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 .
DETAILED ACTION
Claims 1-16 are pending.
Priority
Applicant’s claim for priority to the filing date of EP22157248.0 filed 17 February 2022 and PCT/EP2023/052626 filed 03 February 2023 is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The effective filing date is 17 February 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 13 August 2024, 25 September 2024, 07 October 2024, and 23 September 2025 are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-11, in the reply filed on 29 June 2026 is acknowledged. Applicant’s election without traverse of the species of Bacillota strain Bacillus velezensis and species of gerKC sequence SEQ ID NO: 2 is also acknowledged.
Claims 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, and claims 5-6 are withdrawn as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 June 2026.
Claims 1-4 and 7-11 are under examination.
Claim Objections
Claims 1-4 and 7-11 are objected to because of the following informalities:
Claims 1-4 and 7-11 lack preceding articles at the beginning of the claims’ preambles, so it is suggested that Applicant amend the claim to include the article “A/An” or “The” as the first word of the claims.
Claim 10’s limitation “or a feed or food additive containing said Bacillota strain” on line 2 is redundant and should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4, 7-8, and 10 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.
Regarding claims 2, 4, 7, 8, and 10, following the phrase "preferably" are narrower limitations. The phrases starting with the word “preferably” render the claims 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.
Regarding claim 8, claim 8 recites the Bacillota strain is a B. velezensis strain, wherein the genomic DNA of the strain is at least 99% identical to the genomic DNA of the strain CECT 5940, and wherein the strain exhibits increased outgrowth and/or germination in comparison to the strain CECT 5940. The limitation of the genomic DNA of Bacillus velezensis CECT 5940 is indefinite in the absence of a sequence identifier, i.e. no SEQ ID NO: is presented. Neither does the disclosure point to any particular sequence where the genomic DNA sequence may be located so that one of ordinary skill in the art would be able to determine that a given Bacillus velezensis strain would be at least 99% identical to the sequence of the genomic DNA of Bacillus velezensis CECT 5940. It is also unclear if the term “the genomic DNA” encompasses the entire genomic sequence of Bacillus velezensis CECT 5940, or if it only encompasses 16s rRNA sequences that are more commonly used for comparison of bacterial strains in the art. Additionally, the BRI of the limitation “wherein the genomic DNA of the strain is at least 99 % identical to the genomic DNA of the strain CECT 5940” includes a Bacillus velezensis strain comprising genomic DNA that is 100% identical to Bacillus velezensis CECT 5940 strain, thus the limitation includes the Bacillus velezensis CECT 5940 strain itself. It is unclear how the limitation “wherein the strain exhibits increased outgrowth and/or germination in comparison to the strain CECT 5940” would be able to be achieved by the Bacillus velezensis CECT 5940 strain itself.
Regarding claim 10, the phrase "such as" renders the claim indefinite because it is unclear whether the limitation “antibiotics” following the phrase is part of the claimed invention. See MPEP § 2173.05(d).
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 and 7-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more.
Claims 1-4 and 7-11 are drawn to the statutory category of a composition of matter (Step 1: Yes).
Claim 1 recites an endospore-forming Bacillota strain which exhibits improved outgrowth and/or germination characteristics. Bacteria belonging to the phylum Bacillota include naturally occurring species that can be isolated from the environment. For example, Bacillota member Bacillus amyloliquefaciens CECT 5940 was isolated from soil and has not been genetically modified, as evidenced by pg. 6 sec. 2.2 of Bories et al. (Safety and efficacy of Ecobiol® (Bacillus amyloliquefaciens) as feed additive for chickens for fattening, The EFSA Journal (2008) 773, 1-13). Claim 1 recites the limitation “which exhibits improved outgrowth and/or germination characteristics, which is interpreted as an intended capability or property of the claimed strains, but does not add any new structural limitations to the composition.
Claim 2 recites “wherein the strain possesses probiotic activity, in particular ability to inhibit pathogenic bacteria, preferably selected from C. perfringens, S. enteritidis, S. typhimurium, E. coli, C. difficile, Vibrio parahaemolyticus and combinations thereof, ability to grow in presence of bile and/or ability to produce organic acids, preferably lactic acid”, claim 3 recites “wherein the improved outgrowth and/or germination characteristics are due to an enhanced activity of the germination receptor GerK”, and claim 4 recites “wherein the improved outgrowth and/or germination characteristics are due to at least one mutation, preferably 1 to 10 mutations, more preferably 1 to 5 mutations, above all 2 to 4 mutations, in at least one subunit of the germination receptor GerK, wherein the subunit is preferably the spore germination protein KC (GerKC)”. These limitations are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition.
