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 .
Status of Claims
Claims 1-4, 17-18, 28 and 168-180 are pending following the Reply filed 07/22/2026. Claims 3, 18, 170, 172, 176 and 180 have been amended without introducing new matter. All pending claims have been examined on the merits.
Withdrawn
The objection to claim 18 is withdrawn in light of the amendments.
The rejections under 35 U.S.C. 112(b) are withdrawn in light of the amendments.
The rejection under 35 U.S.C. 112(d) is withdrawn in light of the amendments.
Claim Interpretation
Claim 3 recites, “wherein said one or more microorganisms associated with said plant seed are disposed in an interspace between a seed coat and a seed embryo of said plant seed.” In view of the prior art of Mitter et al. (US 20160338360 A1; Cite No. 002 in the IDS filed 06/28/2023; hereafter, “Mitter”), the seed is enclosed in a covering called the seed coat (see pg. 17, para. [0252]), and the embryo is embedded within the endosperm (see pg. 17, para. [0254]). As set forth in the previous Office Action, it is reasonably interpreted that the “interspace” may be any location within the seed that separates the seed coat from the seed embryo, which includes the endosperm. This interpretation is maintained. See Response to Arguments for further discussion.
Claim 17 recites, “wherein said one or more microorganisms associated with said plant seed are disposed in an interspace between a seed pericarp and a seed aleurone cell layer of said plant seed.” In view of the prior art of Crang et al. (previously cited), the pericarp is the wall of a fruit surrounding the seed (see pg. 709, col. 1, para. 18; pg. 650, Fig. 19.1), and the aleurone layer is the outermost layer of the endosperm (see pg. 696, col. 2, para. 2). As set forth in the previous Office Action, it is reasonably interpreted that the “interspace” may be any location within the seed that separates the seed pericarp from the seed aleurone cell layer, which includes the seed coat. This interpretation is maintained. See Response to Arguments for further discussion.
Claim 180 recites, "wherein said one or more microorganisms are present in an amount
of at least 2,000 CFU". As set forth in the previous Office Action, given its broadest reasonable interpretation, this limitation refers to the total amount of microorganisms in the composition, not in an individual seed (nor in the “interspace” recited in parent claim 17). This interpretation is maintained. See Response to Arguments for further discussion.
Maintained Rejections and New Rejections Necessitated by Amendment
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 1-4, 17-18, 28 and 168-180 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Based upon an analysis with respect to the claims as a whole, these claims do not recite something significantly different than the judicial exception. The rationale for this determination is explained below and is in keeping with the latest guidance regarding analysis of judicially excepted subject matter:
Step 1: It must first be determined if the claims are directed to a statutory category and, if so, proceed to step 2A, Prong One. The claims are directed to a composition and fall within the statutory category of a composition of matter.
Step 2A, Prong One: Prong One requires the Examiner to evaluate whether the claims recite a judicial exception and, if so, proceed to Prong Two.
Product of Nature Definition
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". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, 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 Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
The Markedly Different Characteristics Analysis
The first step in the analysis is to select the appropriate counterpart to the nature-based product. When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP § 2106.04(c)(II)(A).
The second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673. See MPEP § 2106.04(c)(II)(B).
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. See MPEP § 2106.04(c)(II)(C).
Independent claim 1 recites a composition comprising a plant seed and one or more microorganisms associated with said plant seed, wherein the microorganisms are selected to produce or promote the formation of bicarbonate. It is interpreted that the selected microorganisms must be capable of producing or promoting the formation of bicarbonate.
The dependent claims further recite the type of plant seed (claims 2 and 174), the location within the plant seed the microorganisms are disposed (claims 3-4 and 17), the enzymes the microorganisms comprise and/or produce (claims 18 and 175-176), the type of microorganisms (claims 28 and 169), the age of the plant seeds (claims 170 and 172), the minerals produced by the microorganisms (claims 177 and 179), the microorganisms’ ability to fix nitrogen (claim 178), and the number (CFUs) of microorganisms that are present in the seed or composition (claims 168, 171, 173 and 180).
Regarding independent claim 1, Shahzad et al. (previously cited; hereafter “Shahzad”) teaches that microorganisms are adapted to an endophytic mode, living symbiotically with plants through vertical transmission in seeds (see Abstract), including members of Bacillus (see pg. 240, col. 1, para. 1). Xiao et al. (Cite No. 002 in the IDS filed 05/20/2025; hereafter, “Xiao”) teaches that Bacillus mucilaginosus has five carbonic anhydrase genes which were shown to promote carbonate formation (see Abstract). Hence, plant seeds comprising endophytic bacteria, such as those in the genus Bacillus, which are naturally associated with said plant seeds, is an appropriate natural counterpart to the compositions of the claimed invention. Thus, in the case of claim 1, the recited judicial exception does not possess any markedly different characteristics when compared to its natural counterparts.
Regarding the type of plant seed (claims 2 and 174), Afzal et al. (previously cited; hereafter, “Afzal”) teaches that nearly 300,000 plant species that exist on earth are thought to be a host to one or more endophytes, which include both bacteria and fungi (see pg. 37, col. 1, para. 1), which can exist within plant parts, such as seeds (see pg. 36, col. 2, para. 2). Afzal teaches that Bacillus has been isolated from maize, rice, soybean, among other plant types (see pg. 40, Table 1). Shahzad discloses the isolation of Bacillus from Asian rice seeds (see Abstract), which, in view of Mitter (previously cited), is a grass plant (see Mitter at pg. 13, para. [0203]).
Regarding the location within the plant seed the microorganisms are disposed (claims 3-4 and 17), in view of Shahzad et al., 2018 (previously cited; hereafter, “Shahzad 2018”), seed endophytes are transmitted into the seed endosperm through various means (see pg. 5, col. 1, para. 3) and have the ability to form endospores, thus providing protection from changing conditions inside the seed (see pg. 2, col. 2, para. 1). Shahzad 2018 teaches that the spermosphere is a region that surrounds seeds, in which seed microbes, germinating seeds, and soil microbes may interact (see pg. 6, col. 1, para. 2). Hence, it is understood that endophytes, such as those of Bacillus, have been found to be naturally disposed throughout the endosphere and spermosphere of plant seeds, which includes the “interspaces” (e.g., endosperm, seed coat) recited by the claims.
