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 .
Claims Status
1. The Office acknowledges the receipt of Applicant’s Request for Continued Examination and Information Disclosure Statement (IDS) filed June 10, 2026. Upon further consideration and review of the newly submitted IDS, new rejections are set forth below. The Office regrets any inconvenience to Applicant. Claims 1-6, 8-11, 13-15, 20, 22, 24, 29 and 31-33 are pending and are examined in the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections
2. Claims 8-11, 13, 14, 29, 31 and 32 are objected to because of the following: In these claims, it is suggested “sequence” be inserted after “nucleic acid”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
3. Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 5, the three recitation of “a domain” is unclear. The recitation of “a” implies there is more than one of each domain. However, Table 1 indicates there is only one of each domain. It is suggested “a” preceding “domain” be deleted.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 103
4. Claims 1, 5-6, 8, 10-11, 13-15, 20, 22, 24, 29 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Baum et al. (U.S. Pub. No. 20170327547 (previously cited)) in view of Applicant’s admitted prior art.
In regard to claim 1, Baum teaches a polypeptide having insecticidal activity comprising an amino acid sequence having SEQ ID NO:41 which has 95% sequence identity to Applicant’s SEQ ID NO:1. A sequence alignment of the prior art sequence (Db) and Applicant’s SEQ ID NO:1 (Qy) is provided below.
Query Match 95.0%; Score 6235.5; Length 1243;
Best Local Similarity 94.6%;
Matches 1180; Conservative 25; Mismatches 35; Indels 7; Gaps 2;
Qy 1 MTSNRKNENEIINALSIPTVSNHSAQMDLSPDARIEDSLCIAEGNNINPLVSASTVQTGI 60
|||||||||||||||||| ||||||||:|| ||||||||||||||||:| ||||||||||
Db 1 MTSNRKNENEIINALSIPAVSNHSAQMNLSTDARIEDSLCIAEGNNIDPFVSASTVQTGI 60
Qy 61 NIAGRILGVLGVPFAGQLASFYSFIVGELWPSGRDPWEIFLEHVEQLVRQQITENARNTA 120
|||||||||||||||||:||||||:|||||| |||||||||||||||:|||:||| |:||
Db 61 NIAGRILGVLGVPFAGQIASFYSFLVGELWPRGRDPWEIFLEHVEQLIRQQVTENTRDTA 120
Qy 121 LARLQGLGASFRAYQQSLEDWLENRDDARTRSVLYTQYIALELDFLNAMPLFAINNQQVP 180
|||||||| ||||||||||||||||||||||||||||||||||||||||||||| ||:||
Db 121 LARLQGLGNSFRAYQQSLEDWLENRDDARTRSVLYTQYIALELDFLNAMPLFAIRNQEVP 180
Qy 181 LLMVYAQAANLHLLLLRDASLFGSEFGLTSQEIQRYYERQAEKTREYSDYCVRWYNTGLN 240
|||||||||||||||||||||||||||||||||||||||| |||||||||| ||||||||
Db 181 LLMVYAQAANLHLLLLRDASLFGSEFGLTSQEIQRYYERQVEKTREYSDYCARWYNTGLN 240
Qy 241 NLRGTNAESWLRYNQFRRDLTLGVLDLVALFPSYDTRIYPINTSAQLTREIYTDPIGRTN 300
|||||||||||||||||||||||||||||||||||||:||:|||||||||||||||||||
Db 241 NLRGTNAESWLRYNQFRRDLTLGVLDLVALFPSYDTRVYPMNTSAQLTREIYTDPIGRTN 300
Qy 301 APSGFASTNWFNNNAPSFSAIEAAVIRPPHLLDFPEQLTIFSALSRWSNTQYMNYWVGHR 360
|||||||||||||||||||||||||||||||||||||||||| |||||||||||||||||
Db 301 APSGFASTNWFNNNAPSFSAIEAAVIRPPHLLDFPEQLTIFSVLSRWSNTQYMNYWVGHR 360
Qy 361 LESRTIRGSLSTSTHGNTNTSINPVTLQFTSRDVYRTESYAGTNILLTTPVNGVPWARFN 420
|||||||||||||||||||||||||||||||||||||||:|| |||||||||||||||||
Db 361 LESRTIRGSLSTSTHGNTNTSINPVTLQFTSRDVYRTESFAGINILLTTPVNGVPWARFN 420
Qy 421 WRNPLNSLRGSLLYTIGYTGVGIQLFDSETELPPETTERPNYESYSHRLSNIRLIIGNTL 480
|||||||||||||||||||||| |||||||||||||||||||||||||||||||| ||||
Db 421 WRNPLNSLRGSLLYTIGYTGVGTQLFDSETELPPETTERPNYESYSHRLSNIRLISGNTL 480
Qy 481 RAPVYSWTHRSATLTNTIDPERINQIPLVKGFRVWGGTSVITGPGFTGGDILRRNTFGDF 540
|||||||||||| |||| : ||||||||||||||||||||||||||||||||||||||
Db 481 RAPVYSWTHRSADRTNTISSDSINQIPLVKGFRVWGGTSVITGPGFTGGDILRRNTFGDF 540
Qy 541 VSLQVNINSPITQRYRLRFRYASSRDARVIVLTGAASTGVGGQVSVNMPLQKTMEIGENL 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 VSLQVNINSPITQRYRLRFRYASSRDARVIVLTGAASTGVGGQVSVNMPLQKTMEIGENL 600
