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 without traverse of species of SEQ ID NO: 41 in the reply filed on 06/11/2026 is acknowledged.
Therefore claims 1-10 are pending and the claims 1-10 along with Applicant’s elected species of SEQ ID NO: 41 are examined in this office action.
Improper Markush Groups
Claims 1-10 are rejected under the judicially-created basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-722 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. and Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or common use that flows from the substantial structural feature and/or common use that flows from the substantial structural feature for the following reasons:
Claims 1, 5, 6 and 10 recite transformed plant comprising a recombinant nucleic acid molecule encoding a pesticidal polypeptide of SEQ ID NOs: 10-41, 43-45, 235-255, or 258-273. Specification provides the description of the sequence in Tables 1-4, and it is clear there are numerous different proteins that do not appear to be from the same family of proteins, and therefore they do not have the same function for example Tables 1-4 showed that they have different insecticidal activity to for example for insects corn earworm (CEW), European corn borer (ECB) and Fall army worm (FAW) etc. There are some engineered variants among the sequences to have no insecticidal activity or are not tested for insecticidal activity for CEW, ECB or FAW etc. or other insects showed in the tables. Therefore, they constitute proteins that does not have common use as have insecticidal activity against the common insects. Furthermore, sequence alignment in Figures 6 and 7 showed the polypeptides has various identity to each other ranging from about 81%-98%. This shows that the recited proteins of SEQ ID NOs: 10-41, 43-45, 235-255, or 258-273 do not share a substantial feature and/or common use that flows from the substantial structural feature and/or common use that flows from the substantial structural feature.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or groupings 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 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 USC 134 and 37 CFR 41.31 (a)(1).
Claim Rejections - 35 USC § 112 –Written Description Requirements
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 1-10 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.
Analysis of Breadth of Claims
Claims 1, 5, 6 and 10 recite polypeptide having at least 95% sequence identity to SEQ ID NO: 41 which comprises large number of variants of SEQ ID NO: 41.
Claims 1, 5, 6 and 10 recite SEQ ID NO: 41 and its variants having at least 95% sequence identity have activity against any plant pest.
Claims 3 and 8 recite SEQ ID NO: 41 and its variants having at least 95% sequence identity have activity against a large number of plant pest comprising fall armyworm (Spodoptera frugiperda), com earworm (Helicoverpa zea), European com borer (Ostrinia nubilalis) etc.
What is Described in the Specification
Applicant describes:
Engineered polypeptide sequences were designed in silico using a previously identified native Cry89Aa class toxin, originally found in a Bacillus thuringiensis species (PCT/US2022/028078; SEQ ID NO: 1 as disclosed herein) (page 44, paragraph 135).
engineering method altered SEQ ID NO: 1 by exchanging domain III (SEQ ID NO: 151) of SEQ ID NO: 1, a Cry89Aa class native polypeptide (formerly Cry1N class, as disclosed in U.S. Provisional Patent Application No. 63/665,914 and International Patent Application No. PCT/US2025/014957) (page 43, paragraph 135).
SEQ ID NO: 139 is domain I region, SEQ ID NO:145 is the domain II region and SEQ ID NO:161 is the border/linker II region and SEQ ID NOs:146-151 is domain III region (page 44, paragraph 137).
Engineered Variant 0563B (SEQ ID NO: 41) showed insecticidal activities in Tables 3 and 4, show it does not have insecticidal activity against European corn borer (ECB).
Corn plants were stably transformed to express either the Engineered Variant Engineered Variant 0563B (SEQ ID NO: 41) insecticidal protein which showed increased insecticidal activity to fall armyworm resistant to Cry1F and Vip3A insecticidal proteins (Cry1F rFAW and Vip3A rFAW) (page 55, paragraph 156).
Difference Between What was Described and What is Claimed
Applicant has not described a polypeptide having at least 95% sequence identity to SEQ ID NO: 41 would have pesticidal activity against any plant pest (claims 1, 5, 6 and 10).