Regarding the limitation of “wherein said one or more microorganisms are artificially incorporated into said interspace and are not naturally present in said interspace” (recited in claim 3), this limitation is directed to a product-by-process step which does not alter the characteristics of the claimed product. For a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart. See also MPEP § 2113 for more information on product-by-process claims. In the instant case, whether the microorganisms are naturally present in the seed or were placed there deliberately, the composition would be expected to have the same characteristics.
Regarding the enzymes the microorganisms comprise and/or produce (claims 18 and 175-176), Xiao teaches Bacillus mucilaginosus comprises and expresses genes encoding carbonic anhydrases which have been shown to produce these enzymes, including CA4 (see Abstract). In view of Chen, et al. (Cloning, Expression and Characterization of Two Beta Carbonic Anhydrases from a Newly Isolated CO2 Fixer, Serratia marcescens Wy064. Indian J Microbiol. 2019 Mar;59(1):64-72. Epub 2018 Dec 28; cited on Form 892), CA4 is a gamma-class carbonic anhydrase (see pg. 68, col. 1). Therefore, this is a natural characteristic of the bacteria.
Regarding the type of microorganisms (claims 28 and 169), Gond et al. (previously cited) teach Bacillus is an endospore-forming bacterial species (see pg. 79, col. 1, para. 2).
Regarding the age of the plant seeds (claims 170 and 172), Solberg, et al. (cited on Form 892) teach that even under ambient conditions, the half-life of seed longevity in an orthodox seed is from 5 to 10 years (see Abstract), and Mitter teaches bacterial cells detected in maize seeds were recoverable after 12 months of storage (see pg. 47, para. [0517]). As it would be expected that a plant seed and its endophytes may remain viable 6 months of storage, there is nothing relating to this limitation which would make the claimed plant seed markedly different from its counterparts in nature.
Regarding the minerals produced by the microorganisms (claims 177 and 179), Xiao teaches that a carbonic anhydrase produced by Bacillus mucilaginosus promotes CaCO3 formation by capturing CO2 (see Title and Abstract). Hence, the ability of the claimed microorganisms to produce minerals, such as CaCO3, is not a markedly different characteristic compared to their natural counterparts.
Regarding the microorganisms’ ability to fix nitrogen (claim 178), Kandel et al. (previously cited) teach that endophytes promote plant growth through nitrogen fixation (see Abstract), and Zhang et al. (previously cited) teach that Bacillus mucilaginosus possesses the ability to fix nitrogen (see pg. 2, col. 1, para. 3). Hence, the ability of the claimed microorganisms to fix nitrogen is not markedly different from that of their natural counterparts.
Regarding the number (CFUs) of microorganisms that are present in the seed or composition (claims 168, 171, 173 and 180), in view of the specification, there is no evidence that the claimed plant seed having 250 CFU of bacteria or the claimed composition of plant seed having 2,000 CFUs of bacteria is due to any change that has been made to the plant seed or the bacteria. In a study by Girsowicz, et al. (previously cited), bacterial CFU was found in a range of plant species of seeds, ranging from 0.3x104 CFU/g to 8.8x104 CFU/g (see pg. 60, col. 1, para. 2). According to Mitter, another group detected bacterial populations inside rice seeds ranging in population size from 102 to 106 CFU/g fresh weigh (see pg. 15, para. [0242]). Hence, there is evidence in the art that the quantity of bacteria associated with plant seeds would be expected to vary, and the quantity of microorganisms in the claimed product does not appear to be due to any change made to the natural product that results in a markedly different characteristic.
Regarding the storage of said plant seeds for at least 6 months measured from the time said one or more microorganisms are incorporated into said plant seed (claim 180), this limitation is directed to a product-by-process step, which does not change the interpretation of the final product. Solberg, et al. (previously cited) teach that even under ambient conditions, the half-life of seed longevity in an orthodox seed is from 5 to 10 years (see Abstract), and Mitter teaches bacterial cells detected in maize seeds were recoverable after 12 months of storage (see pg. 47, para. [0517]). As it would be expected that a plant seed and its endophytes may remain viable 6 months of storage, there is nothing relating to this limitation which would make the claimed plant seed markedly different from its counterparts in nature.
The courts have emphasized that 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, 569 U.S. at 580, 106 USPQ2d at 1974-75.
Thus, the claims recite the judicial exception of a plant seed and the judicial exception of one or more microorganisms, which occur together in nature and have the same inherent characteristics as their natural counterparts. Hence, the recited judicial exceptions, even in combination, are directed to natural products without any markedly different characteristics compared to their counterparts in nature.
Step 2A, Prong Two:
Step 2A, prong 2 requires the Examiner to evaluate whether the claim recites
additional elements that integrate the exception into a practical application of that exception and, if not, proceed to step 2B. In order to integrate the recited judicial exception into a practical application, the claim will apply, rely on, or use the judicial exception that imposes a meaningful limit such that the claim is more than a drafting effort to monopolize the judicial exception.
Examiners evaluate integration by identifying additional elements in the claim beyond the judicial exception and evaluating those elements individually and in combination to determine
whether they integrate the exception in to a practical application. Examples that have been found
by the Courts in which the exception was not integrated into a practical application include:
- Mere instructions to implement an abstract idea on a computer
- Adding generic instructions that the judicial exception should be used ("apply it")
-Adding insignificant extrasolution activity to the exception ("mere data gathering")
- Generally linking the use of the exception to a particular technological environment or
field of use
In the instant case, the claims do not recite any additional elements, beyond the judicial exception itself, to integrate the judicial exceptions into a practical application.
Hence, the claims are still directed to the judicial exception under Step 2A, Prong Two.
