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 .
THIS IS A TRACK ONE APPLICATION.
Priority
The instant application, filed 03/25/2025 and having 1 RCE-type filing therein is a Divisional of 18492006 , filed 10/23/2023, now U.S. Patent # 12279621 and having 1 RCE-type filing therein.
Claim Status
Claims 1 and 6-8 are pending.
Claims 2-5 are cancelled.
Claims 1 and 6-8 are rejected.
Information Disclosure Statement
The Examiner has considered the reference(s) provided in the 8/4/26 Information Disclosure Statements, except where crossed through, and provides a signed and dated copy of such herewith.
Claim Interpretation – Retained for the Record and Supplemented
The claims terms are given their broadest reasonable interpretation (“[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 75 USPQ2d 1321, 1326 (Fed. Cir. 2005) (en banc).) The broadest reasonable interpretation of the claims must also be consistent with the interpretation that those skilled in the art would reach.” MPEP 2111, with reference to In re Cortright, 49 USPQ2d 1464, 1468.
In claim 1, when R1 is hydrogen, this is interpreted to be one of the two hydrogens attached to the amino group of the N-terminus amino acid. When Y1 is absent, this hydrogen is interpreted to be one of the hydrogens of the N-terminus asparagine of Z’s SEQ ID NO:1. To interpret this in another way would conflict with the normal valency of N-terminus amino groups.
Also, MPEP 2103 states in part, “Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation.” Further, MPEP 2111.04 states in part, “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.”
Accordingly, the “optionally substituted” language of claim 2, and the “optionally” language of claims 3, 6 and 7 do not limit the scope of the respective claim or claim limitation.
Supplementing the above, considering the ordinary and customary approaches to formulaically indicate a C-terminus amidation, the examiner interprets the “[NH2]” of the claim 1 formula on line 5 to represent an amidated form of the C-terminus leucine, replacing the carbonyl -OH, thus forming at the C-terminus (-CONH2), an amidated form of this terminus. Any disagreement with this interpretation should be made of record with appropriate support for the applicant’s differing interpretation.
Per para 299 of the corresponding PGPUB No. 20250261651, “Adjuvants may enhance product performance, for example, by increasing the efficiency of the delivery of active ingredients, reducing the level of active ingredient required, or extending the spectrum of effectiveness.” A solvent, carrier or diluent that enhances product performance such as by increasing the efficiency of the delivery of active ingredient therefore also is an adjuvant.
Per para 320 of the corresponding PGPUB No. 20250261651, where it states, “The composition may comprise one or more synergists, i.e. compounds which increase the efficacy of insecticides against their targets, often by inhibiting an insect's ability to metabolise the active agent,” notwithstanding the second sentence, “Common synergists include piperonyl butoxide and MGK-264 (n-octyl bicycloheptane dicarboximide), or peptidase inhibitors,” a solvent, carrier or diluent which increases the efficacy of insecticides against their targets therefore also is a synergist.
As indicated above, the examiner interprets compound class terms such as adjuvants and synergists to be encompassed, depending on a particular fact or circumstance, by other class terms, such as carrier, diluent and solvent.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Response to Arguments
Applicant's arguments filed 8/4/26 have been fully considered but they are not persuasive.
As stated in the application specification, “[0308] Aqueous dispersants may be used, for example, to improve stability in the spray tank after dilution in water, and may include modified styrene acrylic polymers, and polymeric amphoteric dispersants and adjuvants.”
Applicant’s amendment extends the concept of stability from aqueous dispersants to improving stability generally, which is not supported in the application as filed.
This basis of rejection can be overcome by adding after “… that improves stability of the insecticidal compound” the following “in a spray tank after dilution with water”, this conforming to the specification statement.
Claims 1 and 6-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 states in part, as to the agricultural composition, “wherein the dispersant is in an amount that increases spray retention, spreading, foliar uptake, and penetration enhancement of the insecticidal compound or improve stability of the insecticidal compound in an oil dispersion, or wherein the dispersant is an aqueous dispersant in an amount that improves stability of the insecticidal compound.”
Apart from generic listings that include the word dispersants, the specification states the following regarding dispersants (from PGPUB):
[0306] Dispersants may be aqueous or non-aqueous. An oil dispersion (OD) formulation typically comprises a solid active ingredient dispersed in oil. The oil can vary from paraffinic to aromatic solvent types and vegetable oil or methylated seed oils. Typically the active ingredient is uniformly suspended in the oil phase. Although primarily used for water sensitive active ingredients, OD formulations have extended to other active ingredients due to their better spray retention, spreading, foliar uptake, and penetration enhancement (e.g. across the insect cuticle) as the carrier oil often acts as an adjuvant.
