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 .
Claim Status
Claims 1-24 are pending.
Claims 1-5, 12-13, 17-18, and 20-24 are withdrawn from examination as being part of non-elected Groups.
Claims 6-11, 14-16 and 19 are being examined.
Claim Rejections - 35 USC § 112(a)
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.
Written Description
Claims 6-11, 14-16 and 19 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 claims contain 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. This is a new rejection based on claim amendments.
Claim 6 and 14 are drawn to a recombinant nucleic acid molecule operably linked to one or more heterologous promoter sequences that direct expression in plant tissue and encoding a polypeptide having at least 98% sequence identity to any one of SEQ ID NOs: 1, 2, 4-8, 10, 12, 15, 21-22, 24, 25 and 29-34, wherein the polypeptide has pesticidal activity against a Lepidopteran or a Coleopteran plant pest.
The Applicant describes identifying a novel polypeptide sequence (SEQ ID NO: 1) comprising insecticidal activity (spec, p.33, para 000116, line 1-2) and then created several variants (SEQ ID NO: 2-56). Some of which has increased insecticidal activity, altered spectrum of insecticidal activity, increased durability, or increased stability against specific Lepidopteran or Coleopteran pest(s) (spec, p.33, para 000116, line 2-4). Different proteins are expressed in either E coli (spec, p. 33, Example 2, line 1-2) or in transiently expressed in Nicotiana benthamiana to identify specific insecticidal activity (spec, p. 36, para 000122, line 1-2). The results of insecticidal activity of various proteins are summarized in Table 1 and Table 2. Table 1 describes insecticidal activity of E coli expressed proteins against specific insect pests viz Fall armyworm (FAW, Spodoptera frugiperda), European corn borer (ECB, Ostrinia nubilalis), sugarcane borer (SCB, Diatraea saccharalis) and western corn rootworm (WCR, Diabrotica virgifera virgifera) (spec, p. 34, Table 1, para 000121). Table 2 describes insecticidal activity of transiently expressed proteins in tobacco (Nicotiana benthamiana) leaves against specific insect pests viz. Fall armyworm (FAW), European corn borer (ECB), sugarcane borer (SCB), corn earworm (CEW, Helicoverpa zea,) and soybean looper (SBL, Chrysodeixis includens) (spec, p.37, Table 2, para 000123).
Not all the claimed polypeptide sequences (i.e., SEQ ID NOs: 1, 2, 4-8, 10, 12, 15, 21-22, 24, 25 and 29-34) are tested by the Applicant against representative species of the Lepidopteran or a Coleopteran pest. The specification shows that only three proteins (SEQ ID NOs: 15, 22 and 24) expressed in E. coli showed activity against western corn rootworm (WCR). On the other hand, E. coli expressed SEQ ID NO: 15 showed activities only against WCR among all the insect pests tested while the western corn borer is not even included in the leaf disk assay in Table 2. However, SEQ ID NO: 15 is not included in the leaf disk assay at all. Table 2 shows that SEQ ID NOs: 6, 7 and 10 do not show any activity when expressed in a plant leaf. However, the same proteins showed activity against CEW, FAW and SCB when expressed in prokaryotic E. coli host (Table 1). Thus, there is a clear distinction between activity of different proteins when expressed in E coli as compared to plant leaves.
Several sequences (SEQ ID NOs: 12, 15, 21-25 and 29-34) encompassed by the claims are not even tested in a plant tissue. It is also noted in Table 2 that SEQ ID NO: 1 is expressed in a plant leaf assay, using different expression cassettes to be active in plant tissues, which gave different results. It is unclear what the differences are between these cassettes, and how they affect the activity of SEQ ID NO: 1 in the assay. It is unclear whether a particular plant-expressible promoter, other regulatory element(s), or the expressed sequence itself, is/are necessary for pesticidal activity in a plant or post-translational modification of the protein(s) in a plant leaf compared to the ones expressed in E. coli. A skilled artisan would acknowledge that prokaryotic E. coli has certain disadvantages in producing biologically active eukaryotic proteins for several reasons including lack of post-translation protein modification(s), lack of chaperons might cause unfolding/misfolding of the heterologous (eukaryotic) proteins. Moreover, all the examples in Table 1 describes expression of the polynucleotide sequences in E. coli and does not describe a “polynucleotide sequence encoding the polypeptide is operably linked to one or more heterologous promoter sequences that direct expression in plant tissue”, as recited by claims 6 and 14.
The Applicant does not describe any structure function relationship of these novel proteins expressed in different hosts in respect to its insecticidal activities against specific Lepidopteran or a Coleopteran insect pest(s) while claiming the broad genus. There is no specific domain or amino acid sequence assigned to the specific and novel insecticidal activity.