Step 2B:
Step 2B requires the Examiner to first identify whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluate those additional elements individually and in combination to determine whether they contribute to an inventive concept (i.e., amount to significantly more than the judicial exception(s)).
In the instant case, the claims do not recite any additional elements, beyond the judicial exception itself, and therefore cannot amount to significantly more than the judicial exception(s).
In conclusion, claims 1-4, 17-18, 28 and 168-180 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1, 2, 4, 18, 28, 169, 175 and 177-179 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farmer, et al. (WO 2020076797 A1; Cite No. 001 in the IDS filed 06/28/2023), hereafter, “Farmer”, as evidenced by Xiao and Gond (both previously cited).
Regarding claim 1, Farmer teaches a composition for reducing greenhouse gases, improving carbon utilization, and/or enhancing sequestration of carbon, the composition comprising one or more beneficial microorganisms (see claim 1), wherein the composition can be applied directly to the seeds of a plant prior to planting (see pg. 13, lines 24-31). Farmer teaches the microorganisms are bacteria, such as Bacillus mucilaginosus (see pg. 28, lines 19-23). In view of Xiao, Bacillus mucilaginosus produces carbonate from atmospheric CO2 (see Title and Abstract); therefore, this is an inherent characteristic of the bacterium. Hence, Farmer teaches a composition comprising a plant seed and a microorganism, wherein said microorganism is one that is capable of producing carbonate.
Regarding claim 2, Farmer teaches the plant may be any species of fruit plant or tree (see pg. 9, lines 28-29).
Regarding claim 4, Farmer teaches the composition can be applied directly to the plant seeds as a seed treatment (see pg. 13, lines 24-25), wherein the mode of application can include spraying, pouring, sprinkling, dunking, or misting of the seeds using the composition in the form of a liquid, emulsion, oil, gel or paste (see pg. 13, lines 1-8).
In view of the instant specification, there is no description of what is included or excluded by the term “coating”. Hence, it is reasonably interpreted that this would include any application that involves covering the seeds externally with a formulation comprising the microorganisms. Hence, Farmer teaches the microorganisms associated with said plant seed are disposed (i.e., applied directly) as a coating of said plant seed (e.g., by spraying, misting, etc.).
Regarding claim 18, Farmer teaches the microorganism is Bacillus mucilaginosus, as discussed above. In view of Xiao, this species comprises carbonic anhydrase enzymes (see Abstract); therefore, this is an inherent characteristic of the bacterium.
Regarding claim 28, Farmer teaches the microorganism is Bacillus mucilaginosus, as discussed above. In view of Gond, members of Bacillus are endospore-forming bacteria (see pg. 79, col. 1, para. 2); therefore, this is an inherent characteristic of the bacterium.
Regarding claim 169, Farmer teaches the microorganism is a Bacillus species, as discussed above.
Regarding claim 175, Farmer teaches the microorganism is Bacillus mucilaginosus, as discussed above. In view of Xiao, Bacillus mucilaginosus comprises multiple genes encoding carbonic anhydrases (see Title and Abstract); therefore, this is an inherent characteristic of the bacterium. Hence, Farmer teaches the microorganism is one that produces the formation of one or more carbonic anhydrase enzymes.
Regarding claim 177, Farmer teaches the microorganism is Bacillus mucilaginosus, as discussed above. In view of Xiao, Bacillus mucilaginosus comprises enzymes that are capable of producing carbonate and CaCO3 (see Title and Abstract); therefore, this is an inherent characteristic of the bacterium. In view of the instant claims (i.e., dependent claim 179), CaCO3 meets the limitation of “one or more other minerals”.
Regarding claim 178, Farmer teaches the composition further comprising a microorganism capable of fixing nitrogen (see pg. 20, lines 14-15).
Regarding claim 179, Farmer teaches the microorganism is Bacillus mucilaginosus, as discussed above. In view of Xiao, Bacillus mucilaginosus produces carbonate and CaCO3, which is an inherent characteristic of the bacterium, as discussed above.
Claim(s) 1 and 175-176 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farmer, as evidenced by Xiao and Chen, et al. (Cloning, Expression and Characterization of Two Beta Carbonic Anhydrases from a Newly Isolated CO2 Fixer, Serratia marcescens Wy064. Indian J Microbiol. 2019 Mar;59(1):64-72. Epub 2018 Dec 28; cited on Form 892), hereafter, “Chen”.
Regarding claim 176, Farmer teaches the microorganism is Bacillus mucilaginosus, as discussed above. In view of Xiao, Bacillus mucilaginosus comprises multiple genes encoding carbonic anhydrases, including CA4 (see Title and Abstract). In view of Chen, CA4 is a gamma-class carbonic anhydrase (see pg. 68, col. 1). Therefore, this is an inherent characteristic of the bacterium. Hence, Farmer teaches the microorganism is one that produces the formation of a gamma-carbonic anhydrase enzyme.
Claim(s) 1, 3, 17, 168, 170-174 and 180 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitter, et al. (US 20160338360 A1; Cite No. 002 in the IDS filed 06/28/2023), hereafter, “Mitter” as evidenced by Han, et al. (Cite No. 018 in the IDS filed 06/28/2023), hereafter, “Han”.
Regarding claim 1, Mitter teaches a synthetic combination (i.e., composition) of a purified bacterial population in association with a seed of an agricultural plant (see claim 89). In a particular embodiment, Mitter teaches the microorganism is an endophytic bacterium selected from Bacillus (see pg. 22, para. [0298]) and can be any one of the microorganisms in Table 15 (see pg. 22, para. [0297]) which includes Bacillus subtilis (see pg. 125, Table 15).
In view of Han, Bacillus subtilis is known to induce biomineralization using carbonic anhydrases to produce bicarbonate and carbonate (see Abstract; pg. 2, para. 1) as was confirmed in Han’s study (see pg. 19, para. 3). Hence, the ability of the microorganism to produce or promote the formation of bicarbonate or carbonate is an inherent property of Bacillus subtilis, and the claim is anticipated by Mitter.