[0307] Oils suitable for use in OD dispersions include linseed, rapeseed and soyabean oils.
[0308] Aqueous dispersants may be used, for example, to improve stability in the spray tank after dilution in water, and may include modified styrene acrylic polymers, and polymeric amphoteric dispersants and adjuvants.
(Above para 306 corresponds to the previously recited para 280 of the specification on pages 43-44.)
There is no support in the application as filed for claim 1’s broad statement about extending the concept of stability from aqueous dispersants to improving stability generally (beyond in the spray tank), nor of improving the stability of the insecticidal compound itself.
Claim 1 accordingly is rejected based on the above, and claims depending from claim 1, claims 6-8, also are rejected based on the rejections of claim 1 under this section.
Claim Rejections - 35 USC § 101
Response to Arguments
Applicant’s arguments, see pages 1-3, filed 8/4/26, with respect to Claims 1 and 6-8 rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. have been fully considered and are persuasive. The rejection of claims 1 and 6-8 under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more has been withdrawn. At a minimum the adjuvant limitation provides a markedly different characteristic to the agricultural composition.
Claim Rejections - 35 USC § 103
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.
Response to Arguments
Applicant's arguments filed 8/4/26 have been fully considered but they are not persuasive.
As to applicant arguments at bottom of page 4 (note Remarks’ pages are not numbered), applicant overlooks or ignores Fonagy’s Abstract’s statement, “The rationale behind this approach is, that, since neuropeptides regulate key biological processes, these “special agents” or their synthetic analogues, mimetics, agonists or antagonists may be effective tools in combating insect pests in an environmentally more sound manner than with conventional pesticides,” (underline emphasis added) which includes insect neuropeptides as “special agents” in the alternative to “their synthetic analogues, mimetics, agonists or antagonists” so suggests their use “as is”. This clearly responds to applicant’s argument of “no clear and unambiguous teaching …” on page 5 of Remarks. Improvements to penetrate cuticle, etc., do not take away from this basic statement and suggestion.
As to applicant arguments against Lee (“no suggestion that PBANs …”), in response to applicant's arguments against the references individually, 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). This also applies to a similar argument against Boerjan (the third argument) at least with regard to those made against species of insect (i.e., distinguishing Locusta migratoria and Plutella xylostella).
Particularly against the first argument against Boerjan, please note the following from its first page, “However, only very few cases of a clear physiological effect upon oral uptake of an insect peptide have as yet been reported, namely trypsin modulating oostatic factor (TMOF) [3,4] and pheromone biosynthesis activating neuropeptide (PBAN) [11].” This clearly extends beyond applicant argument the overall prior art teachings and use of oral uptake effect, including specifically for the class of PBANs, which contain the PRXamide motif, and counters applicant specific arguments against Boerjan as not dealing with PBANs (“so belongs to a different class of insecticides” is thus countered). A reference is good for all it teaches, and the teachings of Boerjan encompass knowledge in the art not only of dispersing corazonin in vegetable oil for oral administration to an insect, but also per the above of a PBAN, and a TMOF, so suggests broader applicability than applicant argues. Specifically at to the second argument against Boerjan, the broad use of vegetable oil for oral ingestion by insects would not reasonably only be understood to apply to the specific considerations of Boerjan for its specific peptide because Boerjan teaches such use more broadly, for instance on its first page, “Lipidization is a technique used in the pharmaceutical industry for improving the efficacy of some drugs upon oral intake [5,9,16].” As to the fourth argument against Boerjan, applicant appears to conjecture, without technical reasoning nor evidence, that a slow release (which does not necessarily follow based on use of vegetable oil dispersion) “may or may not be desirable.” As such this is unpersuasive.
Claim(s) 1 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Adrien Fonagy, Acta Phytopathologica et Entomologica Hungarica 41 (1–2), pp. 137–152 (2006) (“Fonagy”, previously provided), in view of Lee and Boo, Peptides 26 (2005) 2404–2411 (“Lee”), previously provided, Martins, Insect Molecular Biology (2012) 21(4), 414–421 (“Martins”), previously provided, and Boerjan et al., Peptides 32 (2011) 1536-1539 (“Boerjan”, previously provided).
