased seeds per pod (Table 8) in homozygous deletion mutants and decreased seeds per pod in both homozygous and heterozygous mutants (page 104).
The results showed decreased branches per plant in deletion mutants compared to wildtype control (page 103, Table 2).
Difference Between What was Described and What is Claimed
Applicant has not described a polynucleotide comprising 80% sequence identity to SEQ ID NOs:69, 79 and a polypeptide comprising 80% sequence identity to SEQ ID NOs:71.
Applicant has not described a polypeptide comprising 90% sequence identity to SEQ ID NOs:87.
Applicant has not described any mutation that would include deletion, substitutions and additions other than 21 bp deletion (AAGTAGCTCCTCAAACTTGGA; SEQ ID NO:114) starting at position 2190 of SEQ ID NO:69 giving rise to the edited allele sequence of SEQ ID NO:113 (page 103, lines 7-12).
Base deletion of one or more nucleotides would comprise any number of deletions that would encompass deletion of whole HD-Zip gene (claim 73), instead applicant has not described complete deletion of HD-Zip gene.
Applicant has not described the mutation would case phenotype of increased seed weight (e.g., grain weight), modified flowering time (e.g., an earlier time of flowering), increased seed number (e.g., grain number), shorter stature (claim 76) other than the specific 21 deletion would increase pods per plant.
Applicant has not described function of any of the protein comprising a region of consecutive amino acid residues having at least 90% sequence identity to SEQ ID NO: 108.
Applicant has not described the “altering the function of the HD-Zip polypeptide” of the plant comprising the mutation in the HD-Zip transcription factor (HD-Zip) polypeptide (claims 1, 2, 6, 8, 12, 15-17, 23, 65, 69, 72, 73, 75, 79, 84, 94, 97, and 98) other than altering functions expressly showed in Tables 1-8.
Applicant has not described contacting a sequence having at least 80% identity to SEQ ID NO:79 other than the sequence of SEQ ID NO:109 as a spacer (claim 65).
Analysis
The purpose of the written description is to ensure that the inventor had possession at the time the invention was made, of the specific subject claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
The polynucleotides comprising 80% sequence identity to SEQ ID NOs:69, 79 and that encodes amino acid sequence that has at least 80% identity to SEQ ID NO: 71 and that comprises polypeptide comprising a region of consecutive amino acid residues having at least 90% sequence identity to SEQ ID NOs: 87 would encompass large genus of number of nucleic acid and amino acid sequences. See for example SEQ ID NO: 71 has 214 amino acids, the 90% of SEQ ID NO: 71 would have ~21 AA changes (i.e., substitutions, deletions, insertions, or additions) relative to SEQ ID NO: 71, and this encompasses a genus of proteins that includes at least ~2021 molecules. For this reason, the genus of proteins having at least 80% identity to SEQ ID NO: 71 and at least 90% identity to SEQ ID NOs: 87 are a very large genus of molecules. Similarly, SEQ ID NO:69 comprises 8330 nucleotides and see for example 90% identity to SEQ ID NO:69 comprises at least ~833 AA changes (i.e. substitutions, deletions, insertions, or additions) relative to SEQ ID NO: 69, and this encompasses a genus of proteins that includes at least ~4833 molecules. For this reason, the genus of molecules having at least 80% identity to SEQ ID NOs: 69, 71, 79 and molecules comprises 90% identity to SEQ ID NOs: 87, 113, 115 are a very large genus of molecules.
Furthermore, the state of the art at the time of the instant invention was that although the skilled artisan would appreciate for example a soybean plant comprising specific mutations in HD-Zip gene of SEQ ID NO:69 encoding SEQ ID NO:71, one would not be able to readily predict function of mutations in a polynucleotides and encoded polypeptides with 80% identity to SEQ ID NO: 69, 71, 79 and 90% identity to SEQ ID NOs: 87, 113, 115 and it is impossible to predict such a broad sequence variation will have any functions. For example, Guo et al. (Published: 2004, Journal: Proceedings of the National Academy of Sciences, 101(25), 9205-9210) teaches that while proteins are fairly tolerant to mutations resulting in single amino acid changes, increasing the number of substitutions additively increases the probability that the protein will be inactivated (page 9505, Abstract and page 9207, left col., Paragraph 3).
Sessa et al. (Published: 2018, Journal: Int. J. Mol. Sci. 2018, 19, 4047; doi:10.3390/ijms19124047) teaches HD-Zip proteins are unique to plants, and contain a homeodomain closely linked to a leucine zipper motif, which are involved in dimerization and DNA binding (page 1, abstract. Sessa et al. interact with CAAT(A/T)ATTG, CAAT(C/G)ATTG, CATT(A/T)AATG and AT(G/C)AT central core is sufficient for DNA binding (page 2, first paragraph). Sessa et al. teaches HD-Zip TF contain LxLxL type of ERF associated amphiphilic repression (EAR) motif and they function as negative regulators of the gene expression (page2, paragraph 2). Sessa et al. teaches other groups of HD-Zips (III and IV) share MEKHLA domain wherein the region within domain containing region homologous to the PAS (Per-Arnt-Sim)-domain act diversely with intracellular sensor of light, oxygen, or redox-potentials and interact with proteins for embryo patterning (page2, paragraph 2).
