DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim status
Claims 1, 4-7, 9-11, 15-19, 23-24, 26-27, 30 and 32 are pending in the amended claim set filed 09/04/2024. All pending claims have been examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 10/14/2024 and 02/20/2025 have been considered by the examiner.
Priority
The present application claims status as a 371 (National Stage) of PCT/US2023/069754 filed on 07/07/2023. Applicant’s claim for benefit under 35 U.S.C. 119 (e) of Provisional application No. 63/359,248 filed on 07/08/2022 is acknowledged. The present application and all claims are being examined with the earliest effective filing date of 07/08/2022.
Specification
The specification filed 09/04/2024 states, at page 14, line 27 to page 15, line 6, that the claimed biological deposits of NRRL B-68031 and NRRL B-67928 (recited in claims 4 and 19) were deposited under the terms of the Budapest Treaty, and further:
(a) access to the cultures will be available during the pendency of this patent application to one determined by the Commissioner of Patents and Trademarks to be entitled thereto under 37 CFR § 1.14 and 35 U.S.C § 122;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting of the patent;
(c) each of the subject culture deposits will be stored and made available to the public in accord with the provisions of the Budapest Treaty for the Deposit of Microorganisms, i.e., it will be stored with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposit, and in any case, for a period of at least 30 (thirty) years after the date of deposit or for the enforceable life of any patent which may issue disclosing the culture;
(d) depositor acknowledges the duty to replace the deposit should the depository be unable to furnish a sample when requested, due to the condition of the deposit; and
(e) all restrictions on the availability to the public of the subject culture deposit will be irrevocably removed upon the granting of a patent disclosing it.
Further, the specification discloses the depository locations of the deposited strains (see pg. 13, line 32 to pg. 14, line 8).
This disclosure appears to satisfy the conditions for biological deposits under the terms of the Budapest Treaty in view of 37 CFR 1.801- 37 CFR 1.809, which is also sufficient to satisfy the requirements under 35 U.S.C. 112(a) regarding the availability of the biological material.
In addition, the examiner suggests that the claims should be amended to include the depository locations where the deposit numbers are recited in the claims.
Claim Objections
Claim 1 is objected to because of the following informalities: It is understood that the “growth product thereof” recited in line 4 refers to a compound produced by the bacterium, and not, e.g., to the yield of bacterial cells produced. For clarity, please amend “growth product thereof” in line 4 to recite “growth by-product thereof”. This language has literal support in the specification and avoids confusion. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: For clarity, please amend “applied” in line 1 to recite “added”. This language has literal support in the specification and is less vague. Appropriate correction is required.
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 4-5, 7, 9-11, 19, 23-24, 26-27, 30 and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the microorganism" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Suggestion to obviate the rejection: Applicant may, for example, amend this limitation to recite “the iron-capturing Bacillus spp. bacterium”. The claim is interpreted accordingly.
Claim 5 recites the limitation "the microorganism" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Furthermore, assuming “the microorganism” is referring to the Bacillus bacterium recited in claim 1, it is unclear if the method step of “contacting” recited in claim 1 is the same method step of “administering”. On one hand, there is no literal antecedent basis for a step of “administering”, while on the other hand, “contacting, with the livestock animal’s digestive system” reasonably requires a step of administering. Hence, it is unclear whether these limitations are referring to the same method step or two different method steps.
Suggestion to obviate the rejection: Applicant may, for example, amend the limitation of “wherein the microorganism is administered in spore form” to recite “wherein the iron-capturing Bacillus spp. bacterium is in spore form”. The claim is interpreted accordingly.
Claim 7 recites the limitation, “wherein the composition is administered directly to the digestive system orally…”, which renders the claim indefinite, because it is unclear if the method step of “contacting” recited in claim 1 is the same method step of “administering”. On one hand, there is no literal antecedent basis for a step of “administering”, while on the other hand, “contacting, with the livestock animal’s digestive system” reasonably requires a step of administering. Hence, it is unclear whether these limitations are referring to the same method step or two different method steps.
Furthermore, the recitation of “administered directly… orally” leads to different interpretations. On one hand, any oral administration method (e.g., by adding the composition to drinking water and/or feed that the livestock animal ingests, as recited in claim 15) reasonably achieves the goal of contacting the composition directly to the animal’s digestive system (i.e., mouth). On the other hand, it could be interpreted that such methods are “indirect”, and one must physically introduce the composition in a more “direct” manner (e.g., hand or bottle feeding, use of an oral syringe, etc.). However, in view of the instant specification, there is no mention of any “direct” methods of administering the composition orally. Therefore, the intended scope of this limitation is unclear.
