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 .
Claim Status
Claims 1-24 are pending. Claims 1-13 and 21-22 are withdrawn. Claims 14-20, 23 and 24 are examined in the instant application to the extent of SEQ ID NO: 5 and 68. All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendments
Status of Objections
In regard to the specification objection is maintained.Status of Rejections from action:
The rejection of claims 14-20 on the basis that it contains an improper Markush grouping of alternatives is modified in view of the amendments.
The rejection of claims 14-20 on the basis of Double Patenting is withdrawn in view of amendments, because the claim now requires a first and second polynucleotide with sequence identity to a target.
The rejection of claims 14-20 on the basis that it contains indefinite issues under 112(b) is modified in view of the amendments.
The rejection of claims 14-20 on the basis that it contains written description issues under 112(a) is modified in view of the amendments.
The rejection of claims 14-20 on the basis that it contains enablement issues under 112(a) is modified in view of the amendments.
The rejection of claims 14-20 on the basis that Kaweesi et al. anticipates the instant application under 102 is withdrawn in view of the amendments. Because Applicant amended the claims to include two targets.
The rejection of claims 14-20 on the basis that Kaweesi et al. and Baum et al. is added under 103 is added in view of the amendments.
The rejection of claims 14-18 and 20 on the basis that Baum et al. under 102/103 is modified in view of the amendments.
Priority
This application is claiming the benefit of Provisional Application No. 63/514,082 filed July 17, 2023.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. The following links are still active in the specification dated 05/26/2026.
Page 124: https://www.ncbi.nlm.nih.gov/
Page 125: https://itol.embl.de/ and https://blast.ncbi.nlm.nih.gov/Blast.cgi/.
Page 126: https://primer3.ut.ee/
Page 136: https://primer3.ut.ee/
Claim interpretation
The claims are directed to a method of controlling invertebrate pest infestation by providing in a diet to an invertebrate a first and second polynucleotide targeting the same thing, i.e., SEQ ID NO: 5.
Improper Markush Grouping
Claims 14-20 REMAIN rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The claims recite SEQ ID NOs that do not share any primary structural and functional identity. In the absence of structural similarity, structure/function cannot be shared. For example, on page 11-12, Applicant list different species of genes not sharing structure-function relationship such as SEQ ID NO: 5 (a-glucosidase gene, known as SUC2) and SEQ ID NO:13 (4-hydroxy-tetrahydrodipicolinate reductase gene, known as dapB), lacking substantial structural and functional similarity. As such, the Markush groups recited in the claims are improper.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature.
This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Response to Arguments
Applicant primarily argues that claims 14 and 20 now require an additional target and the other SEQ ID NOs. are different targets in the B. tabaci genome (Remarks, 05/26/2026, pgs. 14-15). The Office acknowledges the arguments but are unpersuasive.
Claims 14 and 20 now require two different target sequences, both of those targets can easily come from two different regions on the exact same elected gene (SEQ ID NO:5). For example, one RNAi molecule targeting region 1-21 and the other targeting region 100-120 of SEQ ID NO: 5. Because one does not actually need any other sequence ID’s to practice the claims, all the other SEQ ID NOs. remain completely excluded.
Furthermore, simply saying all these sequences come from the whitefly genome and cause RNAI silencing isn’t enough to pass MPEP 2117, that’s just a shared functional outcome, not a shared physical structure. An osmoregulation gene (SUC2 SEQ ID NO:5) in the whitefly gut and an amino acid gene essential symbiosis genes enriched in the bacteriocyte (including argH, LysA, BCAT, and dapB SEQ ID NO:13) are completely different structural entities with zero sequence identity or function, making them entirely different species.
Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 112
Claims 14-20 REMAIN rejected, and claims 23 and 24 are NOW 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.
In regard to claim 14, Applicants are claiming a polynucleotide that is 21 bases in length that targets a polypeptide/amino acid sequence. However, SEQ ID NO: 5 is an amino acid sequence. The structure of a polynucleotide sequence with 85% identity to 21 contiguous nucleotides is unclear.
Claim 20 presents the same issue and is therefore rejected for the same reason as provided from claim 14.
Claims 15-19 and 23-24 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
Applicant is advised to amend the claims appropriately.
