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 .
The objections to claims 1, 2, 7, 21, 22 & 24 are withdrawn in light of Applicant’s amendments.
The rejection of claims 5, 10, & 24 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second
paragraph, is withdrawn in light of Applicant’s amendments.
The rejection of claim 24 under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al CN 105968177A is withdrawn in light of Applicant’s amendments.
The rejection of claim(s) 1-4, 6, 7, & 21-24 under 35 U.S.C. 103 over Yang et al (CN 105968177A) taken with the evidence of Terol et al (2021) Front. Microbiol. Sec. Microbial Physiology and Metabolism. 12. and Malik et al (1999) J. Plant Biochemistry & Biotechnology. 8: 01-13 is withdrawn in light of Applicant’s amendments.
The rejection of claims 1-13, 16-17 & 21-24 under 35 U.S.C. 103 over Yang, Terol, and Malik and further in view of Dale et al (2017) Nature Communications. 8:1496 taken with the evidence of Miki et al (2004) Journal of Biotechnology. 107: 193–232 is withdrawn in light of Applicant’s amendments.
The rejection of claims 1-14, 16-17 & 21-24 under 35 U.S.C. 103 as being unpatentable over Yang, Terol, Malik, Dale and Miki, and further in view of Ainley et al (US 11,198,883 B2) is withdrawn in light of Applicant’s amendments.
The rejection of claims 1-4, 6, 7, & 18-24 under 35 U.S.C. 103 as being unpatentable over Yang, Terol, and Malik and further in view of Mostafa (2021) J. Food Sci. 86:3778–3797 taken with the evidence of Kumara et al (2015) Tropical Agricultural Research. 26 (2): 329 – 342 is withdrawn in light of Applicant’s amendments.
Election/Restrictions
Claim 2 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/13/2025.
Amended claim 2 is drawn to a banana plant comprising a nucleic acid sequence other than the sequence encoding a first antimicrobial peptide, and therefore does not read on the elected species.
Specification
Due to Applicant' s amendment of the specification, the objection is modified from the objection as set forth in the Office action mailed 6/30/2025. Applicant' s arguments filed 9/30/2025 have been fully considered but they are not persuasive.
The use of the term pluriStrainer, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant urges that pluriStrainer® is not indicated as trademarked on the pluriSelect website and thus assumes that the term pluriStrainer® is not trademarked. No amendment of this term was provided (Remarks, page 25, paragraph 1).
This argument is unpersuasive, because Applicant has not provided evidence that pluriStrainer® is not a registered trademark. The product data sheet for the pluriStrainer® 750 µm cell strainer (available from https://www.pluriselect-usa.com/us/brands/pluristrainer/pluristrainer-750-um-cell-strainer.html#additional, accessed on 4/13/2026) has been attached to this Office Action as evidence of the use of the registered trademark by pluriSelect.
Claim Objections
Claims 1, 5, 10, & 24 are objected to because of the following informalities:
Claim 1 (line 8): “the at least a first antimicrobial peptide” should read --the first antimicrobial peptide--.
Claim 5 (line 6): a comma is needed after “SEQ ID NO: 119”.
Claim 10 (line 4): a comma is needed after “SEQ ID NO: 36”.
Claim 24 (line 6): “at least a third nucleic acid” should read --a third nucleic acid--.
Claim 24 (line 17): “at least a fifth nucleic acid” should read --a fifth nucleic acid--.
Claim 24 (line 21): “the seventh nucleic acid sequence has” should read --a seventh nucleic acid sequence having--.
Claim 24 (line 23): “the eighth nucleic acid sequence has” should read --an eighth nucleic acid sequence having--.
Claim 24 (line 25): “the ninth nucleic acid sequence has” should read --a ninth nucleic acid sequence having--.
Appropriate correction is required.
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, 3-14, & 16-18 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.
This is a new rejection necessitated by Applicant’s amendment.
Claim 1 (lines 7-15) recites an antimicrobial peptide having at least 95% sequence identity to SEQ ID NO: 197 or 179. SEQ ID NOs: 197 and 179 are nucleic acid sequences. It is indefinite as to whether this limitation should be interpreted as requiring an amino acid sequence matching SEQ ID NO: 197 or 179, or whether this should be interpreted as requiring a nucleic acid sequence of SEQ ID NO: 197 or 179, in keeping with original claim 2. Because of two distinct interpretations, claim 1 and dependent claims 3-14, 16-18 are indefinite.
Written Description
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, 3-14 & 16-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for 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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 6/30/2025, as applied to claims 1-14 & 16-24. Applicant' s arguments filed 9/30/2025 have been fully considered but they are not persuasive.
Claims 1-14 & 16-24 require a banana plant or banana product comprising a nucleic acid construct comprising a nucleic acid sequence encoding an antimicrobial peptide. Claims 1-14 & 16-18 require that the antimicrobial peptide has at least 95% sequence identity to SEQ ID NO: 197 or 179, but because SEQ ID NO: 197 and 179 are nucleic acid sequences this requirement has been examined under the interpretation that the nucleic acid sequence has at least 95% sequence identity to SEQ ID NO: 197 or 179. Claims 22 & 24 require that the nucleic acid sequence has at least 95% sequence identity to SEQ ID NO: 197 or 179.
Nucleic acids with 95% identity to the 860 nucleotide-long SEQ ID NO: 197 would have 43 nucleotide substitutions relative to SEQ ID NO: 197. Nucleic acids with 95% identity to the 732 nucleotide-long SEQ ID NO: 179 would have 36 nucleotide substitutions relative to SEQ ID NO: 179. These nucleic acids encompass sequences in which every substitution is in a different codon and in which every substitution results in codon that encodes a different amino acid. Thus, nucleic acids with 95% identity to SEQ ID NO: 197 encompass nucleic acids encoding antimicrobial peptides with 43 amino acid substitutions relative to the 91 amino acid-long SEQ ID NO: 198 or 66 amino acid-long SEQ ID NO: 199. Antimicrobial peptides with 43 amino acid substitutions would have 52.7% or 34.8% identity respectively to SEQ ID NO: 198 and 199, the snakin antimicrobial proteins encoded by SEQ ID NO: 197 (specification, paragraph [00249-00251]).
Similarly, nucleic acids with 95% identity to SEQ ID NO: 179 encompass nucleic acids encoding antimicrobial peptides with 36 amino acid substitutions relative to the 116 aa-long SEQ ID NO: 180 or the 92 aa-long SEQ ID NO: 181. Antimicrobial peptides with 36 amino acid substitutions would have 69% or 60.9% sequence identity to SEQ ID NO: 180 or 181 respectively. SEQ ID NO: 180-181 are the snakin antimicrobial proteins encoded by SEQ ID NO: 179 (paragraphs [00232-00233]).
The only species of antimicrobial peptides described in the specification are antifungal proteins in the category of defensins, lipid transfer proteins (LTP), snakins, and thaumatin-like proteins (TLP) (paragraph [00514]). The instant specification describes eight candidate snakins (SEQ ID NO: 160, 163, 166, 181, 187, 190, 199, and 202; table 15). The instant specification provides nucleic acid sequences that encode antimicrobial peptides (SEQ ID NOs: 4, 106, 125, 128, 131, 134, 137, 140, 143, 146, 149, 152, 155, 158, 161, 164, 167, 170, 173, 176, 179, 182, 185, 188, 191, 194, 197, 200, 203, 206, 209, 215, 216, 217, and 218). The most similar nucleic acid sequences to SEQ ID NO: 197 taught by the instant specification are SEQ ID NO: 223, which is a 13578bp-long snakin antimicrobial peptide expression vector not a snakin sequence alone (paragraph [00275]), and SEQ ID NO: 185, which is a putative snakin and has 84% identity over a mere 18% of the sequence. See alignment below. There were no antimicrobial peptide nucleic acid sequences in the instant specification with significant similarity to SEQ ID NO: 179. Thus, the specification does not describe species over the full scope of claimed nucleic acids.
Sequence ID: Query_8006221Length: 1051Number of Matches: 1
Range 1: 706 to 862
Alignment statistics for match #1
Score
Expect
Identities
Gaps
Strand
152 bits(82)
3e-39
132/157(84%)
0/157(0%)
Plus/Plus
Query 494 CGGTGCTCGGCGACGTCGCACAAGAAGCCATGCTTGTTCTTCTGCAAGAAGTGCTGCGCC 553
|||||||| || || | |||||||||| ||| ||||||||||| ||||||||||||||
Sbjct 706 CGGTGCTCCGCCACCGCCTACAAGAAGCCCTGCATGTTCTTCTGCCAGAAGTGCTGCGCC 765
Query 554 GCGTGCCTGTGCGTGCCGCCTGGCACCTACGGCAACAAGGAGGCGTGCCCCTGCTACAAC 613
|||||| ||||||||||| || || || ||||||||| | | |||||||||||||||
Sbjct 766 AAGTGCCTCTGCGTGCCGCCCGGGACGTATGGCAACAAGCAAGTCTGCCCCTGCTACAAC 825
Query 614 AACTGGAAGACGAAGGAAGGTGGCCCCAAGTGTCCCT 650
||||||||||||||| ||| || |||||||| ||||
Sbjct 826 AACTGGAAGACGAAGAGAGGCGGTCCCAAGTGCCCCT 862
The instant specification describes anti-microbial peptides as having specific motifs, such as heveins, cyclotides, hairpinins, and thionins (paragraph [00520]). The specification describes snakins as antimicrobial peptides that respond to biotic and abiotic stresses with modes of action that are not elucidated but may involve interaction cell membranes to cause pore formation and cell leakage [00517]. The instant specification teaches that snakins have a structural motif, but that the number of basic amino acids was not correlated with activity in these peptides (paragraph [00545]). Figure 18 depicts the signature motif as C-x(3)-C-x(3)-C-x(8)-C-x(3)-C-x(2)-C(2)-x(2)-C-x-C-x(11)-C-x-C-x(12)-C.
While the claims are drawn to nucleic acids with 95% identity to SEQ ID NO: 197 or SEQ ID NO: 179 encoding antimicrobial peptides, the specification describes no sequences with at least 95% identity to SEQ ID NO: 197 or SEQ ID NO: 179 that are not SEQ ID NO: 197 or SEQ ID NO: 179. Thus, the specification does not describe species over the full scope of the claimed nucleic acid sequences that encode snakin proteins, or even antimicrobial proteins broadly, with 90% sequence identity to SEQ ID NOs: 197 or 179 and thus does not describe the full scope of the claimed nucleic acids.
Plant antimicrobial peptides (AMPs) such as defensins, LTPs, and snakins are known in the art (Tam et al (2015) Pharmaceuticals. 8: 711-757 (published 11/16/2015, hereafter Tam) table 1). Cysteine-rich peptides with AMP characteristics are under-predicted and may account for 3% of expressed proteins (Tam page 712, paragraph 4-page 713, paragraph 1). Snakins, which is the AMP family instant SEQ ID NOs: 197 and 179 were classified within (Ma09_p27770.1 and Ma07_p21450.1; specification table 15), are AMPs predicted to have two long α-helices (Tam page 734, paragraphs 5-6).