Regarding claim 3, Mitter teaches the inoculant microbe is located in the endosperm of the seed, wherein the microbe is viably and stably incorporated into the seed (see pg. 7, para. [0120]). As discussed under Claim Interpretation, it is interpreted that the claimed “interspace” may be any location within the seed that separates the seed coat from the seed embryo, which includes the endosperm.
Regarding claim 17, Mitter teaches the inoculant microbe is located in the seed coat of the seed (see pg. 7, para. [0120]). As discussed under Claim Interpretation, it is interpreted that the claimed “interspace” may be any location within the seed that separates the seed pericarp from the seed aleurone cell layer, which includes the seed coat.
Regarding claim 168, Mitter teaches the inoculant microbe is present at a concentration of at least 300 CFU/seed (see pg. 8, para. [0126]). As the range taught by Mitter is within the claimed range and is also narrower than the claimed range, the claim is anticipated by Mitter.
Regarding claim 170, Mitter teaches an embodiment wherein the plant seed containing microorganisms is stored for at least 3 months (see pg. 19, para. [0276]). Hence, the plant seed of Mitter is at least 3 months old.
Regarding claim 171, Mitter teaches the inoculant microbe is present at a concentration of at least 10,000 CFU/seed (see pg. 8, para. [0126]). As the range taught by Mitter is within the claimed range and is also narrower than the claimed range, the claim is anticipated by Mitter.
Regarding claim 172, Mitter teaches the plant seed containing microorganisms is stored for at least 6 months (see pg. 19, para. [0276]). Hence, the plant seed of Mitter is at least 6 months old.
Regarding claim 173, Mitter teaches the inoculant microbe is present at a concentration of at least 3,000 CFU/seed (see pg. 8, para. [0126]). As the range taught by Mitter is within the claimed range and is also narrower than the claimed range, the claim is anticipated by Mitter.
Regarding claim 174, Mitter teaches the agricultural plant is maize (see pg. 13, para. [0203]).
Regarding claim 180, Mitter teaches the inoculant microbe is present at a concentration of at least 3,000 CFU/seed (see pg. 8, para. [0126]), and the plant seed obtained by the method is stored for at least 6 months (see pg. 8, para. [0276]). Mitter teaches that the microbe can be transmitted to and remain viable in the seed, which can provide an environment that allows the microbe to withstand the stresses of desiccation, temperature variation, and be preserved for extended periods of time (see pg. 22, para. [0296]). Mitter discloses the recovery of 104 (10,000) viable cells in a 6 month-old seed (see pg. 47, para. [0517]).
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 1-4, 17-18, 28 and 168-180 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8 and 14 of U.S. Patent No. 11,805,774 (referred to hereafter as the “reference claims”) in view of Mitter, as further evidenced by Han. This is an obvious-type double patenting rejection.
Regarding instant claim 1, reference claim 1 recites “A modified plant seed comprising at least 10,000 CFU of bacteria artificially incorporated between a seed coat and an embryo of said modified plant seed, wherein said bacteria are incorporated between the seed coat and an aleurone cell layer.” Reference claim 8 recites “The modified plant seed of claim 7, wherein said bacteria comprise bacteria from Bacillus sp.”
The reference claims do not explicitly teach wherein said one or more microorganisms are, or are derived from, one or more microorganisms selected to produce or promote the formation of bicarbonate or carbonate.
Mitter teaches methods and materials for providing a benefit to a seed, seedling or plant by producing seeds that are internally colonized with endophytes (microorganisms) (see Abstract). Mitter teaches the association with certain microbes can promote plant growth using an array of mechanisms, including playing an essential role in biological nitrogen fixation (see pg. 1, para. [0006]). Mitter teaches a synthetic combination (i.e., composition) of a purified bacterial population in association with a seed of an agricultural plant (see claim 89). In a particular embodiment, Mitter teaches the microorganism is an endophytic bacterium selected from Bacillus (see pg. 22, para. [0298]) and can be any one of the microorganisms in Table 15 (see pg. 22, para. [0297]) which includes Bacillus subtilis (see pg. 125, Table 15).
In view of Han, Bacillus subtilis is known to induce biomineralization using carbonic anhydrases to produce bicarbonate and carbonate (see Abstract; pg. 2, para. 1) as was confirmed in Han’s study (see pg. 19, para. 3). Hence, the ability of the microorganism to produce or promote the formation of bicarbonate or carbonate is an inherent property of Bacillus subtilis.
In view of U.S. Patent No. 11,805,774, the modified plant seeds comprising artificially incorporated bacteria are “for improving plant growth and other properties” (see Abstract).
Thus, both Mitter and ‘774 are in the same field of endeavor and both teach compositions comprising plant seeds comprising microorganisms for the purpose of improving plant growth, particularly in plants used to produce agricultural products. Therefore, it would have been obvious at the time of filing to have combined the teachings of these references to provide a modified plant seed comprising Bacillus subtilis. A person of ordinary skill would have been motivated to select a species of Bacillus (as taught by the reference claims) suitable for enhancing plant growth, which Mitter teaches can be accomplished using Bacillus subtilis. As both references teach members of this genus to be useful for the same purpose, there would have been a reasonable expectation of success when using the species taught by Mitter.
Regarding the examiner’s reliance on the specification of the patented reference claims, see MPEP 804(I)(B)(1) which states:
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Regarding instant claims 2 and 174, reference claim 13 recites “The modified plant seed of claim 1, wherein said modified plant seed is a maize seed, wheat seed, rice seed, sorghum seed, barley seed, rye seed, sugar cane seed, millet seed, oat seed, soybean seed, cotton seed, alfalfa seed, bean seed, quinoa seed, lentil seed, peanut seed, lettuce seed, tomato seed, pea seed, or cabbage seed.” In view of Mitter, “grassland plants” include maize, wheat, and rice (see pg. 13, para. [0203]).
Regarding instant claims 3, 17, 168, 171, 173, and 180, reference claim 1 recites “A modified plant seed comprising at least 10,000 CFU of bacteria artificially incorporated between a seed coat and an embryo of said modified plant seed, wherein said bacteria are incorporated between the seed coat and an aleurone cell layer.” Hence, the reference claim meets all of the further limitations of instant claims 3, 17, 168, 171, 173, and 180.
