DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Non-final office action filed on 9/3/2026 is acknowledged.
3. Claim filed on 9/3/2026 is acknowledged.
4. Claim 11 has been cancelled.
5. New claims 12-19 have been added.
6. Claims 1-10 and 12-19 are pending in this application.
7. Claims 6-10 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.
8. Applicant elected without traverse of Group 1 (claims 1-5) and elected without traverse of an insecticidal composition comprising (a) a cyclic peptide consisting of SEQ ID NO: 1 and (b) a peptide consisting of SEQ ID NO: 3 as species of insecticidal composition in the reply filed on 4/13/2026 and the interview held on 4/21/2026.
Restriction requirement was deemed proper and made FINAL in the previous office action. Group 1 is drawn to an insecticidal composition comprising: a. a cyclic peptide comprising the amino acid sequence that is at least 90% identical to any one of SEQ ID NOs: 1, 2, and 6; and b. a second peptide comprising the amino acid sequence that is at least 90% identical to any one of SEQ ID NOs: 3 to 5, or a second peptide comprising a variant of a peptide comprising the amino acid sequence of SEQ ID NO: 3, wherein the amino acid sequence has an amino acid substitution on position N29, and which retains the insecticidal activity of the peptide. A search was conducted on the elected species; and prior art was found. Claims 1-5 and 12-19 are examined on the merits in this office action.
Claim Interpretations
9. Instant claim 3 remains interpretated as set forth in Section 9 of the Non-final office action dated 6/3/2026.
Withdrawn Objections and Rejections
10. Objection to the specification is hereby withdrawn in view of Applicant’s amendment to the specification.
11. Objection to claim 5 is hereby withdrawn in view of Applicant’s amendment to the claim.
12. Rejection to claims 1-3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is hereby withdrawn in view of Applicant’s amendment to the claim.
Maintained/Revised Objections
13. (Revised due to Applicant’s amendment to the claim) Claim 1 remains objected to for the following minor informality: Applicant is suggested to amend claim 1 as "An insecticidal composition comprising: (a) a cyclic peptide comprising the amino acid sequence that is at least 90% identical to any one of SEQ ID NOs: 1, 2 and 6; and (b) a second peptide comprising the amino acid sequence that is at least 90% identical to any one of SEQ ID NOs: 3 to 5, or a second peptide comprising a variant of SEQ ID NO: 3 with N29 being substituted".
14. (Revised due to Applicant’s amendment to the claim) Claim 2 remains objected to for the following minor informality: Applicant is suggested to amend claim 2 as “…wherein the cyclic peptide comprises the amino acid sequence of any one of SEQ ID NOs: 1, 2 and 6; and the second peptide comprises the amino acid sequence of any one of SEQ ID NOs: 3 to 5, or the second peptide comprises a variant of SEQ ID NO: 3 with N29 being substituted”.
15. (Revised due to Applicant’s amendment to the claim) Claim 3 remains objected to for the following minor informality: Applicant is suggested to amend claim 3 as “…wherein N29 in SEQ ID NO: 3 is substituted with A, L, P or T”.
16. (Revised due to Applicant’s amendment to the claim) Claim 4 remains objected to for the following minor informality: Applicant is suggested to amend claim 4 as “…wherein the cyclic peptide comprises the amino acid sequence of any one of SEQ ID NOs: 1, 2 and 6; and the second peptide comprises the amino acid sequence of any one of SEQ ID NOs: 3 to 5”.
Response to Applicant's Arguments
17. Applicant fails to address all the minor issues in claims 1-4. Therefore, these objections are deemed proper and are hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 101
18. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
19. (Revised due to Applicant’s amendment to the claim) Claims 1-5 and 12-19 remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-5 and 12-19 are directed to an insecticidal composition comprising multiple natural products.
As evidenced by instant specification, the cyclic peptide of instant SEQ ID NOs: 1 and 2 and the peptides of instant SEQ ID NOs: 3 and 4 are all naturally occurring peptides (see page 2, line 41 to page 3, line 2 of instant specification). And these peptides have insecticidal activity.