Sessa et al. teaches HD-Zips are involved in various developmental and environmental responses (i.e. abiotic responses, developmental pathways, plant adaptation etc.) (page 2, last paragraph), ABA signaling, acts as an integrator of MeJa and ET pathways, plant, cotyledon, leaf and supporting organ growth, leaf patterning, cell growth, lateral organ development etc. (page 3, paragraphs 1-3). Furthermore, Li et al. (Published: 2022, Front. Plant Sci. 13:102707 doi: 10.3389/fpls.2022.1027071) teaches complex network for different HD-Zip protein for abiotic stress resistance (i.e. salt, drought, metal, cold stress etc.) (see Figure 4 below). Thus HD-Zips are part of complex networks and regulate hormonal pathways involved in diverse functions. Therefore, there is dearth of description of altering the any HD-Zip function. Instead applicant has only described the 21 bp deletion (AAGTAGCTCCTCAAACTTGGA; SEQ ID NO:114) starting at position 2190 of SEQ ID NO:69 giving rise to the edited allele sequence of SEQ ID NO:113 would cause altered function as showed in Table 6, an increased pods per plant in deletion mutant, decreased seeds per plant (Table 7), decreased seeds per pod in both homozygous and heterozygous mutants (Table 8) (page 104) compared to control plants etc. Therefore, applicant has not described the end use of any alteration of the function of HD-Zip protein with any mutation in the HD-Zip in EAR motif gene which would have diverse functions.
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Applicant has not described the mutation would cause phenotype of increased seed weight (e.g., grain weight), modified flowering time (e.g., an earlier time of flowering), increased seed number (e.g., grain number), shorter stature (claim 76) other than the specific 21 deletion would increase pods per plant. Applicant description of measurement of soybean phenotypes in Tables 1-8 clearly showed that the deletion does not effect on the recited traits. Therefore, there is dearth of description of altering the function of the SEQ ID NO:69 encoding SEQ ID NO:71 would have effect on the recited traits. Furthermore, Table 1-8 showed the mutation causes opposing effect on different traits for example Tale 6 showed increased pods per plant in deletion mutant compared to control plants and decreased seeds per plant (Table 7), decreased seeds per pod (Table 8) in homozygous deletion mutants and decreased seeds per pod in both homozygous and heterozygous mutants (page 104). The results showed decreased branches per plant in deletion mutants compared to wildtype control (page 103, Table 2). Therefore there is dearth of description of altering the function of the SEQ ID NO:69 encoding SEQ ID NO:71 would cause phenotype of increased seed weight (e.g., grain weight), modified flowering time (e.g., an earlier time of flowering), increased seed number (e.g., grain number), shorter stature (claim 76).
Applicant has not described function of any of the protein comprising a region of consecutive amino acid residues having at least 90% sequence identity to SEQ ID NO: 108. SEQ ID NO: 108 is five nucleotide long with domain “LELTI”. Alignment of SEQ ID NO:108 to the uniport database showed it has 100% identity to more than 450 diverse proteins from different species (see part of alignment below). Instead, applicant has not described any endogenous HD-Zip gene comprising the SEQ ID NO:108 other than the SEQ ID NO:71 from soybean that would have any use by altering its function by a mutation.
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Applicant has not described contacting a sequence having at least 80% identity to SEQ ID NO:79 other than the sequence of SEQ ID NO:109 as a spacer (claim 65). SEQ ID NO: 79 is larger than the spacer described in the claim (63 nucleotides of SEQ ID NO: 79 vs. 23 nucleotides long SEQ ID NO: 109) (see alignment below). Applicant has not described when the nuclease domain bind to any other sequence other than SEQ ID NO:109 would cause mutation leading to the altercation in the phenotype. Therefore, applicant has not described any use of the method of claim 65 with such broadly produced variants of mutants. Instead applicant’s example in Tables 1-8 showed specific mutation i.e. 21 bp deletion (AAGTAGCTCCTCAAACTTGGA; SEQ ID N0:114) starting at position 2190 of SEQ ID N0:69 and the 21 bp deletion is in-frame and results in the deletion of the amino acids "SSSSNLE" (SEQ ID NO:116) at amino acids 6-12 of SEQ ID NO:71 giving rise to the amino acid sequence of SEQ ID NO:115 (page 103, lines 6-14) are required to have alternation in phenotypes in a soybean plant.
Query: None Query ID: lcl|Query_3237087 Length: 63
Sequence ID: Query_3237089 Length: 23
Range 1: 1 to 23
Score:42.8 bits(46), Expect:1e-10,
Identities:23/23(100%), Gaps:0/23(0%), Strand: Plus/Plus
Query 21 CCAAGTAGCTCCTCAAACTTGGA 43
|||||||||||||||||||||||
Sbjct 1 CCAAGTAGCTCCTCAAACTTGGA 23
Given the virtually large variations in structural variables associated with these embodiments, the claims read on an extremely broad and highly diverse genomic structures that needs to have any mutations that results in a plant having any of the altered functions or range of phenotypes as recited in claim 76.