Claim 7 recites the Bacillota strain is a strain of the genus Bacillus, or of the species B. subtilis, B. amyloliquefaciens, B. velezensis, B. licheniformis, B. paralicheniformis, B. pumilus, B. megaterium, B. lentus, B. laterosporus, B. alevi, B. cereus, B. badius, B. thurigiensis, B. coagulans, B. siamensis, B. glycinifermentans, B. methylotrophicus, B. thuringensis, B. polyfermenticus, B. vallismortis, B. tequilensis, B. atrophaeus, B. mojavensis, B. sonorensis, B. inaquosus and B. safensis. The Bacillus genus is classified under phylum Bacillota, including the species Bacillus velezensis, as evidenced by pg. 1 of USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026).
Claim 8 recites the Bacillota strain is a B. velezensis strain wherein the genomic DNA of the strain is at least 99 % identical to the genomic DNA of the strain CECT 5940. Bacillus amyloliquefaciens CECT 5940 was isolated from soil and has not been genetically modified, as evidenced by pg. 6 sec. 2.2 of Bories et al. (Safety and efficacy of Ecobiol® (Bacillus amyloliquefaciens) as feed additive for chickens for fattening, The EFSA Journal (2008) 773, 1-13). Bacillus amyloliquefaciens CECT 5940 was reclassified as Bacillus velezensis CECT 5940, as evidenced by the abstract of Bampidis et al. (Safety and efficacy of the feed additive consisting of Bacillus velezensis CECT 5940 (Ecobiol®) for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (Evonik Operations GmbH), EFSA Journal 2021;19(6):6620, 8 pp. https://doi.org/10.2903/j.efsa.2021.6620, published 16 June 2021). Since Bacillus velezensis CECT 5940 was isolated from soil, and has at least 99% identity to the genomic DNA of Bacillus velezensis CECT 5940 as recited in the claim, claim 8 is still directed to a naturally occurring bacterial strain. Claim 8 recites “wherein the strain exhibits increased outgrowth and/or germination in comparison to the strain CECT 5940”, which is interpreted as an intended capability or property of the claimed strain, but does not add any new structural limitations to the composition.
Claim 9 recites a feed or food additive containing a Bacillota strain. As established above, Bacteria belonging to the phylum Bacillota include naturally occurring species that can be isolated from the environment, such as the soil. The claim does not recite any additional structural limitations, thus still recites a product of nature.
Claim 10 recites the feed or food composition containing the Bacillota strain further comprises carriers, proteins, carbohydrates, fats, further probiotics, prebiotics, enzymes, vitamins, immune modulators, milk replacers, minerals, amino acids, coccidiostats, acid-based products, medicines, or antibiotics. The BRI of carriers includes natural compounds such as water. Proteins, carbohydrates, fats, enzymes, vitamins, minerals, and amino acids are ubiquitous naturally occurring compounds regularly isolated from nature. The BRI of probiotics includes additional naturally occurring bacteria.
Claim 11 recites a pharmaceutical composition containing a Bacillota strain and a pharmaceutically acceptable carrier. As established above, Bacteria belonging to the phylum Bacillota include naturally occurring species that can be isolated from the environment, such as the soil. The BRI of pharmaceutically acceptable carriers includes natural compounds such as water.
Therefore the instant invention recites a judicial exception of a product of nature (Step 2A Prong One: Yes).
This judicial exception is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are drawn to a naturally occurring strain of bacteria and compositions comprising said natural strain. The claims do not recite any method steps or active applications of the claimed strains and compositions for any specific useful purpose.
Therefore, the instant invention is directed to the judicial exception of a product of nature and does not include any additional elements that amount to significantly more than the recited judicial exception of a product of nature, and so the instant invention is not patent eligible subject matter under 35 USC §101 (Step 2A Prong Two: No and Step 2B: No).
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.
