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 5-25 are pending.
Claims 1 and 5-18 are examined.
Claims 19-25 are withdrawn.
Election/Restrictions
Newly submitted claim 25 is withdrawn because the claim is only directed to non-elective species, SEQ ID NO: 9. Applicant elected SEQ ID NO: 1 from List 2 in the Remarks filed 5/16/2024.
Withdrawn objections
The objections to claim 1 are withdrawn in light of amendments made by Applicant.
The objection to claim 7 is withdrawn in light of amendments made by Applicant.
Withdrawn rejections
The rejection of claim 13 under 35 USC 112(b) is withdrawn in light of amendments made by Applicant.
The rejection of claims 1-4 under 35 USC 102(a)(1) is withdrawn in light of amendments made by Applicant.
Claim objection
Claim 1 is objected to for the following minor informalities:
Reciting “modifications in the wild type protein sequence of SEQ ID NO: 1 or SEQ ID NO: 3 comprising amino acid substitution at position 147, 162 or 163” because it is not clear whether the substitutions are relevant to only SEQ ID NO: 1, only SEQ ID NO: 3 or either of the sequences.
Reciting “comprising modification” in line 2 and “comprising amino acid substitution” in lines 3, 6 and 8. These recitations are missing an article.
Appropriate correction is required.
Improper Markush Grouping
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives.
This rejection is modified as applied to claim 5 in the Non-Final Rejection filed 7/18/2024 in response to amendments made by Applicant.
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 Markush grouping of amino acid substitutions in the modified PriL protein is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: each of the substitutions encompassed by the alternative members of the Markush group of claim 1 have distinct structures.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Applicant’s arguments regarding improper Markush group rejection
Applicant’s arguments, see pages 8-9 of the Remarks filed 10/18/2024, with respect to the rejection of claim 5 for comprising an improper Markush group have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the addition of SEQ ID NO: 7 and 11 and the modifications thereof in claim 1.
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 5-18 remain 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 modifications 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 comprises a F147C substitution according to SEQ ID NO: 5. Applicant claims the modified PriL gene encodes a sequence of SEQ ID NO: 7 comprising a substitution at position 4, 166 or 200; Applicant claims the modified PriL gene encodes a sequence of SEQ ID NO: 11 comprising a substitution at position 147, 162 or 163. Applicant claims the modification is an amino acid substitution comprising: a F147D, G162D, or Q163H of SEQ ID NO: 5. Applicant claims the modification of the protein of claim 1 confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV in a plant wherein the gene is homozygous (claim 6). Applicant claims a modified PriL protein of claim 1 (claim 7), 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 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 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 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 6, 8, 10-11, 14-15 and 18 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.
Applicant claims a modified PriL gene which encodes a protein comprising modifications 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 comprises a F147C substitution according to SEQ ID NO: 5. Applicant claims the modified PriL gene encodes a sequence of SEQ ID NO: 7 comprising a substitution at position 4, 166 or 200; Applicant claims the modified PriL gene encodes a sequence of SEQ ID NO: 11 comprising a substitution at position 147, 162 or 163. Applicant claims the modification is an amino acid substitution comprising: a F147D, G162D, or Q163H of SEQ ID NO: 5. Applicant claims the modification of the protein of claim 1 confers Begomovirus resistance from ToLCNDV, ToLCPMV, CuLCV, MCLCV, MLCV, SqLCV, CuLCrV, TYLCV, WmCSV or WmCMoV in a plant wherein the gene is homozygous (claim 6). Applicant claims a modified PriL protein of claim 1 (claim 7), 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 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 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 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 10/18/2024 have been fully considered but they are not persuasive.
Applicant argues on pages 9-11 of the Remarks filed on 10/18/2024 that Cucurbita moschatai and Curcurbita pepo having SEQ ID NO: 1, 3 and 11 have amino acid substitutions at positions 147, 162 or 163 and Cucumis melo having SEQ ID NO: 7 has amino acid substitutions at positions 4, 166 and 200 are demonstrated in the Specification. Applicant argues that no undue or unreasonable experimentation is needed to practice the invention as claimed.
This argument has been fully considered but it is not persuasive. 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., Cucurbita moschatai and Curcurbita pepo having SEQ ID NO: 1, 3 and 11 have amino acid substitutions at positions 147, 162 or 163 and Cucumis melo having SEQ ID NO: 7 has amino acid substitutions at positions 4, 166 and 200) are narrower in scope than as recited in the rejected claims. 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).
Conclusion
Claims 1 and 5-18 remain rejected.
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
/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662