The structural features that distinguish nucleic acid sequences encoding antimicrobial peptides with 95% identity to SEQ ID NO: 197 or SEQ ID NO: 179 from nucleic acids with 95% identity to SEQ ID NO: 197 or 179 without antimicrobial snakin activity are not described in the specification. Instant claims 19-21 & 23 do not even require sequences with 95% identity to SEQ ID NO: 197 or SEQ ID NO: 179 but are drawn to sequences encoding antimicrobial peptides broadly. Because the genus of nucleic acid sequences encoding snakins is highly variant, one of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species.
Hence, Applicant has not, in fact, described nucleic acids that encode an antimicrobial peptide including a nucleic acid sequence with 95% sequence identity to SEQ ID NO: 197 or 179 over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Applicant urges that amended claims recite 95% sequence identity. Applicant urges that a high identity of the claimed genus is a structural feature of each of the nucleic acid molecules encoding the claimed polypeptide sequences within the genus. Applicant urges that the specification describes domains present in the proteins of the claimed genus and argues that this satisfies the written description requirement according to the Written Description Training Materials of March 25, 2008 (Remarks, page 27, paragraph 2).
This argument is unpersuasive, because even the claims that require 95% sequence identity to SEQ ID NO: 197 or 179 only broadly require that the encoded peptide be antimicrobial. Peptides can have antimicrobial activity through diverse mechanisms. The instant specification describes four types of antimicrobial proteins: defensins, lipid transfer proteins, snakins, and thaumantin-like proteins (paragraph [00514]). One of skill in the art would not have expected these diverse antimicrobial proteins to share domains or structural features because these proteins do not share a universal mode of action (paragraphs [00515-00518]).
Even within the class of snakin antimicrobial peptides, the instant specification describes that modes of action are not completely elucidated and that “many” are believed to interact with cell membranes to cause pore formation (paragraph [00517]). However, the instant specification also describes that snakins can be involved in abiotic stresses (paragraph [00517]). The instant specification describes that snakins comprise a structure motif similar to snake venoms (paragraph [00545]), but does not describe which features are present in encompassed peptides with antimicrobial activity but not in snakin peptides without antimicrobial activity. Additionally, amended Figure 18 no longer identifies conserved amino acids.
In fact, in the description of Ma09_p27770.1, “nothing obvious stands out for the sequence of Ma09_p27770.1 vs others” and there is no clear correlation between activity and number of basic amino acids (paragraph [00545]). The instant specification does not teach why Ma09_p27770.1 may be the best lead in terms of antimicrobial activity. The instant specification does not, in fact, describe domains required for the recited antimicrobial activity because the instant specification does not describe any features of the recited sequences that are necessary for the function.
The prior art does not make up for the lack of description in the instant specification.
Applicant urges that having a percent identity to a sequence identifier would have put one of skill in the art in possession of the entire genus of nucleic acid sequences having a given percent identity to that sequence (Remarks, page 27, paragraph 3).
This argument is unpersuasive, because the claims are not drawn to the genus of all nucleic acid molecules with 95% sequence identity to SEQ ID NO: 197 or 179, but instead to the genus of nucleic acid molecules that encode an antimicrobial peptide. Some claims are further restricted to the genus of nucleic acid molecules with 95% sequence identity to SEQ ID NO: 197 or 179 that encode an antimicrobial peptide. This genus encompasses polypeptides with as little as 34.8% sequence identity to the disclosed antimicrobial peptide of SEQ ID NO: 199 and as little as 60.9% sequence identity to the disclosed antimicrobial peptide of SEQ ID NO: 181. Applicant has not described nucleic acid sequences encodnig peptides with this level of sequence divergence that also function as antimicrobial peptides. Applicant has not sufficiently described the structural features responsible for the antimicrobial activity of encoded polypeptides that would demonstrate to one of skill in the art that they were in possession of the full genus of nucleic acid molecules encoding antimicrobial peptides over the full scope of the claims at the time of filing of the instant application.
Applicant urges that the specification teaches conserved amino acids between Ma09_p27770.1 and other snakin proteins. Applicant urges that identification of domains responsible for the activity provides necessary information for a person of skill to conclude that Applicant would have been in possession of the claimed genus based on the disclosure of a single sequence. Applicant references Example 11B claim 2 in the Guidelines as such a scenario because Example 11B claims a sequence identity to a specific sequence, identifies a domain responsible for the particular activity, and predicts in the specification that the domain will result in a protein having the particular activity. Applicant urges that because the Guidelines say Example 11B provides sufficient Written Description, the disclosure of SEQ ID NO: 197 and the teaching in the specification that the protein encoded by SEQ ID NO: 197 is the most effective snakin protein against TR4 is sufficient. Applicant urges that the instant specification describes a domain related to the activity of the claimed proteins. Applicant urges that that is all that is required to satisfy the Written Description requirement (Remarks, page 27, paragraph 4-page 29, paragraph 1).
This argument is unpersuasive, because Example 11B in the “Guidelines” does not apply to the instant Application. The polypeptide of Example 11B has a novel activity. The specification of example 11B discloses data from deletion studies to confirm two domains critical to activity Y and proposes that conservative mutations in these domains will result in a protein with activity Y and that mutations outside the two disclosed domains will not affect activity Y (Guidelines page 40 paragraph 1). Furthermore, claim 2 of Example 11B is drawn to a polypeptide with at least 85% amino acid sequence identity wherein the polypeptide has activity Y (Guidelines page 40 paragraph 3).
In contrast, the instant claims recite an activity that is not novel (“antimicrobial”) and can be achieved by diverse mechanisms. The instant specification describes four types of antimicrobial proteins: defensins, lipid transfer proteins, snakins, and thaumantin-like proteins (paragraph [00514]). One of skill in the art would not have expected these antimicrobial proteins across the four described types of antimicrobial proteins to share domains or structural features because these proteins do not share a universal mode of action (paragraphs [00515-00518]).
Unlike Example 11B, the instant specification does not propose that conservative mutations in the single disclosed snakin motif will result in a protein with antimicrobial activity or that mutations outside the motif will not affect activity. The instant specification describes that modes of action of snakins are not completely elucidated (paragraph [00517]).
Unlike Example 11B, the instant specification does not describe experiments demonstrating domains or residues that are critical to activity. The instant specification describes that snakins can be involved in activity other than antimicrobial, including abiotic stress (paragraph [00517]), but does not describe features of the conserved motif that are present in encompassed peptides with antimicrobial activity but not in peptides that respond to other stresses. Additionally, amended Figure 18 no longer identifies conserved amino acids.
As summarized above, in the description of Ma09_p27770.1, “nothing obvious stands out for the sequence of Ma09_p27770.1 vs others” and there is no clear correlation between activity and number of basic amino acids (paragraph [00545]). The instant specification does not describe any features of the recited sequences as necessary for the function of antimicrobial activity and so Written Description is not met.
Scope of Enablement
Claims 1-14 & 16-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a banana plant with increased resistance to Fusarium oxysporum f. sp cubense and a method of making said banana plant comprising a nucleic acid sequence encoding an antimicrobial peptide with 100% identity to SEQ ID NO: 197 or 179, does not reasonably provide enablement for a banana plant with increased resistance comprising any nucleic acid sequence encoding an antimicrobial peptide with 90% identity to SEQ ID NO: 197 or 179. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 6/30/2025, as applied to claims 1-14 & 16-24. Applicant' s arguments filed 9/30/2025 have been fully considered but they are not persuasive.
The claims require a nucleic acid sequence encoding an antimicrobial peptide with at least 95% sequence identity to SEQ ID NO: 197 or 179.
Nucleic acids with 95% identity to the 860 nucleotide-long SEQ ID NO: 197 would have 43 nucleotide substitutions relative to SEQ ID NO: 197. Nucleic acids with 95% identity to the 732 nucleotide-long SEQ ID NO: 179 would have 36 nucleotide substitutions relative to SEQ ID NO: 179. These nucleic acids encompass sequences in which every substitution is in a different codon and in which every substitution results in codon that encodes a different amino acid. Thus, nucleic acids with 95% identity to SEQ ID NO: 197 encompass nucleic acids encoding antimicrobial peptides with 43 amino acid substitutions relative to the 91 amino acid-long SEQ ID NO: 198 or 66 amino acid-long SEQ ID NO: 199. Antimicrobial peptides with 43 amino acid substitutions would have 52.7% or 34.8% identity respectively to SEQ ID NO: 198 and 199, the snakin antimicrobial proteins encoded by SEQ ID NO: 197 (specification, paragraph [00249-00251]).
Similarly, nucleic acids with 95% identity to SEQ ID NO: 179 encompass nucleic acids encoding antimicrobial peptides with 36 amino acid substitutions relative to the 116 aa-long SEQ ID NO: 180 or the 92 aa-long SEQ ID NO: 181. Antimicrobial peptides with 36 amino acid substitutions would have 69% or 60.9% sequence identity to SEQ ID NO: 180 or 181 respectively. SEQ ID NO: 180-181 are the snakin antimicrobial proteins encoded by SEQ ID NO: 179 (paragraphs [00232-00233]).
The only species of antimicrobial peptides described in the specification are antifungal proteins in the category of defensins, lipid transfer proteins (LTP), snakins, and thaumatin-like proteins (TLP) (paragraph [00514]). The instant specification teaches eight candidate snakins (SEQ ID NO: 160, 163, 166, 181, 187, 190, 199, and 202; table 15). The instant specification provides nucleic acid sequences that encode antimicrobial peptides (SEQ ID NOs: 4, 106, 125, 128, 131, 134, 137, 140, 143, 146, 149, 152, 155, 158, 161, 164, 167, 170, 173, 176, 179, 182, 185, 188, 191, 194, 197, 200, 203, 206, 209, 215, 216, 217, and 218; claim 2 lines 6-13). The most similar nucleic acid sequences to SEQ ID NO: 197 taught by the instant specification are SEQ ID NO: 223, which is a 13578bp-long snakin antimicrobial peptide expression vector not a snakin sequence alone (paragraph [00275]), and SEQ ID NO: 185, which is a putative snakin and has 84% identity over 18% of the sequence. See alignment above. There were no antimicrobial peptide nucleic acid sequences in the instant specification with significant similarity to SEQ ID NO: 179. Thus, the specification does not describe species over the full scope of claimed nucleic acids.
Myriad plant antimicrobial peptides (AMPs) are known in the art (Tam et al (2015) Pharmaceuticals. 8: 711-757 (published 11/16/2015, hereafter Tam) table 1). Despite some conserved structural motifs within AMP families (Tam table 1), AMPs display peptide promiscuity, which refers to multiple functions for a single peptide in addition to being antimicrobial (Tam page 713, paragraph 8). AMPs are bioprocessed from precursors so that mature sequences are often hypervariable to provide sequence diversity (Tam page 713, paragraph 9). There are over a thousand known AMPs, and cysteine-rich peptides with AMP characteristics are under-predicted and may account for 3% of expressed proteins (Tam page 712, paragraph 4-page 713, paragraph 1).
