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 .
Priority
The present application is a National Stage entry of International application PCT/US2021/027834 filed 16 April 2021, which claims the benefit of Foreign application IN202111049368 filed 10/28/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 04/24/2024, in the matter of Application N° 18/704,200. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-12 are pending.
Claims 1-12 are presented for examination and rejected as set forth below.
Claim Objections
Claim 11 is objected to because of the following informalities: the spelling for “agriculturally”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
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.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 10 does not fall within at least one of the four categories of patent eligible subject matter, because instant claim 10 recites both a product (“composition as claimed in claim 9”) and a process (“method as claimed in claim 1” from claim 9), and as reflected in the phrase “the composition as claimed in claim 9”. Claim 10 is thus rejected as follows on the theory that the claim is directed to neither a “process” nor a “product” exclusively.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “selected from the group comprising,” which is an improper Markush grouping and indefinite. See MPEP 2173.05(h).
Claim 10 recites “the composition” (that depends from claim 1 or claim 9), in which there is no term “composition” in claim 1 or 9 (i.e., the composition could be “flupyrimin” and/or “an agriculturally acceptable salts thereof”, etc.). Therefore, there is insufficient antecedent basis, and the Examiner interprets claim 1 to describe flupyrimin to be within a composition. However, clarification is required.
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.
Claims 1-2 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Horikoshi (US20140315839A1; same patent family as WO2013129688A1 cited on the IDS filed 05/24/2024), as evidenced by Onozaki (J. Agric. Food Chem. 2017).
Applicant’s claims are broadly directed to (in independent claim 1): a method of controlling infestation of corn insects comprising: applying flupyrimin or an agriculturally acceptable salts thereof on a plant or a part thereof or at the locus or on plant propagation material.
Regarding nomenclature of flupyrimin, as evidenced by Onozaki, Onozaki teaches flupyrimin = FLP = N-[(E)-1-(6-chloro-3-pyridinylmethyl)pyridin-2(1H)-ylidene]-2,2,2-trifluoroacetamide], as shown below (pg 7865, paragraph 2)).
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Horikoshi teaches a method for applying pest control compositions on plants, including N-[1-((6-chloropyridin-3-yl)methyl)pyridin-2(1H)-ylidene]-2,2,2-trifluoroacetamide (FLP), (Horikoshi – claims 17-18).
Regarding claims 1, 5, and 11: Horikoshi teaches a method for applying pest control compositions on plants, including N-[1-((6-chloropyridin-3-yl)methyl)pyridin-2(1H)-ylidene]-2,2,2-trifluoroacetamide and salt forms (Horikoshi – claims 17-18) (i.e., this compound is flupyrimin [FLP, N-[(E)-1-(6-chloro-3-pyridinylmethyl)pyridin-2(1H)-ylidene]-2,2,2-trifluoroacetamide], as evidenced by Onozaki (pg 7865, paragraph 2)).
Horikoshi teaches FLP for targeting corn leaf aphid (i.e., a “corn insect”) [0208]. Horikoshi teaches pest control by FLP on a seed (Horikoshi - claim 19).
Regarding claim 2: Horikoshi teaches pest control by FLP for Diabrotica virgifera virgifera (reads on “Diabrotica virgifera virgifer”), whereby due to complexity of the species name, it’s unclear which is misspelled) and Spodoptera spp, among many target species [0208].
Regarding claim 6: Horikoshi teaches pest control by FLP, using emulsifiable concentrates, liquid formulations, suspensions, wettable powders, flowables, dust, granules, tablets, oils, aerosols, fumigants and the like [0233] with embodiments found in Preparation Examples 1-15 [0402-0430].
Regarding claim 7: Horikoshi teaches more preferably 100 g active per 100 kg of seeds [0277].
Regarding claim 8: Horikoshi teaches preferable application rates of 1 g to 1 kg per 10 acres [0282]. This mathematically translates (where 1 hectare (ha) = 2.47 acres): 1 g/10 acres to 1 kg/10 acres = 0.1 g/acre to 0.1 kg/acre = 2.5 g/ha to 250 g/ha (i.e., that this range is substantially similar, and also overlapping, to the instant range of 10 to 700 g /ha, and therefore prima facie obvious) [0282]. With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
Regarding claims 9-10: Horikoshi teaches incorporation of additional insecticides (Horikoshi – claim 16). Horikoshi teaches preferred additional agents such as flonicamid (Horikoshi – claim 14) and benzoyl urea-based compounds (reads on “benzoylureas” of claim 10) (Horikoshi – claim 12).