Claims 1-4 and 7-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wood et al. (US 11406672 B2, published 09 August 2022, effectively filed 14 March 2018) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Bampidis et al. (Safety and efficacy of the feed additive consisting of Bacillus velezensis CECT 5940 (Ecobiol®) for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (Evonik Operations GmbH), EFSA Journal 2021;19(6):6620, 8 pp. https://doi.org/10.2903/j.efsa.2021.6620, published 16 June 2021).
Claim Interpretation
Claim 1 recites the limitation “which exhibits improved outgrowth and/or germination characteristics”, claim 2 recites “wherein the strain possesses probiotic activity, in particular ability to inhibit pathogenic bacteria, preferably selected from C. perfringens, S. enteritidis, S. typhimurium, E. coli, C. difficile, Vibrio parahaemolyticus and combinations thereof, ability to grow in presence of bile and/or ability to produce organic acids, preferably lactic acid”, claim 3 recites “wherein the improved outgrowth and/or germination characteristics are due to an enhanced activity of the germination receptor GerK”, claim 4 recites “wherein the improved outgrowth and/or germination characteristics are due to at least one mutation, preferably 1 to 10 mutations, more preferably 1 to 5 mutations, above all 2 to 4 mutations, in at least one subunit of the germination receptor GerK, wherein the subunit is preferably the spore germination protein KC (GerKC)”, and claim 8 recites “wherein the strain exhibits increased outgrowth and/or germination in comparison to the strain CECT 5940”. These limitations are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition; thus, if a composition in the prior art teaches all of the structural limitations of the claimed composition, these limitations will be considered anticipated.
Regarding claims 1 and 7, Wood teaches a probiotic composition comprising Bacillus amyloliquefaciens CECT 5940 (Wood col. 5 lns. 22-26 and col. 7 lns. 46-47). The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1). The strain Bacillus amyloliquefaciens CECT 5940 has been reclassified as Bacillus velezensis CECT 5940, as evidenced by Bampidis (Bampidis Abstract).
Regarding claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since Wood teaches all of the structural limitations of the claimed composition, these limitations will be considered anticipated.
Regarding claim 8, Wood’s composition comprises Bacillus velezensis CECT 5940 itself, which is a Bacillus velezensis strain that has at least 99% identity to the genomic DNA of Bacillus velezensis CECT 5940 as recited in the claim.
Regarding claims 9-10, Wood teaches the probiotic composition is a food or feed additive composition (Wood col. 24 lns. 19-24). Wood also teaches the composition may include additional probiotics (Wood col. 5 ln. 22 through col. 8 ln. 22), and other additives including carbon sources like carbohydrates and oils, nitrogen sources, inorganic salt, organic acid, vitamins, minerals, acetic acid, and amino acids (Wood col. 10 lns. 18-34).
Regarding claim 11, Wood teaches the probiotic compositions is a pharmaceutical composition mixed with pharmaceutically acceptable carriers (Wood col. 24 lns. 19-24 and 40-43)
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.
Claim Interpretation
Claim 1 recites the limitation “which exhibits improved outgrowth and/or germination characteristics”, claim 2 recites “wherein the strain possesses probiotic activity, in particular ability to inhibit pathogenic bacteria, preferably selected from C. perfringens, S. enteritidis, S. typhimurium, E. coli, C. difficile, Vibrio parahaemolyticus and combinations thereof, ability to grow in presence of bile and/or ability to produce organic acids, preferably lactic acid”, claim 3 recites “wherein the improved outgrowth and/or germination characteristics are due to an enhanced activity of the germination receptor GerK”, claim 4 recites “wherein the improved outgrowth and/or germination characteristics are due to at least one mutation, preferably 1 to 10 mutations, more preferably 1 to 5 mutations, above all 2 to 4 mutations, in at least one subunit of the germination receptor GerK, wherein the subunit is preferably the spore germination protein KC (GerKC)”, and claim 8 recites “wherein the strain exhibits increased outgrowth and/or germination in comparison to the strain CECT 5940”. These limitations are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition; thus, if a composition in the conflicting claims recites all of the structural limitations of the claimed composition, these limitations will be considered anticipated.
Claims 1-4, 7, and 9-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-16 of U.S. Patent No. US 11,173,184 B2, as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, 9, and 11, conflicting claims 1-8 and 10-16 recite a composition comprising Bacillus subtilis DSM 32315. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 10, conflicting claim 10 recites that the feed/ food composition further comprises other ingredients selected from the group consisting of: proteins, carbohydrates, fats, further probiotics, prebiotics, enzymes, vitamins, immune modulators, milk replacers, minerals, amino acids, coccidiostats, acid-based products, medicines, and combinations thereof.