Response to Arguments
The Applicant argues that “The claim language thus identified the target as a nucleotide sequence (i.e., the coding sequence for SEQ ID NO:5, which is SEQ ID NO:6, a 2,031-nucleotide sequence), not the amino acid sequence of SEQ ID NO:5 itself. Accordingly, Applicants submit that the claims as originally drafted were not indefinite.” (Remarks, 05/26/2026, pgs.18-19).
The Applicant mentions that SEQ ID NO: 6 is the coding sequence for SEQ ID NO: 5, however the Applicant is arguing limitations not present in the claims and do not recite SEQ ID NO: 6 and not limited to SEQ ID NO:6, therefore, as it stands it is unclear to what nucleotide structure the Applicant is claiming.
Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 112(a)(Written Description)
Claims 14-20, REMAIN rejected, and claims 23 and 24 are NOW 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.
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Applicant’s disclosure is as follows.
Applicant describes feeding for five days on artificial diets of dsRNA construct against SUC3 (SEQ ID NO: 70), SUC4 (SEQ ID NO: 71), SUC7 (SEQ ID NO: 73), and SUC12 (SEQ ID NO: 74) from Bemisia tabaci (pg. 129) and resulting in 71-78% whitefly mortality. Additionally, the specification describes that all 4 treatments significantly delayed offspring development and caused physical abnormalities, dsRNA SUC4 and dsRNA SUC7 were the most effective overall because they also increase adult mortality and, in the case of dsRNA SUC4, significantly reduced the total number of progeny produced (pg. 131 and fig. 46).
The claims encompass two polynucleotide sequences having at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5. Furthermore, the scope of the claims encompasses the nucleic acids obtained from any source so long as they share at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5.
The specification does not describe the features of sequences having as little as 85% sequence identity to at least 21 contiguous nucleotides targeting SEQ ID NO: 5 which confer silencing activity. Therefore, one skilled in the art cannot identify whether the genus of structures as claimed would have functionality.
(1) Applicant has not described the polynucleotides that target SEQ ID NO: 5 (2) Applicant’s haven’t described the genus of structures (i.e., 85% to at least 21 contiguous nucleotides to SEQ ID NO: 5).
Applicant does not describe common structures or motifs for the polynucleotide functionality that is shared by B. tabaci or from any other invertebrates having the same silencing activity. Therefore, the lack of such identifying characteristics is not sufficient to show the applicant was in possession of the invention as claimed.
The specification fails to describe that variants with at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5 will have silencing activity or off-target effects thereof across different invertebrates rendering it unknown if the variants will retain functional activity and silencing activity. This is because the specification does not describe functional domains or motifs such that one would have no idea if the variants possess the necessary structures to be functionally active and silencing 85% sequence identity to at least 21 contiguous nucleotides targeting SEQ ID NO: 5.
The claims encompass dsRNA sequences of 21 nucleotides designed to silence SEQ ID NO: 5 requires at least 85% sequence identity. The threshold allows for up to 3 nucleotide substitutions within 21 contiguous nucleotide segments across the entire length of the target sequence SEQ ID NO: 5.
The Applicant claims a genus of sequence defined by 85% sequence identity to any 21 contiguous nucleotide stretch within SEQ ID NO: 5, which SEQ ID NO: 6 encodes. In SEQ ID NO: 6 having 2,031 nucleotide, there are 2,011 such 21 nucleotide segments. Within each segment allowing for 1,330 distinct 3 base substitutions, the total number of potential variants exceeds 2.8 million.
This genus encompasses numerous distinct nucleotide variants. In the absence of describing exactly where the dsRNA targets SEQ ID NO: 5, one of skill in the art would not be led to believe that Applicant possesses this vast genus of dsRNA sequences that retain functional activity. Without defining which variations preserve silencing efficacy, there is no evidence that these sequences would successfully target SEQ ID NO: 5 or SUC2 and/or achieve the claimed silencing activity.
Therefore, the specification fails to provide adequate description on the motifs, catalytic domains, etc. in these sequences that confers the specifically claimed function of silencing SEQ ID NO: 5 or SUC2 with said at least 85% sequence identity to at least 21 contiguous nucleotides limitation.
Applicant has shown one structure/sequence which is not deemed to be a representative number of structures/sequences from the genus of sequences having 85% sequence identity to at least 18 contiguous nucleotides to SEQ ID NO: 5 that retain function and thus cause mortality.