Suggestion to obviate the rejection: Applicant may, for example, amend the limitation of “wherein the composition is administered directly to the digestive system orally…” to recite “wherein the step of contacting comprises administering the composition to the digestive system orally…”. The claim is interpreted accordingly.
Claim 9 recites “further comprising administering a prebiotic” without reciting the recipient of the administration, which renders the claim indefinite, because administering necessarily requires a recipient.
Suggestion to obviate the rejection: Applicant may, for example, amend the phrase above to recite “wherein the composition further comprises a prebiotic”. There appears to be written support for this limitation in the specification (see, e.g., pg. 6, lines 29-33).
For the sake of applying prior art, the claim is broadly interpreted as further comprising administering the prebiotic to the animal of claim 1 or wherein the composition of claim 1 further comprises the prebiotic.
Claim 10 recites “further comprising administering a germination enhancer” without reciting the recipient of the administration, which renders the claim indefinite.
Suggestion to obviate the rejection: Applicant may, for example, amend the phrase above to recite “wherein the composition further comprises a germination enhancer”. There appears to be written support for this limitation in the specification (see pg. 16, lines 7-10).
For the sake of applying prior art, the claim is broadly interpreted as further comprising administering the germination enhancer to the animal of claim 1 or wherein the composition of claim 1 further comprises the germination enhancer.
Claim 11 recites “further comprising administering one or more of the following components” without reciting the recipient of the administration, which renders the claim indefinite.
Suggestion to obviate the basis for rejection above: Applicant may, for example, amend the phrase above to recite “wherein the composition further comprises one or more of the following components”. There appears to be written support for this limitation in the specification (see pg. 17, lines 1-9).
For the sake of applying prior art, the claim is broadly interpreted as further comprising administering the one or more components to the animal of claim 1 or wherein the composition further comprises the one or more components.
Furthermore, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 11 recites the broad recitation “seaweed”, and the claim also recites “(Asparagopsis taxiformis)” which is the narrower statement of the range/limitation. Further, the claim recites the broad recitation “(steroidal saponin-producer)”, and the claim also recites “Yucca schidigera extract” which is the narrower statement of the range/limitation. Further, the claim recites the broad recitation “(triterpenoid saponin-producing plant species)”, and the claim also recites “Quillaja saponaria extract”.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Applicant is reminded that examples are properly set forth in the specification, not in the claims, and that a narrower limitation of a previously recited broader limitation may be presented in a separate dependent claim.
Suggestion to obviate the basis for rejection above: Applicant may, for example, remove the limitations recited in parentheses.
For the sake of applying prior art, either limitation (narrower or broader) may meet the claim.
Claim 19 recites the limitation "the microorganism" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Suggestion to obviate the rejection: Applicant may, for example, amend this limitation to recite “the iron-capturing Bacillus spp. bacterium”. The claim is interpreted accordingly.
Claim 27 recites the broad recitation “seaweed”, and the claim also recites “(Asparagopsis taxiformis)” which is the narrower statement of the range/limitation. Further, the claim recites the broad recitation “(steroidal saponin-producer)”, and the claim also recites “Yucca schidigera extract” which is the narrower statement of the range/limitation. Further, the claim recites the broad recitation “(triterpenoid saponin-producing plant species)”, and the claim also recites “Quillaja saponaria extract”.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. See MPEP § 2173.05(c).
Applicant is reminded that examples are properly set forth in the specification, not in the claims, and that a narrower limitation of a previously recited broader limitation may be presented in a separate dependent claim.
Suggestion to obviate the basis for rejection above: Applicant may, for example, remove the limitations recited in parentheses.
For the sake of applying prior art, either limitation (broader or narrower) may meet the claim.
Claims 23-24, 26-27, 30 and 32 are rejected for depending from an indefinite claim and for failing to obviate the basis for the rejection of the claim(s) from which they depend.
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 19, 23-24, 26-27, 30 and 32 are rejected under 35 U.S.C. § 101 because the claims as a whole are not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, these claims do not recite something significantly different than a 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.
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step 1 – Is the claim directed to a process, machine, manufacture, or composition of matter?
Step 2A – Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Step 2A, prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
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).
Step 2A, prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a);
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d);
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e).
Step 2B – If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step 2A, Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step 1: It must first be determined if the claim is directed to a statutory category and, if so, proceed to step 2A, prong 1.
In this case, the claims are directed to a composition comprising a bacterium and/or a growth by-product of the bacterium and fall within the statutory category of a composition of matter.
Step 2A, prong 1: Prong 1 requires the Examiner to evaluate whether the claim recites a judicial exception and, if so, proceed to prong 2.