Claims 1-4, 7, 9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claims 1-5, 8, and 10-12 of U.S. Patent No. US 12,012,624 B2, as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, 9, and 11, conflicting claims 1-5, 8, and 10-12 recite a strain Bacillus subtilis. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Claims 1-4 and 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6, 8-11, and 14-15 of U.S. Patent No. US 12,329,788 B2, as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026), Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus), and Bampidis et al. (Safety and efficacy of the feed additive consisting of Bacillus velezensis CECT 5940 (Ecobiol®) for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (Evonik Operations GmbH), EFSA Journal 2021;19(6):6620, 8 pp. https://doi.org/10.2903/j.efsa.2021.6620, published 16 June 2021)
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, 9, and 11, conflicting claims 1, 3, 6, 8-11, and 14-15 recite compositions comprising Bacillus subtilis DSM 32315 and Bacillus amyloliquefaciens CECT 5940. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 8, the conflicting claims’ composition comprises Bacillus amyloliquefaciens CECT 5940, which was reclassified as Bacillus velezensis CECT 5940, as evidenced by Bampidis (Bampidis Abstract). The Bacillus amyloliquefaciens/velezensis CECT 5940 has at least 99% identity to the genomic DNA of Bacillus velezensis CECT 5940 as recited in the instant claim.
Regarding instant claim 10, conflicting claim 5 recites that the feed/ food composition further comprises other ingredients selected from the group consisting of: proteins, carbohydrates, fats, further probiotics, prebiotics, enzymes, vitamins, immune modulators, milk replacers, minerals, amino acids, coccidiostats, acid-based products, medicines, and combinations thereof.
Claims 1-4, 7, 9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. US 10,913,960 B2, as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026, hereinafter “USDA Bacillus”), USDA (Clostridium, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000AxhLAAS/clostridium, accessed 06 August 2026, hereinafter “USDA Clostridium”), Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus), and Creative Diagnostics (An overview of Clostridium, https://www.creative-diagnostics.com/blog/index.php/an-overview-of-clostridium/, 04 May 2018, accessed 06 August 2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, 9, and 11, conflicting claim 4 recites a cell selected from the group consisting of: Escherichia coli, Pseudomonas sp., Pseudomonas fluorescens, Pseudomonas putida, Pseudomonas stutzeri, Acinetobacter sp., Burkholderia sp., Burkholderia thailandensis, Cyanobakterien, Klebsiella sp., Klebsiella oxytoca, Salmonella sp., Rhizobium sp. and Rhizobium meliloti, Bacillus sp., Bacillus subtilis, Clostridium sp., Corynebacterium sp., Corynebacterium glutamicum, Brevibacterium sp., Chlorella sp. and Nostoc sp. The Bacillus and Clostridium genera are classified under phylum Bacillota, as evidenced by pg. 1 of USDA Bacillus and pg. 1 of USDA Clostridium. The species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2), as do the species within the genus Clostridium, as evidenced by Creative Diagnostics (Creative Diagnostics pg. 1 para. 1).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Claims 1-4, 7, 9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. US 12,312,622 B2, as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, 9, and 11, conflicting claim 9 recites a microorganism belonging to the genus Bacillus. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (pg. 1). The species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Claims 1-4, 7, 9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. US 11236372 B2, as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026, hereinafter “USDA Bacillus”), USDA (Clostridium, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000AxhLAAS/clostridium, accessed 06 August 2026, hereinafter “USDA Clostridium”), Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus), and Creative Diagnostics (An overview of Clostridium, https://www.creative-diagnostics.com/blog/index.php/an-overview-of-clostridium/, 04 May 2018, accessed 06 August 2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, 9, and 11, conflicting claim 17 recites a microbial cell selected from the group consisting of: Acinetobacter sp., Bacillus sp., Brevibacterium sp., Burkholderia sp., Chlorella sp., Clostridium sp., Corynebacterium sp., Cyanobakterien, Escherichia sp., Pseudomonas sp., Klebsiella sp., Salmonella sp., Rhizobium sp., Saccharomyces sp., Pichia sp., and Nostoc sp. The Bacillus and Clostridium genera are classified under phylum Bacillota, as evidenced by pg. 1 of USDA Bacillus and pg. 1 of USDA Clostridium. The species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2), as do the species within the genus Clostridium, as evidenced by Creative Diagnostics (Creative Diagnostics pg. 1 para. 1).