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
This Application is a 371 of PCT/HU2022/050007, filed Jan. 31, 2022, and claims foreign priority to HUP2100117, filed Mar. 19, 2021 in the Republic of Hungary. A certified English translation of the foreign application must be submitted in reply to this action. Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Sept. 14, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 25-41 are currently pending and subject to examination.
Claim Rejections – 35 USC § 112(b)
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 25-27 and 30-33 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.
Claims 25-27 and 30-33 are “use” claims. One of ordinary skill in the art cannot determine the metes and bounds of these claims because they attempt to claim a process without setting forth the steps involved in the process.
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
MPEP § 2173.05(q).
Regarding claim 30, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.”
Claims 25-27 and 30-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed towards a use of azadirachtin A and do not claim a process, machine, manufacture or composition of matter.
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
MPEP § 2173.05(q).
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.
Claim(s) 25-26, 28-30, 33 and 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (The Canadian Entomologist, May/June 1991, p. 707-710) (of record, IDS cite no. 9) in view of Cornell University (USDA Research, Education & Economics Information System, “Plant Based Green Seed Coatings And Organic Seed Treatments For Insect Management”, Sept. 30, 2018, p. 1-5) (herein “Cornell”) as evidenced by Seif et al. (Annals of Agricultural Science, 2016, Vol. 61, no. 2, p. 187-199) and Trifolio-M (“Composition of NeemAzal”, p. 1, 2016 (WayBackMachine)).
Claim 25 is directed towards: “Use of azadirachtin A for controlling a soil-dwelling pest of a field crop by seed dressing of said field crop, wherein the field crop is corn and the soil-dwelling pest is Western corn rootworm larva.” Claim 28 is directed towards: “A method for controlling a soil-dwelling pest of a field crop, comprising applying an effective amount of azadirachtin A, or of azadirachtin A and azadirachtin B to seeds of said field crop by seed dressing, and sowing the dressed seeds, wherein the field crop is corn, and wherein the soil-dwelling pest is Western corn rootworm larva.”
Xie et al. teaches azadirachtin A for controlling a soil-dwelling pest of a field crop wherein the field crop is corn and the soil-dwelling pest is Western corn rootworm larva. Xie determined that azadirachtin A is toxic to western corn rootworm larvae and protects corn from damage when applied to the soil as a drench (Xie, p. 708-709):
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Xie, p. 709.
While Xie does not teach that the azadirachtin A is applied as a seed dressing, one of ordinary skill in the art would have a reasonable expectation of success to apply azadirachtin A as a seed dressing because it is commonly known in the art that azadirachtin A can be applied as a seed dressing to control soil dwelling pests.
For example, Cornell teaches that NeemAzal (>40% azadirachtins), can be applied as a seed coat to snap bean seeds for the control of seed corn maggot:
Neem seed and leaf extracts can perform the dual function of fertilizer and pesticide. At the same time they are also bio-degradable and degrade into an eco-friendly soil conditioner. Azadirachtin, the active ingredient of neem products is responsible for stopping the growth cycle of insects and pests, fungi etc. Neem extract also acts as an insect repellent and insect feeding inhibitor, thereby protecting the plants. In this study, experiments were performed in a germinator, greenhouse and field to examine the benefits of using neem products for organic farming and sustainable agriculture. The pest target in this case was seed corn maggot (Delia platura). Neemazal (>40% active ingredient Azadirachtin) was the neem technical product provided by Parry America Inc. to Dr. Taylor's Lab, and applied as a film coat to snapbean (Phaseolus vulgaris L, cv Huntington) seeds with four dosage rates (0.025, 0.05, 0.1 and 0.2g/100g seeds) compared to the conventional seed treatment insecticide thiamethoxam (Cruiser 5FS). Results from the field trial showed that percentage damaged seedlings using the conventional insecticide were significantly less than nontreated control and neem treatments. However, the lowest dosage of neemazal (0.025g/100g seeds) performed slightly better than nontreated control seeds.
Cornell, p. 3.
Therefore, claim 1 was prima facie obvious at the time of filing.
Claim 26 is directed towards The use of claim 25, wherein azadirachtin A is used by seed dressing of the corn at a dose of 0.022 - 0.7 mg/seed. Claim 29 is directed towards the method of claim 28, wherein azadirachtin A is applied to corn seeds in an amount of 0 022 - 0.7 mg/seed.
While Xie does not teach the azadirachtin A seed dressing of corn at a dose of 0.022 – 0.7 mg/seed, one of ordinary skill in the art would have a reasonable expectation of success to apply azadirachtin A at a dose of 0.022 – 0.7 mg/seed because values within this range are commonly known in the art.