Given the broad diversity of antimicrobial peptides and corresponding diversity of nucleic acid sequences encoding them, one of ordinary skill in the art would be required to screen through all possible nucleic acid sequences encompassed by the claims to determine which additional sequences, if any, encode peptides with snakin activity. Thus, the claims are not enabled over the full scope of a banana plant with increased resistance comprising any nucleic acid sequence encoding an antimicrobial peptide with 95% identity to SEQ ID NO: 197 or 179.
Applicant urges that amended claims 1, 2, 22, and 24 recite 95% sequence identity and are not overly broad and would not require undue experimentation (Remarks, page 29, paragraph 4-5). Applicant urges that there is extensive knowledge in the art that provides significant guidance to those of ordinary skill with respect to nucleic acid constructs encoding antimicrobial proteins including snakins based on knowledge of the coding sequence of the polypeptide (Remarks page 29, paragraph 6-page 30, paragraph 1).
This argument is unpersuasive, because antimicrobial peptides and snakins are highly diverse. Even within the snakin genus of antimicrobial peptides, peptides are known have functions other than antimicrobial activity. The instant specification describes that snakins can be involved in abiotic stress response (paragraph [00517]). Because of the high diversity of encompassed sequences and unpredictability of function, undue experimentation would be required to identify which sequences have the claimed antimicrobial activity.
Applicant urges that the skill in the art is high because a practitioner would have at least a Ph.D. and several years of experience in the art (Remarks, page 30, paragraph 2).
This argument is unpersuasive, because years of experience for practitioners would not change the large number of sequences encompassed by the claims that would need to be tested nor the fact that snakins are diverse and can have diverse functions.
Applicant urges that procedures for making nucleic acid constructs and testing antimicrobial proteins are conventional and taught in Example 4 of the instant specification and so are not undue (Remarks, page 30, paragraph 3).
This argument is unpersuasive, because the claims encompass nucleic acids encoding peptides with as little as 34.8% sequence identity to the antimicrobial peptides taught by the specification. The number of sequences that would need to be constructed and assayed in order to determine which encompassed sequences encode antimicrobial peptides and which do not would require undue experimentation.
Applicant urges that because a substantial body of research had been performed on nucleic acid constructs encoding antimicrobial proteins, this provided an increased level of predictability in the art in view of the specification teaching (Remarks, page 30, paragraph 4-page 31, paragraph 1).
This argument is unpersuasive, because the prior art does not teach the necessary structural features of snakin peptides to provide antimicrobial activity. Snakins, and antimicrobial peptides more broadly, are highly diverse and have different functions. The mechanism of action is unknown and so there is high unpredictability in testing antimicrobial proteins encoded by nucleic acid molecules encompassed by the claims.
Applicant urges that the instant specification provides guidance to enable the claims because the specification discloses SEQ ID NO: 197 and that nucleic acid constructs encoding the snakin antimicrobial protein inhibit TR4 fungal growth. Applicant urges that the extensive amount of direction and guidance provided by the specification supports that the claimed method could be practiced without undue experimentation (Remarks, page 31, paragraph 2).
This argument is unpersuasive, because teaching that one sequence within the large genus of encompassed sequences has antimicrobial activity would not have allowed one of skill in the art to practice the claimed invention over the full scope of the invention without undue experimentation. The instant specification teaches, regarding the protein encoded by SEQ ID NO: 197, “nothing obvious stands out for the sequence of Ma09_p27770.1 vs others” and there is no clear correlation between activity and number of basic amino acids (paragraph [00545]). The instant specification does not teach why Ma09_p27770.1 may be the best lead in terms of antimicrobial activity. The instant specification does not describe domains or residues required for the recited antimicrobial activity. Thus the instant specification does not provide extensive amount of direction and guidance to enable the invention over the full scope of sequences with 95% identity to SEQ ID NO: 197 or 179 encoding antimicrobial peptides.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghag et al (2012) PLos ONE. 7(6). e39557 (published 6/22/2012, hereafter Ghag).
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 6/30/2025, as applied to claims 1, 4, 6-7, 9-10, 16-17 & 21. Applicant' s arguments filed 9/30/2025 have been fully considered but they are not persuasive.
Claim 21 is drawn to a method of producing a banana plant comprising introducing into a banana plant a nucleic acid construct comprising a nucleic acid sequence encoding an antimicrobial peptide operably linked to a heterologous or gene edited promoter.
Ghag discloses that banana is an important food crop in the word (page 1, left column, paragraph 1). Ghag discloses that Fusarium oxysporum f. sp. cubense causes Fusarium wilt, which is an important economic infestation of banana (page 1, left column, paragraph 2). Ghag discloses that there are no natural sources of resistance against Fusarium oxysporum from cultivated banana and development of resistance is through incorporation of resistance genes from other organisms by genetic engineering, including antimicrobial peptides (page 1, right column, paragraph 2-page 2, paragraph 1).
Ghag discloses a construct comprising a PhDef1 and PhDef2 coding sequence under control of a Zea mays polyubiquitin promoter and upstream of a nos 3’ UTR and comprising a GUS expression cassette and hpt expression cassette (figure 1a). Ghag discloses banana plants transformed with the construct (figure 1 k) and a method of introducing the construct into banana plants via Agrobacterium and selecting plant transformants based on GUS staining (which involves a β-glucuronidase gene) (page 3, left column, paragraph 3-right column, paragraph 2). RNA was extracted from banana leaves (page 5, right column, paragraph 2). Ghag discloses that transgenic plants had no or mild symptoms compared to plants without the transgenes when challenged with Fusarium (page 7, right column, paragraph 2) and that because the defensins used in the study work at the level of innate, non-specific immunity that can by useful against race 4 of Fusarium oxysporum (page 10, left column, paragraph 2).
The method of making the transgenic banana plants of Ghag anticipates the method of introducing a nucleic acid construct encoding an antimicrobial peptide into a banana plant (instant claim 21).
Claim 21 is anticipated by Ghag.
Applicant urges that amended claim 1 recites that the nucleic acid sequence has at least 95% sequence identity to one of a list of SEQ IDs. PhDef1 and PhDef2 coding sequences disclosed by Ghag are not DNA molecules with at least 95% sequence identity to the full-length sequence of SEQ ID NO: 197 (Remarks, page 33, paragraph 4-page 34, paragraph 1).
This argument is unpersuasive, because claim 21 does not depend on claim 1 and does not require any sequence identity to a recited sequence, merely a nucleic acid sequence encoding an antimicrobial peptide.
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.
Claim(s) 1,3-4, 6, 7, & 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (CN 105968177A, published 9/28/2016, hereafter Yang. Machine English translations of the description and claims have been provided previously) in view of GenBank record HG996473.1 (bases 33225552-33226282, available 8/25/2021, hereafter GenBank record HG996473.1) and Srivastava et al (2018) Trends in Plant Science. 23(3): 248-259. Published 12/6/2017, hereafter Srivastava), taken with the evidence of Terol et al (2021) Front. Microbiol. Sec. Microbial Physiology and Metabolism. 12. (published 6/20/2021, hereafter Terol) and Malik et al (1999) J. Plant Biochemistry & Biotechnology. 8: 01-13 (published 12/30/2012, hereafter Malik).
This is a new rejection necessitated by Applicant’s amendments. Applicant’s remarks filed 9/30/2025 have been considered as they pertain to the rejection below, but they are not persuasive.
Claims 1, 3-4, 6, 7, & 21-24 are drawn to a transgenic banana plant comprising a nucleic acid construct comprising a nucleic acid sequence encoding an antimicrobial peptide, plant parts of said banana, and a method of producing such a banana plant comprising introducing a nucleic acid construct. Amended claim 1 recites that the peptide has at least 95% sequence identity to SEQ ID NO: 197 or 179 and it is indefinite as to whether this limitation should be interpreted as requiring an amino acid sequence matching SEQ ID NO: 197 or 179, or whether this should be interpreted as requiring a nucleic acid sequence of SEQ ID NO: 197 or 179, in keeping with original claim 2. For purposes of examination, claim 1 and dependent claims have been interpreted to require a nucleic acid sequence having at least 95% sequence identity to SEQ ID NO: 197 or 179, as also required by claims 22 & 24.
Yang teaches a snakin family protein, MaSN2, from banana which is an antimicrobial peptide (paragraph [0005, 0009], Yang SEQ ID NO: 2) encoded by the cDNA nucleic acid sequence of Yang SEQ ID NO: 1. Yang SEQ ID NO: 1 has 97% sequence identity to instant SEQ ID NO: 179 but with gaps. See alignments below, where Yang SEQ ID NO: 1 is on the top.
179
Sequence ID: Query_3929999Length: 732Number of Matches: 3
Range 1: 388 to 574
Alignment statistics for match #1
Score
Expect
Identities
Gaps
Strand
315 bits(349)
3e-90
182/187(97%)
0/187(0%)
Plus/Plus
Query 165 AGAGTGCGGCGACGCTTGCAAGGACCGGTGCAAGCTGCACTCGCGGCAGAACGTGTGCTC 224
|||||||||||||||||||||||| |||||||||||||||||||||||||||||||||||
Sbjct 388 AGAGTGCGGCGACGCTTGCAAGGAGCGGTGCAAGCTGCACTCGCGGCAGAACGTGTGCTC 447
Query 225 TCGAGCTTGCATCACCTGCTGCAGCGTCTGCAAGTGCGTGCCGCCGGGGACCTATGGCCA 284
|||||| |||||||||||||||||| ||||||||||||||||||||||||||||||||||
Sbjct 448 TCGAGCCTGCATCACCTGCTGCAGCTTCTGCAAGTGCGTGCCGCCGGGGACCTATGGCCA 507
Query 285 CACGGAGTTGTGCGGCAAGTGCTACACCGACTGGAAGACGCACGGGAACCGGACCAAGTG 344
||||||| |||||||||||||||| |||||||||||||||||||||||||||||||||||
Sbjct 508 CACGGAGCTGTGCGGCAAGTGCTATACCGACTGGAAGACGCACGGGAACCGGACCAAGTG 567
Query 345 CCCCTGA 351
|||||||
Sbjct 568 CCCCTGA 574
Range 2: 207 to 315
Alignment statistics for match #2
Score
Expect
Identities
Gaps
Strand
193 bits(213)
3e-53
108/109(99%)
0/109(0%)
Plus/Plus
Query 58 GTCTCGTCCGACGCAAAGGACGCGTTCATGGAGGCGGGCTATGCCAAGGCTCCTGTGGTC 117
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 207 GTCTCGTCCGACGCAAAGGACGCGTTCATGGAGGCGGGCTATGCCAAGGCTCCTGTGGTC 266
Query 118 GCTCCTGTTCCGGCTCCTCCTGCACCTCGCATCATCAAGGACACCAAAG 166
|||||||||||||||||||| ||||||||||||||||||||||||||||
Sbjct 267 GCTCCTGTTCCGGCTCCTCCCGCACCTCGCATCATCAAGGACACCAAAG 315
Range 3: 67 to 125
Alignment statistics for match #3
Score
Expect
Identities
Gaps
Strand
103 bits(113)
4e-26
58/59(98%)
0/59(0%)
Plus/Plus
Query 1 ATGGCTCTTAAGCTGGCCGTGTTTGTCTTTGCATCTCTACTCGTCATCACCACCAGAGT 59
|||||||||||||||||| ||||||||||||||||||||||||||||||||||||||||
Sbjct 67 ATGGCTCTTAAGCTGGCCATGTTTGTCTTTGCATCTCTACTCGTCATCACCACCAGAGT 125
Notably, Yang SEQ ID NO: 2 has 100% sequence identity to the entire sequence of instant SEQ ID NO: 180, the protein encoded by instant SEQ ID NO: 179. See alignment below.
