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 .
Information Disclosure Statement
Initialed and dated copy of Applicant’s information disclosure statement(s) (IDS) filed on
07/30/2024 is attached to the instant Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. It is noted that there appears to have been 3 copies of the same IDS submitted on 07/30/2024; only one copy has actually been considered by the Examiner.
Status of Claims
Claims 1-32 are pending and examined in this Office action.
Claim Objections
Claims 7, 9-11, 13, 24-26, and 28 are objected to because of the following informalities:
Claims 7 and 22 are objected to for the terms “Cry, MTX, and VIP”. Abbreviations should be fully written out the first time they are used in a claim.
Claims 9-10 and 24-25 are objected to for capitalizing the term “totivirus”. Only proper nouns and the first word of each claim should be capitalized.
Claims 10 and 25 are objected to for the phrase “selected from the any one” in line 2, which should read ---selected from any one---; in line 3, the term “FAW-macule-like” should read ---FAW macula-like---; also in line 3, “Apodoptera” should read ---Spodoptera---.
Claims 10, 13, 25, and 28 are objected to for the terms “Helicoverpa armigera” and “Spodoptera frugiperda”. The scientific names of organisms should be written in italics.
Claims 11 and 26 are objected to for the phrase “a transport peptide”. This phrase should be written as ---the transport peptide--- when referring back to “a transport peptide” of the parent claim.
Claims 13 and 28 are objected to for the terms “CEW, SAW, FAW”. Abbreviations should be fully written out the first time they are used in a claim.
Claims 13 and 28 are also objected to for the misspelling of “Helicverpa”, which should read
---Helicoverpa---; also, “stink bug” should not be capitalized. Only proper nouns and the first word of each claim should be capitalized.
Appropriate correction is required.
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.
Claims 1-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christian (Christian et al., Patent No.: US 6,177,075 B1, Date of Patent: Jan. 23, 2001).
Claim 1 recites “[a] plant comprising an expression construct wherein said expression construct contains a promoter operably linked to a nucleotide sequence that comprises a nucleotide sequence that encodes a transport peptide operably fused to a cargo molecule.”
It is noted that the “transport peptide” required by the claims is any of instant sequences SEQ ID NOs: 1-4. Lepidopteran virus, Helicoverpa armigera stunt virus (HaSV) encodes HaSV-CP (coat protein), which is instant sequence SEQ ID NO: 2. Instant sequence SEQ ID NO: 2 shares 100% sequence identity to capsid protein P71 (Christian SEQ ID No. 50).
In regard to claims 1 and 17, Christian teaches and claims a capsovector (i.e., expression construct) for use in controlling insect pests, the capsovector consisting of capsid protein (P71) (i.e., transport peptide; see note above) of a small RNA insect virus which is assembled into a viral capsid encapsidating an exogenous nucleic acid which encodes an insecticidal protein toxin (i.e., cargo molecule), wherein said small RNA insect virus possesses a gene encoding said capsid protein (i.e., a nucleotide sequence that encodes a transport peptide) (Christian, claims 1, 3, 7, 10).
Christian teaches and claims that capsovectors can be produced in transgenic crop plants (i.e., a plant comprising an expression construct) targeted by the host insect pests or produced for spray applications by transgenic plants or recombinant microorganisms (Christian, column 54, Example 12, lines 55-62; Figure 14) (Christian, claims 1-4 and 7-11).
Christian teaches and claims the modified capsid protein P71 is fused to a fragment of a cytotoxin (i.e., transport peptide operably fused to a cargo molecule) of either a plant or bacterial origin (Christian, column 62, lines 30-32) (Christian, claims 1-4 and 7-11).
Christian teaches that transgenic plants may be prepared by introducing a DNA construct including a cDNA or DNA fragment encoding all or a desired infectious portion of HaSV, into the genome of a plant. The cDNA or DNA fragment may be operably placed between a plant promoter and a polyadenylation signal. Promoters may cause constitutive or inducible expression of the sequences under their control (i.e., promoter operably linked to a nucleotide sequence) (Christian, column 11, lines 5-13). The instant Specification defines "associated with/operatively linked" as nucleic acid sequences that are related physically or functionally. For example, a promoter or regulatory DNA sequence is said to be "associated with" a DNA sequence that codes for an RNA or a protein if the two sequences are operatively linked, or situated such that the regulator DNA sequence will affect the expression level of the coding or structural DNA sequence (instant Specification, page 7, paragraph 0026).
