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 16-21, 23-29, and 31-36 are pending. Claims 17-20, 29, and 31-36 are withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, 21, and 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Essghaier (Journal of Applied Microbiology 106.3 (2009): 833-846, of record in Office Correspondence mailed on 09/24/2025) in view of Nielsen (WO 2013153159 A1, published 10/17/2013) and Sapkota (Environmental health perspectives 115.5 (2007): 663), and as evidenced by EU435361 (Bacillus subtilis strain B1-33 16S ribosomal RNA gene, partial sequence, published 02/2009, of record in Office Correspondence mailed on 09/24/2025).
Regarding claims 16, 21, 23-26, and 28, Essghaier teaches that Bacillus subtilis strain B1-33 can form spores, has anti-fungal activity, and is sensitive to erythromycin, ampicillin, and chloramphenicol (Abstract, Table 1). EU435361 reports that Bacillus subtilis strain B1-33 comprises 16S rDNA 100% identical to instant SEQ ID NO: 2 (pages 1-2). Essghaier does not teach pelleted animal feed comprising the strain, or that Bacillus strain is non-hemolytic and sensitive to vancomycin, clindamycin, gentamicin, kanamycin, streptomycin, and tetracycline.
However, Nielsen teaches a pelleted animal feed comprising spores of Bacillus subtilis, a carrier, and animal feed ingredients (page 15 lines 5-10, claim 12). Nielsen teaches Bacillus subtilis strain is sensitive to ampicillin, vancomycin, gentamicin, kanamycin, streptomycin, erythromycin, clindamycin, tetracycline and chloramphenicol (claims 1 and 5-6). Nielsen teaches the strain has antimicrobial activity against E. coli and Clostridium perfringens. Nielsen teaches the strains and its spores are safe for administration to animals and have a probiotic (health, feed utilization and growth promoting) effect (page 1 lines 21-23). Thus, since hemolytic strains are considered pathogenic and are not considered probiotic, it is understood that the Bacillus subtilis strain taught by Nielsen is non-hemolytic Nielsen teaches the composition comprises 107 to 1012 CFU/g of Bacillus (page 14 lines 32-33).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Essghaier by adding Essghaier’s Bacillus subtilis strain to Nielsen’s pelleted animal feed as suggested by Nielsen. One of ordinary skill in the art would be motivated to do so in order to form a beneficial animal feed composition. Since Nielsen teaches Bacillus strains that are sensitive to antibiotics and have antimicrobial activity are added as probiotics to animal feeds, there is a reasonable expectation of success.
The limitations (non-hemolytic and sensitive to vancomycin, clindamycin, chloramphenicol, gentamicin, kanamycin, streptomycin, erythromycin and tetracycline) are understood as characteristics of Bacillus strain having 16S rDNA with more than 99.5% sequence identity to SEQ ID NO:2 (specification Tables 5.1-5.4). Since Essghaier’s strain has a 16S rDNA with 100% sequence identity to SEQ ID NO:2, then these characteristics will be present in the Essghaier’s strain.
While Nielsen does not disclose the 16S rDNA of the strain, Applicant discloses a Bacillus of amyloliquefaciens species has a 16S rDNA with 99.6% sequence identity to SEQ ID NO: 2 (i.e. Bacillus subtilis) (See Figure). Thus, it is understood that a threshold over 99.6% sequence identity to SEQ ID NO:2 classifies a strain as Bacillus subtilis species. Since Nielsen’s strain belongs to Bacillus subtilis species, then it is understood that the strain would have a 16S rDNA with more than 99.6% sequence identity to SEQ ID NO: 2
Essghaier and Nielsen do not teach the composition comprises forage, vegetable proteins, one or more enzymes, one or more minerals, and/or one or more vitamins.
However, Sapkota teaches that animal feed ingredients comprise forage, plant proteins, enzymes, minerals, and vitamins (Table 1).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify Essghaier’s teaching by adding forage, plant proteins, enzymes, minerals, and vitamins as suggested by Sapkota. Since Nielsen and Sapkota teach compositions for animal feed, there is a reasonable expectation of success. MPEP 2144.06 I states that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.
Regarding claim 27, Essghaier and Nielsen do not teach DSM 29870 ipsis verbis. However, Essghaier teaches the strain comprises 16S rRNA 100% identical to 16S rDNA of DSM 29870 (i.e. SEQ ID NO: 2) and is sensitive to erythromycin, ampicillin, and chloramphenicol. Nielsen teaches a strain of the same species of Bacillus subtilis, same isolation source from soil as instant strain (page 18 line 22 of Nielsen, instant specification page 48 lines 12-13), and has the same therapeutic effect on weight gain (Table 7 of Nielsen, instant Table 9.3), same sensitivity to antibiotics as discussed above, and same antimicrobial activity against E. coli and Clostridium perfringens (claim 1 of Nielsen, instant specification page 4 line 20). MPEP 2144.08 II discusses the obviousness of species when prior art teaches genus, while taking into consideration the teachings of structural similarity and similar properties or uses. Since Essghaier and Nielsen teach a strain with similar structure and similar properties of uses to the instant strain, it is understood that Essghaier’s and Nielsen’s strains and the instant strain are the same or obvious variants.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16, 21, and 23-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6 of U.S. Patent No. 11473052 in view of Sapkota.
