DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group II claims 14-20, and the species of SEQ ID NO: 5 and SUC2 in the reply filed on December 11, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The restriction is made FINAL.
Claim Status
Claims 1-22, are pending. Claims 1-13 and 21-22, are withdrawn, because SEQ ID NO: 68 and Chorismate mutase was not one of the elected species. Claims 14-20, are examined in the instant application.
Priority
This application is claiming the benefit of Provisional Application No. 63/514,082 filed July 17, 2023.
Information Disclosure Statement (IDS)
The IDS submitted on 11/12/2024, 11/22/2024, 12/23/2024 and 07/07/2025 has been considered. Signed copies is attached.
Drawings
The drawings are objected to because figure 47 does not have a legend and the Office cannot accurately distinguish between treatments. Therefore, Applicant is advised to appropriately amend the figure. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Page 124: https://www.ncbi.nlm.nih.gov/ and http://www.whiteflygenomics.org/.
Page 125: https://itol.embl.de/, http://www.e-mai.org/ and https://blast.ncbi.nlm.nih.gov/Blast.cgi/.
Page 126: https://primer3.ut.ee/
Page 136: https://primer3.ut.ee/
Improper Markush Grouping
Claims 14-20 are 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).
Double Patenting
Claims 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11, 13-15, 17-24 and 26-28 of U.S. Pub No. US 20250194603 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant Applicant and US 20250194603 A1 teach on managing whitefly.
In regard to claims 14, 17 and 20, Colvin et al. discloses on “A recombinant polynucleotide molecule comprising at least one polynucleotide sequence having at least about 85% sequence identity to at least 18 contiguous nucleotides of a target nucleotide sequence, wherein said target nucleotide sequence: a) encodes a polypeptide involved in the trehalose biosynthesis pathway”… “ wherein said recombinant polynucleotide molecule disrupts the activity of said one or more polypeptides when provided in the diet of an invertebrate pest” (claim 1), which SUC2 glucosidase hydrolyzes sucrose into glucose acting like a “gatekeeper” that provides the carbon skeleton necessary for the pathways to function. Without that upstream supply of glucose, the trehalose pathway has no substrate to work with. In other words, SUC2 is indirectly is involved int the trehalose biosynthesis pathway and a key target to manage whitefly (claim 1 and 3). Additionally, Colvin et al. disclose SEQ ID NO: 45 having at least 100% sequence identity to Applicants SEQ ID NO: 5 (see alignment below and claim 4).
Sequence 45, US/18979189
GENERAL INFORMATION
APPLICANT: National Resources Institute (en)
TITLE OF INVENTION: COMPOSITIONS AND METHODS FOR MANAGEMENT OF WHITEFLY (en)
FILE REFERENCE: AGOE:014US
CURRENT APPLICATION NUMBER: US/18/979,189
CURRENT FILING DATE: 2024-12-12
NUMBER OF SEQ ID NOS: 137
SEQ ID NO 45
LENGTH: 676
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..676
QUALIFIERS: mol_type = protein
organism = Bemisia tabaci
Query Match 100.0%; Score 3631; Length 676;
Best Local Similarity 100.0%;
Matches 676; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MTVLFVNIFAAAIVATCFVTVTCAVAGADNSKTEDCDDTALFEQSMATHPKQSKLGAGSE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MTVLFVNIFAAAIVATCFVTVTCAVAGADNSKTEDCDDTALFEQSMATHPKQSKLGAGSE 60
Qy 61 RKADEKLEWWQTSVFYQIYPMSFKDANGDGKGDLQGIASKADHFVDIGVGAVWLSPIYSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RKADEKLEWWQTSVFYQIYPMSFKDANGDGKGDLQGIASKADHFVDIGVGAVWLSPIYSS 120
Qy 121 PMADFGYDISNYTEINEIFGNLDDLVHLREKLHARGVKLILDFVPNHSSNEHPWFLNSVK 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 PMADFGYDISNYTEINEIFGNLDDLVHLREKLHARGVKLILDFVPNHSSNEHPWFLNSVK 180
Qy 181 KIDPYTNYYVWRDPVIDANGKKSPPNNWLSIFNSGSAWEWNEERGQYYLHQFAVQQPDLN 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 KIDPYTNYYVWRDPVIDANGKKSPPNNWLSIFNSGSAWEWNEERGQYYLHQFAVQQPDLN 240
