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 .
Claim Status
Applicant’s amendment filed on January 21, 2025, has been received and entered. Claims 11-15 have been canceled. Claims 1-10 are pending in this instant application.
Priority
Acknowledgment is made of applicant's claim for domestic priority to the filing dates of the United States Provisional Patent Application Serial No. 63/598,305 filed on November 13, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 7, 2025 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Question 1: Do the claim(s) fall into a statutory category of invention?
Yes. Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to a natural phenomenon without significantly more.
Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111.
The claims recite a composition comprising or a fungicidal combination applied to a plant comprising a multi-site fungicide; and salicylic acid, salts or analogues thereof and an agriculturally acceptable excipient wherein the multi-site fungicide is selected from copper, copper complexes, copper salts, sulphur, sulphur complexes, sulphur salts, and combinations thereof; a dithio-carbamate selected from amobam, ferbam, mancozeb, maneb, metiram, propineb, thiram, zinc, thiazole, zineb, ziram,and combinations thereof; a phthalimide selected from captan, captafol, folpet, andcombinations thereof; a chloronitrile such as chlorothalonil; a sulfamide selected from dichlofluanid, tolylfluanid, and a combination thereof; a bis-guanidine selected from guazatine, iminoctadine, and a combination thereof; a triazine such as anilazine; a quinone such as dithianon; a quinoxaline selected from chinomethionat, quinomethionate, and a combination thereof; a maleimide such as fluoroimide, a thiocarbamate such as methasulfocarb; or combinations thereof.
The claimed composition qualifies as a composition of matter. See 35 U.S.C. § 101
Question 2A (prongs 1 and 2): Are the claims directed to a judicial exception that is not integrated into a practical application?
Yes.
With respect to the first prong of Step 2A, whether the claims recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Salicyclic acid, salts and analogues thereof is derived from willow tree bark (Mormile et al. Pub. No.: WO 2020/021314; Pub. Date: Jan. 30, 2020 page 1 lines 6-10) and copper coper, zinc, sulfur are natural elements and their claimed salts, complexes, and derivatives also occur in nature. The claimed agriculturally acceptable excipient is not limited and includes naturally occurring substances for instance water. As noted the composition and combination are directed to naturally occurring components. Further, the fact that such naturally occurring ingredient may have been formulated into a range and applied to a plant or plant part would not change this outcome (i.e., produce markedly different properties).
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
With respect to the second prong of Step 2A, the claims not recite sufficient additional elements that integrate the recited judicial exception (i.e., the product of nature exception(s)) into a practical application, when viewing the additional elements individually and as an ordered combination. The only limitation in addition to the judicial exception would be formulating naturally occurring ingredients into a range and applying the ingredients/compositions to a plant or plant part would not change this outcome (i.e., produce markedly different properties). However, none of these additional limitations would integrate the judicial exception(s) when viewed alone or in combination. For example, merely producing a new formulation by admixing natural ingredients in specific amounts/ratios (even with excipients) was held not to be an integration by the Supreme Court. Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13 … Thus, Appellant’s recitation of a mixture of specific amounts of nature-based products does not support a finding of subject matter eligibility on this record.”). See also Appeal 2017-005470 (13/446,128) (“Appellants' claims are directed to a composition of matter … [comprising a] dosage ratio of Vitamin D3 to 25-0H D3 is from about 6:1 to 1:6; and that a single weekly dosage contains from 7µg to 350 µg each of Vitamin D and 25-0H D3 … However, we cannot structurally distinguish the chemical compositions recited in the claims from those occurring naturally in biological systems. Nor does the fact that Appellants claim different dosage amounts or ratios suffice to add significantly more to the naturally-occurring substances than the administration of the same naturally-occurring substances themselves. Funk Brothers Seed Co. v. Kala Inoculant Co., 333 U.S. 127, 131 (1948) … Consequently, we find that the claims are directed to a judicially created exception to Section 101.”).
With respect to the instant applying step the courts have also identified limitations that did not integrate a judicial exception into a practical application: [1] Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f)
Accordingly, the analysis must continue to step 2B.
Question 2B: Do the claim(s) as a whole recite an inventive concept?
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05.
No.
In making this Step 2B determination, an evaluation must be performed as to whether there are specific limitations or elements recited in the claim, in addition to the judicial exceptions, that are not well-understood, routine, conventional activity in the field (and not written at a high level of generality) which would be indicative of an inventive concept.