In regard to claims 2 and 18, Christian teaches sequences derived from viral and non-viral sources that are responsible for the toxic activity and if required, translation into protein that confer the toxicity. RNA sequences leading to toxicity of the organism or cell can either be translated into protein or the sequences cause secondary structures to be made on the RNA strand that lead to toxicity (i.e., wherein the cargo molecule is a nucleotide sequence encoding a protein) (Christian, column 61, lines 12-20).
In regard to claims 3-4 and 19-20, Christian teaches and claims sequences incorporated into the recombinant vector may be any nucleic acid sequence, or protein sequence or parts thereof which are useful in exerting an insecticidal effect (i.e., wherein the cargo molecule is active against a plant pathogen) when incorporated in the recombinant vector of the invention (Christian, column 9, lines 14-17; claims 1 and 7).
In regard to claims 5-7 and 21-22, Christian teaches that the idea is to fuse the binding domain from the capsid protein (i.e., small molecules with pesticidal activity) to either large proteins (preferably indigestible, causing protein to aggregate in or on the midgut cells) or toxin domains from other proteins with suitable properties but normally different binding specificities (i.e., wherein the transport protein and the cargo molecule form a fusion peptide upon expression in a plant). Christian further teaches mapping binding sites using Bt/HaSV fusion proteins; analysis of the CryIA(c) Bt toxin (i.e., wherein the pesticidal protein is a Cry protein) has identified domains which may be involved in determining the host-specificity of this Bt by acting as receptor-binding sites (i.e., wherein the cargo molecule is a nucleotide sequence that encodes a binding protein for small molecules with pesticidal activity) (Christian, column 38, lines 26-42).
In regard to claims 8-11 and 23-26, Christian teaches and claims a capsovector for use in controlling insect pests, the capsovector consisting of modified capsid protein or modified capsid protein and capsid protein of a small RNA insect virus (i.e., wherein the transport peptide is derived from a plant pathogen virus), and wherein said small RNA insect virus belongs to the family Tetraviridae (i.e., wherein the plant pathogen virus is an Omegatetravirus); in which the insect small RNA insect virus is Heliothis armigera stunt virus (HaSV) (i.e., wherein the plant pathogen virus is Helicoverpa armigera stunt virus); in which the capsid protein is P71 (SEQ ID No. 50) (i.e., wherein the nucleotide sequence that encodes a transport peptide encodes a protein having between 70% and 100% sequence identity to SEQ ID NO: 2; see alignment below) (Christian, Example 12, columns 54-64; claims 1-3, 6-7, 9-10, and 14).
CHRISTIAN SEQ ID NO: 50 ALIGNED WITH INSTANT SEQUENCE SEQ ID NO: 2
Qy 1 MGDAGVASQRPHNRRGTRNVRVSANTVTVNGRRNQRRRTGRQVSPPDNFTAAAQDLAQSL 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MGDAGVASQRPHNRRGTRNVRVSANTVTVNGRRNQRRRTGRQVSPPDNFTAAAQDLAQSL 60
Qy 61 DANTVTFPANISSMPEFRNWAKGKIDLDSDSIGWYFKYLDPAGATESARAVGEYSKIPDG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DANTVTFPANISSMPEFRNWAKGKIDLDSDSIGWYFKYLDPAGATESARAVGEYSKIPDG 120
Qy 121 LVKFSVDAEIREIYNEECPVVTDVSVPLDGRQWSLSIFSFPMFRTAYVAVANVENKEMSL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LVKFSVDAEIREIYNEECPVVTDVSVPLDGRQWSLSIFSFPMFRTAYVAVANVENKEMSL 180
Qy 181 DVVNDLIEWLNNLADWRYVVDSEQWINFTNDTTYYVRIRVLRPTYDVPDPTEGLVRTVSD 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 DVVNDLIEWLNNLADWRYVVDSEQWINFTNDTTYYVRIRVLRPTYDVPDPTEGLVRTVSD 240