Qy 241 YNCKELVEEMKEVLRFWLSHGVDGFRMDAVPYLFEDSLFRNEPYVDENIKNSKMYDSLIH 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 YNCKELVEEMKEVLRFWLSHGVDGFRMDAVPYLFEDSLFRNEPYVDENIKNSKMYDSLIH 300
Qy 301 IYSMDRPKTYEMIGQFRKVLDDFAKEHNTPPKVILSEAYTSLNYTMKYYGDAKNPGSHMP 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 IYSMDRPKTYEMIGQFRKVLDDFAKEHNTPPKVILSEAYTSLNYTMKYYGDAKNPGSHMP 360
Qy 361 FNFLMINECHKDSSANDFNAAIHNWMDNMPDDHWANWVMGNHDQPRIATRYGPELVDAIN 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 FNFLMINECHKDSSANDFNAAIHNWMDNMPDDHWANWVMGNHDQPRIATRYGPELVDAIN 420
Qy 421 MLVMLLPGTAITYNGEEIGMSNGYIRWDQTIDPAGINVGPKEYEKYSRDGCRTPFQWDDS 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 MLVMLLPGTAITYNGEEIGMSNGYIRWDQTIDPAGINVGPKEYEKYSRDGCRTPFQWDDS 480
Qy 481 ISAGFSSNSRTWLPVNPNSYYLNLKNQKEESYSHYHIYKRLTTLRKTRTFQRGAWKTYVL 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 ISAGFSSNSRTWLPVNPNSYYLNLKNQKEESYSHYHIYKRLTTLRKTRTFQRGAWKTYVL 540
Qy 541 SNWVLAIERMMEGEDSYVLVINLGSEYEPIKLSDQIKSLPDTMKVHTASVNSAIKNGESV 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 SNWVLAIERMMEGEDSYVLVINLGSEYEPIKLSDQIKSLPDTMKVHTASVNSAIKNGESV 600
Qy 601 NTASSGFLMRPKSALVLTTSKEDPPNPAPASSSVSLKTSLCVLVFGILFAILSVKAICYC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 NTASSGFLMRPKSALVLTTSKEDPPNPAPASSSVSLKTSLCVLVFGILFAILSVKAICYC 660
Qy 661 RTSKSSTVITDLKSGQ 676
||||||||||||||||
Db 661 RTSKSSTVITDLKSGQ 676
In regard to claims 15-16, Colvin et al. teaches that the polynucleotide molecules is a dsRNA molecule (claim 19).
In regard to claim 18-19, Colvin et al. teaches on targeting whitefly (claim 14).
Claim Rejections - 35 USC § 112
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 14-20, 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.
In regard to claim 14, Applicants are claiming a polynucleotide that is 18 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 18 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 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.
Claim Rejections - 35 USC § 112(a)(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 14-20, 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.
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 significant 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).
Claims encompass any polynucleotide having as little as 85% sequence identity to at least 18 contiguous nucleotides of SEQ ID NO: 5 to disrupt activity in all invertebrate pest – the specification only describes SUC2 (SEQ ID NO: 5) as a potential target.
The claimed invention lacks adequate written description for the following reasons. Claims 14-20 are directed to a polynucleotide molecule that targets any invertebrate pest having silencing activity, wherein the polynucleotide is obtained from any source having any sequence structure.
Additionally, the claims encompass a polynucleotide sequence having at least 85% sequence identity to at least 18 contiguous nucleotides to SEQ ID NO: 5. Furthermore, the scope of the claims encompasses the nucleic acids obtained from any source or a polynucleotide so long as they share at least 85% sequence identity to at least 18 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 18 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 polynucleotide that target SEQ ID NO: 5 (2) Applicant’s haven’t described the genus of structures (i.e., 85% to at least 18 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 18 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 18 contiguous nucleotides targeting SEQ ID NO: 5.
A dsRNA sequence of 18 nucleotides designed to silence SEQ ID NO: 5 requires at least 85% sequence identity. The threshold allows for up to 2 nucleotide substitutions within 18 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 18 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 2,014 such 18 nucleotide segments. Within each segment allowing for 1,377 distinct 2 base substitutions, the total number of potential variants exceeds 2.7 million.