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Claims 1-4, 7, 9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8-10, 12, and 14 of U.S. Patent No. US 12697356 B2, as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, 9, and 11, conflicting claims 1, 3-5, 8-10, 12, and 14 recite a feed or foodstuff composition comprising Bacillus subtilis DSM 32540. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Claims 1-4 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 74-76 and 82-86 of copending Application No. 17/421,917 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026), Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus), and Bampidis et al. (Safety and efficacy of the feed additive consisting of Bacillus velezensis CECT 5940 (Ecobiol®) for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (Evonik Operations GmbH), EFSA Journal 2021;19(6):6620, 8 pp. https://doi.org/10.2903/j.efsa.2021.6620, published 16 June 2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claims 74-76 and 82-86 recite the microorganisms comprising selected from the group consisting of: Bacillus subtilis strain DSM 32540; Bacillus subtilis strain DSM 32592; Bacillus licheniformis strain DSM 32314; Bacillus pumilus strain DSM 32539; Bacillus amyloliquefaciens strain CECT 5940; and Bacillus subtilis strain DSM 32315. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 8, the conflicting claims recite the microorganism Bacillus amyloliquefaciens CECT 5940, which was reclassified as Bacillus velezensis CECT 5940, as evidenced by Bampidis (Bampidis Abstract). The Bacillus amyloliquefaciens/velezensis CECT 5940 has at least 99% identity to the genomic DNA of Bacillus velezensis CECT 5940 as recited in the instant claim.
Claims 1-4 and 7-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7 and 12-13 of copending Application No. 18/838,764 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1 and 7, conflicting claim 6 recites a microorganism belonging to the phylum Bacillota, the genus Bacillus, and the species B. subtilis, B. amyloliquefaciens, B. velezensis, B. licheniformis, B.paralicheniformis, B. pumilus, B. megaterium, B. lentus, B. laterosporus, B. alevi, B. cereus, B. badius, B. thurigiensis, B. coagulans, B. siamensis, B. glycinifermentans, B. methylotrophicus, B. thuringensis, B. polyfermenticus, B. vallismortis, B. tequilensis, B. atrophaeus, B. mojavensis, B. sonorensis, B. inaquosus or B. safensis. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 8, conflicting claim 7 recites a microorganism of the strain Bacillus velezensis having genomic DNA that is at least 99 % identical to the genomic DNA of the strain CECT 5940.
Regarding instant claim 9, conflicting claim 11 recites a feed or food additive comprising the Bacillota microorganisms discussed above.
Regarding instant claim 10, conflicting claim 12 recites the feed or food additive composition further comprises carriers, proteins, carbohydrates, fats, further probiotics, prebiotics, enzymes, vitamins, immune modulators, milk replacers, minerals, amino acids, carriers, coccidiostats, acid-based products, medicines, and antibiotics.
Regarding instant claim 11, conflicting claim 13 recites a pharmaceutical composition comprising the Bacillota microorganisms discussed above and a pharmaceutically acceptable carrier.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 38, 46-49, and 54-60 of copending Application No. 17/792,582 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7 and 9, conflicting claims 38, 46-49, and 54-60 recites the Bacillus strains DSM 33349, DSM 33350, DSM 33351, and DSM 33352. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 and 20-21 of copending Application No. 17/788,239 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7 and 9, conflicting claims 18 and 20-21 recites the strains B. pumilus DSM33297; B. pumilus DSM33355; B. pumilus DSM33301; B. subtilis DSM 33298; B. licheniformis DSM33354; B. megaterium DSM33300, B. megaterium DSM33356; and B. subtilis DSM33353. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 10-12 of copending Application No. 17/296,465 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1 and 7, conflicting claim 1 recites a probiotic strain of a genus Bacillus megaterium, including Bacillus megaterium DSM 32963, Bacillus megaterium DSM 33296, and Bacillus megaterium DSM 33299. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 9, conflicting claims 10 and 12-13 recite a feed or food additive comprising Bacillus megaterium, including Bacillus megaterium DSM 32963, Bacillus megaterium DSM 33296, and Bacillus megaterium DSM 33299.