Applicant has not described variants of SEQ ID NO: 41 having at least 95% sequence identity would have activity against a large number of plant pest comprising fall armyworm (Spodoptera frugiperda), com earworm (Helicoverpa zea), European com borer (Ostrinia nubilalis) etc. (claims 3 and 8).
Analysis
The purpose of the written description is to ensure that the inventor had possession at the time the invention was made, of the specific subject claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
Applicant has not described any nucleotide sequence encoding at least for example 95% identity to SEQ ID NO: 41 would have recited function of pesticidal activity against any plant pest. For example, a polypeptide sequence of SEQ ID NO: 41 is 632 amino acids (AA) long. For example, a 95% identity to SEQ ID NO: 1 would have ~32 AA changes (i.e., substitutions, deletions, insertions, or additions) relative to SEQ ID NO: 41, and this encompasses a genus of proteins that includes at least ~2032 molecules. For this reason, the genus of proteins having at least 95% identity to SEQ ID NO: 41 is a very large genus of molecules.
Furthermore, the state of the art at the time of the instant invention was that although the skilled artisan would appreciate the polypeptide sequence comprising SEQ ID NO: 41, one would not be able to readily predict function of polypeptide which has at least 95% identity to SEQ ID NO: 41 and it is impossible to predict such a broad sequence variation will have any required function of activity against any plant pathogen or pest. For example, Guo et al. (Published Year: 2004, Journal: Proceedings of the National Academy of Sciences, Vol. 101(25), pages: 9205-9210) teaches that while proteins are fairly tolerant to mutations resulting in single amino acid changes, increasing the number of substitutions additively increases the probability that the protein will be inactivated (page 9209, right. col., paragraph 2).
Furthermore, Selvapandiyan et al. (Published: 2001, Journal: Applied and Environmental Microbiology, 67(12), 5855-5858) teaches deletion of 39 amino acid from N-terminus and 154 amino acids from C-terminus in a protein from B. thuringiensis differentially effected the toxicity against larvae of different species of insects suggesting different mechanism of toxicity happens in different size of toxic fragment (Selvapandiyan, page 5858, left paragraph 2, and Table 3). Selvapandiyan further teaches no toxic activity was observed with 220 amino acid deletion from C-terminal of the insecticidal VIP protein (Selvapandiyan, page 5858, left paragraph 2, and Table 3) showing the toxin fragment required to be of certain size to be active. In contrast, applicant does not describe toxin fragment of SEQ ID NO: 41.
Applicant teaches Engineering method altered SEQ ID NO: 1, originally found in Bacillus thuringiensis, by exchanging domain III (SEQ ID NO: 151) of SEQ ID NO: 1, a Cry89Aa class native polypeptide (formerly Cry1N class, as disclosed in U.S. Provisional Patent Application No. 63/665,914 and International Patent Application No. PCT/US2025/014957) (page 43, paragraph 135) to produce the variants.
Furthermore, Wei et al. (Published 2018, Journal: Plant Biotechnology Journal 16: 649–659) teaches their disclosed insecticidal protein is selective protein with highly specific to certain coleopteran insect species, especially to the members of the corn rootworm complex and it is not active against the spotted lady beetle and various lepidopteran and hemipteran insect species wherein the protein does not have shared motifs, domains or signatures to other known proteinaceous toxins (page 655, left last paragraph). Therefore, many of the variants of the insecticidal proteins are selective and highly specific to the pest as showed by applicant in Table 1.
Therefore, there is dearth of description of any nucleic acid encoding protein with 95% identity to the SEQ ID NO: 41 has insecticidal (i.e. pesticidal) activity for any plant pests or in any of the plant pest recited in claims 3 and 8.
Given the large structural variable associated with these embodiments, the claims read on an extremely broad and highly diverse structures that would require to have specific function activity against any plant pests or the plant pest. Thus, in view of the analysis presented above, a skilled artisan would appreciate that the claims are directed to extremely broad and highly diverge genus of sequence variants that are required to have the specific function activity against any plant pests or large number of plant pest recited in claims 3 and 8.