Claim 1 is as follows:
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Fonagy broadly teaches the need and importance of potential application of insect neuropeptides for pest control, Title, Abstract, the Abstract specifically teaching, “Thanks to the development of insect neuroendocrinology – in parallel to this – an even increasing need for modern, yet environmentally sound strategies of plant protection has arisen, becoming a driving force for insect physiologists to concentrate their efforts to combat pests more efficiently. The ultimate aim of these researchers is, however, not the total eradication of harmful insects, but rather, selective targeting by using species- or group-specific control strategies which can only be achieved by taking note of recent results in insect physiology, endocrinology, biochemistry and ecology. The rationale behind this approach is, that, since neuropeptides regulate key biological processes, these “special agents” or their synthetic analogues, mimetics, agonists or antagonists may be effective tools in combating insect pests in an environmentally more sound manner than with conventional pesticides,” underline emphasis added.
Fonagy thus suggests the use of insect neuropeptides for application to pest control, in a manner that is species-specific or alternatively group-specific, and in the body of the article discusses particular PBANs (pheromone biosynthesis activating neuropeptides), but does not teach the specifically claimed peptide of SEQ ID NO:2.
The level of ordinary skill in the art is high, and the person of ordinary skill in the art has an advanced degree in chemistry, biology, or biochemistry, and many such persons have training and/or education in insect pest management techniques.
Lee, however, teaches sequencing the gene encoding PBAN in the diamondback moth Plutella xylostella, Title, Abstract.
Lee identifies the specifically claimed amino acid sequence NADEDQQQSVDFTPRL (this also the elected peptide) as beta-NP (beta neuropeptide), Fig. 1 page 2407. This sequence, NADEDQQQSVDFTPRL is one of several distinct neuropeptides identified by Lee, Id. Further, Lee teaches that “All of the peptides are amidated in their C-termini and shared a conserved motif, FXPR(or K)L structure, as reported from other PBAN cDNAs,” Abstract, meeting the C-terminus amidation limitation for the elected and claimed species of peptide compound.
Lee suggests that this and other PBAN-like peptides “can act as PBAN in the moth, based on the report that all peptides containing the FXPRL-NH2 motif in their C-termini are involved in pheromonotropic activity,” page 2409.
While Fonagy does not teach this particular PBAN for use in pest control, a particular motivation for using this selected peptide is that this neuropeptide may have greater specificity to physiologically affect individuals of this moth species versus other moths and other insects. This is because this beta neuropeptide sequence comprising in its entirety NADEDQQQSVDFTPRL has the least ‘homology’, ranging from 35-38.8% identity, compared with other moth sequences, examine Table 1 page 2407 and Figure 1, page 2408, and associated text. This would suggest that it is more specific to this moth species, a clear advantage when desiring per Fonagy to be species specific, so as to not harm non-target insects. A PBAN peptide having lower identity compared with closer species on its face would be a better selection when considering Fonagy’s ‘selective targeting’ approach for species- or group-specific insect control strategies, see Abstract and last paragraph of page 146.
A further key motivation to focus on this peptide identified by Lee for pest control, rather than any others such as those set forth in Fonagy, is that Martins, Abstract, teaches that the diamondback moth Plutella xylostella is one of the most economically important agricultural pests, its larvae causing damage by feeding on the foliage of cruciferous vegetables. In view of this economic importance, this would substantially raise interest to select such peptide by one of ordinary skill in the art who is developing insect control peptides for specific agricultural pest insects. (Emphases added)
Therefore considering the teachings of the references cited thus far one of ordinary skill in the art would have considered using one of Lee’s FTPRL-ending beta neuropeptide sequences to mimic or antagonize the receptor of the diamondback moth, so to function as an active ingredient in an agricultural composition that can be used to spray or otherwise apply onto plants of interest to control and/or reduce infestation of an agricultural crop by the diamondback moth (that is, as the active agent of an insect control or plant protection type of agricultural composition). Per above based on the distance in sequence identity from other species’ PBANs this approach reasonably would be more species specific on its effect on this moth versus other moths and other insects so as to improve the probability of administering it to affect the diamondback moth target species rather than other insect and moth species that may not be harmful to agriculture including those that might be beneficial.
Neither Fonagy, Lee nor Martin explicitly teach this insecticidal compound, the claimed peptide having the formula of claim 1, admixtured with one or more adjuvants, preservatives, dispersants, emulsifying agents, or synergists that are in amounts to achieve their respective functions as set forth in claim 1 in functional limitations.
