DETAILED ACTION
Claims 1-6 and 9-21 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The objection to the specification is withdrawn in light of Applicant’s amendment.
The objection to claims 6, 11, 17, 19, and 22 because of informalities is withdrawn in light of Applicant’s amendment to the claims.
The objection to claim 21 under 37 CFR 1.75 as being a substantial duplicate of claim 9 is withdrawn in light of Applicant’s amendment to the claim.
The rejection of claims 18-19 and 22 under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more is withdrawn in light of Applicant’s amendment to the claims.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 rejection of claims 2 and 18-19 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the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention is withdrawn in light of Applicant’s amendment to the claims.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 2-6 and 18-19 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 9-12 under 35 U.S.C. 102(a)(1) as being anticipated by Sampson et al (US 2010/0005543) is withdrawn in light of Applicant’s amendment to the claims.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(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.
Claims 1-6 and 9-21 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 14 May 2026, as applied to claims 1-22. Applicant’s arguments filed 8 June 2026 have been fully considered but they are not persuasive.
The claims, to the extent they read on the elected species, are broadly drawn to a recombinant nucleic acid comprising a heterologous promoter operably linked to a nucleic acid that encodes a pesticidal protein with 95% identity to SEQ NO:10, 20 or 28, host cells, plants and seeds comprising the recombinant nucleic acid, insect inhibitory compositions comprising it, commodity products comprising the nucleic acid or the protein, methods of producing seed from the plant, and methods comprising contacting a pest with the protein.
SEQ ID NO:9 encodes SEQ ID NO:10, which is TIC4006 (¶35-36), SEQ ID NO:19 encodes SEQ ID NO:20, which is TIC4006 with an alanine inserted after the starting methionine (¶45-46), and SEQ ID NO:27 encodes SEQ ID NOI:28, which is TIC4006 with a 5’ HIS tag (¶53-54)
The specification fails to teach how to use proteins of SEQ NOs:10, 20 or 28. The specification fails to teach any pest that the protein has activity against. Example 2 describes assaying SEQ NO:10 (TIC4006) against a number of pests, but it did not have activity against any of them.
The specification also fails to teach how to make nucleic acid that encodes a pesticidal protein with 95% identity to SEQ NO:10, 20 or 28.
Nucleic acids encoding proteins with 95% identity to the 1213 amino acid long SEQ ID NO:10 or the 1214 amino acid long SEQ ID NO:20 encompass those encoding proteins with 60 amino acid substitutions relative to SEQ ID NO:10 and 20.
The guidance in the specification with respect to making amino acid substitutions in the claimed proteins is as follows:
The specification suggests analyzing proteins using alignment algorithms (¶70), but does not teach what proteins to use in this comparison.
The specification suggests using nucleic acids encoding the disclosed proteins as probes to identify related sequences (¶89), but does not teach where to find or how to make these related sequences.
The specification fails to teach which amino acid substitutions would convert SEQ NO: 10, 20 and 28 to pesticidal proteins, including ones pesticidal to Hemipterans, as required by instant claims 7-8.
Thus, one of skill in the art would have to make the claimed pesticidal proteins, if it is possible to do so, by random mutagensis. However, making large numbers of amino acid substitutions in proteins is unpredictable.
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 (Guo et al, 2004, Proc. Natl. Acad. Sci. USA 101: 9205-9210; pg 9209, right column, paragraph 2). As there are, for example, 20460 (2.98 x 10598) proteins with 460 amino acid substitutions relative to SEQ ID NO:10, even assaying a representative sample of these proteins in an attempt to find any that have pesticidal activity would entail undue experimentation. Thus, making and analyzing proteins with up to 460, 461 or 468 amino acid substitutions that also have pesticidal activity would require undue experimentation.
Thus, extensive teachings are required for making nucleic acids encoding pesticidal proteins with up to 60 amino acid substitutions relative to SEQ NO:10, 20 or 28, as encompassed by the claimed nucleic acids. These teachings are not provided for by the specification. The specification also fails to overcome the unpredictability in the art of making large numbers of amino acid substitutions in pesticidal proteins as it provides no working examples of proteins with up to 60 amino acid substitutions relative to SEQ NO:10, 20 or 28.
Given the claim breath, unpredictability, and lack of guidance as discussed above, undue experimentation would have been required by one skilled in the art to develop and evaluate pesticidal protein-encoding nucleic acids that encode proteins with 95% identity to SEQ NO:10, 20 or 28. Thus, the instant invention is not enabled.