Regarding instant claim 10, conflicting claim 7 recites the composition comprising probiotic strain of a genus Bacillus megaterium, including Bacillus megaterium DSM 32963, Bacillus megaterium DSM 33296, and Bacillus megaterium DSM 33299 also comprises a basic amino acid salt.
Regarding instant claim 11, conflicting claim 11 recites a pharmaceutical composition comprising Bacillus megaterium, including Bacillus megaterium DSM 32963, Bacillus megaterium DSM 33296, and Bacillus megaterium DSM 33299.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-7, 12-13, and 19 of copending Application No. 18/702,912 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, 9, and 11, conflicting claims 1-2 and 12 recite a probiotic strain of Bacillus subtilis, and conflicting claims 5, 13, and 19 recite the specific strains Bacillus subtilis DSM 32315, Bacillus subtilis DSM 32540, and Bacillus subtilis DSM 32592. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 10, conflicting claims 1 and 7 recite the composition comprising the Bacillus subtilis strains also further comprises a dipeptide of amino acids glutamine or glutamic acid, and conflicting claim 6 further limits the dipeptide to comprise amino acids glycine-glutamine, glycine-glutamic acid, alanine-glutamine, alanine-glutamic acid, and their acetylated forms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, 9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 5 of copending Application No. 19/116,456 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1 and 7, conflicting claims 1 and 2 recite Bacillus megaterium DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claims 9 and 11, conflicting claim 5 recites the composition comprising the Bacillus megaterium DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355 is in the form of a feed or food product or a pharmaceutical product.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 20, 22, 25, 27, 30, 32, and 35 of copending Application No. 18/861,952 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, 9, and 11, conflicting claims 17, 22, 27, and 32 recite a composition comprising a probiotic Bacillus subtilis strain, and claims 20, 25, 30, and 35 recite specific strains Bacillus subtilis DSM 32315, Bacillus subtilis DSM 32540, and Bacillus subtilis DSM 32592. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 10, conflicting claims 17, 22, 27, and 32 recite the composition further comprises dipeptide of amino acids glycine-glutamine, glycine-glutamic acid, alanine-glutamine, alanine-glutamic acid and its acetylated forms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, and 11-12 of copending Application No. 18/704,505 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1 and 7, conflicting claims 1, 3-4, and 11 recite probiotic Bacillus sp. strains, including Bacillus megaterium DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 10, conflicting claims 1 and 5 recite the composition comprises additional probiotic strains, and conflicting claim 6 recites the composition further comprises proteases (enzymes) and prebiotics: inulins, fructooligosaccharides (FOS), galactooligosaccharides (GOS), resistant starch, beta-glucans, glucomannans, galactoglucomannans, guar gum, and xylooligosaccharides.
Regarding instant claims 9 and 11, conflicting claim 12 recites the composition comprising the probiotic Bacillus sp. strains, including Bacillus megaterium DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355 is in the form of a feed or food product or a pharmaceutical product.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 14, 22, 36, and 41 of copending Application No. 17/294,947 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claims 2, 14 and 41 recite microorganisms Bacillus subtilis QST713, Bacillus thuringiensis, and Bacillus spp. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 10-11, conflicting claim 22 recites a composition comprising a mixture of a microorganism and a substrate (carrier), conflicting claim 36 limits the substrate to silica, diatomaceous earth, silica gel, and silcate (minerals), and water-insoluble natural fiber material (carbohydrates), and conflicting claim 41 limits the microorganism to Bacillus subtilis QST713, Bacillus thuringiensis, and Bacillus spp.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 6, 9, 14, and 16-17 of copending Application No. 19/115,010 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird- taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1 and 7, conflicting claims 2 and 16-17 recite probiotic strains Bacillus megaterium DSM 33300, Bacillus pumilus DSM 33297, Bacillus pumilus DSM 33355, and Bacillus spp. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 10, conflicting claim 6 recites the composition further comprises digestive enzymes proteases (enzymes), and conflicting claim 14 limits the enzymes to lactase, glutenase, gliadin hydrolase, protein hydrolase, carbohydrate hydrolase, lipid hydrolase, and lipase.