In this case, independent claim 1 recites an iron-capturing Bacillus spp. bacterium, wherein the bacterium is Bacillus subtilis B4 NRRL B-68031 or Bacillus amyloliquefaciens NRRL B-67928. In view of the instant specification, the deposited bacteria are strains of the species recited above, whose cultures have been deposited with the NRRL Culture Collection (see, e.g., pg. 5, lines 4-5; pg. 13, line 32 to pg. 14, line 8). There is no indication in the specification, or in the prior art of record, that either of these bacterial strains have been modified in any way from the naturally occurring isolates from which they were derived (i.e., their natural counterparts). Therefore, they would be presumed to have the same characteristics as their naturally occurring counterparts, absent any evidence to the contrary. See below for further discussion.
The claim also recites “an iron-capturing growth by-product thereof” which may be provided in the composition alone or in combination with the bacterial strain. In view of dependent claim 30, the by-product may include biosurfactants, enzymes, organic acids, fatty acids, amino acids, proteins, peptides, alcohols, polyketides, natural antibiotics, aldehydes, amines, sterols or vitamins, which are all naturally occurring products.
Per MPEP 2106.04(c), the markedly different characteristics analysis is part of Step 2A Prong One, because the courts use this analysis to identify product of nature exceptions. Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
However, if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.
If the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception.
When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart.
Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts.
In the instant case, the claim includes compositions comprising one of the recited naturally-occurring bacterial strains by itself or the growth by-product by itself, which are by definition directed to a naturally occurring product and thus fall under the product of nature exception. For example, a composition comprising a naturally produced amino acid by itself, which is within the scope of the claim, is by definition directed to the judicial exception.
Furthermore, a composition comprising both the naturally-occurring bacterial strain and its growth by-products is still directed to the judicial exception, because the closest natural counterpart of the resultant nature-based combination would be a naturally-occurring bacterial colony which necessarily comprises both the bacteria as wells as its growth by-products.
Furthermore, in view of the prior art of Rizzi, et al. (Iron Homeostasis in Bacillus subtilis Requires Siderophore Production and Biofilm Formation. Appl Environ Microbiol. 2019 Jan 23;85(3):e02439-18; cited on Form 892), iron-capturing is a natural function of naturally occurring Bacillus subtilis strains (see Abstract), and B. subtilis is known to produce siderophores, such as bacillibactin and 2,3-dihydroxybenzoic acid (each recited in claim 24), to assist in iron acquisition during biofilm formation (see pg. 2, paras. 3-5). Therefore, neither the iron-capturing capability of these organisms nor the production or presence of their by-products amounts to a markedly different characteristic when comparing the claimed product as a whole to its closest natural counterpart. Hence, even if one were to argue that the bacteria or its by-products were somehow not naturally occurring, the claim would still be directed to the product of nature exception, because these elements are disclosed to have the same characteristics as their natural counterparts in view of the prior art.
Therefore, claim 19 is directed to the judicial exception.
Claim 23 recites the bacterial strain in spore form or biofilm form. These are natural forms of the bacteria which do not distinguish them from their naturally occurring counterparts. For example, Rizzi, et al. teaches these states to be present in naturally occurring Bacillus subtilis (see pg. 2, para. 3). Therefore, the claim is still directed to the judicial exception.
Claim 24 recites the composition comprising a further iron-capturing agent, which may include bacillibactin or 2,3-dihydroxybenzoic acid. These are natural by-products of the bacteria, produced by the same bacteria in nature, and they themselves are found together in nature. For example, Rizzi, et al. teaches naturally occurring Bacillus subtilis to produce both of these nature-based compounds, under the same conditions, as previously discussed. Therefore, the claim is still directed to the judicial exception.
Claim 26 recites the composition further comprising L-alanine, L-leucine or manganese, which are natural products that would necessarily be present in any naturally occurring bacterium. In particular, alanine and leucine are essential amino acids produced and utilized by all cellular life. Hence, a composition comprising any bacterial strain would be expected to have these by-products, and their counterparts in nature would be expected to comprise the same. Therefore, the claim is still directed to the judicial exception.
Claim 27 recites the composition further comprising one or more components, which may include carboxylic acid, which is a natural product that would necessarily be present in any naturally occurring bacterium, as it is an essential component of fatty acid molecules, such as palmitic acid, which are produced to form cellular membranes, as well as an essential component of amino acids (see Alberts, et al. Molecular Biology of the Cell. 4th edition. New York: Garland Science; 2002. The Chemical Components of a Cell; cited on Form 892; pg. 15, para. 3; pg. 16, para. 5).
Claim 30 recites the composition comprising a microbial growth by-product which may include biosurfactants, enzymes, organic acids, fatty acids, amino acids, proteins, peptides, alcohols, polyketides, natural antibiotics, aldehydes, amines, sterols or vitamins, which are all naturally occurring products. Clearly, any naturally-occurring bacterial cell would be expected to produce and utilize such elements. For example, a composition comprising the living bacteria would necessarily have amino acids (i.e., for protein synthesis) and fatty acids (i.e., for cellular membranes), which are also present in naturally-forming colonies of the same bacteria. Therefore, the claim is still directed to the judicial exception.