Furthermore, with regards to the limitations recited in instant claims 16-19, in the instant case, since the cyclic peptide of instant SEQ ID NOs: 1 and 2 and the peptides of instant SEQ ID NOs: 3 and 4 meet all the structural limitations of the cyclic peptide and/or the second peptide recited in instant claims 1 and 5, the cyclic peptide of instant SEQ ID NOs: 1 and 2 and the peptides of instant SEQ ID NOs: 3 and 4 would necessarily have the inherent property of the cyclic peptide and/or the second peptide recited in instant claims 1 and 5. Therefore, the cyclic peptide of instant SEQ ID NOs: 1 and 2 and the peptides of instant SEQ ID NOs: 3 and 4 have insecticidal activity when ingested by insect recited in instant claims 16-19. And the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
The instant claims 1-5 and 12-19 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed insecticidal composition in instant claims 1-5 and 12-19 does not recite features or steps demonstrating a marked difference from what exists in nature; and the claimed insecticidal composition in instant claims 1-5 and 12-19 does not recite meaningful limitations that add something of significance to the judicial exception. Therefore, the claimed insecticidal composition in instant claims 1-5 and 12-19 is not significantly different than a judicial exception (natural product).
Response to Applicant's Arguments
20. Applicant argues that “Such a two-component composition is not naturally occurring. In other words, the fact that individual components in a composition are naturally occurring does not by itself make the composition "naturally occurring". In other words, claims 1-5 are not directed to a judicial exception.”
21. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner understands that instant claimed insecticidal composition itself does not exist in nature. However, in the instant case, as stated in Section 19 above, instant claims 1-5 and 12-19 are directed to an insecticidal composition comprising multiple natural products. Furthermore, the claimed insecticidal composition does not recite features or steps demonstrating a marked difference from what exists in nature; and the claimed insecticidal composition does not recite meaningful limitations that add something of significance to the judicial exception. Taken all these together, the rejection is deemed proper and is hereby maintained.
Claim Rejections - 35 U.S.C. § 103
22. 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 of this title, 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.
23. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
24. (Revised due to Applicant’s amendment to the claim) Claims 1-5 and 12-19 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Herzig et al (Toxins, 2015, 7, pages 4366-4380, filed with IDS) in view of Cranfield et al (Langmuir, 2017, 33, pages 6630-6637, cited and enclosed in the previous office action), and as evidenced by the Spodoptera littoralis document (accessed 2026, pages 1-6, from https://planthealthportal.defra.gov.uk/data/pests/7009/data).
The instant claims 1-5 and 12-19 are drawn to an insecticidal composition comprising: a. a cyclic peptide comprising the amino acid sequence that is at least 90% identical to any one of SEQ ID NOs: 1, 2, and 6; and b. a second peptide comprising the amino acid sequence that is at least 90% identical to any one of SEQ ID NOs: 3 to 5, or a second peptide comprising a variant of a peptide comprising the amino acid sequence of SEQ ID NO: 3, wherein the amino acid sequence has an amino acid substitution on position N29, and which retains the insecticidal activity of the peptide.
Herzig et al, throughout the literature, teach ω-hexatoxin-Hv1a (Hv1a) is an insecticidal toxin from the deadly Australian funnel-web spider, wherein the Hv1a consists of the amino acid sequence SPTCIPSGQPCPYNENCCSQSCTFKENENG NTVKRCD (identical to the peptide of instant SEQ ID NO: 3), and wherein it inhibits CaV channels in the insect central nervous system, for example, Abstract; page 4367, Figure 1; and page 4368, the 2nd paragraph. It meets the limitations of the second peptide recited in instant claims 1-5. Herzig et al further teach Hv1a exhibits insecticidal activity against Spodoptera littoralis (cotton leafworms), for example, the paragraph bridging pages 4369-4370. And as evidenced by the Spodoptera littoralis document, Spodoptera littoralis infects Gossypium hirsutum (see page 4). It meets the limitations of claims 16-19 that are relevant to the cyclic peptide.
The difference between the reference and instant claims 1-5 and 12-19 is that the reference does not explicitly teach an insecticidal composition comprising (a) a cyclic peptide consisting of SEQ ID NO: 1 and (b) a peptide consisting of SEQ ID NO: 3 as the elected species of insecticidal composition; the limitations of the cyclic peptide recited in instant claims 1-5; the limitations of instant claim 12-15, and the limitations of claims 16-19 that are relevant to the cyclic peptide.
However, Cranfield et al, throughout the literature, teach kalata B1 (kB1) and kalata B2 (kB2) are cyclic disulfide-rich peptides that are chemically and thermally stable and possess insecticidal properties; wherein kB1 consists of the amino acid sequence GLPVCGETCVGGTCNTPGCTCSWPVCTRN (identical to the cyclic peptide of instant SEQ ID NO: 1), and kB2 consists of the amino acid sequence GLPVCGETC FGGTCNTPGCSCTWPICTRD (identical to the cyclic peptide of instant SEQ ID NO: 2); and wherein kB1 and kB2 exert their effect through altering membrane packing constraints and inducing purely lipidic conductive pores, for example, Abstract; and page 6631, Figure 1B.
