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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/28/25 has been entered.
Election/Restrictions and Claim Status
Applicants’ amendments and arguments and declaration filed 8/28/25 are acknowledged.
Previously, Group 2 and the species of [Hy]-PAFSSWG-[NH2] were elected.
Claims 1-7, 10, 13 and 15-24 have been canceled.
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 25-26 have been added as new claims.
Claims 8-9, 11-12, 14 and 25-26 are being examined.
Priority
The priority information is provided in the filing receipt dated 11/16/23.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/13/25 has been considered by the examiner.
Claim Rejections - 35 USC § 103
Claims were previously rejected based on the references cited below. An updated rejection appears below.
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.
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) 8-9, 11-12, 14 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherkenbeck et al. (NPL cite 2 of IDS 3/21/24; ‘Scherkenbeck’) in view of Huybrechts et al. (NPL cite 8 of IDS 3/21/24; ‘Huybrechts’) in view of Alford et al. (Foreign patent citation 1 of IDS 3/21/24; ‘Alford’).
Scherkenbeck teach insect neuropeptides for insect control (title and abstract). Scherkenbeck teach that the mode of action of the majority of the peptides is comparable to commercial insecticides with applications in crop protection (page 4072 first paragraph). Scherkenbeck specifically teach myokinins including leucokinins which comprise PAFNSWGamide (leucokinin I Table 3) and PGFSSWGamide (leucokinin II Table 3) and AFSSWGamide (locustakinin Table 3). Scherkenbeck teach the peptides with myotropic and diuretic activities (page 4074 last paragraph). Scherkenbeck teach the short sequences and interference of vital physiological processes renders the myokinins as prime candidates (page 4074 last paragraph). Scherkenbeck teach the development of effective delivery systems to address peptide instability (page 4071 last complete paragraph). With respect to myokinins, Scherkenbeck teach that the in vivo activity of helicokinin I (which comprises WGamide see Table 3) increases significantly following addition of ACE inhibitors such as captopril or enalapril which suppress the proteolytic degradation of the kinins (page 4074 last paragraph).
Scherkenbeck does not teach administration of a peptide as claimed.
Huybrechts teach that known leucokinins include PAFSSWGamide (table 1). Huybrechts recognizes that leucokinins and pyrokinins are structurally similar peptides (page 88 2nd column first complete paragraph).
Alford teach peptides having activity against aphids for plant protection (abstract). Alford teach peptides that are pyrokinins (page 2 first paragraph). Alford teach methods of inhibiting infestations of a plant comprising contacting the plant with a peptide (claims 19-21). Alford teach dispersants that are known to improve stability (page 31 lines 4-6). Alford teach application by spraying (page 43). Alford teach a composition with a carrier (claim 53) specifically an aqueous composition (claim 54). Alford teach agents to increase bioavailability (page 30 lines 23-27). Alford refers to leucokinins and myokinins (page 47 first reference, page 50 2nd – 4th and 7th references). Alford recognizes synthesis of peptides (page 32 last complete paragraph and pages 32-33 connecting paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Scherkenbeck based on the teachings and suggestions of Scherkenbeck. Scherkenbeck teach insect neuropeptides for insect control (title and abstract) including leucokinins (Table 3). Huybrechts teach that known leucokinins include PAFSSWGamide (table 1). Thus one would have been motivated to use the known peptide taught by Huybrechts. Since Scherkenbeck suggest insect control and effective delivery systems one would have been motivated to use components taught by Scherkenbeck. Since Scherkenbeck teach that the in vivo activity of helicokinin I (which comprises WGamide see Table 3) increases significantly following addition of ACE inhibitors such as captopril or enalapril which suppress the proteolytic degradation of the kinins (page 4074 last paragraph) one would have been motivated to include ACE inhibitors with the kinin peptides. Since Scherkenbeck suggest insect control and effective delivery systems, one would have been motivated to perform via the known steps taught by Alford (claims 19-21) using the known carriers taught by Alford (claims 53-54). One would have had a reasonable expectation of success since methods of administration were known (see Alford claims 19-21) and methods of synthesizing peptides were known (Alford page 32 last complete paragraph and pages 32-33 connecting paragraph). Further, Scherkenbeck teach similar peptides to the peptide of Huybrechts with myotropic and diuretic activities (page 4074 last paragraph) and Scherkenbeck teach that the mode of action of the majority of the peptides is comparable to commercial insecticides with applications in crop protection (page 4072 first paragraph). Further, Scherkenbeck teach that the in vivo activity of helicokinin I (which comprises WGamide see Table 3) increases significantly following addition of ACE inhibitors such as captopril or enalapril which suppress the proteolytic degradation of the kinins (page 4074 last paragraph).