This genus encompass 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 18 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(U)) 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 18 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
Claim Rejections - 35 USC § 112(a)(Enablement)
Claims 14-20, 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 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 any polynucleotide sequence having at least 85% sequence identity to at least 18 contiguous nucleotides to SEQ ID NO: 5. to disrupt activity of any polypeptide in all invertebrate pest.
(B) The nature of the invention.
The nature of the claimed invention is directed to any RNAi sequence having at least 85% sequence identity to at least 18 contiguous nucleotides to SEQ ID NO: 5. to disrupt activity of any polypeptide in all invertebrate pest, achieved by feeding said RNAi construct, 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 18 contiguous nucleotides to SEQ ID NO: 5 that confer function for said polynucleotide. Additionally, the art does not teach RNAi constructs with as little as 85% sequence identity to 18 contiguous nucleotides.
(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 claimed invention lacks adequate enabling guidance for the following reasons. Claims 14-20, are directed to a polynucleotide molecule that targets any invertebrate pest having silencing activity, wherein the polynucleotide is obtained from any source having any sequence structure.
Additionally, the claims encompass a polynucleotide sequence having at least 85% sequence identity to at least 18 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 a polynucleotide so long as they share at least 85% sequence identity to at least 18 contiguous nucleotides to SEQ ID NO: 5.
The specification does provide the adequate amount of direction or guidance regarding the features of sequences having as little as 85% sequence identity to at least 18 contiguous nucleotides targeting SEQ ID NO: 5 which confer silencing activity. From the disclosure of 85% sequence identity to at least 18 contiguous nucleotides targeting SEQ ID NO: 5, one skilled in the art cannot predict the structures of other polynucleotides from other invertebrate species.
(1) Applicant’s haven’t taught the polynucleotide that target will SEQ ID NO: 5 (2) Applicant’s haven’t taught the structures (i.e., 85% to at least 18 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 18 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 or 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 18 contiguous nucleotides to SEQ ID NO: 5.
A dsRNA sequence of 18 nucleotides designed to silence SEQ ID NO: 5 requires at least 85% sequence identity. The threshold allows for up to 2 nucleotide substitutions within 18 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 18 nucleotide stretch within SEQ ID NO: 5, which SEQ ID NO: 6 encodes. In SEQ ID NO: 6 having 2,031 nucleotide, there are 2,014 such 18 contiguous nucleotide segments. Within each segment allowing for 1,377 distinct 2 base substitutions, the total number of potential variants exceeds 2.7 million.
This genus encompass numerous distinct nucleotide variants. In the absence of guidance indicating where in the polynucleotides having at least 85% sequence identity to at least 18 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 18 contiguous nucleotides to SEQ ID NO: 5, and lead to conferring tolerance heavy metal stress, salt stress, drought or combination thereof.
Therefore, the specification fails to teach 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 18 contiguous nucleotides limitation. Applicant has not shown one structure/sequence having at least 85% sequence identity to at least 18 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(U)) 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 18 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.
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).
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 18 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.
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 14-20, are rejected under 35 U.S.C. 102(a)(1) as being anticipated 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)).
In regard to claims 14-20, Kaweesi discloses that ENSSSA1UGT002066 is an Alpha-glucosidase (SUC2) for sucrose hydrolysis (p. 89). Additionally, Kaweesi discloses 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 6 amino acid segment within SEQ ID NO: 5. This sequence is encoded by an 18-nucleotide segment that shares at least 85% sequence identity to at least 18 contiguous nucleotides of SEQ ID NO: 5 (see alignment below bolded amino acids). Furthermore, KX390871.1 has multiple segments with at least 18 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 discloses a “dsRNA against sucrase (dsSUC) (NCBI Accession KX390871)” (p.124). Overall, Kaweesi discloses on SUC2 being a critical gene and developing a dsRNA against SUC2.