Contrary to the teachings of the instant invention, Thomas et al. (The Plant journal : for cell and molecular biology vol. 25,4 (2001): 417-25. doi:10.1046/j.1365-313x.2001.00976.x (previously cited)) investigated the relationship between the length of RNA sequence identity with a transgene and its effectiveness at gene silencing in Nicotiana benthamiana, and demonstrated that silencing was achieved when the homology was 23 consecutive nucleotides or longer (see p. 419, col. 1, last ¶ and Table 1). Describing, that one skilled in the art would require at a minimum of 23 consecutive to show possession of having a dsRNA with silencing capabilities.
Because of the lack of a description of a representative number of structures/sequences, the absence of information in the art on conserved regions required for activity, and the impact of 15% variation to at least 21 contiguous nucleotides to SEQ ID NO: 5 would have numerous variation relative to across the whole sequence of SEQ ID NO: 5, one skilled in the art would not know the structures that confer the various traits.
Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111.
Response to Arguments
Applicant argues that the specification provides a representative number of species within the claimed genus citing dsRNA constructs targeting four GH13 family members, SUC3 (SEQ ID NO:70), SUC4 (SEQ ID NO:71), SUC7 (SEQ ID NO:73), and SUC12 (SEQ ID NO:74) and increasing 18 contiguous nucleotide to 21 contiguous nucleotides. (Remarks, 05/26/2026, pgs.20-21). The Office acknowledges the arguments, but are unpersuasive.
The Applicant is reminded that the claims are examined to the extent of SEQ ID NO: 5. The claims encompass polynucleotides having as low as 85% sequence identity to a 21 contiguous nucleotide segment generates millions of sequence variants without providing written description support for a representative number of species MPEP 2163.3.ii. Disclosing single, distinct species for other target genes, such as dsRNA constructs targeting four GH13 family members, SUC3 (SEQ ID NO:70), SUC4 (SEQ ID NO:71), SUC7 (SEQ ID NO:73), and SUC12 (SEQ ID NO:74), does not establish possession of the full scope of 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5 variants. These other examples represent separate biological targets rather than a structurally representative sample of the full scope of 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5.
Furthermore, none of the working examples actually test or demonstrate RNAI activity for molecules modified to having as little as 85% sequence identity threshold across 21 contiguous nucleotides segments. Therefore, the specification lacks description and representative number of species of polynucleotides having at least 85% sequence identity threshold across 21 contiguous nucleotides to SEQ ID NO: 5.
Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 112(a)(Enablement)
Claims 14-20 REMAIN rejected, and claims 23 and 24 are NOW rejected, under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
“The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification of a patent enable any person skilled in the art to which it pertains to make and use the claimed invention. Although the statute does not say so, enablement requires that the specification teach those in the art to make and use the invention without ‘undue experimentation.’ In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (emphasis in original); see also In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993) (“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’”) “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” Wands, supra.
Some experimentation, even a considerable amount, is not “undue” if, e.g., it is merely routine, or if the specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. Factors to consider include “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id.
Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons. To comply with 35 USC 112(a) enablement, one skilled in the art must be able to make and use the claimed invention.
(A) The breadth of the claims
The breadth of the claims encompasses two target polynucleotides molecules having at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5. to disrupt activity of any polypeptide in all invertebrate pests.
(B) The nature of the invention.
The nature of the claimed invention is directed to two RNAi sequences having at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5 to disrupt activity of any polypeptide in all invertebrate pest, achieved by feeding said RNAi constructs, resulting in reduced glucosidase/SUC2 activity and whitefly death.
(C) The state of the prior art
The state of the prior art does not teach the structures having at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5 that confer function for said polynucleotides.
(D) The level of one of ordinary skill
The level of one of ordinary skill in the art is high.
(E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claims encompass two polynucleotide sequences having at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5. Furthermore, the scope of the claims encompasses the nucleic acids obtained from sources other than B. tabaci, or polynucleotides so long as they share at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5.
The specification does not provide the adequate amount of guidance regarding the features of sequences having as little as 85% sequence identity to at least 21 contiguous nucleotides targeting SEQ ID NO: 5 which confer silencing activity, and the specification does not provide sufficient guidance for one skilled in the art to predictably make or use the structures of other polynucleotides from other invertebrate species that retain function.
