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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments, filed 9/3/2026 respect to the rejection(s) of claim(s) under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amended claims.
Applicant’s request that the double patenting rejections be held in abeyance is noted. However, they have been maintained/modified herein.
Election/Restrictions
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 1-2, 4-6, and 8-20 are pending. Claims 10-16 are withdrawn. Claims 1, 2, 5, and 8-9 are currently amended. Claims 17-20 are new.
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.
Claim Interpretation
Claims 1-2 and 4-6 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.
Claim 2 is 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
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.
Claims 4-6 are 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 4 recites a variant of SEQ ID NO: 1, wherein the amino acid sequence has an amino acid variant on position N29. However, claim 1, from which claim 4 depends, recites that the amino acid variant of SEQ ID NO: 1 on position N29 1 should be selected from R, D, C, Q, E, G, H, I, L, K, M, F, P, S, W, Y or V. Consequently, claim 4 is broader than its parent claim, claim 1. Claims 5 and 6 are also rejected for this same reasoning. 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 § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 4-6, 8, 9, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US20070066529A1, published 3/22/2007).
King teaches a method of controlling acarine pests comprising applying to the locus of the acarine pests, an isolated polypeptide toxin, wherein the polypeptide toxin has acaricidal activity. In one embodiment, the polypeptide toxin comprises three intrachain disulfide bonds and/or is a component of a venom of an Australian funnel web spider of the genus Atrax or Hadronyche (Abstract). One such peptide is SEQ ID NO: 18, which consists of the sequence SPTCIPSGQPCPYNENCCSQSCTFKENEAGNTVKRCD (N29 to A substitution/variant; emphasis added; [0034]; Sequence Listing; claim 9).
King does not expressly teach the instant SEQ ID NO: 1 wherein N29 is substituted for an amino acid residue selected from R, D, C, Q, E, G, H, I, L, K, M, F, P, S, W, Y or V.
However, King also teaches nonnaturally occurring variants that differ from SEQ ID NO: 18 and retain biological function. The variants may comprise those polypeptides having conservative amino acid changes, i.e., changes of similarly charged or uncharged amino acids. Genetically encoded amino acids are generally divided into four families: (1) acidic (aspartate, glutamate); (2) basic (lysine, arginine, histidine); (3) non-polar (alanine, valine, leucine, isoleucine, proline, phenylalanine, methionine, tryptophan); and (4) uncharged polar (glycine, asparagine, glutamine, cystine, serine, threonine, tyrosine). Phenylalanine, tryptophan, and tyrosine are sometimes classified jointly as aromatic amino acids. As each member of a family has similar physical and chemical properties as the other members of the same family, it is reasonable to expect that an isolated replacement of a leucine with an isoleucine or valine, an aspartate with a glutamate, a threonine with a serine, or a similar replacement of an amino acid with a structurally related amino acid will not have a major effect on the binding properties of the resulting molecule ([0076]).
Based on these teachings, regarding claims 1, 4, 6, 8, and 17-20 it would be obvious to generate a hexatoxin polypeptide comprising SEQ ID NO: 1 with N29 substituted to I, L, K, M, F, P, W, or V. One would be motivated to do so because King teaches SEQ ID NO: 1 with a N29 substitution to A can be used to treat acarine pests and the peptide retains acaricidal activity, and King also teaches further modification of the peptides taught based on conservative substitutions. One would have a reasonable expectation of success given that SEQ ID NO: 1 with the N29 to A substitution retained such activity and conservative substitutions do not impact peptide functionality.
Regarding claims 2 and 5, the substitution of A29 of SEQ ID NO: 18 of King to I, L, K, M, F, P, W, or V would result in 100% sequence identity to the instant SEQ ID NO: 1, wherein the amino acid variant position is not included in the percent identity calculation.
Regarding claim 9, King teaches acaricidal compositions comprising a purified omega-ACTX polypeptide and an agriculturally acceptable carrier ([0111]). Further, regardless of the method of application, the amount of the active component(s) are applied at an acaricidally-effective amount, which will vary depending on such factors as, for example, the specific acarines to be controlled, the specific host or environment to be treated, the environmental conditions, and the method, rate, and quantity of application of the acaricidally-active composition ([0114]).
Double Patenting
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.
Claims 1, 2, 4-6, 8-9, and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-19 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. The claims of copending Application No. ‘636 read on the instant claims and peptides because SEQ ID NO: 3 of copending Application No. ‘636 is identical to the instant SEQ ID NO: 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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.
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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.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