Thus, in view of the analysis presented above, a skilled artisan would appreciate that the claims are directed to extremely broad and highly diverge genus of sequence variants that are required to having any of the altered functions.
Given the large size and structural diversity associated with the claimed genus, Applicant’s disclosure is not representative of the claimed genus as a whole. This point is particularly relevant because, as discussed above, the prior art speaks to the disconnection between the structure and functions of the broadly claimed variants.
"The test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to one skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm, Inc, v EH Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Lockwood v. Amer. Airlines, ina, 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). "An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations. Lockwood, 107 F.3d at 1572, 41 USPG2d at 1966". While the written description requirement does not demand either examples or an actual reduction, actual "possession" or reduction to practice outside of the specification is not enough. Ariad Pharm, Inc. v. Eli Lilly & Co., 598 F,3d 1336,1352 (Fed. Cir. 2010). Rather, it is the specification itself that must demonstrate possession. Id.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. The court stated that, “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F. 3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Thus, based on the analysis above, Applicant has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly. As a result, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Applicant argues the soybean HD-Zip17-1 coding sequence (SEQ ID NO:70) that corresponds to the genomic sequence of SEQ ID NO:69 shares 95.6% sequence identity with the coding sequence of HD-Zip17-2 (SEQ ID NO:89). Applicant argues the region of the HD-Zip17-1 gene of SEQ ID NO:79 shares 92% sequence identity with the region of the HD-Zip17-2 gene of SEQ ID NO:98; the HD-Zip17-1 protein (SEQ ID NO:71) shares 96.7% sequence identity with the HD-Zip17-2 protein (SEQ ID NO:90); and the polypeptide region HD-Zip17-1 including the EAR motif (SEQ ID NO:87) shares 93.3% sequence identity with the polypeptide region HD-Zip17-2 including the EAR motif (SEQ ID NO:107). Applicant argues therefore specification Provide species of a polynucleotide comprising 80% sequence identity to NOs:69 and 79, a polypeptide comprising 80% sequence identity to SEQ ID NO:71, and a polypeptide comprising 90% sequence identity to SEQ ID NO:87 (Response to rejection, page 9, paragraph 2).
Applicant argues specification describes method, algorithms and database for identifying sequence within the scope of the claim for example Soybase and BLAST algorithms (Response to rejection, page 9, paragraph 3).
Applicant argues the claims as amended recite that the mutation is in an EAR motif of the HD-Zip polypeptide or that the target site comprises a nucleotide sequence encoding the EAR motif, the claims do not encompass deletion of whole HD-Zip gene (Response to rejection, page 9, last paragraph).
Applicant argues the amended claims recite a specific region of the HD-Zip gene and HD-Zip polypeptide to target as EAR motif. Applicant argues in view of teachings of specification and Sessa et al., the HD-Zip genes in plants and the function of the same would have been adequately described from the view of one of ordinary skill in the art (Response to rejection, page 10, paragraph 3).
Applicant's arguments have been fully considered but they are not persuasive since:
Regarding argument that specification provides species of a polynucleotide comprising 80% sequence identity to NOs:69 and 79, a polypeptide comprising 80% sequence identity to SEQ ID NO:71, and a polypeptide comprising 90% sequence identity to SEQ ID NO:87, the argument was not found persuasive since for example 90% identity to SEQ ID NO:69 comprises at least ~833 AA changes (i.e. substitutions, deletions, insertions, or additions) relative to SEQ ID NO: 69, and this encompasses a genus of proteins that includes at least ~4833 molecules. Therefore the polynucleotide comprising 80% sequence identity to NOs:69 and 79, a polypeptide comprising 80% sequence identity to SEQ ID NO:71, and a polypeptide comprising 90% sequence identity to SEQ ID NO:87 are large genus of molecules. The recitation of the mutation is in EAR motif in any of the large genus of HD-Zip protein does not described structure, function and their relation in recited mutant soybean plants. The plant having mutation in the Ear motif of HD-Zip would encompass any structure since there is no limitation of what kind of mutations are created and what is the structure of the produced plant (product). For example mutation such as insertion, deletion and substitution would produce any kind of protein structures and it is not clear what characters (i.e. function) are associated with the structures. Instead applicant has not described any other change in the characters of the soybean plant due to mutation other than the traits measure in Tables 1-8. Therefore relating to structure vs. function, the claims remain drawn to any unspecified genetic structure that would require to have 80% sequence identity to NOs:69 and 79, a polypeptide comprising 80% sequence identity to SEQ ID NO:71, and a polypeptide comprising 90% sequence identity to SEQ ID NO:87. The specification makes clear that specific mutation in specific position in specific sequence leads to the recited phenotypes of Tables 1-8, thus it is necessary to claim the produced plants as such.
Regarding argument on claims do not encompass deletion of whole HD-Zip gene was not found persuasive since for example claim 1 recite starting material as HD-Zip gene with 80% and 90% identities to recited sequence and the recites the end product has altered function which does not limit the gene would have been completely deleted from the plant since altered function would be any of change in function as a regulatory of gene expression.