(1) Applicants have not taught or provided examples of the genus of polynucleotides that will target SEQ ID NO: 5 (2) Applicant’s haven’t taught the structures (i.e., 85% to at least 21 nucleotides to SEQ ID NO: 5) that confer functional activity.
Applicant does not teach common structures or motifs for the polynucleotide functionality that is shared by B. tabaci or from any other invertebrates having the same silencing activity that would allow one skilled in the art to predict their structures of glucosidase polynucleotides or SUC2 from any other invertebrate species having the same silencing activity.
The specification fails to TEACH, or fails to provide GUIDANCE for making variants with at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5 will have silencing activity or off-target effects thereof across different invertebrates rendering it unknown if the variants will have the same functional activity and silencing activity. The lack of guidance and the lack of working examples means one skilled in the cannot make and use a polynucleotide having as little as 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5.
The claims encompass dsRNA sequences of 21 nucleotides designed to silence SEQ ID NO: 5 requires at least 85% sequence identity. The threshold allows for up to 3 nucleotide substitutions within 21 contiguous nucleotide segments across the entire length of the target sequence SEQ ID NO: 5.
The Applicant claims a genus of sequence defined by 85% sequence identity to any 21 nucleotide stretch within SEQ ID NO: 5, which SEQ ID NO: 6 encodes. In SEQ ID NO: 6 having 2,031 nucleotide, there are 2,011 such 21 contiguous nucleotide segments. Within each segment allowing for 1,330 distinct 3 base substitutions, the total number of potential variants exceeds 2.8 million.
This genus encompasses numerous distinct nucleotide variants. In the absence of guidance indicating where in the polynucleotides having at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5 such variations can be sustained, undue trial and error experimentation would be required to make the claimed polypeptide which would retain the activity of polynucleotides having at least 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5, and lead to controlling invertebrate pest infestation.
Therefore, the specification fails to teach sequences that retain the specifically claimed function of silencing SEQ ID NO: 5 or SUC2. Applicant has not shown one structure/sequence having at least 85% sequence identity to at least 21 nucleotides to SEQ ID NO: 5 that retain function and thus having silencing activity.
Contrary to the teachings of the instant invention, Thomas et al. (The Plant journal : for cell and molecular biology vol. 25,4 (2001): 417-25. doi:10.1046/j.1365-313x.2001.00976.x (previously cited)) investigated the relationship between the length of RNA sequence identity with a transgene and its effectiveness at gene silencing in Nicotiana benthamiana, and demonstrated that silencing was achieved when the homology was 23 consecutive nucleotides or longer (see p. 419, col. 1, last ¶ and Table 1). Teaching that one skilled in the art would require at a minimum of 23 consecutive to predictably have silencing capabilities.
Because of the lack of representative sequences, the lack of information on conserved regions required for activity, and the impact of 15% variation to at least 21 nucleotides to SEQ ID NO: 5 would have numerous variation relative to across the whole sequence of SEQ ID NO: 5, there is not enough guidance to predictably make and/or use the claimed sequences to predictably produce constructs with silencing activity. Let alone two targets resulting in disrupting activity of said polynucleotides.
The claimed invention lacks adequate enabling guidance with regard to the genus of sequence variations that comprise silencing activity is obtained. The scope of the claims encompass any species of invertebrate. However, Applicant has no working example with SEQ ID NO: 5 (SUC2), especially polynucleotides having at least 85% sequence identity to at least 21 contiguous nucleotides.
Given the breadth of the claims, the lack of sufficient guidance, the absence of working examples regarding the structure of polynucleotide sequences having at least 85% sequence identity to at least 21 nucleotides to SEQ ID NO: 5 which confer functional activity, the state of the prior art, and unpredictability in the art, one skilled in the art cannot make and use the claimed invention as commensurate in scope with the claims without excessive burden and undue experimentation.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
Response to Arguments
Applicant argues that the specification provides enabling guidance, working examples of targeting four GH13 family members, SUC3 (SEQ ID NO:70), SUC4 (SEQ ID NO:71), SUC7 (SEQ ID NO:73), and SUC12 (SEQ ID NO:74), and increasing 18 contiguous nucleotide to 21 contiguous nucleotides. (Remarks, 05/26/2026, pgs.21-25). The Office acknowledges the arguments but they are unpersuasive.