Range 1: 1 to 116
Alignment statistics for match #1
Score
Expect
Method
Identities
Positives
Gaps
238 bits(606)
4e-88
Compositional matrix adjust.
116/116(100%)
116/116(100%)
0/116(0%)
Query 1 MALKLAVFVFASLLVITTRVSSDAKDAFMEAGYAKAPVVAPVPAPPAPRIIKDTKECGDA 60
MALKLAVFVFASLLVITTRVSSDAKDAFMEAGYAKAPVVAPVPAPPAPRIIKDTKECGDA
Sbjct 1 MALKLAVFVFASLLVITTRVSSDAKDAFMEAGYAKAPVVAPVPAPPAPRIIKDTKECGDA 60
Query 61 CKDRCKLHSRQNVCSRACITCCSVCKCVPPGTYGHTELCGKCYTDWKTHGNRTKCP 116
CKDRCKLHSRQNVCSRACITCCSVCKCVPPGTYGHTELCGKCYTDWKTHGNRTKCP
Sbjct 61 CKDRCKLHSRQNVCSRACITCCSVCKCVPPGTYGHTELCGKCYTDWKTHGNRTKCP 116
Yang teaches a vector construct MaSN2-pGEX-6p-1 comprising a polynucleotide sequence encoding the MaSN2 gene operably linked to a Ptac promoter and also comprising a glutathione S-transferase and Amp construct operably linked to the same promoter (figure 4) for introduction into Saccharomyces cerevisiae. Yang teaches a vector MaSN2-PYES2 comprising a polynucleotide sequence encoding the MaSN2 gene operably linked to a PGAL1 promoter and CYC1TT and also comprising an Ampicillin resistance selectable marker (figure 2).
Yang teaches that the MaSN2 gene is induced in Musa acuminata banana seedlings by methyl viologen, mannitol, and low temperature in addition to Fusarium wilt (paragraph [0015, 0053]). Yang envisions using the gene for genetic engineering improvement of banana against wilt disease (paragraph [0053]) and teaches the use of the antimicrobial peptide and gene in banana breeding to improve banana tolerance to Fusarium wilt (Yang claim 4).
Yang teaches that the MaSN2 protein expressed in a prokaryote inhibits the growth of Fusarium wilt species 4 (paragraph [0027, 0078]; figure 6a).
Yang teaches a motivation to find and use an antibacterial substance to kill Fusarium oxysporum f.sp. cubense, including race 4, because the disease is spreading and devastating to bananas (paragraph [0006]).
Yang does not teach a banana plant transformed with a nucleic acid construct comprising a nucleic acid sequence encoding the MaSN2 antimicrobial peptide. Yang does not teach a nucleic acid sequence having 95% sequence identity to the full-length sequence of SEQ ID NO: 179.
GenBank record HG996473.1 teaches a nucleic acid sequence with 98% identity to the full-length sequence of instant SEQ ID NO: 179 (see first alignment below) and that the coding sequence of this genomic DNA encodes a protein identical to Yang SEQ ID NO: 2 and instant SEQ ID NO: 180. See second alignment below. GenBank record HG996473.1 teaches that the sequence from bases 33225552 to 33226282 encompasses an mRNA that includes a 5’UTR and a 3’UTR.
Alignment statistics for match #1
Score
Expect
Identities
Gaps
Strand
1284 bits(695)
0.0
719/731(98%)
0/731(0%)
Plus/Minus
Query 2 CTATATAAGCAGCGGCAGCTCTTCTCATCTTGCTCACCACCTAACCGGCACGGTACTGCT 61
||||||||||||| |||||||||||||| |||||||||||||||||||||||||||||||
Sbjct 33226282 CTATATAAGCAGCAGCAGCTCTTCTCATGTTGCTCACCACCTAACCGGCACGGTACTGCT 33226223
Query 62 ACACCATGGCTCTTAAGCTGGCCATGTTTGTCTTTGCATCTCTACTCGTCATCACCACCA 121
||||||||||||||||||||||| ||||||||||||||||||||||||||||||||||||
Sbjct 33226222 ACACCATGGCTCTTAAGCTGGCCGTGTTTGTCTTTGCATCTCTACTCGTCATCACCACCA 33226163
Query 122 GAGTAAGCCAGCCATCTGAGTTCTACTCTTCGGACGAAGGGAACCGCGCGTAGCGCGTCT 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 33226162 GAGTAAGCCAGCCATCTGAGTTCTACTCTTCGGACGAAGGGAACCGCGCGTAGCGCGTCT 33226103
Query 182 GATGAACACGTGTTCGATGTTGCAGGTCTCGTCCGACGCAAAGGACGCGTTCATGGAGGC 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 33226102 GATGAACACGTGTTCGATGTTGCAGGTCTCGTCCGACGCAAAGGACGCGTTCATGGAGGC 33226043
Query 242 GGGCTATGCCAAGGCTCCTGTGGTCGCTCCTGTTCCGGCTCCTCCCGCACCTCGCATCAT 301
||||||||||||||||||||||||||||||||||||||||||||| ||||||||||||||
Sbjct 33226042 GGGCTATGCCAAGGCTCCTGTGGTCGCTCCTGTTCCGGCTCCTCCTGCACCTCGCATCAT 33225983
Query 302 CAAGGACACCAAAGGTGAGGAGCTCTTGTCGTTTGGTTCTGCGTAGGTCATTGGCAAGCG 361
||||||||||||||||||| ||||||||||||||||||||||||||||||||||||||||
Sbjct 33225982 CAAGGACACCAAAGGTGAGAAGCTCTTGTCGTTTGGTTCTGCGTAGGTCATTGGCAAGCG 33225923
Query 362 TCATCGACGTGCTTTGCTGGTGGTGCAGAGTGCGGCGACGCTTGCAAGGAGCGGTGCAAG 421
|||||||||||||||||||||||||||||||||||||||||||||||||| |||||||||
Sbjct 33225922 TCATCGACGTGCTTTGCTGGTGGTGCAGAGTGCGGCGACGCTTGCAAGGACCGGTGCAAG 33225863
Query 422 CTGCACTCGCGGCAGAACGTGTGCTCTCGAGCCTGCATCACCTGCTGCAGCTTCTGCAAG 481
|||||||||||||||||||||||||||||||| |||||||||||||||||| ||||||||
Sbjct 33225862 CTGCACTCGCGGCAGAACGTGTGCTCTCGAGCTTGCATCACCTGCTGCAGCGTCTGCAAG 33225803
Query 482 TGCGTGCCGCCGGGGACCTATGGCCACACGGAGCTGTGCGGCAAGTGCTATACCGACTGG 541
||||||||||||||||||||||||||||||||| |||||||||||||||| |||||||||
Sbjct 33225802 TGCGTGCCGCCGGGGACCTATGGCCACACGGAGTTGTGCGGCAAGTGCTACACCGACTGG 33225743
Query 542 AAGACGCACGGGAACCGGACCAAGTGCCCCTGAACGCCGGCACCGTCTGCTGCAGCTCCG 601
||||||||||||||||||||||||||||||||| ||||| ||||||||||||||||||||
Sbjct 33225742 AAGACGCACGGGAACCGGACCAAGTGCCCCTGAGCGCCGCCACCGTCTGCTGCAGCTCCG 33225683
Query 602 CCTTTCTTTCCGCGACCAAGAAGCTAGAAGATCACTCTGTTCTTTTGGCTCTGTTTTGAT 661
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 33225682 CCTTTCTTTCCGCGACCAAGAAGCTAGAAGATCACTCTGTTCTTTTGGCTCTGTTTTGAT 33225623
Query 662 CGAGACACGAGTGTTCGTCTCATGTTTTCGTTGGCCTGGAGGAGAATAAATCGTGTTGTG 721
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 33225622 CGAGACACGAGTGTTCGTCTCATGTTTTCGTTGGCCTGGAGGAGAATAAATCGTGTTGTG 33225563
Query 722 TTCATGCTCTA 732
|||||||||||
Sbjct 33225562 TTCATGCTCTA 33225552
Protein alignment of instant SEQ ID NO: 180, Yang SEQ ID NO: 2, and the protein encoded by GenBank HG996473
180 MALKLAVFVFASLLVITTRVSSDAKDAFMEAGYAKAPVVAPVPAPPAPRIIKDTKECGDA
Yang2 MALKLAVFVFASLLVITTRVSSDAKDAFMEAGYAKAPVVAPVPAPPAPRIIKDTKECGDA
HG996473 MALKLAVFVFASLLVITTRVSSDAKDAFMEAGYAKAPVVAPVPAPPAPRIIKDTKECGDA
************************************************************
180 CKDRCKLHSRQNVCSRACITCCSVCKCVPPGTYGHTELCGKCYTDWKTHGNRTKCP
Yang2 CKDRCKLHSRQNVCSRACITCCSVCKCVPPGTYGHTELCGKCYTDWKTHGNRTKCP
HG996473 CKDRCKLHSRQNVCSRACITCCSVCKCVPPGTYGHTELCGKCYTDWKTHGNRTKCP
********************************************************
Srivastava teaches that UTRs control gene expression and protein function in many plant genes (page 249, paragraph 2). UTRs can regulate expression and provide functional specificity to genes in a length-dependent manner (page 250, box 1).
Terol provides evidence that Ptac is a promoter induced by lactose (page 2, left column, paragraph 3).
Malik provides evidence that the Amp gene is an ampicillin resistance marker gene that has been used in constructs for integration into a plant genome (page 4, left column, paragraph 5).
Before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to substitute a genomic DNA sequence for a cDNA sequence encoding an identical protein to that taught by Yang. One of ordinary skill in the art would have been motivated to substitute the genomic DNA sequence for the cDNA sequence, because the genomic DNA sequence would include non-coding DNA such as UTRs that could regulate expression and function. One of ordinary skill in the art would have had reasonable expectation of success because both the genomic DNA and cDNA were known to encode an identical protein and methods of creating nucleic acid constructs were routine in the art prior to the filing of the instant application.