Response to Arguments
Applicant urges that the specification teaches one of skill in the art how to make and use the claimed invention; the claimed proteins are characterized in that they are pesticidal and have 95% identity to SEQ ID NO:10, 20, or 28, which is enough for one of skill in the art to make and use them (response pg 10).
This is not found persuasive. The specification teaches no protein with 95% identity to SEQ ID NO:10, 20, or 28 that is pesticidal. The specification also does not teach how to make proteins with 95% identity to SEQ ID NO:10, 20, or 28 that are pesticidal.
Applicant urges that mutagensis may be done by one of skill in the art because the methods are routine; conservative amino acid substitutions can be made, as well as other substitutions based on hydrophobicity, change and size (response pg 10-11).
This is not found persuasive. Without guidance as to which conservative amino acid or other substitutions will make pesticidal proteins with 95% identity to SEQ ID NO:10, 20, or 28, making a testing the full scope of proteins with 95% identity to SEQ ID NO:10, 20, or 28 in an attempt to get ne that is pesticidal would require undue experimentation, if it is even possible to do. Further, maintaining the characteristics in Table 2 would only allow swapping the positions of amino acids in SEQ ID NO:10, 20, or 28, as replacing an amino acid in SEQ ID NO:10, 20, or 28would alter the number of each type of amino acid in the protein, which would change the molecular weight, isoelectric point, change and type of each class of amino acid.
Applicant urges that one of skill in the art could test the resulting proteins for pesticidal activity using the assays in the specification (response pg 11).
This is not found persuasive. Applicant themselves were not able to identify the pesticidal activity of SEQ ID NO:10 using those methods, which may well be because SEQ ID NO:10 is not pesticidal at all. Further, the specification must teach how to use the claimed invention. A claimed invention is not a research project for the public figure it out a use for.
Claims 1-6 and 9-21 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 that 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 14 May 2026, as applied to claims 1-22. Applicant’s arguments filed 8 June 2026 have been fully considered but they are not persuasive.
The claims require a nucleic acid that encodes a pesticidal protein 95% identity to SEQ NO:10, 20 or 28 or a pesticidal protein encoded by the nucleic acid.
SEQ ID NO:9 encodes SEQ ID NO:10, which is TIC4006 (¶35-36), SEQ ID NO:19 encodes SEQ ID NO:20, which is TIC4006 with an alanine inserted after the starting methionine (¶45-46), and SEQ ID NO:27 encodes SEQ ID NOI:28, which is TIC4006 with a 5’ HIS tag (¶53-54)
Nucleic acids encoding proteins with 95% identity to the 1213 amino acid long SEQ ID NO:10 or the 1214 amino acid long SEQ ID NO:20 encompass those encoding proteins with 0 amino acid substitutions relative to SEQ ID NO:10 and 20.
The specification describes SEQ ID NO:2, 4, 6, and 8, which have 83%, 82.9%, 82.7% and 83% identity to SEQ ID NO:10 and similar percent identities to SEQ ID NOs:20 and 28. None of these are proteins within the scope of the claims. Further, of those proetins, only TIC6547 (SEQ ID NO:8) is pesticidal to a Lepidopteran and only TIC4747 (SEQ ID NO:2) and TIC7181 (SEQ ID NO:4) are pesticidal to Hemipterans (example 2). SEQ ID NO:10 itself does not have pesticidal activity toward any Lepidopteran or Hemipteran tested (example 2).
The structural features that distinguish pesticidal proteins with 95% identity to SEQ ID NO:10 from other proteins with 95% identity to SEQ ID NO:10 are not described in the specification. The specification does not describe the necessary and sufficient motifs or domains of a pesticidal protein with95% identity to SEQ ID NO:10, 20, or 28.
Thus, 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 disclosed species.
Hence, Applicant has not, in fact, described nucleic acids that encode pesticidal proteins with 95% identity to SEQ ID NO:10, 20 or 28, 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 written description merely requires a disclosure of a representative number of species or the structural features common the genus; the specification does this via the sequence listing and Tables 1-2 (response pg 12).
This is not found persuasive. The only proteins with 95% identity to SEQ ID NO:10, 20 or 28 described in the specification are SEQ ID NO:10, 20 or 28 themselves. As these proteins are not pesticidal, they cannot represent the genus.
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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