The Applicant is reminded that the claims are examined to the extent of SEQ ID NO: 5. The claims encompass polynucleotides having as low as 85% sequence identity to a 21 contiguous nucleotide segment encompasses millions of sequence variants without providing guidance to make and use these sequences.
Teaching single, distinct species for other target genes, such as dsRNA constructs targeting four GH13 family members, SUC3 (SEQ ID NO:70), SUC4 (SEQ ID NO:71), SUC7 (SEQ ID NO:73), and SUC12 (SEQ ID NO:74), does not provide enabling guidance to make and use the full scope of sequences having 85% identity to at least 21 contiguous nucleotides to SEQ ID NO: 5 variants resulting controlling invertebrate pest infestation. These other examples represent separate biological targets rather than working examples of the full scope of 85% sequence identity to at least 21 contiguous nucleotides to SEQ ID NO: 5 to predictably control invertebrate pest infestation.
Furthermore, none of the working examples test or demonstrate RNAi activity for molecules having as little as 85% sequence identity threshold across 21 contiguous nucleotide segments to control invertebrate pest infestation.
Therefore, the specification lacks description and representative number of species of polynucleotides having at least 85% sequence identity threshold across 21 contiguous nucleotides to SEQ ID NO: 5 resulting controlling invertebrate pest infestation.
Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 103
Claims 14-20 are rejected under 35 U.S.C. 103 as being obvious by Kaweesi et al. (“Identification Of Essential Gene Targets In Cassava Bemisia Tabaci, For Effective Whitefly Management Using Rna Interference”. 2019. Uarists. https://naroinfohub.naro.go.ug/RepDetails?pn=4645 (Applicant’s IDS)) and in view of Baum et al., (US 9238822 B2 (previously cited)).
In regard to claims 14-20, Kaweesi et al. teach that ENSSSA1UGT002066 is an Alpha-glucosidase (SUC2) for sucrose hydrolysis (p. 89). Additionally, Kaweesi et al. teach the amino acid sequence of ENSSSA1UGT002066 which corresponds to NCBI accession KX390871.1 (p. 161). Additionally, KX390871.1 has 100% sequence identity to minimum of 7 amino acid segment within SEQ ID NO: 5.
This sequence is encoded by a 21-nucleotide segment that shares at least 85% sequence identity to at least 21 contiguous nucleotides of SEQ ID NO: 5 (see alignment below bolded amino acids). Furthermore, KX390871.1 has multiple segments with at least 21 contiguous nucleotides, which increase the possible target regions and likelihood of success that one skilled in the art can routinely develop dsRNA (see alignment below). ENSSSA1UGT002066 (SUC2) “were selected as critical osmoregulation genes with enriched expression in the whitefly gut” (p. 161). Lastly, Kaweesi et al. teach a “dsRNA against sucrase (dsSUC) (NCBI Accession KX390871)” (p.124). Overall, Kaweesi et al. teach on SUC2 being a critical gene and developing a dsRNA against SUC2.
Kaweesi et al. does not teach a second polynucleotide can be used to down-regulate the same gene.
In regard to claims 14-20, Baum et al. discloses SEQ ID NO: 3351 having at least 85% sequence identity to at least 21 contiguous nucleotides to Applicants SEQ ID NO: 5 (see alignment in previous Office action). Baum et al. discloses on “a method for suppression of gene expression in an invertebrate pest such as a corn rootworm or related species comprises the step of providing in the diet of the pest a gene suppressive amount of at least one dsRNA molecule transcribed from a nucleotide sequence as set forth in SEQ ID NO:1 through SEQ ID NO:20303” which includes SEQ ID NO: 3351 (i.e. SEQ ID NO: 5) (col. 6 lines 21-26).
Baum et al. teaches that “It may be preferable to use multiple miRNA target sequences corresponding to multiple miRNA genes or to use the same miRNA target sequence multiple times in the chimera of the miRNA target sequence” (i.e. targeting the same gene twice) (col. 92, Ex. 13, lines 48-51).
Baum et al. teach that “it is envisioned that two or more different stabilized dsRNA constructs producing dsRNA molecules of the present invention could be provided together within a single plant to ensure durability of the insect control phenotype. These dsRNA molecules could target the same gene for silencing or, alternatively, target different genes for silencing. Two or more different dsRNA's can be combined together in the same plant, each dsRNA being toxic to a different insect pest, neither of the dsRNA's being toxic to the same insect species” (col. 46, lines 58-67). Baum suggest using two or more dsRNA constructs to target the same gene for silencing because it improves durability.