Given the large size and structural diversity associated with the claimed genus, Applicant’s disclosure is not representative of the claimed genus as a whole. This point is particularly relevant because, as discussed above, the prior art speaks to the disconnection between the structure of the broadly claimed variants in any plants and the recited specific function.
"The test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to one skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm, Inc, v EH Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Lockwood v. Amer. Airlines, ina, 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). "An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations. Lockwood, 107 F.3d at 1572, 41 USPG2d at 1966". While the written description requirement does not demand either examples or an actual reduction, actual "possession" or reduction to practice outside of the specification is not enough. Ariad Pharm, Inc. v. Eli Lilly & Co., 598 F,3d 1336,1352 (Fed. Cir. 2010). Rather, it is the specification itself that must demonstrate possession. Id.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. The court stated that, “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F. 3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Thus, based on the analysis above, Applicant has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly. As a result, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Claim Rejections - 35 USC § 112 – Scope of Enablement
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 1-10 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 transformed plant, seed, or plant part comprising a recombinant nucleic acid molecule encoding a polypeptide SEQ ID NO: 41 operably linked to heterologous promoter that would have insecticidal activity against com earworm (CEW), European com borer (ECB), fall armyworm (sFAW or rFAW) (see Table 3), black cutworm (BCW), southwestern com borer (SWCB), Vip3ArFAW (see Table 4), does not reasonably provide enablement for a recombinant polynucleotide encoding the polypeptide, comprising an amino acid sequence having at least 95% sequence identity compared to the amino acid and polynucleotide sequences of SEQ ID NO: 41 would have any level of pesticidal activity against any plant pest (claims 1, 5, 11 and 14) or plant pest comprising cotton boll worm (Helicoverpa armigera), lesser cornstalk borer (Elasmopalpus lignosellus), etc. (claims 3 and 8). 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/or use the invention commensurate in scope with these claims.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(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. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
The Breadth of the Claims and nature of invention:
Claims 1, 5, 6 and 10 recite polypeptide having at least 95% sequence identity to SEQ ID NO: 41 which comprises large number of variants of SEQ ID NO: 41.
Claims 1, 5, 6 and 10 recite SEQ ID NO: 41 and its variants having at least 95% sequence identity have activity against any plant pest.
Claims 3 and 8 recite SEQ ID NO: 41 and its variants having at least 95% sequence identity have activity against a large number of plant pest comprising cotton boll worm (Helicoverpa armigera), lesser cornstalk borer (Elasmopalpus lignosellus), etc.
A polypeptide sequence of SEQ ID NO: 41 is 632 amino acids (AA) long. For example, a 95% identity to SEQ ID NO: 1 would have ~32 AA changes (i.e., substitutions, deletions, insertions, or additions) relative to SEQ ID NO: 41, and this encompasses a large genus of proteins that includes at least ~2032 molecules. For this reason, the genus of proteins having at least 95% identity to SEQ ID NO: 41 is a very large genus of molecules.
The state of the prior art:
Selvapandiyan et al. (Published: 2001, Journal: Applied and Environmental Microbiology, 67(12), 5855-5858) teaches deletion of 39 amino acid from N-terminus and 154 amino acids from C-terminus differentially effected the toxicity against larvae of different species of insects suggesting different mechanism of toxicity happens in different size of toxic fragment (Selvapandiyan, page 5858, left paragraph 2, and Table 3). Selvapandiyan further teaches no toxic activity was observed with 220 amino acid deletion from C-terminal of the insecticidal VIP protein (Selvapandiyan, page 5858, left paragraph 2, and Table 3) showing the toxin fragment required to be of certain size to be active. In contrast, applicant does not describe toxin fragment of SEQ ID NO: 41.
