Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1 and 5-32 are pending.
Claims 5-10, 13, 19-25 and 27-31 are withdrawn.
Claims 1, 11-12, 14-18, 26 and 32 are examined.
Election/Restrictions
Newly added claim 32 is examined as it is included in the elected invention group and drawn to the elected species.
Applicant elected a plant grown from seed represented by NCIMB accession number 43405, a plant of species C. pepo, from List 4 in the Remarks filed 5/16/2024. Amended claim 7 and newly added claim 30 are withdrawn because the claims are only directed to non-elective species, Cucurbita moschata. Amended claim 8 is withdrawn because the claim is only directed to non-elective species C. sativus. Amended claim 9 and newly added claim 31 are withdrawn because the claims are only directed to non-elective species, Cucumis melo. Amended claim 10 is withdrawn because the claim is only directed to non-elective species C. maxima. Amended claim 13 is withdrawn because the claim is only directed to non-elective species Solanum lycopersicum. Amended claim 27 is withdrawn because the claim is only directed to non-elective species Capsicum annum.
Withdrawn rejections
The rejection of claims 1, 7-11, 14-18 and 27 under 35 USC 101 is withdrawn in light of amendments made by Applicant. The instant claims have been amended to require a plant comprising the modified protein wherein the plant is limited to species in which the modified protein is not known to occur naturally.
The rejection of claims 1, 7-11, 14-18 and 27 are rejected under 35 U.S.C. 102(a)(1) is withdrawn in light of amendments made by Applicant.
Claim Objections
Claims 1, 11 and 26 are objected to because of the following informalities: a Markush group requires a single conjunction between the last two members of the grouping. The use of “and/or” multiple times appears to imply more than one of the members is encompassed and it is unclear which members or combination of members are intended to be encompassed. Appropriate correction is required.
Claims 1 and 26 are objected to because of the following informalities: Applicant recites “SEQ ID No.” whereas Office convention for sequence identifiers is “SEQ ID NO:”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: the claim is lacking a conjunction between “Citrullus lanatus” and “Cucurbita pepo”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 11-12, 14-18 and 26 remain rejected and claim 32 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Due to Applicant’s amendments of the claims, the rejection is modified from the rejection set forth in the Office action mailed 12/23/2025.
Applicant claims a plant comprising modified PriL gene which encodes a protein comprising a modification in a wild-type protein SEQ ID NO: 1 or 3 comprising an amino acid substitution at position 147, 162 or 163 wherein the modification imparts Begomovirus resistance in a plant wherein the gene is homozygously present. The Begomovirus resistance is any from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV. Applicant claims a progeny plant of a seed grown from the plant. Applicant claims the plant and seed belong to the species Cucurbita moschata, Cucurbita pepo, Cucumis melo, Cucumis sativus, Cucurbita maxima, Citrullus lanatus, Solanum lycopersicum, Solanum melongena or Capsicum annuum. Applicant claims a fruit harvested from the plant and a propagation material for producing the plant. Applicant claims the modification is an amino acid substitution comprising: a F147C, G162D, or Q163H of SEQ ID NO: 5 (claim 26). Applicant claims a Cucurbita moschata plant comprising the modified PriL gene comprising a modification in a wild-type protein SEQ ID NO: 1 or 3 comprising an amino acid substitution at position 147, 162 or 163.
Applicant describes identifying a source of resistance to ToLCNDV in C. moschata variety 109238 (paragraph 155), and mapping the source of resistance (paragraphs 157-160) to a modified PriL gene SEQ ID NO: 6 (paragraph 161), encoding protein SEQ ID NO: 5 (paragraph 162). Applicant describes the resistant protein as comprising F147C, G162D and Q163H amino substitutions and the corresponding SNPs of the sequence encoding the resistance protein compared to the susceptible wild-type (paragraph 164, Table 3).
Applicant describes a ToLCNDV resistant Curcurbita pepo plant also homozygously comprising SEQ ID NO: 6, comprising the three SNPs described in Table 3 (paragraph 168). Applicant states that seeds of the resistant Cucurbita pepo and seeds of a Cucumis melo plant were deposited with NCIMB (paragraph 17).
Applicant describes identifying a source of ToLCNDV resistance in Cucumis melo (paragraph 170) and describes identifying modified PriL gene SEQ ID NO: 10 encoding protein SEQ ID NO: 9 (paragraph 172). Applicant describes identifying the Y4H, P166Q and I200T mutations in the resistant PriL protein and the corresponding SNPs of the sequence encoding the resistance protein compared to the wild-type protein (paragraph 174, Table 5).
Applicant describes that modifying the PriL gene may be achieved by chemical means such as EMS or targeted means such as by CRISPR. Applicant does not describe having reduced this to practice.