GenCore version 6.5.2
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: February 6, 2026, 16:21:15 ; Search time 1 Seconds
(without alignments)
0.331 Million cell updates/sec
Title: US-18-773-683-5
Perfect score: 3631
Sequence: 1 MTVLFVNIFAAAIVATCFVT..........ICYCRTSKSSTVITDLKSGQ 676
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 489 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 1 summaries
Database : AASEQ2_02062026_162113.pep:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 1416 39.0 489 1 AASEQ2_02062026_162113
ALIGNMENTS
RESULT 1
AASEQ2_02062026_162113
Query Match 39.0%; Score 1416; DB 1; Length 489;
Best Local Similarity 52.2%;
Matches 258; Conservative 82; Mismatches 136; Indels 18; Gaps 4;
Qy 67 LEWWQTSVFYQIYPMSFKDANGDGKGDLQGIASKADHFVDIGVGAVWLSPIYSSPMADFG 126
| ||: | ||||| ||||::||| |||:||| | |: :||||||:|||: |||||||
Db 2 LAWWEKGVIYQIYPRSFKDSDGDGIGDLKGIAEKIDYLSKLGVGAVWISPIFRSPMADFG 61
Qy 127 YDISNYTEINEIFGNLDDLVHLREKLHARGVKLILDFVPNHSSNEHPWFLNSVKKIDPYT 186
||||:: | :|| : | |: | |:|:||||||||:|:|| || || ::||||
Db 62 YDISDFRAIEPMFGTMKDFERLKRLFHKNGLKMILDFVPNHTSDEHDWFKKSVARVDPYT 121
Qy 187 NYYVWRDPVIDANGKKSPPNNWLSIFNSGSAWEWNEERGQYYLHQFAVQQPDLNYNCKEL 246
||| | | || ||||||| | |||| |||:||||||||| :|||||| :
Db 122 NYYNWVDGKASENGTIQPPNNWLSYF-GGSAWTWNEKRGQYYLHQFHPKQPDLNYRNPLV 180
Qy 247 VEEMKEVLRFWLSHGVDGFRMDAVPYLFEDSLFRNEPY--------VDENIKNSKMYDSL 298
|:|||:|| :|: |||||||||| : || |:|| || |
Db 181 VQEMKDVLTYWMDKGVDGFRMDAVMTIMEDIKLRDEPLSGKTDVLPTDEEYLN------- 233
Qy 299 IHIYSMDRPKTYEMIGQFRKVLDDFAKEHNTPPKVILSEAYTSLNYTMKYYGDAKNPGSH 358
|||: |:| |||:| |||| |||:::: :| | : :|||::| |||||| |||:|
Db 234 -HIYTRDQPGTYEIIKQFRKHLDDYSRKTHT-VKFMATEAYSNLTSTMKYYGTKDNPGAH 291
Qy 359 MPFNFLMINECHKDSSANDFNAAIHNWMDNMPDDHWANWVMGNHDQPRIATRYGPELVDA 418
||| | |:| || | :| :| |:|||:||||: |: :||| :::|
Db 292 FTFNFETIEALTPQSNAPDFKEVIEDWYAALPASKWSNWVLGNHDKRRVGSRYGIDMLDG 351
Qy 419 INMLVMLLPGTAITYNGEEIGMSNGYIRWDQTIDPAGINVGPKEYEKYSRDGCRTPFQWD 478
::|| | | ||::|| |:|||| : :|||||| || :||||: |::::|| ||||||:
Db 352 LHMLQMCLHGTSVTYAGDEIGMVDTFIRWDQTKDPPALNVGPERYQRFTRDPARTPFQWN 411
Qy 479 DSISAGFSSNSRTWLPVNPNSYYLNLKNQKEESYSHYHIYKRLTTLRKTRTFQRGAWKTY 538
| |||||:| :|||||||: : || :|::: ||: |:|| ||:|: | |: |
Db 412 ASTSAGFSTNPKTWLPVNPDYWSHNLVTEKKKASSHFKNYRRLLTLKKSPVIQFGSVNVY 471
Qy 539 VLSNWVLAIERMME 552
||:||| | | ::
Db 472 TLSDWVLVITRTLK 485
Therefore, the claims are anticipated by the art.
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 14-18 and 20 are 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(A)).
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 18 contiguous nucleotides to Applicants SEQ ID NO: 5 (see alignment below bolded section). 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). Therefore, Baum et al. anticipates a method to control the pest infestations by using an inhibitory molecule that is at least 85% sequence identity to at least 18 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 to the method of claim 14, because Baum et al. is teaching and suggesting all the claimed steps. Additionally, one would expect a high level of success because Baum et al. also feeds a dsRNA molecule to control invertebrate pest (col. 6 lines 21-26).