Furthermore, Wei et al. (Published 2018, Journal: Plant Biotechnology Journal 16: 649–659) teaches their disclosed insecticidal protein is selective protein with highly specific to certain coleopteran insect species, especially to the members of the corn rootworm complex and it is not active against the spotted lady beetle and various lepidopteran and hemipteran insect species wherein the protein does not have shared motifs, domains or signatures to other known proteinaceous toxins (page 655, left last paragraph). Therefore, many of the variants of the insecticidal proteins are selective and highly specific to the pest as showed by applicant in Table 1.
Guo et al. (Published: 2004, Journal: Proceedings of the National Academy of Sciences, 101(25), 9205-9210) describes that while proteins are fairly tolerant to mutations resulting in single amino acid changes, increasing the number of substitutions additively increases the probability that the protein will be inactivated (page 9205, right. col., Paragraph 2).
The amount of direction provided by the inventor:
Applicant teaches Engineered polypeptide sequences were designed in silico using a previously identified native Cry89Aa class toxin, originally found in a Bacillus thuringiensis species (PCT/US2022/028078; SEQ ID NO: 1 as disclosed herein) (Spec, page 44, paragraph 135) wherein Engineering method altered SEQ ID NO: 1 by exchanging domain III (SEQ ID NO: 151) of SEQ ID NO: 1, a Cry89Aa class native polypeptide (formerly Cry1N class, as disclosed in U.S. Provisional Patent Application No. 63/665,914 and International Patent Application No. PCT/US2025/014957) (page 43, paragraph 135) to produce the variants.
SEQ ID NO: 139 is domain I region, SEQ ID NO:145 is the domain II region and SEQ ID NO:161 is the border/linker II region and SEQ ID NOs:146-151 is domain III region (page 44, paragraph 137).
Engineered Variant 0563B (SEQ ID NO: 41) showed insecticidal activities in Tables 3 and 4, showed it does not have insecticidal activity against European corn borer (ECB).
Corn plants were stably transformed to express either the Engineered Variant Engineered Variant 0563B (SEQ ID NO: 41) insecticidal protein which showed increased insecticidal activity to fall armyworm resistant to Cry1F and Vip3A insecticidal proteins (Cry1F rFAW and Vip3A rFAW) (page 55, paragraph 156).
The existence of working examples:
The Specification or state of the art 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 because:
Applicant does not teach a polypeptide having at least 95% sequence identity to SEQ ID NO: 41 would have pesticidal activity against any plant pest (claims 1, 5, 6 and 10).
Applicant has not described SEQ ID NO: 41 and its variants having at least 95% sequence identity would have activity against a large number of plant pest comprising for example fall armyworm (Spodoptera frugiperda), com earworm (Helicoverpa zea), European com borer (Ostrinia nubilalis) etc. (claims 3 and 8).
Lack of a working example is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP § 2164.
Genetech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
In the absence of guidance from either the instant disclosure or the art, it would require undue trial and error experimentation for a skilled artisan to make and use the broadly claimed polynucleotide and polypeptides, with no reasonable expectation of success in arriving at a protein variant having 95% identity to SEQ ID NO:41 having pesticidal activity against any plant pest or plant pest for example fall armyworm (Spodoptera frugiperda), corn earworm (Helicoverpa zea), European corn borer (Ostrinia nubilalis) etc. (claims 3 and 8). Given the large variations of polynucleotides and their modifications and predicted variation in gain of functions or loss of functions, the claimed genus specifically does not provide predictability with regard to pesticidal activity against any plant pathogens.