For example, Cornell teaches four dosage rates (0.025, 0.05, 0.1 and 0.2g/100g snapbean seeds) for Neemazal. Seif teaches that the average weight of 100 snap bean seeds is approximately 22 g. Therefore, there are about 450 seeds per 100g. This gives the following doses per seed of NeemAzal:
0.025g/100g = 0.025g/450 seeds = 0.000056 g/seed * 1000 mg/g = 0.056 mg / seed
0.05g/100g = 0.05g/450 seeds = 0.00011g/seed * 1000 mg/g= 0.11 mg/ seed
0.1g/100g = 0.1g/450 seeds = 0.00022 g/seed * 1000 mg/g = 0.22 mg/seed
0.2g/100g = 0.2g/450 seeds = 0.00044 g/seed * 1000 mg/g = 0.44 mg/seed
While Cornell does not teach the amount of azadirachtin A in NeemAzal, this is a standardized product with a defined composition. Trifolio-M shows that NeemAzal has the following composition:
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Trifolio-M, p. 1.
Using the above values, we can calculate the percentage of azadirachtin A per seed:
Azadirachtin A = 34 wt%
0.056 mg NeemAzal/seed * 0.34= 0.019 mg azadirachtin A /seed
0.11 mg NeemAzal /seed * 0.34= 0.037 mg azadirachtin A /seed
0.22 mg NeemAzal/seed * 0.34 = 0.075 mg azadirachtin A /seed
0.44 mg NeemAzal/seed * 0.34=0.1496 mg azadirachtin A /seed
The range 0.019 to 0.1496 mg/seed overlaps the claimed range of 0.022 to 0.7 mg/seed. As such a prima facie case of obviousness exists:
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
MPEP § 2144.05.
Knowing that NeemAzal can be applied as a seed coating and can produce some beneficial results for crops, one of ordinary skill in the art would undertake routine experimentation to determine the optimum or workable range for corn and the control of western corn rootworm. One of ordinary skill in the art would have no difficulty in selecting 0.019 to 0.1496 mg/seed as a starting point because this range is already known in the art. An ordinary artisan would only have to undertake routine experimentation to determine which values are optimal for corn and the control of western corn rootworm.
Therefore, claims 26-29 were prima facie obvious at the time of filing.
Claim 30 is directed towards the use of claim 25, wherein azadirachtin A is used in combination with azadirachtin B, wherein the mass ratio of azadirachtin A to azadirachtin B is 2.5:1 - 10:1, and wherein azadirachtin A and azadirachtin B are used by seed dressing preferably at a cumulative dose of 0.022 - 0.7 mg/seed. Claim 33 is directed towards the use of claim 31, wherein azadirachtin A and azadirachtin B are used by seed dressing at a cumulative dose of 0.022 - 0.7 mg/seed. Claim 35 is directed towards the method of claim 28,wherein azadirachtin A and azadirachtin B are applied to seeds of the field crop by seed dressing, and the mass ratio of azadirachtin A to azadirachtin B is 2.5:1 - 10:1. Claim 36 is directed towards the method of claim 28, wherein azadirachtin A and azadirachtin B are applied to seeds of the field crop by seed dressing in a cumulative amount of 0.022 - 0.7 mg/seed. Claim 37 is directed towards the method of claim 35, wherein azadirachtin A and azadirachtin B are applied to seeds of the field crop by seed dressing in a cumulative amount of 0.022 - 0.7 mg/seed.
While Xie does not teach azadirachtin A in combination with azadirachtin B, particularly wherein the mass ratio of azadirachtin A to azadirachtin B is 2.5:1 - 10:1, and wherein azadirachtin A and azadirachtin B applied as a seed dressing preferably at a cumulative dose of 0.022 - 0.7 mg/seed, one of ordinary skill in the art would have a reasonable expectation of success to use azadirachtin A in combination with azadirachtin B as claimed because these seed coats are commonly known in the art.
For example, as shown above, Cornell teaches a seed coat of NeemAzal. While Cornell does not teach the amount of azadirachtin A in NeemAzal, this is a standardized product with a defined composition. As shown above, Trifolio-M shows that NeemAzal contains 34% azadirachtin A and about 5.5% azadirachtin B. This is a mass ratio of azadirachtin A to azadirachtin B of 34:5.5 or about 6:1, which falls within the claimed range.
Using the amounts of NeemAzol/seed above we can calculate the following total amounts of azadirachtin A and azadirachtin B in the NeemAzal seed coating:
Azadirachtin A = 34 wt%
Azadirachtin B = 5.5 wt%
0.056 mg NeemAzal/seed * 0.395= 0.022 mg azadirachtin A+ azadirachtin B /seed
0.11 mg NeemAzal /seed * 0.395= 0.043 mg azadirachtin A+ azadirachtin B /seed
0.22 mg NeemAzal/seed * 0.395 = 0.087 mg azadirachtin A+ azadirachtin B /seed
0.44 mg NeemAzal/seed * 0.395= 0.17 mg azadirachtin A+ azadirachtin B /seed
The range of 0.022 mg to 0.17 mg/ seed overlaps the claimed range of 0.022 – 0.7 mg/ seed. Therefore, claims 30, 33 and 35-37 were prima facie obvious at the time of filing.