Regarding instant claim 4, Mitter teaches the microbes can be applied by coating the plant seeds (see pg. 32, para. [0380]).
Regarding instant claim 18, in view of Han, Bacillus subtilis inherently comprises carbonic anhydrase enzymes, as discussed above.
Regarding instant claim 28, reference claim 2 recites “The modified plant seed of claim 1, wherein said bacteria comprise endospore forming bacteria or endospores thereof.”
Regarding instant claim 169, reference claim 8 recites “The modified plant seed of claim 7, wherein said bacteria comprise bacteria from Bacillus sp.”
Regarding instant claim 170, Mitter teaches an embodiment wherein the plant seed containing microorganisms is stored for at least 3 months (see pg. 19, para. [0276]). Hence, the plant seed of Mitter is at least 3 months old.
Regarding instant claim 172, Mitter teaches an embodiment wherein the plant seed containing microorganisms is stored for at least 6 months (see pg. 19, para. [0276]). Hence, the plant seed of Mitter is at least 6 months old.
Regarding instant claim 175, in view of Han, Bacillus subtilis inherently produces carbonic anhydrase enzymes, as discussed above.
Regarding instant claim 176, in view of Han, Bacillus subtilis inherently comprises carbonic anhydrase enzymes, as discussed above.
Regarding instant claim 177, in view of Han, Bacillus subtilis inherently induces the production of bicarbonate and carbonate, as discussed above. Han discloses this process results in the precipitation of calcium carbonate (CaCO3), which meets the limitation of “one or more other minerals” (see pg. 2, para. 1).
Regarding instant claim 178, Mitter teaches the seed associated bacteria are able to fix nitrogen, thereby adding to the plant’s nitrogen nutrition (see pg. 66, para. [0624]). Hence, it would have been obvious to have further selected microorganism(s) to fix nitrogen.
Regarding instant claim 179, in view of Han, Bacillus subtilis inherently induces the production of bicarbonate and carbonate, as discussed above. Han discloses this process results in the precipitation of calcium carbonate (CaCO3), which meets the limitation of “one or more other minerals” (see pg. 2, para. 1).
Response to Arguments
Regarding the Claim Interpretation section of the previous Office Action, Applicant argues that the Examiner’s interpretation of “interspace” is overly broad. The specification describes with particularity the precise anatomical location in which microorganisms are deposited by the Microprime™ seed treatment process - specifically, the interspace between the seed pericarp and the seed aleurone cell layer. A person of ordinary skill in the art would understand that the claimed “interspace” refers to this specific anatomical gap, not every region within the seed separating two named structures.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that, during examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification. Because applicant has the opportunity to amend the claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Yamamoto, 740 F.2d 1569, 1571 (Fed. Cir. 1984). See MPEP § 2111.
In view of the prior art of record (e.g., Mitter and Crang, as discussed above) the region between the seed pericarp and the seed aleurone layer contains the seed coat. In view of the sections of the specification and Figures referenced in Applicant’s argument, the examiner has not found any disclosure as to how the seed coat is excluded by the language recited in the claim. It should be noted that the Figures (i.e., Fig. 2) are not particularly detailed and do not clearly show all layers of the seed. The examiner has also not found any prior art describing an “interspace” between these layers that would specifically exclude the seed coat. Hence, a narrower interpretation of the claim cannot be arrived at, because it is not sufficiently clear what “interspace” Applicant intends to be specifically captured by this limitation. Therefore, in absence of any objective evidence to the contrary, the previous interpretations of claims 3 and 17 are maintained.
Applicant further argues that claim 180 depends from claim 17 which recites “wherein said one or more microorganisms associated with said plant seed are disposed in an interspace between a seed pericarp and a seed aleurone cell layer of said plant seed.” Thus, interpretation should be consistent with the recitation in claim 17.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that, during examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification. Because applicant has the opportunity to amend the claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Yamamoto, 740 F.2d 1569, 1571 (Fed. Cir. 1984). See MPEP § 2111.
In the instant case, claim 180 depends from both claims 1 and 17, and while claim 17 does require the microorganisms associated with the plant seed to be disposed in the recited interspace, this does not definitively exclude the microorganisms from also being disposed elsewhere in the composition (or seed). In view of the instant claims, as well as the originally filed specification, the microorganisms of the disclosure can be disposed in more than one location (e.g., interspace between pericarp and aleurone, interspace between seed coat and embryo, as a coating of said plant seed, etc.). As discussed under 35 U.S.C. 101, endophytic bacteria are known to naturally inhabit multiple layers of the seed. Therefore, if Applicant wishes to distinctly require that the one or more microorganisms are “present in an amount of at least 2,000 CFU in said interspace”, Applicant may amend the claim in accordance with this narrower scope.
Regarding the rejections under 35 U.S.C. 112(b), Applicant argues that the examiner's hypothesis about a seed germinated, grown for 3 months, harvested, and stored for 3 months is not the context in which the present invention operates. The claims are directed to plant seeds associated with microorganisms, i.e., treated seeds, and the "age" recited is the shelf stability period following treatment, not the total botanical age of a plant.
Applicant’s arguments have been considered but are moot because the amendments to the claims obviate the rejections under 35 U.S.C. 112(b) which have been withdrawn.
Regarding the rejections under 35 U.S.C. 101, Applicant argues that the claimed compositions are not found in nature. The claimed compositions are the specific product of the Microprime™ seed treatment process, which is a controlled, engineered process in which selected microorganisms are artificially incorporated into a defined anatomical location within a plant seed. No such composition exists in nature. Applicant argues that the microorganisms themselves “are not naturally present in the interspace between the seed pericarp and the seed aleurone cell layer of the plant seed.” (Spec. paragraph [0005]; Numbered Embodiment 64). The claimed composition is therefore, by the express terms of the specification, a structural arrangement that does not occur in nature: selected microorganisms are situated in a defined anatomical location within the seed where they are never found naturally.