Regarding argument on use of algorithms and database to identify scope within the scope of the claim was not found persuasive since applicant lacks description of any of the sequence having 80% sequence identity to NOs:69 and 79, a polypeptide comprising 80% sequence identity to SEQ ID NO:71, and a polypeptide comprising 90% sequence identity to SEQ ID NO:87 and when the sequence are mutated in EAR motif would cause useful phenotype changes other than the changes in characters of Tables 1-8 with specific mutations. For example Sessa et al. teaches HD-Zips are involved in various functions and are involved in complex regulatory networks. Therefore the mutation would create products with large variations in genomic structures leading to unknown functions.
Therefore lack of written description rejection has been maintained.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Anticipated by Creelman et al.
Claims 1, 2, 8, 23, 94 and 97-98 are rejected under 35 U.S.C. 102 (a)(1) and/or (a)(2) as being anticipated by Creelman et al. (US Patent No.: US 10,407,689 B2, Date of Patent: Sep.10,2019).
Claim 1 is drawn to a soybean plant or part thereof comprising at least one mutation in an endogenous homeodomain-leucine zipper transcription factor (HD-Zip) gene encoding HD-Zip transcription factor wherein the mutation alters the function of the HD-Zip polypeptide as a regulator of gene expression. Claim 8 is drawn to the mutation is base deletion and/or a base insertion.
Regarding claim 1, Creelman et al. claim 1, 11, 12 and 17 discloses a soybean plant comprising polynucleotide encoding at least 90% sequence identity to SEQ ID NO: 3 which comprises a mutation in EAR motif which carried out the altered function in plant for example greater yield and biomass. Creelman et al. claim 11 discloses SEQ ID NO:3 is class II HD-Zip superfamily protein. Creelman et al. claim 18 discloses less transcriptional repression compared to the first polypeptide.
The claim is interpreted as “product by process claim” wherein [E]ven though product by process claims are limited by and defined by the process, determination of patentability is based on the product itself. If the product in the product by process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
Furthermore, col 18, Table 1 showed SEQ ID NO:3 is a HD-Zip gene derived from Glycine max (i.e. soybean), therefore the sequence was found in soybean and the gene has a mutation in the applicant exemplified EAR motifs of SEQ ID NOs: 86-87 and 108 of SEQ ID NO:71 (Spec, page 8, lines 25-26).
Here, the recitation of “recombinant” and “transgenic” has been interpreted as method of making the recited plant, therefore the genomic composition and the function would not have been different from the applicant’s mutant plant.
Alignment of SEQ ID NO:71 has 94% identity to Applicant’s SEQ ID NO:71 (see alignment below).
Alignment of SEQ ID NO:71 to the Creelman et al.’s SEQ ID NO:3.
Query: unnamed protein product Query ID: lcl|Query_6814287 Length: 214
>unnamed protein product
Sequence ID: Query_6814289 Length: 213
Range 1: 1 to 213
Score:1024, Identities:204/216(94%), Positives:207/216(95%), Gaps:5/216(2%)
Query 1 MAVLPSSSSNLELTISVPGFASSPVLLPLSSVKELDINQVPLEEDWMASNMEDEEEGSNG 60
MAVLPSSSS+LELTISVPGFASSP LLP SSVKELDINQVPLEEDWMASNMEDEEE SNG
Sbjct 1 MAVLPSSSSSLELTISVPGFASSPTLLPSSSVKELDINQVPLEEDWMASNMEDEEESSNG 60
Query 61 DPPRKKLRLTKEQSRLLEESFRQNHTLNPK--ESLAMQLKLRPRQVEVWFQNRRARSKLK 118
+PPRKKLRLTKEQSRLLEESFRQNHTLNPK ESLAMQLKLRPRQVEVWFQNRRARSKLK
Sbjct 61 EPPRKKLRLTKEQSRLLEESFRQNHTLNPKQKESLAMQLKLRPRQVEVWFQNRRARSKLK 120
Query 119 QTEMECEYLKRWFGSLTEQNRRLQREVEELRAMKVGPPTVISPHSCEPLPASTLSMCPRC 178
QTEMECEYLKRWFGSLTEQNRRLQREVEELRA+KVGPPTVISPHSCEPLPASTLSMCPRC
Sbjct 121 QTEMECEYLKRWFGSLTEQNRRLQREVEELRAIKVGPPTVISPHSCEPLPASTLSMCPRC 180
Query 179 ERVTSTADKPPSAAAAAATLSPKVPPTQSRQPSAAC 214
ERVTSTADKPPSAAA TLS KVPPTQSRQPSAAC
Sbjct 181 ERVTSTADKPPSAAA---TLSAKVPPTQSRQPSAAC 213
Regarding claim 2, Creelman et al. claim 1 discloses a soybean plant comprising mutation in EAR motif. Since the mutation is recited example of EAR motifs of SEQ ID NOs: 86-87 and 108 of SEQ ID NO:71 (Spec, page 8, lines 25-26) the mutation should have been in the position 2206 to position 2220 with reference to nucleotide position numbering of SEQ ID NO:69, since SEQ ID NO:71 is encoded by SEQ ID NO:69 (page 8, lines 14-16).