Qy 601 TSRTFRYTDFSNPFSFRANPDIIGISEQPLFGAGSISSGELYIDKIEIILAD---ATFEA 657
|||||||||||||||||||||||||||||||||||||||||||||||||||| |||||
Db 601 TSRTFRYTDFSNPFSFRANPDIIGISEQPLFGAGSISSGELYIDKIEIILADATTATFEA 660
Qy 658 ESDLERAQKAVNALFTNTNPRRLKTDVTDYHIDQVSNLVACLSDEFCLDEKRELLEKVKY 717
| ||||||:|||||||||||||||| |||||||:||||||||||||||||||||||||||
Db 661 EYDLERAQEAVNALFTNTNPRRLKTGVTDYHIDEVSNLVACLSDEFCLDEKRELLEKVKY 720
Qy 718 AKRLSDERNLLQDPNFTSINKQPDFISIDGQSNFTSIHEQSEHGWWGSENITIQEGNEVF 777
||||||||||||||||||||||||||| : |||||||||||||||||||||||||||:||
Db 721 AKRLSDERNLLQDPNFTSINKQPDFISTNEQSNFTSIHEQSEHGWWGSENITIQEGNDVF 780
Qy 778 KENFFTLPGTLNECYPTYLYQKIGESELKAYTRYQLRGYIEDSQDLEIYLIRYNAKHETL 837
|||: |||| ||||||||||||||:|||||||||| |||||||||||||||||||||||
Db 781 KENYVILPGTFNECYPTYLYQKIGEAELKAYTRYQLSGYIEDSQDLEIYLIRYNAKHETL 840
Qy 838 DVPGTESVWPLSVESPIGRCGEPNRCVPHIEWNPNLDCSCRDGEKCAHHSHHFSLDIDVG 897
|||||||||||||||||||||||||| || ||||:|||||||||||||||||||||||||
Db 841 DVPGTESVWPLSVESPIGRCGEPNRCAPHFEWNPDLDCSCRDGEKCAHHSHHFSLDIDVG 900
Qy 898 CTDLQENLGVWVVFKIKTQEGHARLGNLEFIEEKPLLGEALSRVKRAEKKWRDKREKLQL 957
| || |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 CIDLHENLGVWVVFKIKTQEGHARLGNLEFIEEKPLLGEALSRVKRAEKKWRDKREKLQL 960
Qy 958 ETKRVYTEAKEAVGALFVDSQYDRLQADTNIGMIHAADKLVHRIREAYLSELSVIPGVNA 1017
||||||||||||| ||||||||||||||||||||||||||||||||||||||||||||||
Db 961 ETKRVYTEAKEAVDALFVDSQYDRLQADTNIGMIHAADKLVHRIREAYLSELSVIPGVNA 1020
Qy 1018 EIFEELEGRIITAISLYDARNVVKNGDFNNGLACWNVKGHVDVQQSHHRSVLVIPEWEAE 1077
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 EIFEELEGRIITAISLYDARNVVKNGDFNNGLACWNVKGHVDVQQSHHRSVLVIPEWEAE 1080
Qy 1078 VSQAVRVCPGRGYILRVTAYKEGYGEGCVTIHEIDNNTDELKFKNCEEEEVYPTDTGTCN 1137
||||||||||||||||||||||||||||||||||:|||||||||||||||||||||||||
Db 1081 VSQAVRVCPGRGYILRVTAYKEGYGEGCVTIHEIENNTDELKFKNCEEEEVYPTDTGTCN 1140
Qy 1138 DYTAHQGTAGCADACNSRNVGYDEVYEMNTTASVNYKPTYEEEMYTDVRRDNHCEYDRGY 1197
||||||||| |||||| ||:: ||::|||||||||||||| ||||||||||||||||
Db 1141 DYTAHQGTA----ACNSRNAGYEDAYEVDTTASVNYKPTYEEETYTDVRRDNHCEYDRGY 1196
Qy 1198 VNYPPVPAGYVTKELEYFPETDTVWIEIGETEGKFIVDSVELLLMEE 1244
||||||||||:||||||||||| ||||||||||||||||||||||||
Db 1197 VNYPPVPAGYMTKELEYFPETDKVWIEIGETEGKFIVDSVELLLMEE 1243
Even though Baum does not teach a sequence having 96% sequence identity to Applicant’s SEQ ID NO:1, Applicant’s sequence has 25 conservative amino acid substitutions when compared to the prior art sequence. It is well known in the prior art that conservative amino acid substitutions typically do not alter the functional activity of a protein. As further evidence, page 14 of the specification states:
A further indication that two nucleic acid sequences or proteins are substantially identical is that the protein encoded by the first nucleic acid is immunologically cross reactive with, or specifically binds to, the protein encoded by the second nucleic acid. Thus, a protein is typically substantially identical to a second protein, for example, where the two proteins differ only by conservative substitutions. (emphasis added)
As both SEQ ID NO:41 of the prior art and Applicant’s SEQ ID NO:1 are chimeric Cry proteins having insecticidal activity, and the 1% difference in sequence identity is due to conservative amino acid substitutions, the two proteins are substantially identical as defined in Applicant’s disclosure. There is no evidence that Applicant’s chimeric Cry protein has a different functional activity from that of the prior art. Additionally, no sequence alignment parameters are recited in the claims. There is no evidence that Applicant utilizes the same sequence search program and alignment parameters as the Office to determine sequence identities, as different alignment parameters will result in different sequence identity percentages. Nonetheless, it would have