As noted above, the only limitations in addition to the judicial exception would be the use of the multi-site fungicide; salicylic acid, salts or analogues thereof and an agriculturally acceptable excipient as a fungicide in a ratio and dose range by the application to a plant or plant part. However, none of these additional limitations would rise to an inventive concept either (alone or in combination). For example, merely producing a formulation by admixing the salicylic acid and multi-site fungicide in ratios (even with excipients) to be applied would not lead to an inventive concept in view of Funk Brothers wherein “Appellants' claims are directed to a composition of matter … [comprising a] dosage ratio of Vitamin D3 to 25-0H D3 is from about 6:1 to 1:6; and that a single weekly dosage contains from 7 µg to 350 µg each of Vitamin D and 25-0H D3 … However, we cannot structurally distinguish the chemical compositions recited in the claims from those occurring naturally in biological systems. Nor does the fact that Appellants claim different dosage amounts or ratios suffice to add significantly more to the naturally-occurring substances than the administration of the same naturally-occurring substances themselves. Funk Brothers Seed Co. v. Kala Inoculant Co., 333 U.S. 127, 131 (1948) … Consequently, we find that the claims are directed to a judicially created exception to Section 101.”
This position is also consistent with the prior art which indicates the applying various concentrations of the formulation is routine and conventional in the art (Mormile page 6 line 29 through page 7 line 6) .
Conclusion: Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to a natural phenomenon without significantly more. The claims recite a composition or combination of a fungicide applied to a plant comprising a multi-site fungicide; and salicylic acid, salts or analogues thereof and an agriculturally acceptable excipient wherein the multi-site fungicide is selected from copper, copper complexes, copper salts, sulphur, sulphur complexes, sulphur salts, and combinations thereof; a dithio-carbamate selected from amobam, ferbam, mancozeb, maneb, metiram, propineb, thiram, zinc, thiazole, zineb, ziram,and combinations thereof; a phthalimide selected from captan, captafol, folpet, andcombinations thereof; a chloronitrile such as chlorothalonil; a sulfamide selected from dichlofluanid, tolylfluanid, and a combination thereof; a bis-guanidine selected from guazatine, iminoctadine, and a combination thereof; a triazine such as anilazine; a quinone such as dithianon; a quinoxaline selected from chinomethionat, quinomethionate, and a combination thereof; a maleimide such as fluoroimide, a thiocarbamate such as methasulfocarb; or combinations thereof. Salicyclic acid, salts and analogues thereof is derived from willow tree bark (Mormile et al. Pub. No.: WO 2020/021314; Pub. Date: Jan. 30, 2020 page 1 lines 6-10) and copper coper, zinc, sulfur are natural elements and their claimed salts, complexes, and derivatives also occur in nature. The claimed agriculturally acceptable excipient is not limited and includes naturally occurring substances for instance water. The step of applying various concentrations of the formulation is routine and conventional in the art (Mormile page 6 line 29 through page 7 line 6) and therefore does not amount to significantly more than the judicial exception.
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 2 and 5 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 2 recites “[t] he combination as claimed in claim 1, wherein the multi-site fungicide is an inorganic fungicide selected from copper, copper complexes, copper salts, sulphur, sulphur complexes, sulphur salts, and combinations thereof; a dithio-carbamate selected from amobam, ferbam, mancozeb, maneb, metiram, propineb, thiram, zinc, thiazole, zineb, ziram,and combinations thereof; a phthalimide selected from captan, captafol, folpet, andcombinations thereof; a chloronitrile such as chlorothalonil; a sulfamide selected from dichlofluanid, tolylfluanid, and a combination thereof; a bis-guanidine selected from guazatine, iminoctadine, and a combination thereof; a triazine such as anilazine; a quinone such as dithianon; a quinoxaline selected from chinomethionat, quinomethionate, and a combination thereof; a maleimide such as fluoroimide, a thiocarbamate such as methasulfocarb;or combinations thereof.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 5, recites a ratio ranging from about 1:100 to about 100:1 which is indefinite as there is no indication of what measurement the ratio is in regards to, for instance is it a weight ratio, a weight per volume ratio, a molar ratio? Therefore, the meets and bounds of the claim is indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mormile et al. (Pub. No.: WO 2020/021314; Pub. Date: Jan. 30, 2020).
The claims are directed to a fungicidal combination comprising a mult-site fungicide and salicylic acid, salts or analogues thereof, a composition comprising said fungicidal combination, and an method of controlling fungal disease by applying the fungicidally effective composition or a composition thereof.
Regarding claims 1, 2, and 4-7 Mormile discloses a fungicidal composition comprising a suspension of copper salicylate (abstract) wherein the components of the fungicidal composition comprise salicylic acid 22.51% w/w, the complex copper hydroxide 16.89 % w/w (corresponding to 10.3% of Cu meta) and 50.66 or 48.71 %w/w water (page 8 and 9 Tables 1 and 2). The % w/w of salicyclic acid to copper hydroxide are found within the instantly claimed ratio range of about 1:100 to !00:1.
