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 preliminary amendment filed 06/30/2023 and are being considered on the merits.
Priority
The present application claims status as a continuation of PCT/US2021/056083 filed on 10/21/2021 which claims the benefit of provisional applications 63/257,079 filed on 10/18/2021 and 63/094,870 filed on 10/21/2020. The present application and all claims are being examined with the earliest effective filing date of 10/21/2020.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 06/28/2023, 05/20/2025 and 10/27/2025 are being considered by the examiner.
Drawings
The drawings are objected to because the small text size presented in Figures 3-4 renders them difficult to read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 18 is objected to because of the following informalities: for consistency, please amend “comprises” in line 2 to “comprise”. Appropriate correction is required.
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]). Hence, 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.
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. (cited on Form 892), 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). Hence, 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.
Claim 180 recites, “wherein said one or more microorganisms are present in an amount of at least 2,000 CFU”. Given its broadest reasonable interpretation, this limitation refers to the total amount of microorganisms in the composition, not in an individual seed. See, for example, claims 168, 171 and 173 which explicitly recite “wherein said plant seed comprises” whereas the present claim does not.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 170-173 and 176 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 170 and 172 recite the limitations “wherein said plant seed is at least 3 months old” and “wherein said plant seed is at least 6 months old”, respectively. This renders the claims indefinite because it is has not been set forth on record how the age of the plant seed is defined. For example, the months recited in the claims may be referring to the time that has passed since (1) the seed was harvested, (2) the seed was packaged, (3) the seed was purchased, or (4) the seed was germinated (e.g., a seed grown at least 3 months after germination). However, there is no discussion regarding the age of the seed in the specification and no clear and distinct definition of these phrases found in the prior art. Accordingly, if a seed were germinated, grown for 3 months, harvested, and stored for another 3 months, it is unclear if the use of this seed in the invention would meet the limitation of claim 172, or only the limitation of claim 170. Hence, a person of ordinary skill would not be apprised as to the metes and bounds of the claims.
Claims 171 and 173 are rejected for depending from an indefinite claim and for failing to rectify the basis for rejection of the parent claim.
Claim 176 recites, “The composition of claim 175, wherein said one or more carbonic anhydrase enzymes” and nothing further, which renders the claim indefinite. To obviate the rejection, the examiner suggests adding a further limitation to the “said one or more carbonic anhydrase enzymes” or cancelling the claim. The claim is further examined as having the same limitations as claim 175.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 176 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
As discussed under 35 U.S.C. 112(b), claim 176 does not further limit the subject matter of claim 175, from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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. (cited on Form 892; 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, endophytic bacteria, such as those in the genus Bacillus, and the plant seeds they are naturally associated with, are appropriate natural counterparts to the microorganisms and plant seed of the claimed invention. Thus, in the case of claim 1, the recited judicial exceptions do not possess any markedly different characteristics when compared to their natural counterparts.
Regarding the type of plant seed (claims 2 and 174), Afzal et al. (cited on Form 892; 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 (cited on Form 892; 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 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 (see Abstract).
Regarding the type of microorganisms (claims 28 and 169), Gond et al. (cited on Form 892) teaches 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). As it would be expected that a plant seed may remain viable after 3 or 6 months of storage, there is nothing relating to these limitations 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. (cited on Form 892) teach that endophytes promote plant growth through nitrogen fixation (see Abstract), and Zhang et al. (cited on Form 892) 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. (cited on Form 892), 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.
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 exceptions themselves, to integrate the judicial exceptions into a practical application.
See MPEP 2106.04(II)(A)(2) which states, “Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application” (Emphasis added).
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 exceptions themselves, 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 and 175-179 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 176, as the claim does not recite any further limitation to claim 175, the claim is anticipated for the same reasons as claim 175.
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, 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 embodiments where the inoculant microbe is located in the endosperm 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 coat from the seed embryo, which includes the endosperm.
Regarding claim 17, Mitter teaches embodiments where 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 an embodiment wherein 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 an embodiment wherein 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 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 claim 173, Mitter teaches an embodiment wherein 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 an embodiment wherein the inoculant microbe is present at a concentration of at least 3,000 CFU/seed (see pg. 8, para. [0126]). Hence, the microorganisms must be present in the composition in an amount greater than 2,000 CFU.
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).
Conclusion
No claims are allowed.
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/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651