Claim(s) 25-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (The Canadian Entomologist, May/June 1991, p. 707-710) (of record, IDS cite no. 9) in view of Cornell University (USDA Research, Education & Economics Information System, “Plant Based Green Seed Coatings And Organic Seed Treatments For Insect Management”, Sept. 30, 2018, p. 1-5) (herein “Cornell”) as evidenced by Seif et al. (Annals of Agricultural Science, 2016, Vol. 61, no. 2, p. 187-199) and Trifolio-M (“Composition of NeemAzal”, p. 1, 2016 (WayBackMachine)), as applied to claims 25-26, 28-30, 33 and 35-37 above, and further in view of Hamd et al. (Journal of Plant Diseases and Protection, Vol. 112, No. 6, p. 58-585, 2005) and Nisar et al. (Pest Science Management, Vol. 65, Issue 2, Feb. 2009, p. 113-227).
The rejection of claims 25-26, 28-30, 33 and 35-37 above is incorporated herein by reference.
Claim 27 is directed towards the use of claim 25, wherein azadirachtin A is used by seed dressing of the corn at a dose of 54 - 49 g/ha. Claim 32 is directed towards the use of claim 26, wherein azadirachtin A is used by seed dressing of the corn at a dose of 1.54 - 49 g/ha. Claim 34 is directed towards the method of claim 28, wherein azadirachtin A is applied at a dose of 1.54 - 49 g/ha. Claim 41 is directed towards the method of claim 29, wherein adirachtin A is applied at a dose of 1.54 - 49 g/ha.
Xie teaches that application of 10 ppm azadirachtin solutions applied to the soil offered complete protection (Xie, p. 708). While Xie does not teach the amount of azadirachtin A applied in terms of g/ha, one of ordinary skill in the art would have a reasonable expectation of success to apply azadirachtin A is applied at a dose of 1.54 - 49 g/ha because these doses are commonly known in the art.
For example, Hamd teaches that 1% NeemAzal can be applied at a rate of 16 g/ha azadirachtin A for the control of aphids (Hamd, Abstract). For example, Nisar teaches that Azadirachtin A is a broad spectrum pesticide with activity against insects, fungi, nematodes, viruses and protozoa with a suggested application rate of 12.5 to 40 g/ha (Nisar, Introduction, col. 1, p. 175). Nisar also teaches azadirachtin A as a seed coat (Nisar, Abstract).
Therefore, claims 27, 32, 34 and 41 were prima facie obvious at the time of filing.
Claim 31 is directed towards the use of claim 25, wherein azadirachtin A is used in combination with azadirachtin B, wherein the mass ratio of azadirachtin A to azadirachtin B is 2.5:1 - 10:1, and wherein azadirachtin A and azadirachtin B are used by seed dressing at a cumulative dose of 1.54- 49 g/ha. Claim 35 is directed towards the method of claim 28,wherein azadirachtin A and azadirachtin B are applied to seeds of the field crop by seed dressing, and the mass ratio of azadirachtin A to azadirachtin B is 2.5:1 - 10:1. Claim 38 is directed towards the method of claim 28, wherein azadirachtin A and azadirachtin B are applied at a cumulative dose of 1.54 - 49 g/ha. Claim 39 is directed towards the method of claim 35, wherein azadirachtin A and azadirachtin B are applied at a cumulative dose of 1.54- 49 g/ha. Claim 40 is directed towards the method of claim 36, wherein azadirachtin A and azadirachtin B are applied at a cumulative dose of 54- 49 g/ha.
While Xie does not teach azadirachtin A in combination with azadirachtin B, their ratio and the dose in g/ha, one of ordinary skill in the art would have a reasonable expectation of success to use azadirachtin A and azadirachtin B as claimed because azadirachtin A and B are commonly used together in the art in the claimed ratio and at the claimed amounts.
For example, as shown above, Cornell teaches a NeemAzal seed coat. As shown above, in NeemAzal, azadirachtin A and azadirachtin B are in a ratio of about 6:1. While Cornell does not teach the application rate in g/ha, application rates of 1.54- 49 g/ha are commonly known in the art. For example, Hamd teaches that 1% NeemAzal can be applied at a rate of 16 g/ha azadirachtin A for the control of aphids (Hamd, Abstract). There would be about 2.7 g /ha of azadirachtin B in this application because the ratio of azadirachtin A to azadirachtin B in NeemAzal is 6:1 which would be a total application rate of 18.7 g/ha of azadirachtin A and azadirachtin B. Nisar teaches that Azadirachtin A is a broad spectrum pesticide with activity against insects, fungi, nematodes, viruses and protozoa with a suggested application rate of 12.5 to 40 g/ha (Nisar, Introduction, col. 1, p. 175), and as such one of ordinary skill in the art would have a reasonable expectation of success apply NeemAzal which contains azadirachtin A and B in this range.
Therefore, claims 31, 35, and 38-40 were prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Conclusion
No claim is found to be allowable.
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/HEATHER DAHLIN/Examiner, Art Unit 1629