Current status of the art also does not provide any structure function relationship of these novel proteins expressed in different hosts in respect to its insecticidal activities against specific Lepidopteran or a Coleopteran insect pest(s). A skilled artisan would acknowledge that the leaf disk assay expressing specific proteins in a plant leaf is more valid to show specific insecticidal activity against specific coleopteran or lepidopteran insect feeding on plant parts including leaves.
The structure function relationship is even more important for this invention as this protein appears to be a novel protein with specific insecticidal function. It does not have any prior characterization of its domains and sequences in terms of its function(s), unlike many other insecticidal proteins known in the art. The description of the invention does not characterize SEQ ID NO: 1 such that one skilled artisan would know which amino acid residues should not be changed to retain/improve the claimed functions.
Considering the breadth of the claims, lack of representative species of the broad genus claimed, lack of structure function relationship of the broad genus claimed, and unpredictability of the art, the Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
It is suggested to recite the sequences in claims 6, 9, 14 and 19 that show activity against specific coleopteran or lepidopteran insect pest(s), as recited in claims 7 and 15 when expressed in tobacco leaves.
Response to Applicant’s Arguments
Applicant’s Arguments dated 8/4/2026 regarding claim rejections under 35 USC
112(a) Written Description are fully considered but not found persuasive.
The Applicant amended claims 6 and 14 to recite “… 98% sequence identity...” (line 2) and “… against a Lepidopteran or a Coleopteran plant pest…” (line 4). All the arguments by the Applicant boil down to those two amendments (response, p.7, last two para; p.9, para 2, line 2-5).
The Examiner disagrees. The current 112(a) written description rejection is a modified version of previous Office action as necessitated by claim amendments reciting issues that were not present in any of the claims before. The current 112(a) WD rejection is not based on percent identity of the sequences and/or type of plant pest(s). The rejections are mainly based on “… that direct expression in plant tissue”.
Not all the claimed polypeptide sequences (i.e., SEQ ID NOs: 1, 2, 4-8, 10, 12, 15, 21-22, 24, 25 and 29-34) are tested by the Applicant against representative species of the Lepidopteran or a Coleopteran pest. The specification shows that only three proteins (SEQ ID NOs: 15, 22 and 24) expressed in E. coli showed activity against western corn rootworm (WCR). On the other hand, E. coli expressed SEQ ID NO: 15 showed activities only against WCR among all the insect pests tested while the western corn borer is not even included in the leaf disk assay in Table 2. However, SEQ ID NO: 15 is not included in the leaf disk assay at all. Table 2 shows that SEQ ID NOs: 6, 7 and 10 do not show any activity when expressed in a plant leaf. However, the same proteins showed activity against CEW, FAW and SCB when expressed in prokaryotic E. coli host (Table 1). Thus, there is a clear distinction between activity of different proteins when expressed in E coli as compared to plant leaves.
Several sequences (SEQ ID NOs: 12, 15, 21-25 and 29-34) encompassed by the claims are not even tested in a plant tissue. It is also noted in Table 2 that SEQ ID NO: 1 is expressed in a plant leaf assay, using different expression cassettes to be active in plant tissues, which gave different results. It is unclear what the differences are between these cassettes, and how they affect the activity of SEQ ID NO: 1 in the assay. It is unclear whether a particular plant-expressible promoter, other regulatory element(s), or the expressed sequence itself, is/are necessary for pesticidal activity in a plant or post-translational modification of the protein(s) in a plant leaf compared to the ones expressed in E. coli. A skilled artisan would acknowledge that prokaryotic E. coli has several disadvantages in producing biologically active eukaryotic proteins as it does not have post-translation protein modification(s), lacks chaperons causing unfolding/misfolding of the heterologous (eukaryotic) proteins among other reasons (Francis et al., Strategies to Optimize Protein Expression in E. coli, 2010, Current Protocols in Protein Science, 5.24.1-5.24.29; Abstract, line 3-8).
Moreover, all the examples in Table 1 describe expression of the polynucleotide sequences in E. coli and does not describe a “polynucleotide sequence encoding the polypeptide is operably linked to one or more heterologous promoter sequences that direct expression in plant tissue”.
The Applicant does not describe any structure function relationship of these novel proteins expressed in different hosts (i.e., E coli vs tobacco leaves) in respect to insecticidal activity against specific Lepidopteran or a Coleopteran insect pest(s) while claiming the broad genus, as discussed above.
It is acknowledged, however, that claims 11 and 19 were inadvertently omitted from the 112(a) rejections. It was an honest mistake.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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J.C.
/Jay Chatterjee/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662
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