Query Match 13.9%; Score 281.8; Length 1637;
Best Local Similarity 54.3%;
Matches 734; Conservative 0; Mismatches 587; Indels 30; Gaps 7;
Qy 202 GAATGGTGGCAGACAAGTGTTTTCTATCAAATCTACCCCATGTCTTTCAAAGACGCGAAC 261
|| |||||| | || | || || ||||| || || | || || || ||| ||
Db 275 GATTGGTGGAAAACGGCTACATTTTACCAAATTTATCCAAAATCATTTAAGGACAGTAAT 334
Qy 262 GGGGATGGAAAAGGAGATTTACAAGGGATCGCATCCAAGGCCGATCACTTTGTAGACATT 321
|| ||||||| ||||||||| |||| || || || | || | ||| ||
Db 335 GGAGATGGAATAGGAGATTTGGAAGGAATTATTCAAAAACTAGACTATTTAGCAGATCTT 394
Qy 322 GGCGTGGGAGCAGTATGGCTGTCTCCCATTTATTCCTCTCCAATGGCCGATTTTGGGTAC 381
|| | | | ||||||| || || || ||| || ||| || |||| || |||
Db 395 GGAATCACGGGAATATGGCTATCACCGATCTATAAATCGCCACTGATCGATGAAGGATAC 454
Qy 382 GACATCTCAAATTACACCGAGATAAACGAAATTTTTGGCAACCTGGATGACTTGGTTCAC 441
|||||| ||| | || || || | | |||||| || | | || |||
Db 455 GACATCAGCGATTTTAGGGATATTAATCCATTATTTGGCGACTTAAAAACTTTCGTTAGG 514
Qy 442 CTCAGAGAAAAACTGCATGCCCGTGGAGTCAAGCTGATTTTGGATTTTGTGCCCAATCAT 501
|| |||| | ||| | || ||| | | | | |||| |||| ||| || |||||
Db 515 CTTGTAGAAGGAGCACATTCTCGAGGATTAAGGGTTGTTTTAGATTATGTACCAAATCAC 574
Qy 502 TCCAGCAATGAACACCCTTGGTTCCTCAATTCTGTAAAGAAAATTGACCCTTACACTAAC 561
||||| || | ||| |||||| || |||| ||| || || ||
Db 575 ACCAGCGATCAGCACGAATGGTTCAAAAAATCTGAAAACGGCGAAGAAGGGTATGAGGAC 634
Qy 562 TACTACGTATGGAGGGATCCAGTGATTGACGCTAACGGCAAGAAAAGCCCTCCAAACAAC 621
|| | | |||| ||| | || || |||| | || |||||| ||
Db 635 TATTTTCTTTGGATAGATAGCAAGGATGGATCT------AAGACAGACCTTCCAAATAAT 688
Qy 622 TGGTTGAGTATTTTCAACAGTGGATCTGCATGGGAATGGAACGAAGAGAGAGGACAATAC 681
||| | ||| | ||||| | | |||| |||||||||| || | ||| |||
Db 689 TGGATCAGTGTCTTCAAAAAT---TCTGTCTGGGAATGGAGTGACAAAAGAAATAAATTT 745
Qy 682 TACCTGCATCAATTTGCAGTTCAGCAACCTGATTTGAACTACAATTGTAAGGAGCTCGTA 741
|| || ||||| ||| |||||||| ||| | || | | | || | || |
Db 746 TATCTTCATCAGTTTTTCAAACAGCAACCGGATCTCAATTTCTTTAACGAGAAAGTCCGA 805
Qy 742 GAGGAAATGAAGGAAGTTCTCAGATTTTGGCT---TAGTCATGGCGTGGACGGTTTTCGT 798
| ||||||| ||| | || | | ||||| | || || || ||| | |
Db 806 AAAGAAATGAGGGATATACTAAACTACTGGCTGGAAGAATACGGAGTAGATGGTGTAAGA 865
Qy 799 ATGGATGCAGTACCTTACTTGTTTGAGGATTCTTTGTTCCGTAATGAGCCGTACGTCGAC 858
|| ||||| || ||| | || | |||| || |||||| || | |
Db 866 ATTGATGCTGTGCCTCATTTAGTGGAGGCCAAAAACTTAACTAATGAACCAAGAACCTAT 925
Qy 859 GAGAATATTAAAAACTCCAAAATGTACGACTCTCTTATTCACATTTACTCCATGGATCGA 918