In relation to the peptide as recited in claims 8 and 12, Huybrechts teach PAFSSWGamide (table 1) which corresponds to the elected species where R1 is hydrogen, Y1 is absent, R2 is NH2 and Z is PAFSSWG. In relation to the admixture, Alford teach dispersants that are known to improve stability (page 31 lines 4-6). Alford teach a composition with a carrier (claim 53). Alford teach agents to increase bioavailability (page 30 lines 23-27).
In relation to the contacting of claims 8-9 and 12, Alford teach contacting (claims 19-21).
In relation to the insect of claims 8 and 12, Alford expressly recites aphids (abstract) including Myzus persicae (page 27 lines 18-21).
In relation to claims 11 and 14, Alford teach spraying (page 43 for example).
In relation to claims 25-26, Alford teach a composition with a carrier (claim 53) specifically an aqueous composition (claim 54).
Response to Arguments - 103
Applicant's arguments and declaration filed 8/28/25 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue about a lack of reason to combine, MPEP 2143.01 I recognizes that the motivation to combine references can be found in the nature of the problem to be solved and that the courts have rejected the requirement of an express written motivation to combine. Since Scherkenbeck suggest insect control and effective delivery systems one would have been motivated to use components taught by Scherkenbeck. Since Scherkenbeck teach that the in vivo activity of helicokinin I (which comprises WGamide see Table 3) increases significantly following addition of ACE inhibitors such as captopril or enalapril which suppress the proteolytic degradation of the kinins (page 4074 last paragraph) one would have been motivated to include ACE inhibitors with the kinin peptides. Scherkenbeck suggest insect control and effective delivery systems so one would have been motivated to perform via the known steps taught by Alford (claims 19-21) using the known carriers taught by Alford (claim 53). Scherkenbeck teach insect neuropeptides for insect control (title and abstract) including leucokinins (Table 3) so one would have been motivated to use the known leucokinins taught by Huybrechts that include PAFSSWGamide (table 1).
Although applicants argue (including via the declaration) that Alford does not teach delivery systems that can overcome the rapid degradation of natural peptides in the digestive system of insects, the instant rejection is a multiple reference 103 rejection and as such any single reference does not necessarily anticipate the claims. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the instant case, Scherkenbeck teach that the in vivo activity of helicokinin I (which comprises WGamide see Table 3) increases significantly following addition of ACE inhibitors such as captopril or enalapril which suppress the proteolytic degradation of the kinins (page 4074 last paragraph).
Applicants own specification (page 44 section 00284) recites ‘agents which prevent degradation of the insecticidal compounds’ such as proteases.
Although applicants argue about peptidomimetic approaches, the instant claims recite ‘the compound in admixture’. Thus, the instant claims are not requiring administration of the naked peptide. MPEP 2123 II expressly recognizes that “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed”. Further, MPEP 2143.01 I recognizes that the disclosure of desirable alternatives does not negate a suggestion for modifying the prior art.
In the instant case, Scherkenbeck provides at least two alternatives to address the peptide stability issue: effective delivery systems and chemical modification. First, Scherkenbeck refers to ‘effective delivery systems’ (last complete paragraph on page 4071). Scherkenbeck teach that the in vivo activity of helicokinin I (which comprises WGamide see Table 3) increases significantly following addition of ACE inhibitors such as captopril or enalapril which suppress the proteolytic degradation of the kinins (page 4074 last paragraph). Alford teach dispersants that are known to improve stability (page 31 lines 4-6). Alford teach agents to increase bioavailability (page 30 lines 23-27). Another alternative as set forth by Scherkenbeck, which is described as a strategy from the chemist’s point of view, is chemical modification of the neuropeptides (paragraph connecting pages 4071-4072). The teaching of chemical modification as an alternative does not discredit the use of effective delivery systems.
Scherkenbeck teach that the mode of action of the majority of the peptides is comparable to commercial insecticides with applications in crop protection (page 4072 first paragraph). Alford which was published in 2020 (many years after the 2009 date of Scherkenbeck) teach compositions (pages 29-31) and recognizes agents that are known to improve stability (page 31 lines 4-6) and increase bioavailability (page 30 lines 23-27). MPEP 2143.03 III recognizes that predictability is determined at the relevant time. In this case, Alford was published in 2020 which is much closer in time to the effective filing date of the instant claims.