Before the time of filing of the instant application, it would have been obvious to one of ordinary skill in the art to modify the method taught by Yang of introducing a construct encoding an antimicrobial peptide MaSN2, under control of a heterologous promoter, in S. cerevisiae to instead introduce the construct into a Musa acuminata banana plant. One of ordinary skill would have been motivated to introduce the construct into a banana plant because the encoded MaSN2 protein was shown to inhibit growth of Fusarium wilt “species 4”, and Fusarium wilt is a devastating disease in bananas. One of ordinary skill would have had reasonable expectation of success because the gene is endogenous to banana and was known to be expressed in Musa acuminata banana in response to Fusarium wilt race 4.
Thus, a Musa acuminata banana plant comprising a vector, which reads on a nucleic acid construct, comprising a nucleic acid sequence encoding an antimicrobial peptide with at least 95% sequence identity to the full length of SEQ ID NO: 179, operably linked to a heterologous synthetic promoter and also comprising a selectable marker sequence for antibiotic resistance (instant claims 1, 3-4, 6 & 7) would have been obvious over Yang, as is the method of introducing such a construct into a banana plant (instant claims 21-23) and the construct itself (instant claim 24).
Applicant urges that claim 24 is not anticipated by Yang because SEQ ID NO: 180 is not encoded by elected SEQ ID NO: 197, and the protein disclosed by Yang only has little sequence identity to SEQ ID NO: 197. Applicant urges that amended claims require a nucleic acid sequence with 95% sequence identity to the full-length sequence (Remarks, page 31, paragraph 6-page 32, paragraph 3). Applicant urges that Yang, Terol and Malik do not teach a DNA molecule with at least 95% sequence identity to the full-length sequence of SEQ ID NO: 197 and so the instant invention is not obvious (Remarks, page 34, paragraph 4).
This argument is unpersuasive, because SEQ ID NO: 179 was rejoined in the Office Action mailed 6/30/2025 (page 2, paragraph 5). For purposes of compact prosecution, unelected species that are found in the art during examination are rejoined and addressed. Instant SEQ ID NO: 179 is a species of nucleic acid sequence recited by the claims (claim 24, line 11; claim 1, line 12) and encodes instant SEQ ID NO: 180. Because a cDNA encoding a protein with 100% sequence identity to instant SEQ ID NO: 180 was taught by Yang to be useful as an antimicrobial peptide, and because this sequence has over 95% sequence identity to the full-length sequence of SEQ ID NO: 179, the instant invention would have been obvious to one of ordinary skill in the art.
Claims 8-9, 11-13 & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yang, GenBank record HG996473.1, Srivistava, Terol, and Malik as applied to claims 1, 3-4, 6, 7, & 21-24 above, and further in view of Dale et al (2017) Nature Communications. 8:1496 (published 11/14/2017, hereafter Dale) taken with the evidence of Miki et al (2004) Journal of Biotechnology. 107: 193–232 (published 1/1/2004, hereafter Miki).
This is a new rejection necessitated by Applicant’s amendments. Applicant’s remarks filed 9/30/2025 have been considered as they pertain to the rejection below, but they are not persuasive.
Claims 8-9, 11-13, & 16-17 are drawn to a banana plant comprising a nucleic acid construct comprising a NOS promoter, a kanamycin resistance selectable marker sequence, a NOS terminator, more than one nucleic acid sequences, and a banana plant part.
Dale teaches two genes providing resistance to Fusarium oxysporum: resistance gene analog 2 (RGA), which is a leucine-rich repeat type resistance gene from Musa acuminata, and Ced9, an anti-apoptosis gene that confers resistance to Fusarium oxysporum race 1 (page 2, left column, paragraph 3).
Dale teaches transgene expression cassettes comprising the RGA2 gene under control of the Agrobacterium nopaline synthase promoter and Ced9 under control of the maize Ubi promoter (page 2, left column, paragraph 3-right column, paragraph 1). The constructs also comprise a nptII gene and a Nos-T terminator sequence operably linked to the putative resistance genes (figure 1 a-b). Dale teaches the Ced9 gene operably linked to a cauliflower mosaic virus 35s terminator (page 4, right column, paragraph 2).
Dale teaches a method of introducing the constructs into Cavendish, which is Musa acuminata, via embryogenic cell suspensions transformed with Agrobacterium tumefaciens-mediated transformation and selected (page 4, right column, paragraph 2). Dale teaches that the transgenic banana plants had fewer symptomatic plants when exposed to Fusarium oxysporum f. sp. cubense tropical race 4 compared to control plants without the transgenes, including two transgenic lines described as "immune" (page 2, right column, paragraph 4-page 3, left column, paragraph 1).
Dale teaches vascular tissue of these transgenic banana plants, which was screened for resistance (figure 2, b, d, f) and leaves, which were scored for external symptoms such as yellowing (figure 2: a, c, e; page 5, left column, paragraph 3).
Dale teaches a motivation to transform banana with a resistance gene, because fusarium wilt caused by F. oxysporum f. sp. cubense tropical race 4 infects and kills Cavendish bananas which account for >40% of the world's banana production, and there is no effective chemical control (page 2, left column, paragraphs 1-2). Dale envisions gene editing of native Cavendish RGA2 homologs in the future (page 4, left column, paragraph 2-right column, paragraph 1).
Miki provides evidence that the nptII gene is a selectable marker gene which confers kanamycin resistance by inhibiting protein synthesis (page 198, left column, paragraph 1; table 4).
Before the filing date of the instant application, it would have been obvious to one of ordinary skill in the art to modify the construct and method of Yang to substitute a nptII selectable marker sequence for an amp selectable marker sequence. One of ordinary skill in the art would have been motivated to substitute nptII for an amp selectable marker sequence because choosing one antibiotic selectable marker over another would be a design choice. One of ordinary skill in the art would have had reasonable expectation of success in making these changes to the construct of Yang, because optimizing selectable markers for transgene expression was routine prior to the filing date of the instant application, and Dale teaches that this selectable marker was effective in expressing transgenes conferring resistance to F. oxysporum f. sp. cubense tropical race 4 in banana. Thus, instant claims 1, 2-4 & 6-9 are obvious in view of Yang, GenBank HG996473.1, Srivistava and Dale.
Before the filing date of the instant application, it would also have been obvious to one of ordinary skill in the art to modify the construct of Yang to comprise an RGA2 gene of Dale (which reads on the fourth nucleic acid) as well as the nucleic acid sequence encoding the antimicrobial peptide of MaSN2. One of ordinary skill in the art would have been motivated to add a nucleic acid sequence encoding the RGA2 gene because both RGA2 and the peptide encoded by MaSN2 were known to be effective against F. oxysporum f. sp. cubense race 4. One of ordinary skill in the art would have had reasonable expectation of success of transforming both sequences into banana on a nucleic acid construct, because both genes are endogenous M. acuminata genes, and of transforming both sequences operably linked to a single heterologous promoter because the construct of Yang had both the MaSN2 gene and a selectable marker gene under control of a single heterologous promoter. Thus, instant claims 11-12 are obvious over Yang and Dale.
Before the time of filing of the instant application, it would also have been obvious to one of ordinary skill in the art to modify the method so that the MaSN2 gene of Yang and the RGA2 gene of Dale were operably linked to different heterologous promoters. One of ordinary skill in the art would have been motivated to try different heterologous promoters, such as the inducible promoter of Yang or the Nos promoter of Dale, in order to optimize expression of each transgene. Selection of promoters for transgene constructs was a design choice before the filing date of the instant application. One of ordinary skill in the art would have had reasonable expectation of success, because Dale had taught more than one promoter appropriate for expressing transgenes for resistance to Fusarium wilt. Claim 13 is obvious over Yang and Dale.
Finally, the leaves of the transgenic plants of Dale make obvious a plant part of the transgenic banana plant, including leaf and cell (instant claims 16-17).
Claims 1,2-4, 6-9, 11-13, 16-17 & 21-24 are obvious over Yang, GenBank HG996473.1, Srivistava, Terol, and Malik in view of Dale and Miki.
Applicant urges Dale and Miki do not cure the deficiencies of Yang, Terol, and Malik because they do not teach a DNA molecule with at least 95% sequence identity to the full-length sequence of SEQ ID NO: 197 (Remarks, page 35, paragraph 4).
This argument is unpersuasive, because the species of SEQ ID NO: 179 was rejoined in the Office Action mailed 6/30/2025 (page 2, paragraph 5). Because the amended claims still recite a nucleic acid sequence having a sequence with at least 95% sequence identity to SEQ ID NO: 179, the instant invention would have been obvious to one of ordinary skill in the art as presented in the rejection above.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, GenBank HG996473.1, Srivistava, Terol, Malik, Dale and Miki as applied to claims 1,2-4, 6-9, 11-13, 16-17 & 21-24 above, and further in view of Kang et al (US 20140154223A1, published 6/5/2014, hereafter Kang).
This is a new rejection necessitated by Applicant’s amendments.
Claim 5 is drawn to a transgenic banana plant wherein the heterologous promoter is SEQ ID NO: 116.
The teachings of Yang, GenBank HG996473.1, Srivistava, Terol, Malik, Dale and Miki are presented above. They do not teach SEQ ID NO: 116.
Kang teaches a maize ubiquitin promoter (Kang SEQ ID NO: 5) with 100% sequence identity to SEQ ID NO: 116. See alignment below.
US-14-093-684-5
Filing date in PALM: 2013-12-02
Sequence 5, US/14093684
Publication No. US20140154223A1
GENERAL INFORMATION
APPLICANT: Beijing Dabeinong Technology Group Co., Ltd.
APPLICANT: Beijing Dabeinong Technology Group Co., Ltd.Biotech Center
APPLICANT: Beijing Green Agrosino Plant Protection Technology Co.,
APPLICANT: Ltd.