|| | | | |||| || |||| | |||||||| | | | | |
Db 926 GACCCCAATGCATCTCCCAACGAATATGACTACTTGGATCACATTTTTACAAGAAACCAA 985
Qy 919 CCGAAGACTTACGAAATGATCGGCCAGTTCAGAAAAGTTCTAGACGATTTCGCCAAAGAA 978
|| ||| ||| || || || | | | |||| | |||| | ||| |
Db 986 CCAGAGAGTTATGATTTGGTCTACGAATGGAGAAGCCACATCGACGGAATATCCA---AG 1042
Qy 979 CATAACACACCTCCAAAGGTTATTTTGAGCGAGGCTTACACATCTTTGAACTATACAATG 1038
||| ||| |||| || | ||| || || | | || ||| | |
Db 1043 AATACTTCACAAACAAAAATTTGTATGACAGAAGCAGCTGTTGATCTTAAATATGTAGTA 1102
Qy 1039 AAATACTACGG------AGACGCTAAAAATCCCGGGAGCCACATGCCCTTCAACTTCTTG 1092
||| || || |||| ||| || || | | || || || |
Db 1103 CCATATTATGGTACAGCCGACGGATCAAAATTGGGAGCACATTTCTCATTTAATTTTGTA 1162
Qy 1093 ATGATCAACGAATGTCATAAAGATTCGAGTGCCAACGATTTCAATGCCGCCATTCACAAC 1152
|| | | || | | ||| | ||| ||| | | || |||
Db 1163 TTGCT---TGGATTGGAAACGACTTCCACTGCTGCTGATGTTGCATCATTGATACACGCT 1219
Qy 1153 TGGATGGACAATATGCCTGATGATCATTGGGCCAACTGGGTGATGGGAAACCATGATCAA 1212
||| |||| || | || | | | | || |||||| |||||||||||||| |
Db 1220 TGGGTGGATAAGCTTCCAAAAATATACACGTCTAATTGGGTGTTGGGAAACCATGATAAC 1279
Qy 1213 CCTCGAATTGCGACACGATACGGACCTGAATTAGTAGATGCTATTAATATGCTTGTGATG 1272
| ||||||| || | |||| ||| ||| || | | |||||| |
Db 1280 CACAGAATTGCTACCAAAGCCGGAAAAGAACGAGTGGACTGTTTAAATATGTTATCTGCT 1339
Qy 1273 CTACTACCAGGAACGGCCATCACCTATAACGGCGAAGAAATTGGCATGTCAAATGGTTAC 1332
| || ||||||| | || || ||||| || ||||| |||||| ||| || |
Db 1340 TTCCTGCCAGGAATCCAAGTTACTTACAACGGAGAGGAAATCGGCATGGAAAACGGAGAA 1399
Qy 1333 ATTCGATGGGATCAAACTATTGATCCTGCGGGGATAAATGTCGGACCGAAAGAATATGAG 1392
| || || | | | | ||| | ||| ||| |
Db 1400 GTAGACTGCGAAACACAAGGTCTAGATCACGCCGAAAA------CTGTACAGATTATTAC 1453
Qy 1393 AAATACTCGCGTGATGGATGCAGGACCCCCTTTCAATGGGACGATTCAATTAGTGCAGGA 1452
||| ||| | ||| || || || || ||||||||| |||||||
Db 1454 AAAATCTCCAGAGATTTCGAAAGAACGCCTTTCCAATGGGACAGCAGTGAGTTTGCAGGA 1513
Qy 1453 TTTTCTTCTAACAGCCGGACTTGGTTACCTGTCAACCCTAATTCCTACTATTTGAATTTA 1512
||| | | | ||| ||||| || |||| | | || | | |||
Db 1514 TTTACCGATGGAAAAAAGACATGGTTGCCCGTCAGCTCAAAGAAAGCTGAGTGCAATGCG 1573
Qy 1513 AAGAACCAAAAAGAGGAAAGTTACAGCCACT 1543
|| | ||| | | || | ||||| |
Db 1574 AAAGATCAACTAAAAGACGAAAAGAGCCATT 1604
Conclusion
No claims are allowed.
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/C.J.O./Examiner, Art Unit 1663 /JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662