Regarding claim 8, Creelman et al. claim 1 discloses different substitution of amino acids in the EAR motif.
Regarding claims 23, 94 and 97-98, Alignment of Creelman et al.’s SEQ ID NO: 3 to the SEQ ID NO: 115 has 92% sequence identity, which has the substitution in the EAR motif of SEQ ID NO:71, see alignment above and below.
Query: unnamed protein product Query ID: lcl|Query_4115895 Length: 213
unnamed protein product
Sequence ID: Query_4115897 Length: 207
Range 1: 1 to 207
Score:384 bits(986), Expect:1e-142,
Method:Compositional matrix adjust.,
Identities:198/216(92%), Positives:200/216(92%), Gaps:12/216(5%)
Query 1 MAVLPSSSSSLELTISVPGFASSPTLLPSSSVKELDINQVPLEEDWMASNMEDEEESSNG 60
MAVLP LTISVPGFASSP LLP SSVKELDINQVPLEEDWMASNMEDEEE SNG
Sbjct 1 MAVLP-------LTISVPGFASSPVLLPLSSVKELDINQVPLEEDWMASNMEDEEEGSNG 53
Query 61 EPPRKKLRLTKEQSRLLEESFRQNHTLNPKQKESLAMQLKLRPRQVEVWFQNRRARSKLK 120
+PPRKKLRLTKEQSRLLEESFRQNHTLNPK ESLAMQLKLRPRQVEVWFQNRRARSKLK
Sbjct 54 DPPRKKLRLTKEQSRLLEESFRQNHTLNPK--ESLAMQLKLRPRQVEVWFQNRRARSKLK 111
Query 121 QTEMECEYLKRWFGSLTEQNRRLQREVEELRAIKVGPPTVISPHSCEPLPASTLSMCPRC 180
QTEMECEYLKRWFGSLTEQNRRLQREVEELRA+KVGPPTVISPHSCEPLPASTLSMCPRC
Sbjct 112 QTEMECEYLKRWFGSLTEQNRRLQREVEELRAMKVGPPTVISPHSCEPLPASTLSMCPRC 171
Query 181 ERVTSTADKPPS---AAATLSAKVPPTQSRQPSAAC 213
ERVTSTADKPPS AAATLS KVPPTQSRQPSAAC
Sbjct 172 ERVTSTADKPPSAAAAAATLSPKVPPTQSRQPSAAC 207
Therefore Creelman et al. anticipates the claims.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Applicant asserts Creelman describes primer-based site-directed mutagenesis of AtHB 17 to introduce L84A and L86A amino acid substitutions in the EAR motif of the AtHB 17 and transgenic overexpression of the same in Arabidopsis by introducing into Arabidopsis plants a transformation construct encoding the mutant AtHB 17 gene downstream of a CaMV 35 S promoter. See Creelman, Examples I-V. Applicant argues Creelman prophetically describes transgenic overexpression of EAR mutation variants in C3 plants including soybean and C4 plants including corn and sugarcane. See Creelman, Examples VI-VIII. Applicant argues Creelman fails to teach a soybean plant comprising a mutation in an endogenous HD-Zip gene as claimed.
Applicant's arguments have been fully considered but they are not persuasive since Creelman et al. discloses their disclosed SEQ ID NO:3 is a HD-Zip gene derived from Glycine max (i.e. soybean), therefor the gene would have been endogenous to the soybean plant. The argument about that the transgenic overexpression is not required by claims, is moot point since such limitation are not required by the claims and the soybean HD-Zip gene SEQ ID NO:3 and the soybean plant comprising the sequence anticipate the claims.
Following 35 USC § 103 - rejection has been modified to analyze the new limitation of “wherein the target site comprises a sequence having at least 80% identity to any one or more of the nucleotide sequences of SEO ID NO:79” in claim 65.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Obvious over Creelman et al. and further in view of Zhong et al.
Claims 1, 6, 12, 15-17, 65, 69, 72, 73, 75, 76 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Creelman et al., and further in view of Zhong et al. (Published: 08/2022, Journal: Front. Plant Sci. 13:988505. doi: 10.3389/fpls.2022.988505) and further evidenced by GenEmbl database.
Claims are drawn to a plant or part thereof comprising at least one mutation in an endogenous homeodomain-leucine zipper transcription factor (HD-Zip) gene encoding HD-Zip transcription factor having 80% sequence identity to SEQ ID NOs:69, 79 and a polypeptide comprising 80% sequence identity to SEQ ID NOs:71 and a polypeptide comprising 90% sequence identity to SEQ ID NOs:87, wherein the mutation is in EAR motif and the mutation alters the function of the HD-Zip polypeptide as a regulator of gene expression. Claims are drawn to the mutation is base deletion in the Ethylene-responsive element binding factor-associated Amphiphilic Repression (EAR) motif.
Regarding claim 1, Creelman et al. claim 1, 11, 12 and 17 , Example VII teaches a soybean plant comprising polynucleotide encoding at least 90% sequence identity to SEQ ID NO: 3 which comprises a mutation in EAR motif which carried out the altered function in plant for example greater yield and biomass. Creelman et al. claim 11 teaches SEQ ID NO:3 is class II HD-Zip superfamily protein. Creelman et al. claim 18 teaches less transcriptional repression compared to the first polypeptide.
