CTNF 18/258,720 CTNF 100669 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 08-25-02 Applicant’s election of Group I, claims 1-9, drawn to a hexatoxin peptide variant or composition thereof, in addition to the species of an amino acid which is at least 90% identical to SEQ ID NO: 1, wherein the amino acid sequence has at least one amino acid variant on position N29 , in the reply filed on 4/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim Status Claims 1-16 are pending. Claims 10-16 are hereby withdrawn as non-elected inventions. Claims 3-10 and 14-16 are currently amended. Priority The instant application is the 371 national stage entry of PCT/EP2021/087102, filed 12/21/2021, which claims priority to EP20216063.6, filed 12/21/2020. The priority date of 12/21/2020 is acknowledged. Information Disclosure Statement The IDS filed 6/21/2023 is under consideration. Nucleotide and/or Amino Acid Sequence Disclosures REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above. Required response – Applicant must provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter. Specifically, the file size needs to be listed in bytes, not kilobytes. Specification 07-29-04 The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Pg 45, line 23; Pg 64, line 3; Pgs 74-75, in the references). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Claim Objections 07-05-06 Claim 7 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 6 . When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). 07-30-03-h AIA Claim Interpretation Claims 1-7 each recite some variant of a/the peptide comprises an amino acid sequence of SEQ ID NO: X (emphasis added). Each limitation is being interpreted as a peptide or protein encompassing or containing the entirety of SEQ ID NO: X meets the limitation of the claim. Conversely, smaller fragments encompassed by SEQ ID NO: X (i.e., dipeptides) are being interpreted as not meeting the limitations of the claim. Claims 2 and 3 are being interpreted as the claimed hexatoxin polypeptide exhibits at least 91-100% identity when the variant at the respective position is not considered in the percent identity determination. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 2, 3, and 5 are 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. Claim 2 recites that the peptide is at least 91%, 92%,… or 99% identical to any one of the respective SEQ ID NO’s according to (a) to (f). This limitation renders the scope of this claim indefinite as there are multiple ways to interpret it, the first being at least 91% identity or 92-99% identity and the second being at least 91% or at least 92% or at least… 99%. For purposes of examination, the claim is being interpreted as the latter, wherein the peptide should be at least 91% or at least 92% or at least… 99% identical to one SEQ ID NO from claim 1. Similarly, claim 5 recites that the peptide is at least 90%, 91%, 92%,… or 99% identical to SEQ ID NO: 1. This limitation renders the scope of this claim indefinite as there are multiple ways to interpret it, the first being at least 90% identity or 91-99% identity and the second being at least 90% or at least 91% or at least… 99%. For purposes of examination, the claim is being interpreted as the latter, wherein the peptide should be at least 90% or at least 91% or at least… 99% identical to SEQ ID NO: 1. 07-34-03 AIA The term “ substantially identical ” in claim 3 is a relative term which renders the claim indefinite. The term “ substantially identical ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The percent identity equivalent to “substantially identical” to meet the limitation of the claim cannot be determined. For purposes of examination, the limitation is being interpreted as identical . 07-36 AIA 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 pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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. 07-36-01 AIA Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th 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. Claim 8 depends from claim 1, which recites that the hexatoxin peptide does not comprise the amino acid sequence of SEQ ID NO: 33; SEQ ID NO: 33 has a T at position 29 relative to SEQ ID NO: 1. However, claim 8 recites that the amino acid variant on the respective position is selected from a group that includes T. Therefore, claim 8 does not encompass all the limitations of its parent claim 1 . 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. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim (s) 1-9 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Chambers et al. ((2019), Insecticidal spider toxins are high affinity positive allosteric modulators of the nicotinic acetylcholine receptor. FEBS Lett, 593: 1336-1350.) . Chambers teaches insecticidal peptides derived from ω-hexatoxin-Hv1a (Hv1a), κ-hexatoxin-Hv1c (Hv1c) and ω/κ-hexatoxin-Hv1h (Hv1h; Abstract). Regarding claim 1, Chambers teaches Hv1a has a sequence identical to the instant SEQ ID NO: 1, where position 29 is Asn (Figure 1A). Chambers further teaches mutating position 29 to Ala (Figure 7; Pg 1345, left column, “Relevance of the binding site to insecticidal activity” – right column, first paragraph); this peptide exhibits > 90% identity to the instant SEQ ID NO: 1, shown below: PNG media_image1.png 180 624 media_image1.png Greyscale . Chambers further teaches that Ala substitution at position 29 has little or no detrimental effect on the peptide variant (Pg 1345, right column, first paragraph). Regarding claims 2-3, wherein the amino acid variant is excluded, the Hv1a variant taught by Chambers exhibits 100% identity to SEQ ID NO: 1. Regarding claims 4, 6, and 7, as stated above, the Hv1a variant taught by Chambers comprises an amino acid sequence of SEQ ID NO: 1, wherein the amino acid sequence has an amino acid variant on position N29. Regarding claim 5, as stated above, the Hv1a variant taught by Chambers exhibits >90% identity to the instant SEQ ID NO: 1 and has an Ala at position 29. Regarding claim 8, as stated above, Chambers teaches introducing Ala to position 29 of the Hv1a variant. Regarding claim 9, Chambers describes synthesizing and purifying the Hv1a variant, which includes suitable diluents (Pg 1339, left column, “Peptide synthesis and purification”). The resultant Hv1a variants are then evaluated for insecticidal activity (Pg 1339, right column, “Binding assays,” second paragraph; Figure 7; Pg 1345, left column, “Relevance of the binding site to insecticidal activity” – right column, first paragraph) . Double Patenting 08-33 AIA 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. 08-35 AIA Claim s 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-11 of copending Application No. 18/258,636 (‘636 reference application; claim set filed 6/21/2023) . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of copending Application No. ‘636 anticipate the instant claims. The claims of copending Application No. ‘636 are drawn to an insecticidal composition comprising at least one cyclic peptide with at least 90% sequence identity to one of SEQ ID NO: 1, 2, or 6 and at least one peptide with at least 90% identity to SEQ ID NO: 3 or 5 or a variant thereof where the variant has a mutation at position 29. SEQ ID NO: 3 of copending Application No. ‘636 is identical to the instant SEQ ID NO: 1. This reads on a composition comprising a pestidicially effective amount of a peptide as recited in the instant claims 1 and 9 . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Prior Art Cited but not Referenced Tedford et al. (Scanning mutagenesis of omega-atracotoxin-Hv1a reveals a spatially restricted epitope that confers selective activity against insect calcium channels. J Biol Chem. 2004 Oct 15;279(42):44133-40.) teaches the same subject matter as Chambers above, wherein alanine scanning mutagenesis results in the substitution of Asn29 to Ala in Hv1a. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST. 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, Melissa L Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658 /Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658 Application/Control Number: 18/258,720 Page 2 Art Unit: 1658 Application/Control Number: 18/258,720 Page 3 Art Unit: 1658 Application/Control Number: 18/258,720 Page 4 Art Unit: 1658 Application/Control Number: 18/258,720 Page 5 Art Unit: 1658 Application/Control Number: 18/258,720 Page 6 Art Unit: 1658 Application/Control Number: 18/258,720 Page 7 Art Unit: 1658 Application/Control Number: 18/258,720 Page 8 Art Unit: 1658 Application/Control Number: 18/258,720 Page 9 Art Unit: 1658 Application/Control Number: 18/258,720 Page 10 Art Unit: 1658 Application/Control Number: 18/258,720 Page 11 Art Unit: 1658 Application/Control Number: 18/258,720 Page 12 Art Unit: 1658 Application/Control Number: 18/258,720 Page 13 Art Unit: 1658
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