been prima facie obvious at the time of filing to produce a sequence that has some conservative amino acid substitutions but the same insecticidal activity as the prior art sequence. There is no effect on the end use of the claimed product. That is, an insecticidal protein having a 1% difference in sequence identity from a prior art insecticidal protein due to conservative amino acid substitutions does not produce an unexpected and practically significant difference on the end-use product. Applicant does not disclose an unexpected and practically significant or utilitarian difference between a sequence having 95% sequence identity to SEQ ID NO:1 and a sequence having 96% sequence identity to SEQ ID NO:1 when that difference is due to conservative amino acid substitutions. Accordingly, claim 1 is prima facie obvious in view of the prior art.
With regard to claim 5, Baum teaches domain I from a Cry1B protein, domain II from the Cry1B protein and domain III from a cry1C protein ([0167-[0169]).
With regard to claim 6, in Table 1, the Protox portion of the TIC868_13 toxin (SEQ ID NO:41) is the C-terminal tail from the Cty1B protein (carboxy terminus Cry1Be).
With regard to claim 8, SEQ ID NO:40 is the TIC868_13 nucleic acid sequence encoding SEQ ID NO:41 of the prior art.
With regard to claim 10, even though Baum does not specifically teach codon optimization for plant expression, Baum states “codons of a recombinant nucleic acid molecule encoding for a chimeric insecticidal protein disclosed herein can be substituted by synonymous codons (known in the art as a silent substitution)” [0177]. Moreover, the specification states that codon optimization for plant expression is well known in the prior art (specification, p. 9, lns. 24-33). One skilled in the art would have been motivated to codon optimize the sequence of Baum for plant expression because the insecticidal polypeptide of Baum is expressed in a plant to target a plant pest.
With regard to claim 11, Baum teaches a heterologous promoter operably linked to the coding sequence (claim 4).
With regard to claims 13-15 and 24, Baum teaches a vector comprising the nucleic acid sequence in a plant host cell and a plant [0176].
With regard to claim 20, Baum teaches a bacterial host cell [0017].
With regard to claim 22, Baum teaches a composition comprising the polypeptide [0018].
With regard to claim 29, Baum teaches a seed comprising a nucleic acid sequence encoding the polypeptide (Abstract).
With regard to claim 31, Baum teaches a method of producing a transgenic plant by introducing into a plant cell the nucleic acid sequence, selecting a plant cell comprising the nucleic acid sequence, and regenerating a plant from the selected plant cell [0182].
With regard to claim 32, Baum teaches a method of producing a transgenic plant comprising crossing a first plant comprising the nucleic acid sequence with a second plant [0183].
With regard to claim 33, Baum teaches a method of controlling a lepidopteran pest comprising delivering to the pest the polypeptide [0020].
Accordingly, the claimed invention is prima facie obvious in view of the prior art.
Conclusion
5. Claims 1, 5-6, 8, 10-11, 13-15, 20, 22, 24, 29 and 31-33 are rejected. Claims 2-4 and 9 are objected to because they depend from a rejected claim(s) but would be allowable if rewritten in independent form containing all the limitations of the claim(s) they depend from as appropriate.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JOSE ORDAZ whose telephone number is (703)756-1967. The examiner can normally be reached 8:30 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.J.O./Examiner, Art Unit 1663
/PHUONG T BUI/Primary Examiner, Art Unit 1663
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