With regards to the limitations of claims 16-19 that are relevant to the cyclic peptide, in the instant case, kB1 in Cranfield et al is identical to the cyclic peptide of instant SEQ ID NO: 1. The instant specification discloses the cyclic peptide of instant SEQ ID NO: 1 exhibits insecticidal activity against Spodoptera littoralis (see page 66, Table A). Therefore, kB1 in Cranfield et al would necessarily have the inherent property of exhibiting insecticidal activity against Spodoptera littoralis. And the MPEP states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP § 2112.01 II). Since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise. Furthermore, as evidenced by the Spodoptera littoralis document, Spodoptera littoralis infects Gossypium hirsutum (see page 4). Thus, kB1 in Cranfield et al meets the limitations of claims 16-19 that are relevant to the cyclic peptide.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Herzig et al and Cranfield et al to develop an insecticidal composition comprising: a cyclic peptide selected from kB1 (identical to the peptide of instant SEQ ID NO: 1) or kB2 (identical to the peptide of instant SEQ ID NO: 2), and Hv1a (identical to the peptide of instant SEQ ID NO: 3), wherein kB1 and Hv1a exhibits insecticidal activity against Spodoptera littoralis, and wherein Spodoptera littoralis infects Gossypium hirsutum. It reads on an insecticidal composition comprising (a) a cyclic peptide consisting of SEQ ID NO: 1 and for (b) a peptide consisting of SEQ ID NO: 3 as the elected species of insecticidal composition.
Furthermore, one of ordinary skilled in the art would have been motivated to optimize the ratio of the two peptides in the insecticidal composition for better insecticidal activity, including the various ratios recited in instant claims 12-15, such as a weight ratio of the cyclic peptide to the second peptide in the composition is from 5:1 to 1: 5. It meets the limitations of instant claims 12-15. And, the MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (see MPEP § 2144.05 II A).
One of ordinary skilled in the art would have been motivated to combine the teachings of Herzig et al and Cranfield et al with routine optimization to develop an insecticidal composition comprising: a cyclic peptide selected from kB1 (identical to the peptide of instant SEQ ID NO: 1) or kB2 (identical to the peptide of instant SEQ ID NO: 2), and Hv1a (identical to the peptide of instant SEQ ID NO: 3), wherein the weight ratio of the cyclic peptide to the second peptide in the composition is from 5:1 to 1: 5, wherein kB1 and Hv1a exhibits insecticidal activity against Spodoptera littoralis, and wherein Spodoptera littoralis infects Gossypium hirsutum, because Cranfield et al, throughout the literature, teach kalata B1 (kB1) and kalata B2 (kB2) are cyclic disulfide-rich peptides that are chemically and thermally stable and possess insecticidal properties; wherein kB1 (identical to the cyclic peptide of instant SEQ ID NO: 1) and kB2 (identical to the cyclic peptide of instant SEQ ID NO: 2) exert their effect through altering membrane packing constraints and inducing purely lipidic conductive pores. Furthermore, one of ordinary skilled in the art would have been motivated to optimize the ratio of the two peptides in the insecticidal composition for better insecticidal activity, including the various ratio recited in instant claims 12-15, such as a weight ratio of the cyclic peptide to the second peptide in the composition is from 5:1 to 1: 5. And, the MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (see MPEP § 2144.05 II A). In addition, the MPEP states: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose....” (see MPEP § 2144.06 I).
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Herzig et al and Cranfield et al with routine optimization to develop an insecticidal composition comprising: a cyclic peptide selected from kB1 (identical to the peptide of instant SEQ ID NO: 1) or kB2 (identical to the peptide of instant SEQ ID NO: 2), and Hv1a (identical to the peptide of instant SEQ ID NO: 3), wherein the weight ratio of the cyclic peptide to the second peptide in the composition is from 5:1 to 1: 5, wherein kB1 and Hv1a exhibits insecticidal activity against Spodoptera littoralis, and wherein Spodoptera littoralis infects Gossypium hirsutum.