Applicant does not describe the scope of plant species with resistance to the scope Begomoviruses as claimed other than a C. moschata and a C. pepo comprising SEQ ID NO: 6, encoding SEQ ID NO: 5 which comprises three amino acid substitutions, F147C, G162D and Q163H in addition to a C. melo plant comprising SEQ ID NO: 10, encoding SEQ ID NO: 9 which comprises three different amino acid substitutions, Y4H, P166Q and I200T wherein the plants are resistant only to ToLCNDV.
Mahatma teaches that begomoviruses are highly diverse with a relatively rapid rate of evolution, which allows them to overcome hosts’ resistance (Mahatma et al. Epidemiology of Begomoviruses: A Global Perspective. Plant Viruses: Evolution and Management. Page 181, paragraph bridging left and right columns). The teaching of Mahatma that even known sources of resistance to a specific begomovirus are known to have variations of the begomovirus overcome resistance demonstrates that one of ordinary skill in the art would not recognize a source of resistance to one begomovirus be effective against others.
In addition, Applicant has not described a structure other than the full length of SEQ ID NO: 6 and SEQ ID NO: 10 encoding SEQ ID NO: 5 and SEQ ID NO: 9, respectively. Applicant has not described SEQ ID NO: 6 conferring resistance to a begomovirus in any plant other than C. moschata and a C. pepo nor SEQ ID NO: 10 conferring resistance in any plant other than C. melo; in both cases only to ToLCNDV. In addition, Applicant has not set forth the requisite structure-function relationship for the genus of modified PriL proteins wherein said structure is necessary and sufficient to confer tolerance to a Begomovirus.
Therefore, Applicant has not met the written description requirement as set forth by 35 USC 112(a).
Scope of Enablement
Claims 1, 11-12, 14-18 and 26 remain rejected and claim 32 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a ToLCNDV resistant Curcurbita pepo plant also homozygously comprising SEQ ID NO: 6, comprising the three SNPs described in Table 3 (paragraph 168), does not reasonably provide enablement for resistance to any begomovirus in any plant wherein the modified PriL gene comprises the specific sequences and substituted residues. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Due to Applicant’s amendments of the claims, the rejection is modified from the rejection set forth in the Office action mailed 12/23/2025.
Applicant claims a plant comprising modified PriL gene which encodes a protein comprising a modification in a wild-type protein SEQ ID NO: 1 or 3 comprising an amino acid substitution at position 147, 162 or 163 wherein the modification imparts Begomovirus resistance in a plant wherein the gene is homozygously present. The Begomovirus resistance is any from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV. Applicant claims a progeny plant of a seed grown from the plant. Applicant claims the plant and seed belong to the species Cucurbita moschata, Cucurbita pepo, Cucumis melo, Cucumis sativus, Cucurbita maxima, Citrullus lanatus, Solanum lycopersicum, Solanum melongena or Capsicum annuum. Applicant claims a fruit harvested from the plant and a propagation material for producing the plant. Applicant claims the modification is an amino acid substitution comprising: a F147C, G162D, or Q163H of SEQ ID NO: 5 (claim 26). Applicant claims a Cucurbita moschata plant comprising the modified PriL gene comprising a modification in a wild-type protein SEQ ID NO: 1 or 3 comprising an amino acid substitution at position 147, 162 or 163.
Applicant teaches identifying a source of resistance to ToLCNDV in C. moschata variety 109238 (paragraph 155), and mapping the source of resistance (paragraphs 157-160) to a modified PriL gene SEQ ID NO: 6 (paragraph 161), encoding protein SEQ ID NO: 5 (paragraph 162). Applicant teaches the resistant protein as comprising F147C, G162D and Q163H amino substitutions and the corresponding SNPs of the sequence encoding the resistance protein compared to the susceptible wild-type (paragraph 164, Table 3).
Applicant teaches a ToLCNDV resistant Curcurbita pepo plant also homozygously comprising SEQ ID NO: 6, comprising the three SNPs described in Table 3 (paragraph 168). Applicant states that seeds of the resistant Cucurbita pepo and seeds of a Cucumis melo plant were deposited with NCIMB (paragraph 17).
Applicant teaches identifying a source of ToLCNDV resistance in Cucumis melo (paragraph 170) and teaches identifying modified PriL gene SEQ ID NO: 10 encoding protein SEQ ID NO: 9 (paragraph 172). Applicant teaches identifying the Y4H, P166Q and I200T mutations in the resistant PriL protein and the corresponding SNPs of the sequence encoding the resistance protein compared to the wild-type protein (paragraph 174, Table 5).