Claim 32 recites the composition further comprising a saturated long chain fatty acid selected from stearic acid, palmitic acid and myristic acid. These fatty acids would be expected to be present in naturally occurring colonies of the claimed bacterial strains, because they are essential components produced and utilized in all bacteria. For example, palmitic acid is essential in the forming of cellular membranes, as previously discussed. Therefore, the claim is still directed to the judicial exception.
Step 2A, prong 2: 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
Claim 19 requires at least one of (1) a naturally-occurring bacterial strain, (2) a naturally-occurring growth by-product of said bacterial strain. As the claim can be met by either nature-based product, it does not require any additional elements beyond the nature-based product itself. Therefore, there are no additional elements to integrate the exception into a practical application.
Claim 23 does not recite any additional elements. Therefore, there are no additional elements to integrate the exception into a practical application.
Each of claims 24, 26-27, 30 and 32 require an additional natural compound, which includes compounds which are already found together with the bacterial strain in nature (i.e., naturally-occurring colonies). Therefore, the combination of these nature-based components does not impose a meaningful limit on the judicial exception, and the claims, even when viewed as a whole, are directed to the judicial exception without any integration into a practical application.
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)). This step includes evaluation of the same considerations under Step 2A, Prong 2, as well as two additional considerations:
- Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
- Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Claim 19 requires at least one of (1) a naturally-occurring bacterial strain, (2) a naturally-occurring growth by-product of said bacterial strain. As the claim can be met by either nature-based product, it does not require any additional elements beyond the nature-based product itself. Therefore, there is no combination of additional elements that amounts to significantly more than the judicial exception
Claim 23 does not recite any additional elements. Therefore, there is no combination of additional elements that amounts to significantly more than the judicial exception.
Each of claims 24, 26-27, 30 and 32 require an additional natural compound, which includes compounds which are already found together with the bacterial strain in nature (i.e., naturally-occurring bacterial colonies). This combination of nature-based components does not impose any non-conventional limit on the judicial exception and cannot be said to contribute to an inventive concept, because these components are already known to exist and function together in nature. Therefore, the claims do not require any additional elements that amount to significantly more than the judicial exception.
In conclusion, claims 19, 23-24, 26-27, 30 and 32 are directed to natural products.
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, 4-5, 7, 9-11, 15-19, 23, 26-27, 30 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farmer, et al. (WO 2020/210074 A1; cited in the IDS filed 10/14/2024), hereafter, “Farmer”.
Regarding claim 1, Farmer teaches a method for reducing enteric deleterious atmospheric gases and/or precursors thereof, the method comprising applying a composition comprising one or more beneficial microorganisms and/or one or more microbial growth by-products to a field or pasture, said field or pasture comprising grasses and/or other plants upon which livestock animals graze, wherein the livestock animals ingest the composition in addition to the grasses and/or other plants, and wherein the one or more beneficial microorganisms are selected from Bacillus amyloliquefaciens and Bacillus subtilis (see claim 1). Farmer teaches the method wherein the deleterious atmospheric gas is methane (see claim 26).
Farmer teaches the method wherein the strain of Bacillus amyloliquefaciens is B. amyloliquefaciens NRRL B-67928 (see claim 4), which clearly meets the limitation of “an iron-capturing Bacillus spp. bacterium” in view of instant claim 4.
Farmer teaches the method further comprising applying the one or more microorganisms and/or one or more microbial growth by-products to drinking water and/or to supplemental feed that the livestock animals ingest (see claim 22), which clearly meets the limitation of “contacting, with the livestock animal’s digestive system” in view of instant claim 15.
Regarding claim 4, Farmer teaches the method wherein the strain of Bacillus amyloliquefaciens is B. amyloliquefaciens NRRL B-67928 (see claim 4).
Regarding claim 5, Farmer teaches the composition comprising the Bacillus spp. bacteria in spore form (see pg. 11, line 13), and the method further comprising applying a germination enhancer (see claim 20) for enhancing germination of the spore-form microorganisms in the composition (see pg. 13, line 11).
Regarding the limitation of “but grows in biofilm form upon contact with the livestock animal’s digestive system”, this limitation does not require any further method step and is directed to an inherent property of the bacterium. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Because Farmer teaches the same strain deposited under the same accession number, the recited effects of contacting this strain in spore form with the livestock animal’s digestive system must necessarily be present in the prior art method.
Regarding claim 7, Farmer teaches the method wherein the composition is applied to a field and/or pasture or to drinking water and/or animal feed, such that the livestock animals ingest the composition (see claims 1 and 22), which meets the limitation of administering the composition to the digestive system orally.