Applicant’s arguments have been fully considered but they are not persuasive.
First, if Applicant means to suggest that absolutely no carbonate or bicarbonate-forming microorganisms are found to be associated with plant seeds in nature, this is clearly contradicted by the prior art of record, and the arguments above fail to provide any objective evidence to support this argument. It is apparent that bacteria are commonly associated with plant seeds, and the recited functions of these bacteria are common in nature, as evidenced by the prior art relied upon in the rejection. Applicant is advised to consider the breadth of claim 1, which essentially encompasses any carbonate-producing microorganism having any association with any plant seed.
Second, Applicant is reminded that features recited in the specification (i.e. the Microprime™ seed treatment process, or generic equivalents thereof) are not read into the claims. Furthermore, for product-by-process limitations (i.e., “artificially incorporated”), the markedly different characteristics analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart, not by the process that is used to arrive at the product (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method). See MPEP 2106.04(c). Here, the manipulative action of disposing the bacteria into the plant seed does not by itself avoid the judicial exception where there is no distinguishable difference between the characteristics of an embodiment of the claimed product compared to its closest natural counterpart.
Finally, claims 17 and 180 are the only claims which require the bacteria to be disposed in the “interspace between the seed pericarp and the seed aleurone cell layer”. Applicant is advised to consider the breadth of the remaining claims. Furthermore, the present rejection addresses the fact that bacteria are in fact found between these layers. Applicant’s argument fails to provide any objective evidence to the contrary, other than by reciting general per se statements made in the specification.
Applicant further argues that claim 1 requires microorganisms that "are, or are derived from, one or more microorganisms selected to produce or promote the formation of bicarbonate, or carbonate." This is not merely the presence of microorganisms in a seed; it is the deliberate human selection of microorganisms for a specific functional purpose, i.e., sequestering CO2 via carbonic anhydrase (CA)-mediated conversion of CO2 to bicarbonate and carbonate minerals.
Applicant’s arguments have been fully considered but they are not persuasive.
As discussed in the present rejection, these are clearly natural properties of naturally occurring bacteria, including those associated with plant seeds. These characteristics do not require the “deliberate human selection” of these microorganisms to arrive at a composition within the scope of claim 1, because these microorganisms, capable of performing a substantially widespread and common function throughout bacteria and fungi, are already associated with plant seeds in the manner recited in the claims. Furthermore, Applicant is reminded 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. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244. Hence, even if a claim were to recite a product-by-process limitation for arriving at the final product, if any counterpart in nature has the same characteristics as the final product, the claim is still directed to the exception.
Applicant further argues that the specification further describes experimental confirmation that the selected microorganism - Bacillus subtilis strain S3C23 - produces measurable CA activity (FIG. 10) and induces CaCO3 precipitation significantly faster than abiotic precipitation (FIG. 11). Field results demonstrated that soils associated with Microprime™-treated seeds contained an average of 3.19 tons of CO2 per acre sequestered (Season 2020; Spec. paragraph [0252], Example 5) and 8.18 tons of CO2 per acre (Season 2021; Spec. paragraph [0253], Example 6). These quantified, reproducible results are markedly different from any naturally occurring seed-microorganism combination.
Applicant’s arguments have been fully considered but they are not persuasive.
It should be noted that the features upon which applicant relies (i.e., Bacillus subtilis strain S3C23, MicroprimeTM-treated seeds, CaCO3 precipitation, etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims are not so limited to the examples provided in the specification, and Applicant’s argument fails to address the embodiments of the claimed invention which were discussed in the rejection. Furthermore, one cannot argue a characteristic to be markedly different without identifying, let alone comparing, said characteristic to the closest natural counterpart of the thing being claimed. As discussed in the rejection, naturally occurring species of Bacillus are known to associate with plant seeds and to have carbonic anhydrase activity, which is within the scope of the claims.
Applicant further alleges that the Microprime process places the microorganism in a place that protects the microorganism from desiccation and competing organisms and positions them to optimally colonize the plant root rhizosphere upon germination, and is not a naturally occurring phenomenon. (Spec. paragraphs [0021], [0022], [0023] and FIGS. 6A, 6B, 7 A, 7B, 8A & 8B). This deliberate placement protects the microorganisms from desiccation and competing organisms, positions them to optimally colonize the plant root rhizosphere upon germination, and is not a naturally occurring phenomenon.
Applicant’s arguments have been fully considered but they are not persuasive.
The portions of the specification that Applicant relies upon are directed to results (i.e., population growth before germination) obtained specifically using the S3C23 strain. There is no description or illustration of the actual Microprime process. Furthermore, the protection to endophytic bacteria provided by plant seeds is described in the prior art. See, for example, Afzal (previously cited), which states: “The bacteria use the plant endosphere as a unique protective ecological niche that provides a safe and consistent environment unperturbed by the fluctuating environmental conditions that affect rhizospheric and epiphytic bacteria” and “[t]hese bacteria can exists [sic] within the plant host including aboveground and underground plant parts and even seeds” (pg. 35, col. 2, para. 1). Applicant’s repeated statements that this interaction “does not occur in nature” or is “not a naturally occurring phenomenon” are in clear contradiction with the prior art, and Applicant fails to provide any objective evidence to contrary.
Applicant further argues that the claimed composition overcomes the natural outcome of nutrient depletion by deliberately selecting endospore-forming bacteria and formulating the Microprime™ solution with ingredients that promote endosporulation (Spec. paragraph [0051]), thereby conferring stability that does not occur naturally (Spec. paragraph [0065] and FIG. 9, which depicts the viability of Bacillus subtilis endospores inside treated maize seeds over a period of "one to 18 months after the Microprime™ seed treatment.").
Applicant’s arguments have been fully considered but they are not persuasive.
The sections of the specification that Applicant relies upon do not disclose the ingredients of the Microprime solution, other than stating, “the Microprime™ solution is supplemented with certain salts that will push the bacteria to enter this state of lethargy once it is incorporated into the seed” (see para. [0051]). Moreover, these features are not recited in the claims.