Pursuant to MPEP 2131.03
I. A SPECIFIC EXAMPLE IN THE PRIOR ART WHICH IS WITHIN A CLAIMED RANGE ANTICIPATES THE RANGE
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art.” Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In rePetering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and 0.2-0.4% molybdenum (Mo) were held anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because the graph contained an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed range of compositions.). “If the prior art discloses a point within the claimed range, the prior art anticipates the claim.” UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
Claim Rejections - 35 USC § 103
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.
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.
Claims1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mormile et al. (Pub. No.: WO 2020/021314; Pub. Date: Jan. 30, 2020) as evidenced by Merriam-Webster (“control” https://www.merriam-webster.com/dictionary/control 2026) and Fungicides (National Pesticide Information Center. https://npic.orst.edu/ingred/ptype/fungicide.html. Jan. 6, 2026)
Regarding claims 1-7 Mormile discloses a fungicidal composition comprising a suspension of copper salicylate (abstract) wherein the components of the fungicidal composition comprise salicylic acid 22.51% w/w, a copper compound 16.89 % w/w (corresponding to 10.3% of Cu meta) and 50.66 or 48.71 %w/w water (page 8 and 9 Tables 1 and 2), wherein the copper compound is preferably selected from copper sulfate ( page 3 lines 26-30). The % w/w of salicyclic acid to copper hydroxide are found within the instantly claimed ratio range of about 1:100 to !00:1.
Pursuant to MPEP 2131.03
I. A SPECIFIC EXAMPLE IN THE PRIOR ART WHICH IS WITHIN A CLAIMED RANGE ANTICIPATES THE RANGE
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art.” Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In rePetering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and 0.2-0.4% molybdenum (Mo) were held anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because the graph contained an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed range of compositions.). “If the prior art discloses a point within the claimed range, the prior art anticipates the claim.” UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
Regarding claims 8-10, Mormile discloses the fungicidal composition applied to plants such as leaves, stems, and branches. (page 6 lines 26-30), wherein the quality to be applied to obtain the desired effect can be varied depending on factors such as climate, crop, characteristics of the soil, method of application with the overall dose ranging from 0.51 to 121 per hectare of agricultural crop generally provide a sufficient activity (page 7 lines 1-7), wherein the components of the fungicidal composition comprise salicylic acid 22.51% w/w, a copper compound 16.89 % w/w (corresponding to 10.3% of Cu meta) and 50.66 or 48.71 %w/w water (page 8 and 9 Tables 1 and 2) Accordingly, the 0.51 to 121 dose (measured in w/w) would overlap the instantly claimed ranges of 0.1 g ai/ha to about 2000 g/ai/ha. Additionally, the rate of application is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results depending on factors such as climate, crop, characteristics of the soil, in the method of providing sufficient activity to be an effective fungicide (Mormile page 7 lines 1-7). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the application rate would have been obvious at the time of applicant's invention in view of the teachings of Mormile. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[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); 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.”)
With regard with the “controlling fungal disease in a plant or crop or part thereof”, the specification al filled does not provide a definition of control or controlling. The Merriam-Webster dictionary defines control as “to the exercise of restraint, direction, or influence over” and to “reduce the incidence or severity of especially to innocuous levels”. The definition of fungicides are pesticides that kill or prevent the growth of fungi and their spores, that can be used to control the fungi that damages plants as evidenced by (National Pesticide Information Center). Accordingly, the application of the fungicidal compound/composition to a plant or part thereof as disclosed by Mormile as fully set forth above would act to control fungal disease in a plant or crop or part thereof.
It would have been prima facie obvious to one of ordinary skill in the art at the time of invention to combine salicylic acid 22.51% w/w, a copper compound 16.89 % w/w (corresponding to 10.3% of Cu meta) and 50.66 or 48.71 %w/w water (page 8 and 9 Tables 1 and 2), wherein the copper compound is preferably selected from copper sulfate ( page 3 lines 26-30) to be applied to a plant or part thereof to in sufficient dose to act as a fungicidal composition (page 6 lines 26-30), as disclosed by Mormile, as instantly claimed, with a reasonable expectation of success at the time of filing as a matter of design choice. Said design choice amounting to combining prior art elements according to known methods to yield predictable results. On of ordinary skill in the art would be motivated to do so and have a reasonable expectation of success because Mormile had already disclosed an a fungicide comprising the combination of multi-site fungicide and salicylic acid. It would have only required routine experimentation to modify the composition of Mormile for an effective fungicide wherein the multi-site fungicide is copper sulfate found in combination with salicylic acid as required by the claimed invention.
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art the time of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA R FALKOWITZ whose telephone number is (571)270-3386. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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