DETAILED ACTION
Claims 18-19, 21-30, and 35 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The rejection of claims 18-24 and 28-30 under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more is withdrawn in light of Applicant’s amendment to the claims.
The objections to claims 19 and 21 is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 18-30 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the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 18-30 under 35 U.S.C. 102(a)(1) as being anticipated by Song et al (2007, US 7,179,965) taken with the evidence of Baxter et al (2011, Genetics 189:675-679) is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 18-24 and 30 under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al (2000, FEBS Lett. 473:227-232) is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 18-26 and 28-30 under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al (2006, Crop Science 46:781-789) is withdrawn in light of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Due to Applicant’s amendment of the claims, the rejection is different from the rejection set forth in the Office action mailed 20 January 2026, as applied to claim20. Applicant’s arguments filed 5 February 2026 have been fully considered but they are not persuasive. The previous rejection was overcome by Applicant’s cancellation of the claim.
Claim 23 is drawn to the modified pesticidal protein of claim 22, wherein the modified pesticidal protein comprises a toxin fusion with a partner protein or a protein produced from the fusion of two or more different Bt toxins. Claim 22 recites that the modified pesticidal protein is TIC105.
The specification teaches that TIC105 is a chimera toxin of CrylAb-lAb-1Fa (¶101). Thus, claim 23 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 35 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Neither the instant specification nor the originally filed claims appear to provide support for a claim to a plant genome separate from a plant. The specification mentions a plant genome in the context of a plant comprising it. For example, ¶9 recites “in certain embodiments the pesticidal protein is encoded by a polynucleotide molecule incorporated in the genome of the plant.” In other contexts, a plant is implied, as in ¶20 recites “a method for reducing the number of pesticidal proteins … to be included in a crop species for controlling a first target pest ... [by] providing in the genome of the crop species …”, as controlling a pest would require the nucleic acid encoding the pesticidal protein be in a plant genome in a plant so that the protein can be produced by the plant.
Thus, a plant genome separate from a plant constitutes NEW MATTER. In response to this rejection, Applicant is required to point to support for the claim or to cancel the new matter.
Claims 18-19, 21-30, and 35 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 20 January 2026, as applied to claims 18-30. Applicant’s arguments filed 5 February 2026 have been fully considered but they are not persuasive.
The claims all require a TIC2160 or TIC105 protein modified to bind to the cadherin receptor of any insect, nematode, fungal or bacterial pest.
The specification describes two sequences, SEQ ID NOs:6 and 9, that to bind to the fall armyworm cadherin receptor; the specification describes TIC2160 modified with SEQ ID NO:6 and TIC105 modified with SEQ ID NO:9. The specification also describes a TIC105 variant, SEQ ID NO:12, that to binds to the fall armyworm cadherin receptor.
These species are not representative of the full scope of modifications that bind to the fall armyworm cadherin receptor, much less than the full scope of modifications that result in binding to cadherin receptors of any insect, nematode, fungal or bacterial pest.
The specification fails to describe the full scope of modifications that result in binding to cadherin receptors of the full scope of insect, nematode, fungal or bacterial pests. The claims require a function, binding to cadherin receptors of the full scope of insect, nematode, fungal or bacterial pests, without the specification describing a representative number of species over the full scope of structures responsible for that function.
The specification does not describe the full scope of motifs or domains that bind to cadherin receptors of the full scope of insect, nematode, fungal or bacterial pests.
The structural features that distinguish TIC2160 or TIC105 protein modified to bind to the cadherin receptor of any insect, nematode, fungal or bacterial pest from other modified TIC2160 or TIC105proteins are not described in the specification.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the few disclosed species.
Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, TIC2160 modified with SEQ ID NO:6, TIC105 modified with SEQ ID NO:9, and the TIC105 variant, SEQ ID NO:12 are insufficient to describe the claimed genus.