Furthermore, col. 18, Table 1 showed SEQ ID NO:3 is a HD-Zip gene derived from Glycine max (i.e. soybean), therefore the sequence was found in soybean and the gene has a mutation in the applicant exemplified EAR motifs of SEQ ID NOs: 86-87 and 108 of SEQ ID NO:71 (Spec, page 8, lines 25-26). Such modification and further modification in the same EAR motif in the soybean plant was taught by Creelman et al.
Alignment of SEQ ID NO: 71 has 94% identity to Applicant’s SEQ ID NO:71 (see alignment above).
Regarding claim 6, Creelman et al. claim 18 teaches less transcriptional repression compared to the first polypeptide. Creelman et al. teaches EAR motif is important for conferring transcriptional repression function to the binding gene (col. 16, lines 58-67). Therefore, the mutation would be useful when the mutation results in a dominant negative allele leading to reverting the repression of the binding gene. Thus, someone skilled in the art would select for dominant negative allele.
Regarding claims 12 and 15-17, since Applicant describes SEQ ID NO:86, 87 and 108 are ear motif of HD-Zip polypeptide SEQ ID NO:71 (page 8, lines 27-28), Creelman et al. claim 11 teaches a method for producing plant having a mutated endogenous HD-Zip gene with at least 90% identity to homodomain and leucine zipper of SEQ ID NO:3 by mutagenizing the EAR motif. Figure 1b teaches the Applicant’s SEQ ID NO: 108 as LELTI is an ear motif.
Creelman et al. teaches their method teaches altering the expression of HD-ZIP regulatory polypeptides conserved in diverse plant species to promote certain phenotypes and alter the repression activity of the native HD-ZIP polypeptides by mutagenizing the EAR motif to reduce other phenotypes (col. 15, lines 40-45).
Therefore, it would have been obvious to mutagenize the EAR motif.
Creelman et al. does not specifically teach the mutation is caused by deletion of amino acids using base deletion.
Zhong et al. teaches the CRISPR/Cas9 system which specifically causes deletion in any target region and the deletion results in the deletion mutants by base deletion of 1-4 consecutive base deletion (see Figure F above as part of supplementary Figure S2).
Therefore, someone skilled in the art before the effective date of filing of the invention, from teaching, suggestions and motivation of Creelman et al. would cause mutation in the Ear motif which is SEQ ID NO:108 and would carry it out by targeted base deletion using the more precise CRISPR/Cas9 system taught by Zhong et al. leading to the invention of recited plant with deletion in ear motif and in a region of SEQ ID NO: 108. Someone skilled in the art would screen for alternation of the function the function of the HD-Zip polypeptide to discover the claimed mutated soybean plant. Furthermore, if the deletion would be deletion of groups of three nucleotides while preserving the reading frame there would be an in-frame mutation occurs.
Regarding claims 65 and 72, Creelman et al. claim 11 teaches a method for producing plant having a mutated endogenous HD-Zip gene with at least 90% identity to homodomain and leucine zipper of SEQ ID NO:3 by mutagenizing the EAR motif. Creelman et al. claim 18 teaches less transcriptional repression compared to the first polypeptide.
The translation of Creelman et al.’s SEQ ID NO:3 encodes for a Glycine soja homeobox-leucine zipper protein HOX3-like (LOC114419742), transcript variant X2, mRNA with accession number XM_028385516.1 (translation and search from accessed from NCBI blast (tblastn) database at https://blast.ncbi.nlm.nih.gov/Blast.cgi, accessed in 06/09/2026) which comprise the target sequence comprising the SEQ ID NO:79 which is highlighted below.