APPLICANT: Kang, Yuejing
APPLICANT: Pang, Jie
APPLICANT: Zhang, Aihong
APPLICANT: Cheng, Peng
APPLICANT: Yang, Xu
APPLICANT: Niu, Lihong
APPLICANT: Jia, Zhiwei
APPLICANT: An, Luoxu
APPLICANT: Tian, Kangle
APPLICANT: Jiang, Ziqin
TITLE OF INVENTION: Methods of Pest Control
FILE REFERENCE: 35769.04001
CURRENT APPLICATION NUMBER: US/14/093,684
CURRENT FILING DATE: 2013-12-02
PRIOR APPLICATION NUMBER: CN 201210509817.2
PRIOR FILING DATE: 2012-12-03
NUMBER OF SEQ ID NOS: 13
SEQ ID NO 5
LENGTH: 1992
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Promoter of Maize Ubiquitin gene
ALIGNMENT:
Query Match 100.0%; Score 1992; Length 1992;
Best Local Similarity 100.0%;
Matches 1992; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CTGCAGTGCAGCGTGACCCGGTCGTGCCCCTCTCTAGAGATAATGAGCATTGCATGTCTA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 CTGCAGTGCAGCGTGACCCGGTCGTGCCCCTCTCTAGAGATAATGAGCATTGCATGTCTA 60
Qy 61 AGTTATAAAAAATTACCACATATTTTTTTTGTCACACTTGTTTGAAGTGCAGTTTATCTA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AGTTATAAAAAATTACCACATATTTTTTTTGTCACACTTGTTTGAAGTGCAGTTTATCTA 120
Qy 121 TCTTTATACATATATTTAAACTTTACTCTACGAATAATATAATCTATAGTACTACAATAA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TCTTTATACATATATTTAAACTTTACTCTACGAATAATATAATCTATAGTACTACAATAA 180
Qy 181 TATCAGTGTTTTAGAGAATCATATAAATGAACAGTTAGACATGGTCTAAAGGACAATTGA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 TATCAGTGTTTTAGAGAATCATATAAATGAACAGTTAGACATGGTCTAAAGGACAATTGA 240
Qy 241 GTATTTTGACAACAGGACTCTACAGTTTTATCTTTTTAGTGTGCATGTGTTCTCCTTTTT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GTATTTTGACAACAGGACTCTACAGTTTTATCTTTTTAGTGTGCATGTGTTCTCCTTTTT 300
Qy 301 TTTTGCAAATAGCTTCACCTATATAATACTTCATCCATTTTATTAGTACATCCATTTAGG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 TTTTGCAAATAGCTTCACCTATATAATACTTCATCCATTTTATTAGTACATCCATTTAGG 360
Qy 361 GTTTAGGGTTAATGGTTTTTATAGACTAATTTTTTTAGTACATCTATTTTATTCTATTTT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GTTTAGGGTTAATGGTTTTTATAGACTAATTTTTTTAGTACATCTATTTTATTCTATTTT 420
Qy 421 AGCCTCTAAATTAAGAAAACTAAAACTCTATTTTAGTTTTTTTATTTAATAATTTAGATA 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 AGCCTCTAAATTAAGAAAACTAAAACTCTATTTTAGTTTTTTTATTTAATAATTTAGATA 480
Qy 481 TAAAATAGAATAAAATAAAGTGACTAAAAATTAAACAAATACCCTTTAAGAAATTAAAAA 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 TAAAATAGAATAAAATAAAGTGACTAAAAATTAAACAAATACCCTTTAAGAAATTAAAAA 540
Qy 541 AACTAAGGAAACATTTTTCTTGTTTCGAGTAGATAATGCCAGCCTGTTAAACGCCGTCGA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 AACTAAGGAAACATTTTTCTTGTTTCGAGTAGATAATGCCAGCCTGTTAAACGCCGTCGA 600
Qy 601 CGAGTCTAACGGACACCAACCAGCGAACCAGCAGCGTCGCGTCGGGCCAAGCGAAGCAGA 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 CGAGTCTAACGGACACCAACCAGCGAACCAGCAGCGTCGCGTCGGGCCAAGCGAAGCAGA 660
Qy 661 CGGCACGGCATCTCTGTCGCTGCCTCTGGACCCCTCTCGAGAGTTCCGCTCCACCGTTGG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 CGGCACGGCATCTCTGTCGCTGCCTCTGGACCCCTCTCGAGAGTTCCGCTCCACCGTTGG 720
Qy 721 ACTTGCTCCGCTGTCGGCATCCAGAAATTGCGTGGCGGAGCGGCAGACGTGAGCCGGCAC 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 ACTTGCTCCGCTGTCGGCATCCAGAAATTGCGTGGCGGAGCGGCAGACGTGAGCCGGCAC 780
Qy 781 GGCAGGCGGCCTCCTCCTCCTCTCACGGCACGGCAGCTACGGGGGATTCCTTTCCCACCG 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 GGCAGGCGGCCTCCTCCTCCTCTCACGGCACGGCAGCTACGGGGGATTCCTTTCCCACCG 840
Qy 841 CTCCTTCGCTTTCCCTTCCTCGCCCGCCGTAATAAATAGACACCCCCTCCACACCCTCTT 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 CTCCTTCGCTTTCCCTTCCTCGCCCGCCGTAATAAATAGACACCCCCTCCACACCCTCTT 900
Qy 901 TCCCCAACCTCGTGTTGTTCGGAGCGCACACACACACAACCAGATCTCCCCCAAATCCAC 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 TCCCCAACCTCGTGTTGTTCGGAGCGCACACACACACAACCAGATCTCCCCCAAATCCAC 960
Qy 961 CCGTCGGCACCTCCGCTTCAAGGTACGCCGCTCGTCCTCCCCCCCCCCCCCTCTCTACCT 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 CCGTCGGCACCTCCGCTTCAAGGTACGCCGCTCGTCCTCCCCCCCCCCCCCTCTCTACCT 1020
Qy 1021 TCTCTAGATCGGCGTTCCGGTCCATGGTTAGGGCCCGGTAGTTCTACTTCTGTTCATGTT 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 TCTCTAGATCGGCGTTCCGGTCCATGGTTAGGGCCCGGTAGTTCTACTTCTGTTCATGTT 1080
Qy 1081 TGTGTTAGATCCGTGTTTGTGTTAGATCCGTGCTGCTAGCGTTCGTACACGGATGCGACC 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 TGTGTTAGATCCGTGTTTGTGTTAGATCCGTGCTGCTAGCGTTCGTACACGGATGCGACC 1140
Qy 1141 TGTACGTCAGACACGTTCTGATTGCTAACTTGCCAGTGTTTCTCTTTGGGGAATCCTGGG 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 TGTACGTCAGACACGTTCTGATTGCTAACTTGCCAGTGTTTCTCTTTGGGGAATCCTGGG 1200
Qy 1201 ATGGCTCTAGCCGTTCCGCAGACGGGATCGATTTCATGATTTTTTTTGTTTCGTTGCATA 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 ATGGCTCTAGCCGTTCCGCAGACGGGATCGATTTCATGATTTTTTTTGTTTCGTTGCATA 1260
Qy 1261 GGGTTTGGTTTGCCCTTTTCCTTTATTTCAATATATGCCGTGCACTTGTTTGTCGGGTCA 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1261 GGGTTTGGTTTGCCCTTTTCCTTTATTTCAATATATGCCGTGCACTTGTTTGTCGGGTCA 1320
Qy 1321 TCTTTTCATGCTTTTTTTTGTCTTGGTTGTGATGATGTGGTCTGGTTGGGCGGTCGTTCT 1380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1321 TCTTTTCATGCTTTTTTTTGTCTTGGTTGTGATGATGTGGTCTGGTTGGGCGGTCGTTCT 1380
Qy 1381 AGATCGGAGTAGAATTCTGTTTCAAACTACCTGGTGGATTTATTAATTTTGGATCTGTAT 1440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1381 AGATCGGAGTAGAATTCTGTTTCAAACTACCTGGTGGATTTATTAATTTTGGATCTGTAT 1440
Qy 1441 GTGTGTGCCATACATATTCATAGTTACGAATTGAAGATGATGGATGGAAATATCGATCTA 1500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1441 GTGTGTGCCATACATATTCATAGTTACGAATTGAAGATGATGGATGGAAATATCGATCTA 1500
Qy 1501 GGATAGGTATACATGTTGATGCGGGTTTTACTGATGCATATACAGAGATGCTTTTTGTTC 1560
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1501 GGATAGGTATACATGTTGATGCGGGTTTTACTGATGCATATACAGAGATGCTTTTTGTTC 1560
Qy 1561 GCTTGGTTGTGATGATGTGGTGTGGTTGGGCGGTCGTTCATTCGTTCTAGATCGGAGTAG 1620
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1561 GCTTGGTTGTGATGATGTGGTGTGGTTGGGCGGTCGTTCATTCGTTCTAGATCGGAGTAG 1620
Qy 1621 AATACTGTTTCAAACTACCTGGTGTATTTATTAATTTTGGAACTGTATGTGTGTGTCATA 1680
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1621 AATACTGTTTCAAACTACCTGGTGTATTTATTAATTTTGGAACTGTATGTGTGTGTCATA 1680
Qy 1681 CATCTTCATAGTTACGAGTTTAAGATGGATGGAAATATCGATCTAGGATAGGTATACATG 1740
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1681 CATCTTCATAGTTACGAGTTTAAGATGGATGGAAATATCGATCTAGGATAGGTATACATG 1740
Qy 1741 TTGATGTGGGTTTTACTGATGCATATACATGATGGCATATGCAGCATCTATTCATATGCT 1800
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1741 TTGATGTGGGTTTTACTGATGCATATACATGATGGCATATGCAGCATCTATTCATATGCT 1800
Qy 1801 CTAACCTTGAGTACCTATCTATTATAATAAACAAGTATGTTTTATAATTATTTTGATCTT 1860
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1801 CTAACCTTGAGTACCTATCTATTATAATAAACAAGTATGTTTTATAATTATTTTGATCTT 1860
Qy 1861 GATATACTTGGATGATGGCATATGCAGCAGCTATATGTGGATTTTTTTAGCCCTGCCTTC 1920
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1861 GATATACTTGGATGATGGCATATGCAGCAGCTATATGTGGATTTTTTTAGCCCTGCCTTC 1920
Qy 1921 ATACGCTATTTATTTGCTTGGTACTGTTTCTTTTGTCGATGCTCACCCTGTTGTTTGGTG 1980
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1921 ATACGCTATTTATTTGCTTGGTACTGTTTCTTTTGTCGATGCTCACCCTGTTGTTTGGTG 1980
Qy 1981 TTACTTCTGCAG 1992
||||||||||||
Db 1981 TTACTTCTGCAG 1992
Before the filing date of the instant application, it would have been obvious to one of ordinary skill in the art to modify the construct and method of Yang to use a plant ZmUbi1 promoter in place of a Ptac promoter. One of ordinary skill in the art would have been motivated to use a maize Ubi promoter of SEQ ID NO: 116 in the construct for expressing a MaSN2 protein, because Dale teaches that a maize Ubi promoter was effective in expressing transgenes conferring resistance to F. oxysporum f. sp. cubense tropical race 4 in banana. One of ordinary skill in the art would have had reasonable expectation of success in making these changes to the construct of Yang, because optimizing regulatory elements and selectable markers for transgene expression was routine prior to the filing date of the instant application, Dale teaches that a maize ubi promoter was effective in expressing transgenes conferring resistance to F. oxysporum f. sp. cubense tropical race 4 in banana, and a nucleic acid comprising a sequence with 100% identity to instant SEQ ID NO: 116 was known in the art to be a functional maize ubiquitin promoter.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, GenBank HG996473.1, Srivistava, Terol, Malik, Dale and Miki as applied to claims 1,2-4, 6-9, 11-13, 16-17 & 21-24 above, and further in view of Begemann et al (US20170233756A1, published 8/17/2017, hereafter Begemann).
Claim 10 is drawn to a transgenic banana wherein the terminator sequence is SEQ ID NO: 37.
This is a new rejection necessitated by Applicant’s amendments.
The teachings of Yang, GenBank HG996473.1, Srivistava, Terol, Malik, Dale and Miki are presented above. They do not teach SEQ ID NO: 213.
