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 .
Election/Restrictions
Applicant’s election without traverse of the subject matter of Group 1, Claims 1-9 drawn to a composition comprising protein derived from Bacillus thuringiensis, and prumycin or salt thereof or kanosamine or salt thereof; in the reply filed on January 23, 2026 is acknowledged.
Claims 10-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 23, 2026.
Claims 1-9 are pending and currently under examination.
The examiner has required restriction between a product and method claims. Where applicant elects claims directed to the product, and a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined method claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between composition claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, Applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The priority date is June 02, 2021.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on November 30, 2023 and March 25, 2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a composition of matter by product of nature without significantly more, and a product of nature (prumycin or kanosamine). The claim(s) recite(s) an insecticidal composition comprising an insecticidal protein derived from Bacillus thuringiensis and prumycin or kanosamine. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claim 1, is directed to an insecticidal composition comprising an insecticidal protein derived from Bacillus thuringiensis and prumycin or kanosamine.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 16, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena; i.e., one may not patent every "substantial practical application" of an abstract idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". Products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
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It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from its closest naturally occurring counterpart.
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When a claim recites a nature-based product limitation, examiners use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this analysis to identify product of nature exceptions. If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible. If the claim includes a nature-based product that does not exhibit markedly different characteristics from its closest naturally occurring counterpart in its natural state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception.
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Nature-based Product Claim Analysis
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Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product.
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Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. Where the claim is to a nature-based product in combination with non-nature based elements, the markedly different characteristics analysis should be applied only to the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
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Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
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When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes. In order to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
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If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter. YES, the claims are directed to a process and a composition of matter, which are statutory categories within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception
(e.g., law of nature, natural phenomenon, or an abstract idea; see MPEP 2106.04). YES, the claims are composition claims reciting something that appears to be a nature-based product (i.e., pumycin or kanosamine which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Because the claim states the nature-based products which are plant extracts the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within prumycin or kanosamine. This equates to a bacterial source. The process of deriving proteins from the bacteria material into compositions based upon some property. The closest naturally occurring counterparts of derived protein components are those same components when found existing in the plant in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found in the plant they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.
This judicial exception is not integrated into a practical application because the insecticidal composition is only comprising the protein derived from nature-based components. The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B 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 (see MPEP § 2106.05(b)).
The claims as a whole do not amount to more than the recited exceptions because there aren’t any other additional elements to consider, which does not add an inventive concept to the claims. Thus, the claims are not eligible subject matter under current 35 U.S.C. 101 standards.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wachendorff-Neumann; Ulrike et. al. (US 20150141245 A1) in view of TANAKA KEIJITSU et. al. (EP 3498097 A1, in IDS of 03/25/2025).
In the instant claims recite an insecticidal composition for agricultural or horticultural use, comprising:an insecticidal protein derived from Bacillus thuringiensis; and prumycin or a salt thereof or kanosamine or a salt thereof. Wachendorff-Neumann et. al. ‘245, teaches, “insecticidal protein comprising parts from different secreted proteins from Bacillus thuringiensis, (Background Summary [para. 0186; lines14-15]) (as in instant claims 1 and 3); “The above-mentioned metabolites produced by the nonpathogenic microorganisms include antibiotics, enzymes, siderophores and growth promoting agents, for example kanosamine (Background Summary [para. 0046]) (as in instant claims 1and 4).
Additionally, Wachendorff-Neumann et. al. ‘245, teaches, insecticidal crystal protein from Bacillus thuringiensis or an insecticidal portion thereof, such as the insecticidal crystal proteins listed online at: http://www.lifesci.sussex.ac.uk/Home/Neil_Crickmore/Bt/, or insecticidal portions thereof, e.g., proteins of the Cry protein classes Cry1 Ab, Cry1 Ac; (as recited in instant claim 2).
Although Wachendorff-Neumann et. al. does not explicitly teach 0.1 to 10 mass% of calcium chloride (as in instant claim 5), however, TANAKA et. al. ‘097, teaches “The agricultural and horticultural fungicide composition further including 0.1 mass% to 10 mass% of calcium chloride (Solution to Problem #3)”. Regarding claims 6, 7, and 8, TANAKA ‘097, teaches, “The plant disease controlling method, in which a concentration of prumycin in a liquid to be applied at a time of the applying to a plant is 0.5 ppm or more (Solution to Problem #6), (as in instant claim 6)”; “a concentration of the surfactin in a liquid to be applied at a time of the applying to a plant is 1 ppm or more (Solution to Problem #5), (as in instant claim 6)”;“salt of prumycin is not particularly limited, and examples thereof include a hydrochloride (Description of embodiments [para. 0002]).
It would have been obvious to a person having ordinary skill in the art at the time of the instant applications effective filing date to have provided insecticidal composition for agricultural or horticultural, because Wachendorff-Neumann et. al., and TANAKA et. al. teaches providing the insecticidal treatment composition comprising protein derived from Bacillus Thuringiensis.
"It is prima facie obvious to combine the compositions each of which are taught by the prior art to be useful for the same purpose, in order to form another composition to be used for the very same purpose.... [T]he idea of combining the teachings from the references, flows logically from there having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). One would have had a reasonable expectation of success to achieve the insecticidal composition for agricultural and horticultural use , because the cited references teach providing the composition in a similar manner for providing insecticidal composition, and because, success merely requires preparing the composition thereof, especially in the absence of the criticality of some undisclosed features, or unexpected results.
Wachendorff-Neumann et. al., and TANAKA et. al. is relied upon for the reasons discussed above. If not expressly taught by Wachendorff-Neumann et. al., and TANAKA et. al., based upon the overall beneficial teaching provided by this reference with respect (in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable product, application to the area of the head, and amounts, proportions and ranges thereof in which to perform and providing of a insecticidal compositions for agricultural and horticultural use, is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filled. As evidenced by the references, especially in the absence of evidence to the contrary.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alpa Amin whose telephone number is (571)272-0562. The examiner can normally be reached 8:30 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALPA NILESH AMIN/Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655