Applicant further argues that claims 168, 171, 173, and 180 recite specific minimum CFU levels. The specification explains that "[a]n amount of microorganism or exudate incorporated into the seed must be of a sufficient level in order for effectively sequester CO2 in the soil." (Spec. paragraph [0064]). The Microprime™ process achieves 100% seed loading efficiency with the seed loading of the order of 105 CFU/seed (Spec. paragraph [0237], Table 2). This precise, controlled level of microbial loading is entirely distinct from the random and uncontrolled variation in natural endophyte populations.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that limitations from the specification are not read into the claims. In the instant case, the claims do not recite the seeds as being loaded in “the order of 105 CFU/seed” or as comprising Microprime solution or any ingredients thereof. As discussed in the rejection, the specific minimum CFU levels recited in the claims are within natural limits, as evidenced by Girsowicz.
Applicant further argues that the claims integrate “any alleged exception” into a practical application and recite significantly more, because the compositions “apply” the selected microorganisms to a concrete, real-world use, which is the sequestration of atmospheric CO2 in soil. The selection of the microorganisms, their placement in the seed, and their stabilization as endospores at controlled CFU loadings for a defined shelf-life is an “ordered combination” that is not routine, conventional, or naturally occurring and therefore supplies an invent inventive concept under Step 2B.
Applicant’s arguments have been fully considered but they are not persuasive.
The product as a whole, i.e., composition comprising a plant seed and one or more seed-associated bacteria, is directed to a judicial exception. Therefore, there are no additional elements beyond the judicial exception itself to evaluate under Step 2B. Furthermore, it should be noted that the “ordered combination” Applicant describes in their argument is directed to a method of making the claimed product, while the claims are directed to the product itself.
Applicant further argues that the examiner’s reliance on individual prior art references to show that each claimed characteristic exists somewhere in nature conflates the existence of individual natural components with the existence of the claimed combination as a product.
Applicant’s arguments have been fully considered but they are not persuasive.
The rejection, as well as the arguments above, fully address the “claimed combination as a product”. It is unclear what Applicant means by “conflates the existence of individual natural components”. If Applicant means to suggest that any of the evidentiary natural elements (i.e., bacteria, seeds, enzymes) discussed in the rejection do not occur together in nature (i.e., in combination), Applicant’s argument fails to specifically point out any instance of this deficiency in the rejection.
Regarding the rejections under 35 U.S.C. 102 in view of Farmer, Applicant argues that Farmer teaches a microbial composition that can be applied to seeds as an agricultural treatment, i.e., a microbial formulation. The claimed composition is specifically a composition comprising both the seed and the microorganism as components, not merely a microbial formulation intended for seed application. Farmer's stated purpose is the general reduction of greenhouse gases, and it does not identify carbonate/bicarbonate formation as a selection criterion or as the measurable outcome.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant’s allegation that Farmer’s compositions serve a different purpose than the claimed invention is not germane to a rejection under 35 U.S.C. 102.
"Arguments that the alleged anticipatory prior art is ‘nonanalogous art’ or ‘teaches away from the invention’ or is not recognized as solving the problem solved by the claimed invention, [are] not ‘germane’ to a rejection under section 102." Twin Disc, Inc. v. United States, 231 USPQ 417, 424 (Cl. Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213 USPQ 1, 7 (CCPA 1982)). See also State Contracting & Eng’ g Corp. v. Condotte America, Inc., 346 F.3d 1057, 1068, 68 USPQ2d 1481, 1488 (Fed. Cir. 2003) (The question of whether a reference is analogous art is not relevant to whether that reference anticipates. A reference may be directed to an entirely different problem than the one addressed by the inventor, or may be from an entirely different field of endeavor than that of the claimed invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation recited in the claims.) (Emphasis added). See MPEP 2131.05.
In the instant case, Farmer discloses the application of the microorganisms to the plant seeds which results in a composition meeting all of the limitations of the claims, as discussed in the rejection.
Regarding claims 18 and 175, Applicant further argues that the Examiner relies on the inherency of carbonic anhydrase production in Bacillus mucilaginosus as taught by Xiao. Applicant notes that inherency requires that the characteristic necessarily follow from the prior art disclosure. The issue for anticipation is not whether carbonic anhydrase can exist in microorganisms generally, but whether Farmer expressly or inherently discloses the claimed seed-microorganism composition as arranged in the claims.
Applicant’s arguments have been fully considered but they are not persuasive.
Xiao evidences that Bacillus mucilaginosus inherently has the characteristics recited in the claim. "To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill." Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991). Therefore, Xiao’s disclosure is sufficient evidence to show that this feature is necessarily present in the bacterium and would “naturally flow” from its selection in Farmer’s methods.
Applicant’s argument that the “issue for anticipation is not whether carbonic anhydrase can exist in microorganisms generally” misrepresents the facts presented in the rejection. The question is whether these enzymes exist in Bacillus mucilaginosus, which is answered by the prior art of Xiao. It is not required that the primary reference “expressly” discloses this feature, because it is evidenced to be an inherent property of the microorganism.
Applicant further argues that Farmer does not disclose selecting its microorganisms to produce or promote the formation of bicarbonate or carbonate. The affirmative selection recited in claim 1 is therefore neither expressly nor inherently disclosed by Farmer.
Applicant’s arguments have been fully considered but they are not persuasive.
Farmer discloses the selection of a species which inherently has this property. Applicant is reminded that a reference may be directed to an entirely different problem than the one addressed by the inventor and still be anticipatory. Applicant is also reminded that the prior art disclosure of a “species” anticipates a claimed “genus”. In the instant case, Bacillus mucilaginosus meets the limitation of a microorganism that produces carbonate. This does not require an “affirmative selection” to meet the claim.