Regarding instant claims 9 and 11, conflicting claim 9 recites the composition comprising the probiotic Bacillus megaterium DSM 33300, Bacillus pumilus DSM 33297, Bacillus pumilus DSM 33355, and Bacillus spp is in the form of a feed or food product or a pharmaceutical product.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 10 of copending Application No. 18/683,134 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claim 4 recites microbial strains Bacillus subtilis QST713, Bacillus thuringiensis, and Bacillus spp. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 10-11, conflicting claims 1 and 10 recite a composition comprising a mixture of silica (mineral), polysaccharides (carbohydrate), glycoproteins (proteins), sugars, and microbes, and conflicting claim 4 limits the microbes to Bacillus subtilis QST713, Bacillus thuringiensis, and Bacillus spp.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 15, and 17 of copending Application No. 17/625,955 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026), Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus), PubChem (Geobacillus, https://pubchem.ncbi.nlm.nih.gov/taxonomy/129337, accessed 06 August 2026), and Burgess et al. (Insights into the Geobacillus stearothermophilus species based on phylogenomic principles. BMC Microbiol, 17, 140 (2017). https://doi.org/10.1186/s12866-017-1047-x).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claim 10 recites a probiotic strain within the genus Bacillus and Geobacillus, and conflicting claim 15 recites the strains Bacillus megaterium and Bacillus subtilis. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2). The Geobacillus genus is classified under phylum Bacillota, as evidenced by PubChem (PubChem pg. 1), and the species within genus Geobacillus all form endospores, as evidenced by Burgess (Burgess Abstract).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 10-11, conflicting claim 15 recites a mixture of Bacillus megaterium and Bacillus subtilis and a salt (mineral) and saccharide (carbohydrate), and conflicting claim 17 recites the mixture of conflicting claim 15 further comprises amino acids, fatty acid salts, and monosaccharide (carbohydrate).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17, and 20 of copending Application No. 17/296,450 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claims 15-17 recite bacterial strains Bacillus megaterium DSM 32963, Bacillus megaterium DSM 33296, and Bacillus megaterium strain DSM 33299. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claim 10, conflicting claims 15-17 recite the composition comprises multiple (additional) probiotic strains, including Bacillus megaterium DSM 32963, Bacillus megaterium DSM 33296, and Bacillus megaterium strain DSM 33299.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18/682,348 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claim 9 recites a microorganism of the genus Bacillus. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18/841,851 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claim 9 recites a microorganism of the genus Bacillus. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/866,152 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claim 10 recites a cell of Bacillus spp. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18/866,187 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claim 9 recites a cell of Bacillus spp. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/866,182 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026) and Turball (Medical Microbiology, 4th edition. Galveston TX, University of Texas Medical Branch at Galveston, 1996, Chapter 15 Bacillus).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1, 7, and 9, conflicting claim 8 recites a cell of Bacillus spp. The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1), and the species within genus Bacillus all form endospores, as evidenced by Turball (Turball pg. 1 para. 2).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 37, and 42-45 of copending Application No. 17/296,450 (reference application) as evidenced by USDA (Bacillus velezensis, https://acir.aphis.usda.gov/s/cird-taxon/a0u3d000000BMyIAAW/bacillus-velezensis, accessed 06 August 2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claim 1 and 7, conflicting claims 19 and 42-45 recite an endospore forming microorganism of the genus Bacillus wherein said microorganism is selected from the group consisting of DSM 33855, DSM 33856, DSM 33857 and DSM 33858.
The Bacillus genus is classified under phylum Bacillota, as evidenced by USDA (USDA pg. 1).
Regarding instant claims 2-4, as described above, the limitations of claims 2-4 are interpreted as intended capabilities or properties of the claimed strains, but do not add any new structural limitations to the composition. Since the conflicting claims recite all of the structural limitations of the claimed composition, these limitations are considered anticipated.
Regarding instant claims 9-11, conflicting claim 37 recites a food, feed or pharmaceutical composition comprising an endospore forming microorganism of the genus Bacillus wherein said microorganism is selected from the group consisting of DSM 33855, DSM 33856, DSM 33857 and DSM 33858, and one or more ingredients selected from carriers, proteins, carbohydrates, fats, probiotics, prebiotics, enzymes, vitamins, immune modulators, milk replacers, minerals, amino acids, carriers, coccidiostats, acid-based products, antibiotics; ingredients for treating, preventing or mitigating the course of a condition selected from diarrhea, necrotic enteritis and influenza.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/Alexander M Duryee/Examiner, Art Unit 1657 /LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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