Hence, Applicant has not, in fact, described modified TIC2160 or TIC105 proteins within the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Arguments
Applicant urges that the amended claims recite scaffolds TIC2160 and TIC105 and require that the protein be modified to acquire cadherin receptor-binding ability; the specification disclosed modified TIC2160 and TIC105 variants with the fall armyworm cadherin receptor-binding sequences of SEQ ID NO:6 and 9 (response pg 5-6).
This is not found persuasive because these species only binding to the cadherin receptor of one Lepidopteran, fall armyworm. The claims, on the other hand, encompass TIC2160 and TIC105 variants with modifications that result in binding to the cadherin receptor of the full scope of insect (including Lepidopterans, Coleopterans, Hemipterans, Homopterans, Hymenopterans, and Dipterans), nematode, fungal or bacterial pests, as recited in claim 24. As claim 24 is a dependent claim, plant claim 18 encompasses binding to the cadherin receptor of an even greater range of pests,
Applicant urges that the specification discloses a TIC105 variant, SEQ ID NO:12, that binds cadherin (response pg 6).
This is not found persuasive because the protein of SEQ ID NO:12 only binds to the fall armyworm cadherin receptor. It does not represent the full scope of mutations that bind to the fall armyworm cadherin receptor, much less the full scope of mutations that bind to the full scope of cadherin receptors of the full scope of insect, nematode, fungal or bacterial pests.
Claims 18-19, 21-30, and 35 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 TIC2160 modified with SEQ ID NO:6 and TIC105 modified with SEQ ID NO:9, does not reasonably provide enablement for TIC2160 or TIC105 modified to bind to the cadherin receptor of any insect, nematode, fungal or bacterial pest. 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 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 20 January 2026, as applied to claims 18-30. Applicant’s arguments filed 5 February 2026 have been fully considered but they are not persuasive.
The claims are broadly drawn to a TIC2160 or TIC105 protein modified to bind to the cadherin receptor of any insect, nematode, fungal or bacterial pest, a nucleic acid encoding, and plants and seeds comprising it.
The specification teaches two sequences, SEQ ID NOs:6 and 9, that to bind to the fall armyworm cadherin receptor; the specification teaches TIC2160 modified with SEQ ID NO:6 and TIC105 modified with SEQ ID NO:9. The specification also teaches a TIC105 variant, SEQ ID NO:12, that to binds to the fall armyworm cadherin receptor.
The specification fails to teach sequence that to bind to the cadherin receptor of other Lepidopteran pests. The specification fails to teach sequence that to bind to the cadherin receptor of any Coleopteran, Hemipteran, Homopteran, Hymenopteran, and Dipteran, nematode, fungal or bacterial pest.
The instant specification thus fails to provide guidance for making the full scope of TIC2160 or TIC105 proteins modified to bind to the cadherin receptor of the full scope of insect, nematode, fungal or bacterial pest.
The instant specification thus fails to provide guidance for making the full scope of TIC2160 or TIC105 proteins modified to bind to the cadherin receptor of any insect, nematode, fungal or bacterial pest.
Given the claim breath and lack of guidance as discussed above, undue experimentation would have been required by one skilled in the art to develop and evaluate the full scope of pesticidal proteins that bind to two different receptors of a target pest. Thus, the instant invention is not enabled over the full scope of the claims.
Response to Arguments
Applicant urges that the claims are enabled because they are limited to 2 scaffolds, TIC2160 and TIC105, and a single functional outcome, and teaches how to achieve that by insertion of cadherin binding determinants and PACE evolution (response pg 7).
This is not found persuasive because this does not teach the full scope of cadherin binding determinants for the full scope of cadherin receptors of the full scope of insect, nematode, fungal or bacterial pests. Similarly, the specification does not teach PACE evolution of TIC2160 and TIC105 so that they bind to the full scope of cadherin receptors of the full scope of insect, nematode, fungal or bacterial pests.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
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/Anne Kubelik/Primary Examiner, Art Unit 1663
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