Regarding claim 9, Farmer teaches the method further comprising applying a prebiotic with the one or more beneficial microorganisms and/or one or more microbial growth by-products, wherein the prebiotic is dry animal fodder, straw, hay, alfalfa, grains, forage, grass, fruits, vegetables, oats and/or crop residue (see claim 18).
Regarding claim 10, Farmer teaches the method further comprising applying a germination enhancer with the one or more beneficial microorganisms and/or one or more microbial growth by-products, wherein the germination enhancer is L-alanine, L-leucine or manganese (see claim 20).
Regarding claim 11, Farmer teaches the method further comprising applying one or more of the following components with the one or more beneficial microorganisms and/or one or more microbial growth by-products: seaweed (Asparagopsis taxiformis); kelp; 3-nitrooxypropanol; anthraquinones; ionophores selected from monensin and lasalocid; polyphenols selected from saponins and tannins; organosulfurs; garlic extract; flavonoids selected from quercetin, rutin, kaempferol, naringin, and anthocyanidins; bioflavonoids isolated from green citrus fruits, rose hips and/or black currants; carboxylic acid; and terpenes selected from d-limonene, pinene and citrus extracts (see claim 21).
Regarding claim 15, Farmer teaches the method further comprising applying the one or more microorganism and/or one or more microbial growth by-products to drinking water and/or to supplemental feed that the livestock animals ingest (see claim 22).
Regarding claim 16, Farmer teaches the method further comprising assessing the effect of the method on the reduction of enteric deleterious atmospheric gas emissions and/or precursors thereof in the livestock animal's digestive system and/or waste (see claim 28).
Regarding claim 17, Farmer teaches the method further comprising assessing the effect of the method on the control of methanogenic bacteria in the livestock animal's digestive system and/or waste (see claim 29).
Regarding claim 18, Farmer teaches the method used for reducing the number of carbon credits used by an operator involved in livestock production (see claim 31).
Regarding claim 19, Farmer teaches a composition comprising B. amyloliquefaciens NRRL B-67928, as discussed regarding claim 1.
Regarding claim 23, Farmer teaches a composition comprising Bacillus amyloliquefaciens in spore form (see pg. 3, lines 32-36), wherein the strain of B. amyloliquefaciens is B. amyloliquefaciens NRRL B-67928 (see pg. 4, lines 1-2).
Regarding claim 26, Farmer teaches the composition comprises a germination enhancer, such as L-alanine, L-leucine, or manganese (see pg. 4, lines 24-27).
Regarding claim 27, Farmer teaches the composition comprising additional components, such as seaweed (e.g., Asparagopsis taxiformis), kelp, 3-nitrooxypropanol, anthraquinones, ionophores (e.g., monensin and/or lasalocid), polyphenols (e.g., saponins and tannins), and/or organosulfurs, (e.g., garlic extract) (see pg. 5, lines 23-28).
Regarding claim 30, Farmer teaches the composition comprising one or more additional substances and/or nutrients, such as vitamins, fatty acids, amino acids, proteins and/or peptides (see pg. 5, lines 29-33).
Regarding claim 32, Farmer teaches the composition comprising a saturated long-chain fatty acid, such as myristic acid, palmitic acid and/or stearic acid (see pg. 4, lines 29-30).
Claim(s) 1, 6-7, 9-10, 15 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by King, et al. (US 2017/0079308; cited on Form 892), hereafter, “King”, as evidenced by Rizzi, et al. (Iron Homeostasis in Bacillus subtilis Requires Siderophore Production and Biofilm Formation. Appl Environ Microbiol. 2019 Jan 23;85(3):e02439-18; cited on Form 892), hereafter, “Rizzi”.
Regarding claim 1, King teaches a method of feeding an animal, the method comprising the step of administering to the animal a feed composition or drinking water comprising an effective amount of an additive comprising an isolated Bacillus strain selected from the group consisting of Bacillus strain 86 and Bacillus strain 300 (see pg. 2, para. [0013]), which are disclosed as being Bacillus subtilis strains (see pg. 33, Table 38), wherein the Bacillus strain has an effect of improving the environment of the animal (see pg. 2, para. [0013] and para. [0028]), wherein the improvement to the environment includes reducing the long chain fatty acid content and explosive gases in manure (see pg. 2, para. [0029]), wherein the reduction in long chain fatty acid content causes a reduction in explosive gases, including methane (see pg. 2, para. [0032]).
Per MPEP 2131.01, while normally one reference should be used in making a rejection
under 35 U.S.C. 102, the use of additional references has been held to be proper when the extra
references are cited to show that a characteristic not disclosed in the reference is inherent.