>XM_028385516.1 PREDICTED: Glycine soja homeobox-leucine zipper protein HOX3-like (LOC114419742), transcript variant X2, mRNA
CTTCTGTCTTCCTTTTCATGTGTGTCTCCTTCTGTTTCTCCACTTTACCTTTTTTCTCTCCTTTTTGTTG
ATCCCCCTCTTCCTCTTCTTCATCTCACATCATCTTTTTCTTCATCCCTTTCATTGTTTTCTGTGTGTTT
TCTATGGCGGTTTTACCAAGTAGCTCCTCAAGCTTGGAATTGACCATATCTGTACCTGGTTTTGCTTCTT
CACCAACCCTTCTTCCCTCATCATCTGTGAAAGAATTGGACATAAATCAAGTACCTCTTGAAGAAGATTG
GATGGCATCAAACATGGAAGATGAAGAAGAAAGCAGCAATGGAGAACCTCCTCGAAAGAAACTCCGTCTC
ACAAAGGAACAATCTCGTCTCCTTGAAGAAAGCTTTAGACAAAACCACACGTTGAACCCAAAGCAGAAAG
AGTCTTTGGCAATGCAACTGAAGCTGCGACCAAGGCAAGTGGAGGTGTGGTTTCAGAACCGTAGGGCCAG
GAGCAAGCTGAAGCAGACAGAGATGGAGTGCGAGTACCTCAAGAGGTGGTTCGGTTCCCTCACAGAGCAG
AACCGGAGGCTCCAGAGGGAAGTGGAGGAGCTGCGAGCCATTAAGGTGGGCCCACCCACCGTGATCTCCC
CTCACTCCTGCGAACCGCTCCCGGCCTCCACACTTTCCATGTGTCCCCGCTGCGAGCGTGTCACCTCCAC
CGCCGACAAACCGCCCTCCGCCGCGGCCACTTTGTCCGCTAAAGTGCCGCCAACTCAATCCCGCCAACCC
TCCGCGGCCTGTTGACCCTATAACTATAGTCCATCGCCTACTCTGCACGCCACCTCTACTACCTCATCAT
CTAATTAATCAGAAACAGGGCACAAACTTAACTAAACTTTACAAAACTAAAAAGTTAGTGTGAATGAAGA
TATAATATGTGTTAGAAAAAATAATGTTTTTTTTTTACTAAAAGGGCGTTTTCGTATAGGGAAACTTTTG
TAGTTAGTAGTAGTACTTTCAATGGTCAATGCGTATCTGATTATTGGGCTTTCA
Which has 97% identity to the Applicant’s target site of SEQ ID NO:79 (see alignment below). Therefore Creelman et al.’s SEQ ID NO:3 comprise the target site comprising at least 80% sequence identity to Applicant’s SEQ ID NO:79.
Query: XM_028385516.1 PREDICTED: Glycine soja homeobox-leucine zipper protein HOX3-like (LOC114419742), transcript variant X2, mRNA Query ID: lcl|Query_4241377 Length: 1034
Sequence ID: Query_4241379 Length: 63
Range 1: 5 to 63
Score:99.0 bits(53), Expect:9e-26,
Identities:57/59(97%), Gaps:0/59(0%), Strand: Plus/Plus
Query 140 ttctATGGCGGTTTTACCAAGTAGCTCCTCAAGCTTGGAATTGACCATATCTGTACCTG 198
|||||||||||||||||||||||||||||||| ||||||||||||||||||||| ||||
Sbjct 5 TTCTATGGCGGTTTTACCAAGTAGCTCCTCAAACTTGGAATTGACCATATCTGTCCCTG 63
Creelman et al. does not teach the method include contacting a target site within an endogenous HD-Zip gene in the plant or plant part with a nuclease comprising a cleavage domain (i.e. Ca9) and a nucleic acid binding domain (gRNA).
Zhong et al. teaches editing of HD-Zip I genes in soybean as GmHdz4 using CRISPR/Cas9 and a sgRNA wherein the mutant gmhd4 showed altered function as promoted growth of aboveground parts, and its root system architecture and their example provide new target for molecular breeding in soybean (page 1, Abstract, page 03, right paragraph 2). Zhong et al. teaches their study provide theoretical basis for further studies on HD-Zip genes involved in soybean and feasibility of breeding new germplasm for drought-tolerant soybean by gene editing.
Zhong et al. Figure 2 teaches GmHdz4 was expressed in root, stem, flower, pod etc. and gene was from the soybean cultivar Tianlong No. 1 therefore the gene is endogenous gene in the soybean (page5, left paragraph 1).
Therefore, it would have been obvious to an skilled in the art before the effective date of filling of the invention from teachings, suggestions and motivations from Creelman et al. to mutate a HD-Zip gene as SEQ ID NO: 3 from soybean leading to altered function of the gene that would comprise the recited target site comprising at least 80% identity to SEQ ID NO:79. Furthermore, a skilled in the art would combine the method of using CRISPR/Cas9 system with gRNA targeted to specific target in the HD-Zip gene to produce the specific desired mutation, that would lead to the invention of the method of producing a plant comprising a mutated endogenous HD-Zip gene. Someone skilled in the art would screen for alternation of the function of the variants of HD-Zip polypeptide to discover the claimed mutated soybean plant.
Regarding claims 69 and 73, Zhong et al. teaches the deletion of the mutants are base deletion ranging from 1-4 consecutive base deletion (see Figure F below as part of supplementary Figure S2).
Regarding claim 75, since Applicant describes SEQ ID NOs:86, 87 and 108 are ear motif of HD-Zip polypeptide SEQ ID NO:71 (page 8, lines 27-28), Creelman et al. claim 11 teaches a method for producing plant having a mutated endogenous HD-Zip gene with at least 90% identity to homodomain and leucine zipper of SEQ ID NO:3 by mutagenizing the EAR motif. Figure 1b teaches the Applicant’s SEQ ID NO: 108 as LELTI is an ear motif.
Therefore, it would have been obvious to mutagenize the EAR motif.
Regarding claim 76, Creelman et al. claim 11 teaches the method produce plant with increased yield (i.e. increased pod numbers or seeds per pod in soybean). Therefore, someone skilled in the art would screen for the traits in the mutated plants.
Regarding claims 79 and 94, alignment of SEQ ID NO:115 to Uniprot database showed the sequence is 96.7% identity to the locus A0A445EZH0_GLYSO from Glycine soja a wild cultivar (see alignment above).