Thus, in view of the unpredictability associated with combinatorial substitutions in a protein, the lack of enabling guidance from either the instant disclosure or the art, and breath and diversity of the embodiments encompassed by the claimed genus, the lack of sufficient working examples, and the level of the art at the time of the invention, one of ordinary skill in the art must rely on undue trial and error experimentation to make and test the numerous polypeptides encompassed by the broad genera, in order to make and/or use the invention within the full scope of these claims.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47, 50, 51 and 53 of copending Application No. 19221360 (Hereafter cited as Application ‘360)(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1, 3, 5, Application ‘360 claim 47, 50, 51 and 53 recite a polypeptide having SEQ ID NO:41 operatively linked to a heterologous regulatory element (i.e. promoter) and a plant cell comprising the polypeptide wherein the polypeptide has insecticidal activity against one or more Lepidopteran insect pests selected from fall armyworm (Spodoptera frugiperda), corn earworm (Helicoverpa zea), or European corn borer (Ostrinia nubilalis).
Claims 1-2, 4, and 6-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47, 50, 51, 53, 73-75 and 77 of copending Application No. 19221360 (Hereafter cited as Application ‘360) (reference application). and further in view of Wei et al. (Published 2018, Journal: Plant Biotechnology Journal 16: 649–659). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, Application ‘360 claim 47, 50, 51 and 53 recite a polypeptide having SEQ ID NO:41 operatively linked to a heterologous regulatory element (i.e. promoter) and a plant cell comprising the polypeptide wherein the polypeptide has insecticidal activity against one or more Lepidopteran insect pests selected from fall armyworm (Spodoptera frugiperda), corn earworm (Helicoverpa zea), or European corn borer (Ostrinia nubilalis).
Regarding claim 2, Application ‘360 does not teach the plant is corn plant.
Wei et al. teaches transformation of transgenic corn plant expressing insecticidal protein PIP-47Aa which kills western corn root worm (page 649, Abstract).
Regarding claim 4 and 9, Wei et al. teaches corn expression cassette of PIP-47Aa further comprise an enhancer element (page 657, left paragraph 2).
Regarding claim 6-8 and 10, Application ‘360 claim 73-75 and 77 teaches a modified plant comprising an expression construct.
Application ‘360 claim 47, 50, 51 and 53 recite a polypeptide having SEQ ID NO:41 operatively linked to a heterologous regulatory element (i.e. promoter) and a plant cell comprising the polypeptide wherein the polypeptide has insecticidal activity against one or more Lepidopteran insect pests selected from fall armyworm (Spodoptera frugiperda), corn earworm (Helicoverpa zea), or European corn borer (Ostrinia nubilalis).
Furthermore, Wei et al. teaches transformation of the cornexpressingaplastid-targetedPIP-47Aaunder the control of an enhanced root promoter and regeneration of T0 plants of the transformed corn plants (page 651, last paragraph).
Therefore, it would have been obvious to develop a method of protecting a plant from plant pest for example corn earworm (Helicoverpa zea) by transforming with SEQ ID NO:41 taught by Application ‘360 and transform and regenerate the plants as taught by Wei et al. leading to the invention of method of protecting a plant from plant pest.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Summary
No claim is allowed.
Claims are free of prior art. The closest prior art is Bintrim et al. (US Patent No.: US 7,902,334 B2, Date of Patent: 03/8/2011) teaches SEQ ID NO:15 which has 77.5% identity to applicant’s SEQ ID NO:41 (see alignment below). Bintrim et al. teaches SEQ ID NO:15 is an amino acid sequence that encodes Cry-like protein (col. 12, lines 57-60) which is in a cosmid (col. 42, Table 6). The patentable distinction is that Bintrim et al. does not teach any protein comprising amino acid sequences with at least 95% identity to SEQ ID NO:41 is operably linked to one or more heterologous promoter sequences and the encoded protein has pesticidal activity against any plant pest (claims 1, 5, 6 and 10) or activity against a large number of plant pest comprising for example fall armyworm (Spodoptera frugiperda), com earworm (Helicoverpa zea), European com borer (Ostrinia nubilalis) etc. (claims 3 and 8).
Examiner’s Contact Information
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/SANTOSH SHARMA/Examiner, Art Unit 1663
/DAVID H KRUSE/Primary Examiner, Art Unit 1663
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