Qy 241 YRLTYKAITCEANMPTLVDQGFWIGGQYALTPTSLPQYDVSEAYALHTLTFARPSSAAAL 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 YRLTYKAITCEANMPTLVDQGFWIGGQYALTPTSLPQYDVSEAYALHTLTFARPSSAAAL 300
Qy 301 AFVWAGLPQGGTAPAGTPAWEQASSGGYLTWRHNGTTFPAGSVSYVLPEGFALERYDPND 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 AFVWAGLPQGGTAPAGTPAWEQASSGGYLTWRHNGTTFPAGSVSYVLPEGFALERYDPND 360
Qy 361 GSWTDFASAGDTVTFRQVAVDEVVVTNNPAGGGSAPTFTVRVPPSNAYTNTVFRNTLLET 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GSWTDFASAGDTVTFRQVAVDEVVVTNNPAGGGSAPTFTVRVPPSNAYTNTVFRNTLLET 420
Qy 421 RPSSRRLELPMPPADFGQTVANNPKIEQSLLKETLGCYLVHSKMRNPVFQLTPASSFGAV 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 RPSSRRLELPMPPADFGQTVANNPKIEQSLLKETLGCYLVHSKMRNPVFQLTPASSFGAV 480
Qy 481 SFNNPGYERTRDLPDYTGIRDSFDQNMSTAVAHFRSLSHSCSIVTKTYQGWEGVTNVNTP 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 SFNNPGYERTRDLPDYTGIRDSFDQNMSTAVAHFRSLSHSCSIVTKTYQGWEGVTNVNTP 540
Qy 541 FGQFAHAGLLKNEEILCLADDLATRLTGVYPATDNFAAAVSAFAANMLSSVLKSEATSSI 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 FGQFAHAGLLKNEEILCLADDLATRLTGVYPATDNFAAAVSAFAANMLSSVLKSEATSSI 600
Qy 601 IKSVGETAVGAAQSGLAKLPGLLMSVPGKIAARVRARRARRRAARAN 647
|||||||||||||||||||||||||||||||||||||||||||||||
Db 601 IKSVGETAVGAAQSGLAKLPGLLMSVPGKIAARVRARRARRRAARAN 647
In regard to claims 12-13 and 27-28, Christian teaches the use of small RNA viruses for biological control of insects. In particular, an isolated small RNA virus, particularly H. armigera stunt virus or mutants, variants or derivatives thereof capable of infecting insects, in particular the insect species such as Helicoverpa armigera (i.e., wherein the plant pathogen is lepidopteran; wherein the plant pathogen is Helicoverpa armigera). The small RNA virus isolate of the instant invention is insecticidal and in particular stunts the growth of insect larvae, for example Helicoverpa armigera larvae and inhibits or prevents development into the adult stage (Christian, column 4, lines 41-51). It is noted that the order of Helicoverpa armigera is Lepidoptera.
In regard to claim 14, Christian teaches plants which may be used include plants of both economic and scientific interest. Such plants may be those in general which need protection against the insect pests discussed herein and in particular include tomato (dicot), potato (dicot), corn (monocot), cotton (dicot), field pea (dicot), and tobacco (dicot) (i.e., wherein the plant is either a monocot or a dicot) (Christian, column 11, lines 33-37).
In regard to claims 15-16 and 29-30, Christian teaches upon being eaten by an insect pest, the structure of the capsovector will vector the toxin moiety to inside the midgut cell (i.e., wherein the expressed fusion peptide enters the hemocoel of an insect; note – the hemocoel comprises the midgut) by preventing proteolysis of the toxin moiety in the midgut and entering the midgut cells in a manner similar to what occurs for a virus particle. Upon entry, the capsovector will expose the cytotoxic moiety which will then kill the cell. Large numbers of midgut cells killed by capsovectors will cause antibiosis to the feeding insects (wherein the expressed fusion peptide kills the insect or decreases the insects growth) (Christian, column 62, lines 36-44).
In regard to claims 31-32, Christian teaches constructs similar to those for plant expression are introduced into yeast or bacteria by standard techniques (i.e., a cell comprising the expression construct; wherein the cell is a bacterial cell or a yeast cell) (Christian, column 47, lines 11-12).
Summary
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
/BRATISLAV STANKOVIC/Primary Examiner, Art Unit 1663