Response to Applicant's Arguments
25. Applicant argues about unexpected results as presented in Tables A, B1, B2, D and E of instant specification.
26. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about unexpected results as presented in Tables A, B1, B2, D and E of instant specification:
First, with regards to the peptide of instant SEQ ID NO: 3 (identical to the ω-hexatoxin-Hv1a (Hv1a) taught in Herzig et al), in the instant case, in view of the teachings of Herzig et al as a whole, one of ordinary skilled in the art would understand and reasonably expect that Hv1a (identical to instant SEQ ID NO: 3) exhibits insecticidal activity against Spodoptera littoralis (cotton leafworms).
Second, in the instant case, the synergistic effect observed in Tables A, B1, B2, D and E of instant specification is NOT unexpected. As stated in Section 24 above, Cranfield et al explicitly teach kB1 (identical to the cyclic peptide of instant SEQ ID NO: 1) and kB2 (identical to the cyclic peptide of instant SEQ ID NO: 2) exert their effect through altering membrane packing constraints and inducing purely lipidic conductive pores. And it is well known in the art that drug interactions in a combination can be caused by relatively simple uptake effects, and synergism results if one drug increases the permeability of the cell membrane to another drug, as disclosed in Bollenbach (Curr Opin Microbiol, 2015, 27, pages 1-9, see for example, page 2, the paragraph on right column) and many others. Therefore, one of ordinary skilled in the art would understand and reasonably expect that any combination of the cyclic peptide of instant SEQ ID NO: 1 or 2 with another insecticidal peptide would result in a synergistic effect.
Third, the Examiner would like to point out that as stated in MPEP: “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." (see MPEP § 716.02(d)); and "The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." (see MPEP § 716.02(b)). In the instant case, the insecticidal composition recited in instant claims 1-5 and 12-19 includes all combinations wherein each peptide at any possible amounts and various ratios between the 2 peptides. Furthermore, the data presented in Tables A, B1, B2, D and E of instant specification do not have any statistical analysis.
Taken all these together, the alleged unexpected results as presented in Tables A, B1, B2, D and E of instant specification are insufficient to overcome instant rejection. And the rejection is deemed proper and is hereby maintained.
The Bollenbach is cited only for the purpose of rebutting Applicant's arguments, therefore, it is not cited as a prior art reference.
Obviousness Double Patenting
27. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
28. (Revised due to Applicant’s amendment to the claim) Claims 1-3, 5 and 12-19 remain/are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 4-6 and 8-20 of co-pending Application No. 18/258720 in view of Cranfield et al (Langmuir, 2017, 33, pages 6630-6637, cited and enclosed in previous office action), and as evidenced by the Spodoptera littoralis document (accessed 2026, pages 1-6, from https://planthealthportal.defra.gov.uk/data/pests/7009/data).
29. Instant claims 1-3, 5 and 12-19 are drawn to an insecticidal composition comprising: a. a cyclic peptide comprising the amino acid sequence that is at least 90% identical to any one of SEQ ID NOs: 1, 2, and 6; and b. a second peptide comprising the amino acid sequence that is at least 90% identical to any one of SEQ ID NOs: 3 to 5, or a second peptide comprising a variant of a peptide comprising the amino acid sequence of SEQ ID NO: 3, wherein the amino acid sequence has an amino acid substitution on position N29, and which retains the insecticidal activity of the peptide.
30. Claims 1, 2, 4-6 and 8-20 of co-pending Application No. 18/258720 are drawn to a hexatoxin peptide variant comprising a. an amino acid sequence which is at least 90% identical to any one of SEQ ID NOs: 27 to 29, wherein the amino acid sequence has at least one amino acid variant on position N27; b. an amino acid sequence which is at least 90% identical to any one of SEQ ID NOs: 2, 6, 7, 30 or 32, wherein the amino acid sequence has at least one amino acid variant on position N28; c. an amino acid sequence which is at least 90% identical to any one of SEQ ID NOs: 1, 3, 4, 5, 8 to 24 or 31, wherein the amino acid sequence has at least one amino acid variant on position N29, wherein the amino acid variant on the respective position is an amino acid R, D, C, Q, E, G, H, I, L, K, M, F, P, S, W, Y or V; d. an amino acid sequence which is at least 90% identical to SEQ ID NO: 25, wherein the amino acid sequence has at least one amino acid variant on position N30; e. an amino acid sequence which is at least 90% identical to SEQ ID NOs: 26, wherein the amino acid sequence has at least one amino acid variant on position N31; or f. an amino acid sequence which is at least 90% identical to SEQ ID NO: 34, wherein the amino acid sequence has at least one amino acid variant on position N32; each of which retain the biological activity of the hexatoxin; with the proviso that the peptide does not comprise the amino acid sequence of SEQ ID NO: 33; a composition comprising a pesticidally effective amount of such peptide; a plant, plant tissue or plant propagation material comprising such peptide or having such peptide applied thereto; and various methods of preparing or using such peptide.