Begemann teaches a nucleic acid sequence (Begemann SEQ ID NO: 54) that is a Cauliflower Mosaic Virus 35S polyA terminator comprising a sequence with 100% sequence identity to SEQ ID NO: 37. See alignment below.
US-15-432-109-54
Sequence 54, US/15432109
Publication No. US20170233756A1
GENERAL INFORMATION
APPLICANT: Benson Hill Biosystems, Inc.
TITLE OF INVENTION: Compositions and Methods for Modifying Genomes
FILE REFERENCE: BHP006P7
CURRENT APPLICATION NUMBER: US/15/432,109
CURRENT FILING DATE: 2017-02-14
PRIOR APPLICATION NUMBER: US 62/295,325
PRIOR FILING DATE: 2016-02-15
PRIOR APPLICATION NUMBER: US 62/450,743
PRIOR FILING DATE: 2017-01-26
PRIOR APPLICATION NUMBER: US 62/372,108
PRIOR FILING DATE: 2016-08-08
PRIOR APPLICATION NUMBER: US 62/403,854
PRIOR FILING DATE: 2016-10-04
PRIOR APPLICATION NUMBER: US 62/429,112
PRIOR FILING DATE: 2016-12-02
PRIOR APPLICATION NUMBER: US 62/450,743
PRIOR FILING DATE: 2017-01-26
NUMBER OF SEQ ID NOS: 239
SEQ ID NO 54
LENGTH: 209
TYPE: DNA
ORGANISM: Cauliflower Mosaic Virus
FEATURE:
NAME/KEY: CaMV 35S polyA terminator
LOCATION: (1)..(209)
Query Match 100.0%; Score 175; Length 209;
Best Local Similarity 100.0%;
Matches 175; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TTTCTCCATAATAATGTGTGAGTAGTTCCCAGATAAGGGAATTAGGGTTCCTATAGGGTT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 25 TTTCTCCATAATAATGTGTGAGTAGTTCCCAGATAAGGGAATTAGGGTTCCTATAGGGTT 84
Qy 61 TCGCTCATGTGTTGAGCATATAAGAAACCCTTAGTATGTATTTGTATTTGTAAAATACTT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 85 TCGCTCATGTGTTGAGCATATAAGAAACCCTTAGTATGTATTTGTATTTGTAAAATACTT 144
Qy 121 CTATCAATAAAATTTCTAATTCCTAAAACCAAAATCCAGTACTAAAATCCAGATC 175
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 145 CTATCAATAAAATTTCTAATTCCTAAAACCAAAATCCAGTACTAAAATCCAGATC 199
Before the filing date of the instant application, it would have been obvious to one of ordinary skill in the art to modify the construct and method of Yang to use a cauliflower mosaic virus 35S terminator sequence of SEQ ID NO: 37. One of ordinary skill in the art would have been motivated to use a 35S terminator in the construct for expressing a MaSN2 protein, because Dale teaches a 35S terminator in operable linkage to a transgene conferring resistance to F. oxysporum f. sp. cubense tropical race 4 in banana. One of ordinary skill in the art would have had reasonable expectation of success, because optimizing regulatory elements for transgene expression was routine prior to the filing date of the instant application, and a nucleic acid sequence comprising a sequence identical to instant SEQ ID NO: 37 was known to be a CaMV 35S terminator. Thus, instant claims 1,2-4, 6-13, 16-17 & 21-24 are obvious over Yang, GenBank HG996473.1, Srivistava, Terol, Malik, Dale, Miki, and Begemann.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, GenBank HG996473.1, Srivistava, Terol, Malik, Dale and Miki as applied to claims 1,2-4, 6-9, 11-13, 16-17 & 21-24 above, and further in view of Ainley et al (US 11,198,883 B2 patented 12/14/2021, hereafter Ainley).
This is a new rejection necessitated by Applicant’s amendments. Applicant’s remarks filed 9/30/2025 have been considered as they pertain to the rejection below, but they are not persuasive.
Claim 14 is drawn to the transgenic banana plant wherein the nucleic acid sequence further comprises a 2A self-cleaving peptide nucleic acid sequence.
The teachings of Yang, GenBank HG996473.1, Srivistava, Terol, Malik, Dale and Miki are presented above. They do not teach a 2A self-cleaving peptide nucleic acid sequence.
Ainley teaches that transgene stacking has great potential for production of plants with desirable traits but is difficult (column 2, lines 39-41), in part because conventional transformation leads to effects that may be due to unintended genome disruption and random integration makes it difficult to ascertain the effect of regulatory elements (column 1, lines 55-62). Ainley teaches that self-cleaving 2A peptides allow for the expression of separate enzymes linked in one open reading frame (column 24, lines 44-53). Ainley teaches an example of a construct comprising a self-hydrolyzing 2A from Thosaea asigna between sequences for two Zinc Finger Nuclease fusion proteins (column 49, lines 23-31).
Before the filing date of the instant application, it would have been obvious to one of ordinary skill in the art to modify the nucleic acid construct of Yang and Dale to add a self-cleaving 2A peptide nucleic acid sequence between nucleic acid sequences encoding an antimicrobial peptide and RGA2 gene. One of ordinary skill in the art would have been motivated to introduce a construct comprising both the antimicrobial peptide and RGA2 gene, as presented above, because both genes provided resistance to Fusarium wilt, and one would have been motivated to add the self-cleaving 2A peptide nucleic acid sequence between the genes in order to insert both genes in a single construct driven by the same regulatory elements because Ailey teaches that random integration from transformation of separate constructs may lead to genome disruption and unpredictable regulation. One of ordinary skill in the art would have had reasonable expectation of success because Yang teaches a construct comprising the MaSN2 and selectable marker gene driven by the same promoter. Claim 14, in addition to claims 1,2-4, 6-9, 11-13, 16-17 & 21-24, is obvious over Yang, GenBank HG996473.1, Srivistava, Terol, Malik, Dale, Miki, and Ainley.
Applicant urges Ainley does not cure the deficiency of Yang, Terol, Malik, Dale, and Miki, because it does not teach or suggest a DNA molecule with at least 95% sequence identity to SEQ ID NO: 197 (Remarks, page 36, paragraph 3).
This argument is unpersuasive, because the species of SEQ ID NO: 179 was rejoined in the Office Action mailed 6/30/2025 (page 2, paragraph 5). Because the amended claims still recite a nucleic acid sequence having a sequence with at least 95% sequence identity to SEQ ID NO: 179, the instant invention would have been obvious to one of ordinary skill in the art as presented above.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang, GenBank HG996473.1, Srivistava, Terol, and Malik as applied to claims 1-4, 6, 7, & 21-24 above, and further in view of Mostafa (2021) J. Food Sci. 86:3778–3797 (published 8/1/2021, hereafter Mostafa) taken with the evidence of Kumara et al (2015) Tropical Agricultural Research. 26 (2): 329 – 342 (published 11/20/2015, hereafter Kumara).
This is a new rejection necessitated by Applicant’s amendments. Applicant’s remarks filed 9/30/2025 have been considered as they pertain to the rejection below, but they are not persuasive.
Claims 18-20 are drawn to a banana produced by the transgenic banana plant comprising a detectable amount of the nucleic acid sequence and a banana product comprising a nucleic acid construct comprising a nucleic acid molecule encoding an antimicrobial peptide.
The teachings of Yang, GenBank HG996473.1, Srivistava, Terol, and Malik are presented above. They do not teach the banana or banana product of the transgenic banana plant.
Mostafa teaches banana products, including whole banana (figure 3). Mostafa teaches motivations to use banana products, because banana peels and leaves have antioxidant activities and biological functions (page 3779, left column, paragraph 2) and whole green banana flour used as a wheat substitute can improve nutritional quality of bread without altering digestibility (page 3788, right column, paragraph 1).
Kumara provides evidence that banana peels comprise RNA, which reads on a nucleic acid sequence (table 1).
Before the time of filing of the instant application it would have been obvious to one of ordinary skill in the art to use the Fusarium resistant plant taught by Yang and Malik to harvest a banana and process the banana into a product such as banana peel. One of ordinary skill in the art would have been motivated to do so because banana peels have antioxidant activities and biological functions. One of ordinary skill in the art would have had reasonable expectation of success, because banana product processing was routine prior to the time of filing of the instant application. Thus, claims 18-20 are obvious. Claims 1,3-4, 6, 7, & 18-24 are obvious over Yang, GenBank HG996473.1, Srivistava, Terol, Malik, Mostafa, and Kumara.
Applicant urges that Yang, Terol, Malik, Mostafa, and Kumara do not teach or suggest a DNA molecule with at least 95% sequence identity to the full-length sequence of SEQ ID NO: 197 (Remarks, page 37, paragraph 1).
This argument is unpersuasive, because the species of SEQ ID NO: 179 was rejoined in the Office Action mailed 6/30/2025 (page 2, paragraph 5). Because the amended claims still recite a nucleic acid sequence having a sequence with at least 95% sequence identity to SEQ ID NO: 179, the instant invention would have been obvious to one of ordinary skill in the art as presented above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-6, 9, 11-13, 16-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4-7, 10, 12-15, 19, 21, 22, 25, & 28 of copending Application No. 18/608,644 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims encompass or are obvious over the inventions of the copending claims.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 6/30/2025, as applied to claims 1-6, 9, 11-13, & 16-24. Applicant' s arguments filed 9/30/2025 have been fully considered but they are not persuasive.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
‘644 claim 28, drawn to a nucleic acid construct wherein the second nucleic acid sequence operably linked to a heterologous or gene edited promoter has at least 90% sequence identity to ‘644 SEQ ID NO: 197, makes obvious instant claim 24, drawn to a nucleic acid construct comprising instant SEQ ID NO: 197 operably linked to a heterologous promoter. The two sequences are identical, see alignment below.