Although applicants argue via the declaration about a primary hydrolysis site that is susceptible to cleavage via ACE based on a Smagghe and Nachman references, Scherkenbeck teach that the in vivo activity of helicokinin I (which comprises WGamide see Table 3) increases significantly following addition of ACE inhibitors such as captopril or enalapril which suppress the proteolytic degradation of the kinins (page 4074 last paragraph). Applicants own specification (page 44 section 00284) recites ‘agents which prevent degradation of the insecticidal compounds’ such as proteases.
Although applicants argue via the declaration about a secondary hydrolysis site N-terminal to Phe1 based on a Smagghe and Nachman references, Huybrechts teach PAFSSWGamide (table 1). There is no Phe at position 1 so such hydrolysis site does not appear to be present.
Although applicants argue about peptidomimetic approaches mentioned in Smagghe and Nachman, the instant claims recites ‘the compound in admixture’. Thus, the instant claims are not requiring administration of the naked peptide. MPEP 2123 II expressly recognizes that “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed”. Further, MPEP 2143.01 I recognizes that the disclosure of desirable alternatives does not negate a suggestion for modifying the prior art.
Although applicants argue about no reasonable expectation of success including via declaration arguments, MPEP 2143.02 I recognizes that conclusive proof of efficacy is not required and MPEP 2143.02 II states that obviousness does not require absolute predictability. In the instant case, Scherkenbeck teach insect neuropeptides for insect control (title and abstract). Scherkenbeck teach that the mode of action of the majority of the peptides is comparable to commercial insecticides with applications in crop protection (page 4072 first paragraph). Scherkenbeck teach known activities of peptides with the highly conserved core of FX1X2WGamide where X1 and X2 can be S (section 2.2 on pages 4074-4075) which corresponds to the last 5 residues of the peptide recited in the instant claims. Scherkenbeck teach that the in vivo activity of helicokinin I (which comprises WGamide see Table 3) increases significantly following addition of ACE inhibitors such as captopril or enalapril which suppress the proteolytic degradation of the kinins (page 4074 last paragraph). Alford teach methods of inhibiting infestations of a plant comprising contacting the plant with a peptide (claims 19-21). Alford teach dispersants that are known to improve stability (page 31 lines 4-6). Alford teach application by spraying (page 43). Alford teach a composition with a carrier (claim 53). Alford teach agents to increase bioavailability (page 30 lines 23-27). One would have had a reasonable expectation of success based on the express teachings and suggestions. Additionally, it is noted that the instant claims refer to ‘inhibiting infestation’ or ‘reducing’ an infestation. The specification refers to inhibiting as reducing the rate of (section 0092) and thus does not require complete eradication.
Although applicants argue about claim limitations related to specific insects, instant claims 8 and 12 specifically refer to ‘contacting the plant or a part thereof’ and ‘a site on which the plant is growing or is intended to be grown’. Thus, the active step is contacting a plant (not necessarily contacting a specific insect). In relation to the contacting of claims 8-9 and 12, Alford teach contacting (claims 19-21). In relation to the insect of claims 8 and 12, Alford expressly recites aphids (abstract) including Myzus persicae (page 27 lines 18-21).
In summary, the affidavit under 37 CFR 1.132 filed 8/25/23 is insufficient to overcome the rejection of the claims under 103 as set forth above because: MPEP 716.01(c) states that with respect to opinion testimony that the examiner must consider: “the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion”.
In the instant case it appears that the nature of the matter sought is to overcome the 103 rejection. With respect to the strength of the opposing evidence specifically with respect to arguments about stability, Scherkenbeck teach that the in vivo activity of helicokinin I (which comprises WGamide see Table 3) increases significantly following addition of ACE inhibitors such as captopril or enalapril which suppress the proteolytic degradation of the kinins (page 4074 last paragraph). Thus, Scherkenbeck provides strong support for a known ability to suppress degradation and allow for in vivo activity. Applicants own specification (page 44 section 00284) recites ‘agents which prevent degradation of the insecticidal compounds’ such as proteases. With respect to interest of the expert, the affidavit is signed by one of instant inventors who presumably has a vested interest in the outcome of the case. With respect to the presence or absence of factual support, additional references relate to stability of a naked peptide but the instant claims are not limited to administration of a naked peptide. Instant claims 8 and 12 expressly refer to compositions which can comprise additional components (such as protease inhibitors). In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658