The peptide recited in claims 1, 2, 4-6 and 8-20 of co-pending Application No. 18/258720 meets all the structural limitations of the 2nd peptide recited in instant claims 1-3. And as evidenced by the specification of co-pending Application No. 18/258720, such peptide has insecticidal activity against Spodoptera littoralis (cotton leafworms) that infects (see for example, page 2, lines 29-32; and Table C of the specification). And as evidenced by the Spodoptera littoralis document, Spodoptera littoralis infects Gossypium hirsutum (see page 4).
31. The difference between claims 1, 2, 4-6 and 8-20 of co-pending Application No. 18/258720 and the insecticidal composition recited in instant claims 1-3, 5 and 12-19 is that they do not teach the cyclic peptide recited in instant claims 1-3 and 5; and the limitations of instant claims 12-19.
However, in view of the teachings of Cranfield et al and with routine optimization as set forth in Section 24 above, it would have been obvious to one of ordinary skilled in the art to apply the peptide recited in claims 1, 2, 4-6 and 8-20 of co-pending Application No. 18/258720 and with routine optimization to develop the insecticidal composition recited in instant claims 1-3, 5 and 12-19. And, the MPEP states: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose....” (see MPEP § 2144.06 I).
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Applicant's Arguments
32. Applicant argues that “First, since the rejection relies on Cranfield, which is defective as discussed above, reconsideration and withdrawal are respectfully requested.”; and “Second, without acquiescing to the properness of the rejection, Applicant respectfully requests this provisional rejection to be held in abeyance until allowable matter is indicated.”
33. Applicant's arguments have been fully considered but have not been found persuasive.
With regards to Applicant’s arguments about the cited Cranfield et al reference, these have been addressed in Section 26 above.
Therefore, until a proper terminal disclaimer is filed and approved by the Office, the double patenting rejection is maintained.
New Objections
34. Claims 16 and 17 are objected to for the following minor informality: Applicant is suggested to amend these claims as “…wherein the insect is Spodoptera…”.
35. Claims 18 and 19 are objected to for the following minor informality: Applicant is suggested to amend the term “infests” recited in these claims as “infects”.
New Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Written Description
36. 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.
37. Applicant is required to cancel the new matter in the reply to this Office Action.
Claim 18 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 claims contain 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, at the time the application was filed, had possession of the claimed invention.
The MPEP states that “The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (“If n-propylamine had been used in making the compound instead of n-butylamine, the compound of claim 13 would have resulted. Appellants submit to us, as they did to the board, an imaginary specific example patterned on specific example 6 by which the above butyl compound is made so that we can see what a simple change would have resulted in a specific supporting disclosure being present in the present specification. The trouble is that there is no such disclosure, easy though it is to imagine it.”) (emphasis in original). In Ex parte Ohshiro, 14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989), the Board affirmed the rejection under 35 U.S.C. 112, first paragraph, of claims to an internal combustion engine which recited “at least one of said piston and said cylinder (head) having a recessed channel.” The Board held that the application which disclosed a cylinder head with a recessed channel and a piston without a recessed channel did not specifically disclose the “species” of a channeled piston.” (see MPEP § 2163).
In the instant case, claim 18 recites the limitation “Gossypium spp.”.
With regards to the recited “Gossypium spp.”, the recitation has never been explicitly disclosed and/or discussed in the instant specification. The detailed explanations are as followings:
Lack of Ipsis Verbis Support
The specification is void of any literal support for the limitation “Gossypium spp.” recited in instant claim 18. Therefore, the instant specification fails to provide literal support to such limitation.
Lack of Implicit or Inherent Support
“While there is not in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” See MPEP § 2163. Thus support can be furnished implicitly or inherently for a specifically claimed limitation.
In the instant case, the instant specification discloses Gossypium hirsutum, which is a species of the recited “Gossypium spp.”. However, “Gossypium spp.” is a genus that comprises shrubs and small trees in the mallow family (Malvaceae). Therefore, it is determined that the instant specification fails to provide any implicit or inherent support to the recited “Gossypium spp.”.
Taken all these together, the instant specification fails to provide any types of support to the limitation “Gossypium spp.” recited in instant claim 18.
Conclusion
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.
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