Applicant further argues that Regarding claim 4, Farmer teaches that the composition can be applied by spraying, pouring, or misting. The Examiner broadly interprets "coating" to encompass any external seed application. Applicant submits that the specification defines the coating embodiment as a specific configuration, i.e., the microorganisms are disposed as a coating of said plant seed (See spec. paragraphs [0005], [0062]). Farmer's general disclosure of spraying or misting does not specifically teach forming a coating as a defined structural configuration of the seed-microorganism composition.
Applicant’s arguments have been fully considered but they are not persuasive.
First, the sections of the specification that Applicant cites in their argument do not relate to any specific coating process. Paragraph [0005] merely states, “In some embodiments, the one or more microorganisms associated with the plant seed are disposed as a coating of the plant seed.” It is unclear how this is meant to support Applicant’s argument, because this merely restates what is recited in the claims. Furthermore, paragraph [0062] does not relate to any process of “coating” at all.
The plain meaning of “coating” is to cover a surface with a thin layer of a substance, which is in no way redefined or further limited by Applicant’s disclosure, and therefore is reasonably met by Farmer’s disclosure of “applying directly” the composition to the plant seed by “spraying, pouring, sprinkling, dunking, or misting”, as discussed in the rejection.
Regarding the rejections under 35 U.S.C. 102(a)(1) in view of Mitter, Applicant argues that the examiner relies on Han to establish that Bacillus subtilis inherently produces bicarbonate and carbonate via carbonic anhydrases. Inherency from a single in-vitro study on a specific isolate or strain does not establish that all Bacillus subtilis strains inherently possess and express this characteristic in the soil context.
Applicant’s arguments have been fully considered but they are not persuasive.
Han teaches that Bacillus subtilis is known to use carbonic anhydrases to produce bicarbonate and carbonate, as discussed in the rejection. Applicant’s argument fails to provide any objective evidence to the contrary.
Applicant further argues that Mitter's purpose is entirely distinct from the claimed invention, because Mitter is directed to inoculation of seeds with endophytes for general plant growth promotion, not for the specific purpose of producing or promoting the formation of bicarbonate or carbonate as a way to sequester CO2.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant’s allegation that Mitter’s compositions serve a different purpose than the claimed invention is not germane to a rejection under 35 U.S.C. 102. Applicant is reminded that a reference may be directed to an entirely different problem than the one addressed by the inventor. See MPEP 2131.05. In the instant case, Mitter teaches a composition comprising a bacterial population in association with a plant seed, wherein the bacterium is one which is within the scope of the claims, as discussed in the rejection.
Applicant argues that Mitter is restricted to work with endophytes, whereas the claimed invention does not require the use of endophytes, but rather, any desired microorganism selected to produce or promote bicarbonate or carbonate formation.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that the prior art disclosure of a species anticipates a claimed genus. "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960). In the instant case, it is irrelevant whether Mitter’s disclosure is limited to endophytes, so long as Mitter teaches an endophyte (e.g., Bacillus subtilis) that is within the scope of the claims.
Applicant argues that the Examiner's broad interpretation of "interspace" to include the entirety of the endosperm or seed coat, respectively, is overly expansive and contrary to the specification. As discussed above, the specification uses "interspace" to refer to the specific anatomical gap between the pericarp and the aleurone cell layer.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant’s arguments regarding the examiner’s interpretation of the “interspace” limitations have been fully addressed above.
Applicant argues that claim 3 and claim 168, which depend therefrom, have been amended to recite expressly that one or more microorganisms are artificially incorporated into said interspace and are not naturally present therein. Mitter discloses only naturally occurring seed endophytes residing in the locations in which they naturally occur and does not disclose microorganisms that are artificially incorporated into an intra-seed interspace where they are not naturally present.
Applicant’s arguments have been fully considered but they are not persuasive.
First, Mitter teaches the inoculant microbe is located in the endosperm of the seed, wherein the microbe is viably and stably incorporated into the seed, as discussed in the present rejection. Furthermore, the claims do not exclude naturally occurring seed endophytes, whether they be “artificially incorporated” or not. Furthermore, the “intra-seed interspace” of the claims is interpreted to be any interspace between the two recited layers, as previously discussed.
It should also be noted that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, whether or not a “naturally occurring endophyte” is artificially incorporated or naturally incorporated does not amount to any change in structure.
With respect to the Examiner's finding that Mitter teaches seeds stored for at least 3 and 6 months, Applicant argues that the treated seeds of the present invention have remained shelf-stable and viable for at least 18 months. This is a functional characteristic of the claimed composition, not merely a description of elapsed calendar time. The specification's data showing viability of Bacillus subtilis S3C23 for 18 months post Microprime™ treatment (FIG. 9: with 98.33% seed germination at 18 months) establishes that the claimed composition has a specific, engineered shelf-stability characteristic that goes beyond Mitter' s mere storage of inoculated seeds.
Applicant’s arguments have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “shelf-stable and viable for at least 18 months”, “Bacillus subtilis S3C23”, “engineered”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the Examiner's finding that Mitter discloses inoculant microbe
concentrations of at least 300, 10,000, and 3,000 CFU/seed at various points, Applicant argues that these CFU ranges in Mitter reflect artificially inoculated microbe concentrations post-inoculation - not after months of shelf storage as required by the claims. The specification explains that the Microprime™ process achieves consistent, defined CFU loading levels sufficient for effective CO2 sequestration (see Spec. paragraphs [0064], [0385]). Mitter does not teach maintaining sufficient CFU levels of a carbonate-producing microorganism over such storage periods.
Applicant’s arguments have been fully considered but they are not persuasive.
Mitter discloses the recovery of 104 (10,000) viable cells in a 6 month-old seed, as discussed in the present rejection of claim 180. Furthermore, Applicant’s reference to “at least 300” and “at least 10,000” are directed to the rejections of claims 168, 171 and 173 which do not recite these concentrations to be “after months of shelf storage”. Therefore, Applicant is incorrect in asserting that these are “required by the claims”. Furthermore, the claims do not recite the feature of the “MicroprimeTM process” or any generic equivalent or ingredients thereof. Applicant is reminded that while claims are interpreted in light of the specification, limitations from the specification are not read into the claims.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