Rizzi discloses that Bacillus subtilis acquires iron from its natural environment, producing siderophores which specifically bind to iron for uptake by the bacteria (see pg. 1, “Importance”).
Hence, the isolated Bacillus subtilis strains taught by King meet the limitation of “an iron-capturing Bacillus spp. bacterium”, because iron acquisition is an inherent property of this species of bacterium.
Therefore, King teaches a method for reducing methane produced in a livestock animal’s digestive system and/or waste (i.e., methane in manure), wherein the method comprises contacting, with the livestock animal’s digestive system (i.e., administering to the animal in a feed composition or drinking water), a composition comprising an iron-capturing Bacillus spp. bacterium (i.e., Bacillus subtilis).
Regarding claim 6, King teaches amino acid ingredients that may be added to the animal feed blend include lysine (see pg. 10, para. [0219]).
Regarding claim 7, King teaches administering to the animal a feed composition or drinking water comprising the isolated Bacillus strain, as discussed above, which meets the limitation of administering the composition to the digestive system orally.
Regarding claim 9, in King’s examples, animals were fed feed compositions comprising the Bacillus subtilis strains and corn (see pg. 16, para. [0280], Table 9; pg. 17, para. [0287]), which meets the limitation of a vegetable.
Regarding claim 10, King teaches that ingredients of the animal feed blend include manganese (see pg. 9, para. [0218]).
Regarding claim 15, King teaches administering to the animal a feed composition or drinking water comprising the isolated Bacillus strain, as discussed above.
Regarding claim 18, the claim recites an intended use without reciting any further active steps in the claimed process. Therefore, the claim is anticipated for the same reasons discussed regarding claim 1.
Claim(s) 19, 23-24, 26 and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farmer, et al. (US 2020/0396991 A1; cited on Form 892), hereafter, “Farmer ‘991”.
Regarding claim 19, Farmer ‘991 discloses a culture of the Bacillus amyloliquefaciens, strain “B. amy” deposited under accession number NRRL B-67928 (see pg. 2, para. [0015]). Hence, Farmer teaches a composition comprising Bacillus amyloliquefaciens NRRL B-67928.
Regarding claim 23, Farmer ‘991 teaches that the methods of the disclosure preferably utilize the B. amyloliquefaciens NRRL B-67928 strain (see pg. 3, para. [0037]). Farmer teaches a method comprising inoculating a fermentation reactor comprising a liquid nutrient medium with the Bacillus amyloliquefaciens bacterium to produce a bacterial culture (see pg. 5, para. [0078]), wherein the microbial inoculant comprises propagules of the microorganism, wherein the propagules are spores (see pg. 6, para. [0081]). Therefore, Farmer teaches a composition comprising B. amyloliquefaciens NRRL B-67928 in spore form.
Regarding claim 24, Farmer ‘991 teaches the liquid nutrient medium comprising citric acid (see pg. 6, para. [0084]).
Regarding claim 26, Farmer ‘991 teaches the adding of L-alanine or manganese at the time of inoculation to enhance germination (see pg. 6, para. [0083]).
Regarding claim 30, Farmer ‘991 teaches the liquid nutrient medium comprises organic acids or alcohols (see pg. 6, para. [0084]).
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.
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Claims 1, 4, 7, 9, 11, 15-19, 27 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 9-11 and 13 of U.S. Patent No. 11,758,924 B2, hereafter, “924”. Although the claims at issue are not identical, they are not patentably distinct from each other because they are anticipated by the patented claims.
Claim 1 of 924 recites: A method for killing a methanogenic microorganism in a livestock animal's digestive system, the method comprising applying a composition comprising one or more nongenetically-modified beneficial microorganisms and one or more growth by-products thereof to a field or pasture, said field or pasture comprising grasses and/or other plants upon which livestock animals graze, and placing the livestock animals in the field or pasture to graze, wherein the livestock animals ingest the composition in addition to the grasses and/or other plants, wherein at least one of the one or more beneficial microorganisms is Bacillus amyloliquefaciens NRRL B-67928 at a concentration of about 1x106 to about 1x1013 CFU/ml of the composition, wherein the one or more growth by-products are lipopeptide biosurfactants, and wherein the killing of the methanogenic microorganism reduces enteric deleterious atmospheric gases and/or precursors thereof.
Claim 5 of 924 recites: The method of claim 1, further comprising applying a prebiotic with the one or more beneficial microorganisms and/or one or more microbial growth by-products, wherein the prebiotic is dry animal fodder, straw, hay, alfalfa, grains, forage, grass, fruits, vegetables, oats, crop residue, kelp extract, humic acid, fulvic acid, and/or humate.