Therefore, someone skilled in the art that modifies the EAR motif (i.e. SEQ ID NO: 108 as “LELTI”) as taught by Creelman et al. claim 11 would have change of the five amino acids, therefore the method would produce the plant comprising at least 90% sequence identity to SEQ ID NO:115. The method would produce the nucleic acid of claim 94 comprising mutation in EAR motif.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Applicant argues Example 2 of the specification, compared to SEQ ID N0:69, SEQ ID N0:113 contains a 21 bp deletion, which results in in-frame deletion of the amino acid residues "SSSSNLE" giving rise to the amino acid sequence of SEQ ID N0:115 wherein LE of the deletion are in EAR motif (Response to rejection, page 12, second to last paragraph).
Applicant argues Creelman fails to teach or suggest base deletions resulting in the deletion of amino acid residues in the EAR motif or a reasonable expectation that doing so would result in a nucleic acid as claimed motif (Response to rejection, page 12, second to last paragraph).
Applicant argues Zhong fails to teach or suggest that the GmHdz4 polypeptide has an EAR motif or targeting of an sgRNA to a region of the GmHdz4 gene encoding an EAR motif (Response to rejection, page 13, last paragraph). Applicant argues Creelman and Zhong describe two unrelated polypeptides with different functions from two different classes of HD-Zip transcription factors and there would have been no motivation to combine these references to arrive at the nucleic acid as claimed (Response to Rejection, page 14, first paragraph). Applicant argues Zhong fail to provide the necessary teachings or guidance for selecting an appropriate sgRNA sequence for targeting nucleic acids encoding an EAR motif to have any reasonable expectation of successfully introducing a base deletion (Response to Rejection, page 14, paragraph 2).
Applicant's arguments have been fully considered but they are not persuasive since:
Regarding applicant’s argument that Creelman fails to teach or suggest base deletions resulting in the deletion of amino acid residues in the EAR motif, the argument was not found persuasive since Creelman et al. claim 11 steps a and b specifically teach mutating EAR motif of SEQ ID NO:3 that would improve traits in plant and claim 17 recite the plant can be soybean plant. Furthermore, Creelman et al. FIG. 9 showed deletion mutants.
Regarding argument on fails to teach or suggest that the GmHdz4 polypeptide has an EAR motif, the art is supporting art to specifically teach the targeted deletion method which was known to a skilled in the art. Applicant has not recited specific sgRNA in any claim instead recites target site of unknown size comprise a sequence having at least 80% identity to the nucleotide sequences of SEQ ID NO:79, which comprise Creelman et al. taught SEQ ID NO:3.
Furthermore, where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because the test for obviousness is what the combined teachings of the references would have suggested to a person having ordinary skill in the art (PHOSITA).”
Obvious over Zhong et al. and further in view of Glycine soja in locus XM_028365353
Claim 84 is drawn to a guide nucleic acid that binds to a target site within an endogenous HD-Zip gene.
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (Published: 08/2022, Journal: Front. Plant Sci. 13:988505. doi: 10.3389/fpls.2022.988505) and further in view of Glycine soja in locus XM_028365353 (Published: 2019, NCBI Nucleotide database).
Regarding claim 84, the target site comprising a sequence having at least 80% identity to SEQ ID NO:79 is found in the "Glycine soja" in locus XM_028365353 as Glycine soja homeobox-leucine zipper protein HOX3-like gene (see enclosed PDF). Zhong et al. teaches target sequence of a homeobox-leucine zipper protein is used to develop a guide RNA (page 3, right paragraph 2) (see snippet below).
Therefore, someone skilled in the art would develop gRNA (i.e. guide nucleic acid) from teaching, suggestions and motivation of Zhong et al. to carry out the mutation in the Glycine soja homeobox-leucine zipper protein HOX3-like gene Leading to the invention of the guide RNA.
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Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Applicant argues Zhong fail to provide the necessary teachings or guidance for selecting an appropriate sgRNA sequence for targeting a region of an HD-Zip gene encoding an EAR motif and fail to provide any reasonable expectation of successfully arriving at the guide nucleic acid as claimed (Response to rejection, page 15, paragraph 2).
Applicant's arguments have been fully considered but they are not persuasive since the required component in claim is binding to a target site wherein target site comprise a sequence having at least 80% identity to SEQ ID NO:79, where the alignment showed the locus XM_028365353 comprise the sequence having at least 80% identity to SEQ ID NO:79.
Claim Rejections - 35 USC § 112 – Improper dependent form
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 73 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 73 recite in the method of claim 65 “optionally wherein the region comprises a nucleic acid sequence having at least 80% sequence identity to any one of SEQ ID NOs:72-85 or 91-105” fails to include all the limitations of the claim upon which it depends, since in claim 65 limitation of the target site having “at least 80% sequence identity to any one of SEQ ID NOs:72-85 or 91-105” that is contacted with the nuclease to bind is required component and cannot be optional component of the method.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Summary
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SANTOSH SHARMA/Examiner, Art Unit 1663
/DAVID H KRUSE/Primary Examiner, Art Unit 1663
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