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 5-29 are pending.
Claims 1, 7-18 and 26-27 are examined.
Claims 5-6, 19-25 and 28-29 are withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/26/2025 has been entered.
Election/Restrictions
Amended claims 5 and 6 are withdrawn because the claims are now only directed to non-elective species, SEQ ID NO: 7 and SEQ ID NO: 11, respectively. Applicant elected SEQ ID NO: 1 from List 2 in the Remarks filed 5/16/2024.
Newly added claim 28 is withdrawn because the claim is only directed to non-elective species, SEQ ID NO: 7. Additionally, claim 28 is drawn only to a Cucumis melo plant whereas 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.
Newly added claim 29 is withdrawn because the claim is only directed to non-elective species, a Cucurbita moschata plant whereas Applicant elected a plant grown from seed represented by NCIMB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.
Withdrawn objections
The objections to claim 1 are withdrawn in light of amendments made by Applicant.
Withdrawn rejections
The rejection of claim 1 for having an improper Markush group is withdrawn in light of amendments made by Applicant.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 7-11, 14-18 and 27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a modified PriL gene encoding a modified protein. Dependent claims require the gene is in a plant of family Cucurbitaceae or Solanaceae and in a Markush group of plant species. This judicial exception is not integrated into a practical application because a naturally occurring protein that reads on the instantly claimed “modified” protein is known in the prior art. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims are drawn to a PriL gene and protein encoded by the gene comprising an amino acid substitution at position 147, 162 or 163 of instant SEQ ID NO: 1. Xu (Xu et al. "The genome of Nicotiana attenuata" Accessed via UniProt. 2016) teaches A0A314KID0_NICAT is a PriL protein. The sequence alignment provided below shows that it reads on the instantly claimed modified protein for having an amino acid substitution at position 141 of SEQ ID NO: 1 (F to Y, Y of Xu sequence is highlighted). Therefore, the instantly claimed protein is found in nature.
Claims 8-11, 14-18 and 27 recite additional elements of imparting Begomovirus resistance and requiring that a Cucurbitaceae or Solanaceae plant and plant parts, such as a fruit produced therefrom and a cell thereof, comprises the protein; however, resistance to a Begomovirus does not add structure because it is only an intended use of the product and the protein taught by Xu is comprised by a Solanaceae plant.
Thus, claims 1, 7-11, 14-18 and 27 are not directed to significantly more than a product of nature.
Alignment of instant SEQ ID NO: 1 to A0A314KID0_NICAT of Xu:
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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 and 7-18 remain rejected and claims 26-27 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.
Applicant claims a 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 (claim 1) wherein the modification imparts Begomovirus resistance in a plant wherein the gene is homozygously present (claim 27). Applicant claims a modified PriL protein of claim 1, wherein the protein confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV as a result of the modification (claim 8). Applicant claims a Cucurbitaceae or Solanaceae plant comprising the modified PriL gene of claim 1 (claim 9), the plant of claim 9 comprises the modified PriL gene homozygously which confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV (claim 10), a Cucurbitaceae or Solanaceae seed comprising the gene homozygously which confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV (claim 11) and a progeny plant of the seed grown from claim 11 (claim 15). 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 (claims 12 and 13). Applicant claims a progeny plant from the plant of claim 9 and the plant grown from the seed of claim 11 (claims 14 and 15). Applicant claims a fruit harvested from the plant of claim 9 and 11 (claims 16 and 17). Applicant claims a propagation material for producing the plant of claim 9 that comprises the modified PriL gene that confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV (claim 18). 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 any plant with resistance to any Begomovirus 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, 7-18 and 26-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a 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 amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 2/27/2025, as applied to claims 6, 8, 10-11, 14-15 and 18.
Applicant claims a 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 (claim 1) wherein the modification imparts Begomovirus resistance in a plant wherein the gene is homozygously present (claim 27). Applicant claims a modified PriL protein of claim 1, wherein the protein confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV as a result of the modification (claim 8). Applicant claims a Cucurbitaceae or Solanaceae plant comprising the modified PriL gene of claim 1 (claim 9), the plant of claim 9 comprises the modified PriL gene homozygously which confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV (claim 10), a Cucurbitaceae or Solanaceae seed comprising the gene homozygously which confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV (claim 11) and a progeny plant of the seed grown from claim 11 (claim 15). 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 (claims 12 and 13). Applicant claims a progeny plant from the plant of claim 9 and the plant grown from the seed of claim 11 (claims 14 and 15). Applicant claims a fruit harvested from the plant of claim 9 and 11 (claims 16 and 17). Applicant claims a propagation material for producing the plant of claim 9 that comprises the modified PriL gene that confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV (claim 18). 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.
Claims 1, 7, 9, 12, 13, 16-17 and 26 require a modified protein or a plant comprising a modified protein but do not recite a functional limitation. One of ordinary skill in the art would not be able to envision how to use the claimed invention
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 any plant with resistance to any Begomovirus 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 8/26/2025 have been fully considered but they are not persuasive.
The declaration under 37 CFR 1.132 filed 8/26/2025 is insufficient to overcome the rejection of claims 1 and 5-18 based upon insufficiency of disclosure under 35 U.S.C. 112(a) as set forth in the last Office action.
In summary of the Declaration, 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.
The Applicant and Declaration argues 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.
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. Only a full-length sequence in C. moschata and another full-length sequence in C. melo have been shown by the Applicant to cause resistance to ToLCNDV.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 7-11, 14-18 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu (Xu et al. "The genome of Nicotiana attenuata" Accessed via UniProt. 2016).
The claims are drawn to a PriL gene and protein encoded by the gene comprising an amino acid substitution at position 147, 162 or 163 of instant SEQ ID NO: 1. Claims 8-11, 14-18 and 27 require Begomovirus resistance and requiring that a Cucurbitaceae or Solanaceae plant and plant parts, such as a fruit produced therefrom and a cell thereof, comprises the protein; however, resistance to a Begomovirus does not add structure because it is only an intended use of the product.
Xu discloses a PriL protein, A0A314KID0_NICAT. The sequence alignment provided below shows that it reads on the instantly claimed modified protein for having an amino acid substitution at position 141 of SEQ ID NO: 1 (F to Y, Y of Xu sequence is highlighted). The protein taught by Xu is comprised by a Solanaceae plant.
Therefore, the instant claims 1, 7-11, 14-18 and 27 are anticipated by Xu.
Alignment of instant SEQ ID NO: 1 to A0A314KID0_NICAT of Xu:
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Conclusion
No claims are allowed.
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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