Claim 6 of 924 recites: The method of claim 1, further comprising applying one or more of the following components: seaweed; kelp; 3-nitrooxypropanol; anthraquinones; ionophores selected from monensin and lasalocid; polyphenols selected from saponins and tannins; organosulfurs; garlic extract; flavonoids selected from quercetin, rutin, kaempferol, naringin, and anthocyanidins; bioflavonoids isolated from green citrus fruits, rose hips and/or black currants; carboxylic acid; and terpenes selected from d-limonene, pinene and citrus extracts.
Claim 7 of 924 recites: The method of claim 1, further comprising applying the one or more microorganisms and/or one or more microbial growth by-products to drinking water and/or to supplemental feed that the livestock animals ingest.
Claim 9 of 924 recites: The method of claim 1, wherein the deleterious atmospheric
gas is methane or carbon dioxide and/or the deleterious atmospheric gas precursor is nitrogen and/or ammonia.
Claim 10 of 924 recites: The method of claim 1, further comprising assessing the effect of the method on the reduction of enteric deleterious atmospheric gas emissions and/or precursors thereof in the livestock animal's digestive system and/or waste.
Claim 11 of 924 recites: The method of claim 1, further comprising assessing the effect of the method on the control of methanogenic bacteria and/or protozoa in the livestock animal's digestive system and/or waste.
Claim 13 of 924 recites: The method of claim 1, used for reducing the number of carbon credits used by an operator involved in livestock production.
As can be seen above, the patented claims teach all of the limitations of the instant claims. See also the claim interpretations presented under 35 U.S.C. 112(b) and 35 U.S.C. 102. Therefore, instant claims 1, 4, 7, 9, 11, 15-19, 27 and 30 are anticipated by the patented claims of US 11,758,924 B2.
Claims 5-6, 10, 23-24, 26 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 9-11 and 13 of U.S. Patent No. 11,758,924 B2, hereafter, “924” in view of Farmer (WO 2020/210074 A1; as discussed under 35 U.S.C. 102). This is an obvious-type rejection.
Claims 1, 5-7, 9-11 and 13 of 924 are recited in their entirety above.
Claim 4 of 924 recites: The method of claim 1, wherein the microbial growth by-products are in crude form, said crude form comprising a supernatant resulting from fermentation of a microorganism that produces said growth by-products.
The claims of ‘924 recite a method to have livestock animals ingest a composition comprising B. amyloliquefaciens NRRL B-67928 and growth by-products thereof for the purpose of killing methanogenic microorganisms in the animal’s digestive system in order to reduce enteric deleterious atmospheric gases and/or precursors thereof (see claim 1), wherein the deleterious atmospheric gas is methane (see claim 9).
Farmer, in the same field of endeavor, teaches a method for reducing enteric deleterious atmospheric gases and/or precursors thereof, by also having livestock animals ingest a composition comprising NRRL B-67928 and growth by-products thereof (see claim 1). Similar to ‘924, Farmer also teaches the growth by-products are biosurfactants (see claim 9). Farmer teaches that the cattle industry is important for the production of meats and dairy products; however, growing concerns over climate change and a need for reducing greenhouse gas emissions calls for improved approaches for producing cattle with reduced greenhouse emissions (see pg. 3, lines 11-13). Farmer teaches the composition can help reduce deleterious enteric
atmospheric gases in the digestive systems of livestock animals by controlling, and/or inhibiting
methanogenesis by, methanogenic gut bacteria (see pg. 3, lines 26-29). Furthermore, Farmer teaches that the composition can comprise additional components known to reduce methanogenesis by methanogens, such as, seaweed (e.g., Asparagopsis taxiformis), kelp, 3-nitrooxypropanol, anthraquinones, ionophores, etc. (see pg. 5, lines 23-28).
Therefore, it would have been obvious to have combined ‘924 with Farmer, because both references relate to solving the same problem using a substantially similar method. One would have been motivated to combine these teachings in order to reduce methane emissions in livestock.
Regarding instant claims 5, 10, 23, 26 and 32, Farmer teaches the further limitations of the instant claims, as discussed under 35 U.S.C. 102.
Regarding instant claims 6 and 24, Farmer teaches methods for the cultivation of the microorganisms, wherein the cultivation is supplemented with a carbon source, such as citric acid (see pg. 18, lines 34-36). Farmer also teaches the method previously discussed, wherein the microbial growth by-products are in crude form, said crude form comprising a supernatant resulting from fermentation of a microorganism that produces said growth by-products (see claim 17). This is the same teaching as claim 4 of ‘924 above. Farmer teaches that the by-product can be utilized in “crude form” comprising fermentation broth resulting from cultivation of a biosurfactant-producing microbe (see pg. 15, lines 26-29). Therefore, Farmer suggests that the composition may comprise the cultivation broth comprising citric acid, as well the microbes and any by-products, when used in the method. Furthermore, it would have been obvious to have included citric acid as a carbon source in the composition for the benefit of the bacterium’s growth.