US-18-608-644-197
Filing date in PALM: 2024-03-18
Sequence 197, US/18608644
GENERAL INFORMATION
APPLICANT: Elo Life Systems (en)
TITLE OF INVENTION: TRANSGENIC BANANA PLANTS HAVING INCREASED RESISTANCE TO FUSARIUM OXYSPORUM TROPICAL RACE 4 AND METHODS OF PRODUCING SAME (en)
FILE REFERENCE: ELSS:018US
CURRENT APPLICATION NUMBER: US/18/608,644
CURRENT FILING DATE: 2024-03-18
NUMBER OF SEQ ID NOS: 248
SEQ ID NO 197
LENGTH: 860
TYPE: DNA
FEATURE:
NAME/KEY: source
LOCATION: 1..860
QUALIFIERS: mol_type = genomic DNA
organism = Musa acuminata
ALIGNMENT:
Query Match 100.0%; Score 860; Length 860;
Best Local Similarity 100.0%;
Matches 860; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGCTTGAGAAGGAAGTGTCCACTTTGTTTCTTATCGACTGATCTGTCTACCACTCACAT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGCTTGAGAAGGAAGTGTCCACTTTGTTTCTTATCGACTGATCTGTCTACCACTCACAT 60
Qy 61 GCAAGTTCATCCAGTACCACAGAGGTACAGTCTCCTTGGCTCTATTTAGGTGGAAGCCTC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GCAAGTTCATCCAGTACCACAGAGGTACAGTCTCCTTGGCTCTATTTAGGTGGAAGCCTC 120
Qy 121 GCAGATTCCACAAGCGCACTCCACACTCTCGGCTTCTCATCACCTTCCTCTTCTCGTTGC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GCAGATTCCACAAGCGCACTCCACACTCTCGGCTTCTCATCACCTTCCTCTTCTCGTTGC 180
Qy 181 AATGGCAGCACGGCTTCCCTGCACTTTGCTTCTGGTGCTCCTCCTCACACTCTCTTTCAC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AATGGCAGCACGGCTTCCCTGCACTTTGCTTCTGGTGCTCCTCCTCACACTCTCTTTCAC 240
Qy 241 CGAGGTGCGTTGATCAAACTCTCATCTGCATGCACTTTCAGTAATCTCGCAACATTGCTG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 CGAGGTGCGTTGATCAAACTCTCATCTGCATGCACTTTCAGTAATCTCGCAACATTGCTG 300
Qy 301 GTGTTGTACACTGACAGTAGTGTCTTTGTGTTTCTCTTTCGGCCCTCTAGAGTGTCAGAG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GTGTTGTACACTGACAGTAGTGTCTTTGTGTTTCTCTTTCGGCCCTCTAGAGTGTCAGAG 360
Qy 361 GTGGTTCTCTCAAGCCTTCAGGTACTGCTACGTTCTGAACTCATCCATTGTGTTTGTGTT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GTGGTTCTCTCAAGCCTTCAGGTACTGCTACGTTCTGAACTCATCCATTGTGTTTGTGTT 420
Qy 421 GGTGTGGTCCTGTGGCCGGAGGTGTTACAACCTGTGGGTGGTCATTGCAGAATGCAATAA 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 GGTGTGGTCCTGTGGCCGGAGGTGTTACAACCTGTGGGTGGTCATTGCAGAATGCAATAA 480
Qy 481 CAAGTGCGAGTTCCGGTGCTCGGCGACGTCGCACAAGAAGCCATGCTTGTTCTTCTGCAA 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 CAAGTGCGAGTTCCGGTGCTCGGCGACGTCGCACAAGAAGCCATGCTTGTTCTTCTGCAA 540
Qy 541 GAAGTGCTGCGCCGCGTGCCTGTGCGTGCCGCCTGGCACCTACGGCAACAAGGAGGCGTG 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 GAAGTGCTGCGCCGCGTGCCTGTGCGTGCCGCCTGGCACCTACGGCAACAAGGAGGCGTG 600
Qy 601 CCCCTGCTACAACAACTGGAAGACGAAGGAAGGTGGCCCCAAGTGTCCCTAGTTTTGAAT 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 CCCCTGCTACAACAACTGGAAGACGAAGGAAGGTGGCCCCAAGTGTCCCTAGTTTTGAAT 660
Qy 661 AGTTGGGACGCAAGATGATGGAAGCCAAACCCACTTCCTTTTTTCTCACTATGATTTGCC 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 AGTTGGGACGCAAGATGATGGAAGCCAAACCCACTTCCTTTTTTCTCACTATGATTTGCC 720
Qy 721 AGTCATTCCATCTGTGTTTTTAATTTGCTAAAGAGGAGAGATTCATAATATAAGTGAATC 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 AGTCATTCCATCTGTGTTTTTAATTTGCTAAAGAGGAGAGATTCATAATATAAGTGAATC 780
Qy 781 CCCTCTACTATCATTGCCAATATTTGGCAAAGTTGATATGAGCTAAATAAACTTCAACTC 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 CCCTCTACTATCATTGCCAATATTTGGCAAAGTTGATATGAGCTAAATAAACTTCAACTC 840
Qy 841 CACCACTGGTTTGAGAAGAA 860
||||||||||||||||||||
Db 841 CACCACTGGTTTGAGAAGAA 860
‘644 amended claim 1 & 4, drawn to a Musa acuminata transgenic banana plant comprising a nucleic acid construct with increased resistance to Fusarium oxysporum f.sp. cubense Tropical Race 4 comprising a nucleic acid sequence encoding an antimicrobial peptide, in light of ‘644 claim 26, makes obvious instant claims 1 & 3 drawn to a Musa acuminata transgenic banana plant comprising the nucleic acid construct comprising instant SEQ ID NO: 197 with increased resistance to Fusarium oxysporum f.sp. cubense Tropical Race 4.
‘644 claims 12-14, drawn to the transgenic banana plant comprising the nucleic acid construct comprising two or more nucleic acid sequences, makes obvious instant claims 11-13, to a banana plant comprising the construct comprising two or more of the nucleic acid sequences.
‘644 claims 5-6, drawn to the nucleic acid construct wherein the heterologous promoter is one of a list of promoter types, and from a list of promoter sequences including ‘644 SEQ ID NO: 17, in light of ‘644 claim 28, make obvious instant claims 4-5, drawn to the transgenic banana comprising a nucleic acid construct, wherein the heterologous promoter is one of a list of promoter types, and from a list of promoter sequences including instant SEQ ID NO: 17. ‘644 promoter SEQ ID NO: 17 is identical to instant promoter SEQ ID NO: 17. See alignment below.
Score
Expect
Identities
Gaps
Strand
924 bits(500)
0.0
500/500(100%)
0/500(0%)
Plus/Plus
Query 1 TGGTAGACTATGAAACACTAGTCTACTCAAAGAACTTGAAGAAGACGACTCAGGAAGACA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1 TGGTAGACTATGAAACACTAGTCTACTCAAAGAACTTGAAGAAGACGACTCAGGAAGACA 60
Query 61 GGAGCGTCATCAACAAGTTTCAGCAAAAGCTGATTAGTGGAAAAATCCTTGGATTCCACT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 61 GGAGCGTCATCAACAAGTTTCAGCAAAAGCTGATTAGTGGAAAAATCCTTGGATTCCACT 120
Query 121 CTCCAGCAATCTGCCAGCACATAAAGGTGACAGCAGAAAAAGAAGATTGTGACTACCACT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 121 CTCCAGCAATCTGCCAGCACATAAAGGTGACAGCAGAAAAAGAAGATTGTGACTACCACT 180
Query 181 GCAATCAGTGCGAATCTTCAAAAGGAAAGGCTATCGTTTGCGATAAGCCTGCCGACAGTG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 181 GCAATCAGTGCGAATCTTCAAAAGGAAAGGCTATCGTTTGCGATAAGCCTGCCGACAGTG 240
Query 241 GTCCAGCCGACAATGGAGGGCCCCAGACACGTGAAGACGCGTCTGCCGACAGTGGGTCTA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 241 GTCCAGCCGACAATGGAGGGCCCCAGACACGTGAAGACGCGTCTGCCGACAGTGGGTCTA 300
Query 301 GGACAACAGACACCACGCACTCAGCAAGTGGATGAAATAATTCATCTGCTGACGTAAGGG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 301 GGACAACAGACACCACGCACTCAGCAAGTGGATGAAATAATTCATCTGCTGACGTAAGGG 360
Query 361 ATGACGATCAATCCCACTATCCCAAGACCCTTCACTTCTATATAAGTGAAGTTGCTTCAT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 361 ATGACGATCAATCCCACTATCCCAAGACCCTTCACTTCTATATAAGTGAAGTTGCTTCAT 420
Query 421 TTGGAGAAGGCATCTCGAAATCTCAACACAACTCGAGCTCTCCCTTCTCTCTTCTTTATC 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 421 TTGGAGAAGGCATCTCGAAATCTCAACACAACTCGAGCTCTCCCTTCTCTCTTCTTTATC 480
Query 481 TCTCTAAATGTGTGAGTAGA 500
||||||||||||||||||||
Sbjct 481 TCTCTAAATGTGTGAGTAGA 500
‘644 claim 7, drawn to the nucleic acid construct comprising a selectable marker sequence, in light of ‘644 claim 28, makes obvious instant claim 6, drawn to the transgenic banana plant comprising the nucleic acid construct and further comprising a selectable marker sequence.
‘644 claim 10, drawn to the construct operably linked to a terminator sequence, makes obvious instant claim 9, drawn to a transgenic banana plant comprising the nucleic acid construct wherein the nucleic acid sequence is operably linked to a terminator sequence.
‘644 claim 21, drawn to banana products produced from a banana (‘644 claim 19) from the edited banana plant makes obvious instant claims 18-20 and also makes obvious instant claims 16-17 because a banana is a fruit, which is a plant part encompassed by instant claim 17.
‘644 claim 15, drawn to a plant part of the transgenic banana plant reads on instant claim 16.
‘644 claim 22 is drawn to a method of producing a banana plant with increased resistance to Fusarium oxysporum f. sp. cubense tropical race 4 comprising introducing the nucleic acid construct of ‘644 claim 26; ‘644 claim 25 is drawn to the method wherein the banana plant is a Musa acuminata plant. These claims make obvious instant claims 21-23.
Finally, ‘644 claim 22 (to the method of producing the banana plant) make obvious instant claim 22 in view of ‘644 claim 28 to the nucleic acid construct comprising a nucleic acid sequence of SEQ ID NO: 197.
Instant claims 21 & 23 are obvious over ‘644 claims 22 & 25. Additionally, although ‘644 claims 1, 4-7, 10, 12-15, 19, 21, 22, & 25 do not specifically require a nucleic acid sequence with at least 95% sequence identity to instant SEQ ID NO: 197, it would have been obvious to use a nucleic acid sequence of SEQ ID NO: 197 because ‘644 claim 28 teaches SEQ ID NO: 197 as a nucleic acid sequence encoding an antimicrobial peptide, which is required by the other claims. Thus, prior to the filing of the instant application, one of ordinary skill in the art would have been motivated and have reasonable expectation of success to use SEQ ID NO: 197 as a nucleic acid sequence encoding an antimicrobial peptide in the claims of ‘644, making instant claims 1, 2-6, 9, 11-13, & 16-24 obvious.
Corresponding ‘644 claim
Instant Claim
28
24
1, 4 in view of 28
1, 3
5-6 in view of 28
4-5
1 in view of 7 in view of 28
6
1 in view of 10 in view of 28
9
1 in view of 12-14 in view of 28
11-13
15 in view of 28
16
19 in view of 28
18, 17
21 in view of 28
19, 20
22, 25
21, 23
1 in view of 28
2
22 in view of 28
22
Applicant urges that the rejection was a provisional rejection and asks that the rejection be held in abeyance until after allowable claims have been identified (Remarks, page 37, paragraph 3).
This argument is unpersuasive, and the rejection is not held in abeyance. A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action. Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing will not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. See MPEP § 804(I)(B)(1).
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Victoria L DeLeo whose telephone number is (703)756-5998. The examiner can normally be reached M-F 8:00am-4pm EST.
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/VICTORIA L DELEO/Examiner, Art Unit 1662
/Anne Kubelik/Primary Examiner, Art Unit 1663
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