Overall, Baum et al. teach on a method to control the pest infestations by using inhibitory molecules that is at least 85% sequence identity to at least 21 contiguous nucleotides that would target SEQ ID NO: 5 multiple times.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to modify the teachings of Kaweesi et al. by including additional RNAi target sites because Baum et al. teaches, suggests and provides motivation for doing so (col. 6 lines 21-26 and col. 46, lines 58-67).
One would have a reasonable expectation of success in doing so because each of Kaweesi et al. and Baum et al. teach the successful application of inhibitory RNA in various solutions of dsRNA and Baum et al. suggest that it would be ideal to target the same gene twice to improve silencing activity.
Response to Arguments
Applicant’s arguments with respect to claim(s) 14-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102/103
Claims 14-18 and 20 REMAIN rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, rejected under 35 U.S.C. 103 as being obvious over, Baum et al., (US 9238822 B2 (previously cited)).
In regard to claims 14-18 and 20, Baum et al. discloses SEQ ID NO: 3351 having at least 85% sequence identity to at least 21 contiguous nucleotides to Applicants SEQ ID NO: 5 (see alignment in previous Office action). Baum et al. teaches that “It may be preferable to use multiple miRNA target sequences corresponding to multiple miRNA genes or to use the same miRNA target sequence multiple times in the chimera of the miRNA target sequence” (i.e. targeting the same gene twice) (col. 92, Ex. 13, lines 48-51). Baum et al. discloses on “a method for suppression of gene expression in an invertebrate pest such as a corn rootworm or related species comprises the step of providing in the diet of the pest a gene suppressive amount of at least one dsRNA molecule transcribed from a nucleotide sequence as set forth in SEQ ID NO:1 through SEQ ID NO:20303” which includes SEQ ID NO: 3351 (i.e. SEQ ID NO: 5) (col. 6 lines 21-26).
Baum et al. teach that “it is envisioned that two or more different stabilized dsRNA constructs producing dsRNA molecules of the present invention could be provided together within a single plant to ensure durability of the insect control phenotype. These dsRNA molecules could target the same gene for silencing or, alternatively, target different genes for silencing. Two or more different dsRNA's can be combined together in the same plant, each dsRNA being toxic to a different insect pest, neither of the dsRNA's being toxic to the same insect species” (col. 46, lines 58-67). Baum suggest to using two or more dsRNA constructs to target the same gene for silencing because it improves durability.
Therefore, Baum et al. anticipates a method to control the pest infestations by using inhibitory molecules that is at least 85% sequence identity to at least 21 contiguous nucleotides that would target SEQ ID NO: 5.
Alternatively, if the prior art did not anticipate all the claim limitations, one would have found it obvious to arrive at the method of claim 14, because Baum et al. teaches and suggests all the claimed steps. Additionally, one would have a reasonable expectation of success because Baum et al. also feeds a dsRNA molecule to control invertebrate pest (col. 6 lines 21-26).
Furthermore, Baum et al. suggest targeting the same gene multiple times with RNAi and would have been obvious for one skilled in the art to increase the number of RNAi targets to ensure silencing activity. One would expect a high level of success because Baum et al. already successfully targets said gene, so applying an additional target increases the success rate.
Response to Arguments
Applicant argues that Baum et al. does not teach or suggest utilizing combinatorial RNAi targeting multiple essential gene systems (osmoregulation and symbiosis) in B. tabaci. (Remarks, 05/26/2026, pgs.21-25). The Office acknowledges the arguments but finds them unpersuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., multiple essential gene systems (osmoregulation and symbiosis) in B. tabaci) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the instant case, the claims are open to a method of controlling invertebrate pest infestation, which includes corn rootworm and are not limited to B. tabaci.
Moreover, and as noted above, Baum teaches it is envisioned that two or more different stabilized dsRNA constructs producing dsRNA molecules of the present invention could be provided together within a single plant to ensure durability of the insect control phenotype. These dsRNA molecules could target the same gene for silencing. Thus, Baum teaches and provides motivation for using a first and second polynucleotide to control pest infestation.
Therefore, the rejection is maintained.
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.
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/C.J.O./Examiner, Art Unit 1663 /JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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