Claims 1, 4, 7, 15-19 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of U.S. Patent No. 12,642,284 B2, hereafter, “284”. Although the claims at issue are not identical, they are not patentably distinct from each other because they are anticipated by the patented claims.
Claim 1 of 284 recites: A method for reducing the production of methane from a livestock animal's digestive system, wherein the method comprises feeding, to said livestock animal, feed that comprises Bacillus amyloliquefaciens NRRL B-67928 and an additional microorganism selected from Pleurotus ostreatus, Saccharomyces boulardii or Bacillus subtilis, and a lipopeptide biosurfactant, wherein said microorganism is at a concentration of microbial cells of about 1x109 to about 1x1013 CFU/ml and wherein ingestion of the feed by the livestock animal reduces production of methane from the livestock animal's digestive system.
Claim 3 of 284 recites: The method of claim 1, further comprising assessing the effect of the method on the reduction of methane emissions in the livestock animal's digestive system and/or waste.
Claim 4 of 284 recites: The method of claim 1, further comprising assessing the effect of the method on the control of methanogenic bacteria and/or protozoa in the livestock animal's digestive system and/or waste.
Claim 5 of 284 recites: The method of claim 1, used for reducing the number of carbon credits used by an operator involved in livestock production.
As can be seen above, the patented claims teach all of the limitations of instant claims 1, 4, 7, 15-19 and 30. See also the claim interpretations presented under 35 U.S.C. 112(b) and 35 U.S.C. 102. Therefore, instant claims 1, 4, 7, 15-19 and 30 are anticipated by the patented claims of U.S. 12,642,284 B2.
Claims 5-6, 9-11, 23-24, 26-27 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of U.S. Patent No. 12,642,284 B2, hereafter, “284” in view of Farmer (WO 2020/210074 A1; as discussed under 35 U.S.C. 102). This is an obvious-type rejection.
Claims 1 and 3-5 of 284 are recited in their entirety above.
The claims of ‘284 recite a method for reducing the production of methane from a livestock animal’s digestive system, comprising feeding to the livestock animal a composition comprising B. amyloliquefaciens NRRL B-67928 and a lipopeptide biosurfactant (see claim 1). The claims also suggest that the method may be effective to control methanogenic bacteria in the livestock animal’s digestive system and/or waste, as they recite further assessing whether this effect has been achieved (see claim 4).
Farmer, in the same field of endeavor, teaches a method for reducing enteric deleterious atmospheric gases and/or precursors thereof, by also having livestock animals ingest a composition comprising NRRL B-67928 and growth by-products thereof (see claim 1). Farmer teaches the method wherein the the growth by-product is a lipopeptide biosurfactant (see claims 9 and 11). Farmer teaches that the cattle industry is important for the production of meats and dairy products; however, growing concerns over climate change and a need for reducing greenhouse gas emissions calls for improved approaches for producing cattle with reduced greenhouse emissions (see pg. 3, lines 11-13). Farmer teaches the composition can help reduce deleterious enteric atmospheric gases in the digestive systems of livestock animals by controlling, and/or inhibiting methanogenesis by, methanogenic gut bacteria (see pg. 3, lines 26-29). Furthermore, Farmer teaches that the composition can comprise additional components known to reduce methanogenesis by methanogens, such as, seaweed (e.g., Asparagopsis taxiformis), kelp, 3-nitrooxypropanol, anthraquinones, ionophores, etc. (see pg. 5, lines 23-28).
Therefore, it would have been obvious to have combined ‘284 with Farmer, because both references relate to solving the same problem using a substantially similar method. One would have been motivated to combine these teachings in order to reduce methane emissions in livestock.
Regarding instant claims 5, 9-11, 23, 26-27 and 32, Farmer teaches the further limitations of the instant claims, as discussed under 35 U.S.C. 102.
Regarding instant claims 6 and 24, Farmer teaches methods for the cultivation of the microorganisms, wherein the cultivation is supplemented with a carbon source, such as citric acid (see pg. 18, lines 34-36). Farmer also teaches the method previously discussed, wherein the microbial growth by-products are in crude form, said crude form comprising a supernatant resulting from fermentation of a microorganism that produces said growth by-products (see claim 17). Farmer teaches that the by-product can be utilized in “crude form” comprising fermentation broth resulting from cultivation of a biosurfactant-producing microbe (see pg. 15, lines 26-29). Therefore, Farmer suggests that the composition may comprise the cultivation broth comprising citric acid, as well the microbes and any by-products, when used in the method. Furthermore, it would have been obvious to have included citric acid as a carbon source in the composition for the benefit of the bacterium’s growth.
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
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