Applicant teaches that modifying the PriL gene may be achieved by chemical means such as EMS or targeted means such as by CRISPR. Applicant does not describe having reduced this to practice.
Applicant does not teach the scope of plants claimed with resistance to the scope of Begomoviruses claimed other than a C. moschata and a C. pepo comprising SEQ ID NO: 6, encoding SEQ ID NO: 5 which comprises three amino acid substitutions, F147C, G162D and Q163H in addition to a C. melo plant comprising SEQ ID NO: 10, encoding SEQ ID NO: 9 which comprises three different amino acid substitutions, Y4H, P166Q and I200T wherein the plants are resistant only to ToLCNDV. Mahatma teaches that begomoviruses are highly diverse with a relatively rapid rate of evolution, which allows them to overcome hosts’ resistance (Mahatma et al. Epidemiology of Begomoviruses: A Global Perspective. Plant Viruses: Evolution and Management. Page 181, paragraph bridging left and right columns). The teaching of Mahatma that even known sources of resistance to a specific begomovirus are known to have variations of the begomovirus overcome resistance demonstrates that one of ordinary skill in the art would not recognize a source of resistance to one begomovirus be effective against others. The lack of predictability in the art and the lack of guidance provided by Applicant would not have enabled one of ordinary skill in the art to predictably make and use the full scope of the claimed invention without undue experimentation.
Applicant’s arguments regarding rejection under 35 USC 112(a) for failing to comply with the written description and enablement requirements
Applicant's arguments filed 3/23/2026 have been fully considered but they are not persuasive.
In summary of the Declaration previously submitted (8/26/2025), which was found insufficient to overcome the rejection in the Non-Final Rejection filed 12/23/2025, C. moschata cultivar 109238 exhibited a high level of resistance to ToLCNDV and was identified as being a modified C. moschata PriL gene and protein encoded thereby, SEQ ID NO: 6 and 5, respectively. C. melo cultivar C11R.10700-3 was found to have resistance to ToLCNDV. The resistant PriL gene of C11R.10700-3 was given SEQ ID NO: 10 and the protein SEQ ID NO: 9. Three homozygous alleles are necessary for the resistance trait. C. melo cultivar C11R.10700-3 was found to also possibly have resistance to ToLCPMV and MCLCV due to the modified PriL gene but causation for the putative resistance to ToLCPMV and MCLCV was not as clearly associated with causative loci or alleles as the observed resistance to ToLCNDV from SEQ ID NO: 6 and C. melo from SEQ ID NO: 10.
Similarly, Applicant argues in the Remarks filed 3/23/2026 that having identified an orthologous PriL gene of C. moschata into a different species demonstrate that modification of this gene in other plants susceptible to ToLCNDV similarly confers resistance. Applicant argues that orthologs of the PriL gene of C. moschata were identified in plant species susceptible to ToLCNDV, namely of Cucurbitaceae and Solanaceae. Applicant argues that investigation of whether following modification to the orthologous PriL genes, improved resistance to ToLCNDV would be conferred. Applicant notes that Cucumis melo was confirmed to also have improved resistance (pages 11-16 of Remarks). Applicant also notes that a major effect QTL was identified for resistance to ToLCPMV which contained the same PriL modification (pages 16-20 of Remarks).
This argument has been fully considered but it is not persuasive. The preponderance of the evidence would not lead one of ordinary skill in the art to recognize Applicant to be in possession of the scope of the invention as claimed based on the disclosure provided. It is noted that the scope of the sequences recited in claim 1, e.g., SEQ ID NO: 1, is not required in full length with one or more of the modifications claimed. The sequences are recited as reference sequences. Any sequence also comprising one or more of the modifications, despite having other dissimilar residues, therefore are encompassed by the claims. Applicant has only described a full-length sequence in C. moschata and another full-length sequence comprising each of three modifications in C. melo have been shown by the Applicant to cause resistance to ToLCNDV.
Closest Prior Art
The instantly examined claims are free of the prior art. The closest prior art is Xu (Xu et al. "The genome of Nicotiana attenuata" Accessed via UniProt. 2016). Xu teaches a PriL protein, A0A314KID0_NICAT, which reads on the instantly claimed SEQ ID NO: 1 given that it comprises an amino acid substitution at position 141 of SEQ ID NO: 1; however it is not in one of the species of plants claimed and there would not have been motivation at the time of filing the instantly claimed invention for one of ordinary skill in the art to introgress a sequence encoding the protein of Wu with the expectation of improved resistance to a Begomovirus in one of the instantly claimed plant species. Therefore, the claimed invention is not anticipated nor made obvious by the prior art at the time of filing.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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/DAVID R BYRNES/Examiner, Art Unit 1662
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