Therefore, the reference teaches the obviousness of the claim limitations as described above.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Horikoshi (US20140315839A1; same patent family as WO2013129688A1 cited on the IDS filed 05/24/2024), as evidenced by Onozaki (J. Agric. Food Chem. 2017), as applied to claims 1-2 and 5-11 above, and in further view of Onozaki (J. Agric. Food Chem. 2017).
As discussed above, Horikoshi teaches a method that applies compositions of flupyrimin for pest control in plants, including application to a wide variety of pests that may be present on corn. However, Horikoshi does not explicitly teach the pests to be neonicotinoid resistant, including to the instant neonicotinoid species (instant claims 3-4).
Onozaki teaches flupyrimin (FLP) has outstanding potency to imidacloprid (IMI)-resistant pests (abstract), including to pests resistant to other neonicotinoids (pg 7870, ‘discussion’). Onozaki demonstrates target species, including the instant species Spodoptera frugiperda (reads on “Spodoptera frugiperd” recited by instant claim 2) (pg 7871, paragraph 1). Onozaki teaches neonicotinoid-resistant insect pests are devastating to crops (pg 7865, ‘introduction’).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Horikoshi’s method of pest control in plants using flupyrimin compositions to target neonicotinoid-resistant pests, as taught by Onozaki, because Horikoshi teaches method of applying flupyrimin compositions on a wide variety of pests (including Spodoptera spp [0208]), where in the same vein Onozaki teaches flupyrimin compositions to have outstanding potency against neonicotinoid-resistant pests (including imidacloprid-resistant), thereby making the targeting of this subset of neonicotinoid-resistant pests as obvious. Onozaki teaches neonicotinoid-resistant insect pests are devastating to crops (pg 7865, ‘introduction’), providing motivation to target these kinds of pests.
Claims 1-2 and 5-12 are rejected under 35 U.S.C. 103 as being unpatentable over Horikoshi (US20140315839A1; same patent family as WO2013129688A1 cited on the IDS filed 05/24/2024), as evidenced by Onozaki (J. Agric. Food Chem. 2017), as applied to claims 1-2 and 5-11 above, and in further view of Rengan (WO2020012312A1).
As discussed above, Horikoshi teaches a method that applies compositions of flupyrimin for pest control in plants, including application to a wide variety of pests that may be present on corn. Note that the “kit-of-part” comprises a composition comprising flupyrimin and optionally an additional ingredient, such that the kit could be the composition by itself. However, Horikoshi does not explicitly teach the term “kit” (as meant within the context of the Prior Art) of the pesticide combination (instant claim 12).
Rengan teaches the obviousness to combine separate agrochemical components such as multiple active agents (including flupyrimin on pg 85; Rengan – claim 4) or excipients as pre-mixed compositions or kits (where the actives are kept separate, prior to application) (pg 76-77).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Horikoshi’s method of pest control in plants using flupyrimin compositions in combination with an insecticide (reads on active ingredient) (Horikoshi – claim 8 and 11-12), in a carrier (reads on excipient) (Horikoshi – claim 9), by modifying the composition such that it is distributed in kit form, as taught by Rengan, because a kit configuration is a standard configuration for agrochemical product commercialization (i.e., Rengan teaches the most common solutions to be either pre-mix compositions, or separation of components supplied as a kit on pg 76, including flupyrimin on pg 85), and thus, obvious to implement.
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Horikoshi (US20140315839A1; same patent family as WO2013129688A1 cited on the IDS filed 05/24/2024), Onozaki (J. Agric. Food Chem. 2017), and Rengan (WO2020012312A1):
claims 1-15 of copending Application No. 18/704,216 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach a method of applying a flupyrimin composition to a plant. The copending applications differ by the instant claims focusing on corn pests (compared to the copending ‘216 focused on sugarcane).
This is remedied by Horikoshi, who teaches a method for applying pest control compositions, including N-[1-((6-chloropyridin-3-yl)methyl)pyridin-2(1H)-ylidene]-2,2,2-trifluoroacetamide and salt forms (Horikoshi – claim 17) (as evidenced by Onozaki, this compound is flupyrimin [FLP, N-[(E)-1-(6-chloro-3-pyridinylmethyl)pyridin-2(1H)-ylidene]-2,2,2-trifluoroacetamide], which was discovered by Meiji Seika Pharma (pg 7865, paragraph 2)), targeting corn leaf aphid (i.e., a “corn insect”) [0208] and/or for Diabrotica virgifera virgifera and Spodoptera spp [0208], including the instant species Spodoptera frugiperda. One of ordinary skill in the art would have been motivated to modify the teachings of copending ‘216 because Horikoshi teaches flupyrimin suitable for a wide variety of pests that have the ability to infect a wide variety of plants such as corn [0208].
This is a provisional nonstatutory double patenting rejection.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 4/30/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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