However, Boerjan teaches that dispersion of the insect neuropeptide corazonin in vegetable oil is a simple slow release approach to oral uptake in the selected insect, an albino locust deficient in corazonin, Title, Abstract. Boergan’s results indicate that dispersing corazonin in vegetable oil improves the effect of the dispersed peptide when taken orally by an insect, see Fig. 1 and associated text, so one of ordinary skill in the art would be motivated to formulate the Lee beta neuropeptide NADEDQQQSVDFTPRL-[NH2] (identical to what is claimed when considering Lee teaches such neuropeptides are C-terminally amidated) in a composition comprising an oil such as vegetable oil to improve oral uptake by the insect of interest, here the economically important diamondback moth. Such vegetable oil would function at least as an adjuvant to increase the delivery of the insecticidal compound, here the Lee beta neuropeptide NADEDQQQSVDFTPRL-[NH2].
In view of the respective teachings of the applied references, there would have been a reasonable expectation of success for formulating the amidated beta neuropeptide of Lee with a vegetable or other oil, which per Boerjan would provide for simple slow release and also improve its effect when taken orally by the target insect the diamondback moth. Based on the definitions of terms, see Claim Interpretation above, such vegetable oil so would function as so be classified as an adjuvant (and also as synergist, as well as a carrier and diluent, and also possibly solvent depending on behavior of the peptide in the oil).
Accordingly, claims 1 and 7, which merely further specifies two agricultural composition types, both related to insect control, would have been obvious.
Claim 8 also would have been obvious because the oil taught by Boerjan is a carrier and a diluent.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Adrien Fonagy, Acta Phytopathologica et Entomologica Hungarica 41 (1–2), pp. 137–152 (2006) (“Fonagy”, previously provided), in view of Lee and Boo, Peptides 26 (2005) 2404–2411 (“Lee”), previously provided, Martins, Insect Molecular Biology (2012) 21(4), 414–421 (“Martins”), previously provided, and Boerjan et al., Peptides 32 (2011) 1536-1539 (“Boerjan”, previously provided), as applied to claim 1 above, and further in view of “Suspension Concentrates”, Stepan Agricultural Solutions, 4 pages, 2021 (“Stepan”, previously provided), as evidenced by Batta, MethodsX 3 (2016) 119-127 (“Batta”, previously provided).
Claim 1 is rejected as set forth above.
Claim 6 depends from claim 1 and requires that the composition according to claim 1 is an aqueous composition.
Although it is clear from Boerjan and previously applied prior art that lipid moieties and/or lipid solvents aid in penetration and/or uptake of compounds by insects, so that these references might not initially appear supportive of a purely aqueous solution of a non-lipidated insect neuropeptide for applying to control insects, Stepan teaches that suspension concentrates are useful aqueous solutions used in agriculture. Per Stepan suspension concentrates are “formulations that consist of insoluble, solid active ingredients suspended in water with the aid of dispersing and wetting agents for safer and better application onto crop surfaces,” page 1. Among listed advantages are dustless, absence of flammable liquids improves storage and transportation safety, and adjuvants can be built in to enhance performance. The active ingredient can be from 5 to 80 percent on a weight/volume percent, with water to 100% after other components, page 1.
Based on the teachings of Stepan combined with those of the references applied to claim 1, one of ordinary skill in the art, toward preparing and distributing effective agricultural compositions comprising the claim 1 formula peptide admixed with one or more adjuvants or other claimed components, would have been motivated to provide these in a suspension concentrate formulation, such as for preparing and shipping, for later and further on-site preparation/dilution prior to use. Based on the teaching of Boerjan, the latter could include combining with oil for better uptake; Stepan’s inclusion of its BIO-SOFT® NC-10 nonionic emulsifier as one of a few specified adjuvants for suspension concentrate formulations also would suggest to one of ordinary skill in the art that the final dispersed product could be an emulsion formed from the aqueous suspension concentrate when mixed with oil at the site of use. As evidenced by Batta, pages 126-127, Additional Information Background, invert emulsions (water-in-oil type) are used in a number of types of formulations, including as insect biocontrol agents. At least one motivation to provide the claim 1 formula peptide in a suspension concentrate is to improve storage and transportation safety. There would have been a reasonable expectation of success given the teachings of Stepan, and also those of Boerjan.
Accordingly claim 6 would have been obvious.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 JOSEPH FISCHER whose telephone number is (571)270-7925. The examiner can normally be reached on Monday to Friday, 9:00 AM to 5:00 PM, however noting that the examiner will not normally be working on Wednesday-Friday and on Monday/Tuesday on alternating weeks, but will promptly answer messages upon his return to work.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER, can be reached on 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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/JOSEPH FISCHER/Primary Examiner, Art Unit 1658
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