Regarding claims 16, and 23-28, patent claim 1 recites administering Bacillus subtilis DSM 29870 to an animal (i.e. a strain having 100% sequence identity to SEQ ID NO: 2). Applicant discloses that Bacillus subtilis DSM 29870 comprises SEQ ID NO:2 as 16S rDNA, is non-hemolytic, and is sensitive to at least seven of the antibiotics selected from the group consisting of Vancomycin, Clindamycin, Chloramphenicol, Gentamicin, Kanamycin, Streptomycin, Erythromycin and Tetracycline (Specification page 3). Patent claim 3 recites Bacillus subtilis DSM 29870 is administered to said animal as part of an animal feed composition or an animal feed additive composition. Patent claim 5 recites composition comprising Bacillus subtilis DSM 29870 spores. Patent claim 6 recites Bacillus subtilis DSM 29870 is administered to said animal as part of a composition comprising one or more of the following: calcium carbonate, starch and cellulose. Patent claim 1 does not recite the composition is pelleted and comprises forage, vegetable proteins, one or more enzymes and/or one or more minerals, and/or one or more vitamins.
However, Sapkota teaches animal feed ingredients comprises forage and plant proteins, enzymes, minerals, and vitamins and teaches animal feed is pelleted (Table 1, page 667 left column first para.).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify patent claim 1 by adding forage, plant proteins, enzymes, minerals, and vitamins in the pelleted animal feed as suggested by Sapkota. One of ordinary skill in the art would be motivated to do so in order to provide a nutritious feed composition to the animal.
Regarding instant claim 21, patent claim 4 recites composition comprising from 105 to 1012 colony-forming units of Bacillus subtilis DSM 29870 per gram of said composition.
Claims 16, 21, 23-26, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 9, and 19 of U.S. Patent No. 12,364,720 in view of Sapkota.
Regarding instant claims 16, 21, 23-26, and 28, patent claims 1 and 19 recite administering one or more Bacillus strains to an animal, said one or more Bacillus strains comprising Bacillus subtilis DSM 29871. Applicant discloses Bacillus subtilis 29871 has 16S rDNA of SEQ ID NO: 3 (specification page 1) and discloses Bacillus subtilis DSM 29871 is non-hemolytic and is sensitive to at least seven of the antibiotics selected from the group consisting of Vancomycin, Clindamycin, Chloramphenicol, Gentamicin, Kanamycin, Streptomycin, Erythromycin and Tetracycline (Specification page 3). The 16S rDNA of Bacillus subtilis 29871 (i.e. SEQ ID NO: 3) has 99.93% sequence identity to SEQ ID NO: 2. Patent claim 2 recites Bacillus strains is/are administered to said animal as dried spores. Patent claim 3 recites 1x104 and 1x1018 colony forming units of said one or more Bacillus strains per kilogram of said composition. Patent claim 4 recites Bacillus strains is/are administered to said animal as part of a composition comprising one or more enzymes. Patent claim 6 recites Bacillus strains is/are administered to said animal as part of a composition comprising one or more vitamins. Patent claim 9 recites Bacillus strains is/are administered to said animal as part of a composition comprising extruded animal feed pellets. Patent claim 1 does recite the composition comprises forage, vegetable proteins, and/or one or more minerals.
However, Sapkota teaches animal feed ingredients comprises forage and plant proteins, enzymes, minerals, and vitamins (Table 1).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify patent claim 1 by adding forage, plant proteins, and minerals in the composition as suggested by Sapkota. One of ordinary skill in the art would be motivated to do so in order to provide a nutritious feed composition to the animal.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Applicant argues that Jimenez and Essghaier do not teach the recited strain characteristics, that Essghaier is non-analogous art, and that there is no motivation to combine or expectation of success.
In response to the argument that Essghaier is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Essghaier teaches art related to bacterial strains and their characteristics. Essghaier teaches Bacillus strain with 16S rDNA sequence 100% identical to SEQ ID NO: 2. and is considered analogous art. Nielsen teaches Bacillus strains are added to pelleted animal feeds. Essghaier teaches the strain forms spores, is sensitive to antibiotics and has antimicrobial activity. Similarly, Nielsen teaches a strain of the same species, forms spores, sensitive to antibiotics and has antibacterial activity. Thus, one of ordinary skill in the art would be motivated to combine the teachings of Essghaier and Nielsen. Conclusive proof of efficacy is not required to show a reasonable expectation of success, and obviousness does not require absolute predictability (See MPEP 2143.02(I) and MPEP 2143.02(II)).
Applicant argues the cited references do not teach the recited strain characteristics.
In response to the argument, it is understood that the recited characteristics are characteristics of a Bacillus strain having 16S rDNA with more than 99.5% sequence identity to SEQ ID NO:2. Since Essghaier’s strain has a 16S rDNA with 100% sequence identity to SEQ ID NO:2, then these characteristics will be present in the Essghaier’s strain.
Applicant argues that the obviousness-type double patenting rejections over claims 1 and 3-6 of U.S. Patent No. 11,473,052 in view of Abdollahi are improper because the presently recited claims are clearly broader in scope than the cited claims-they are patentably distinct and encompass pelleted animal feed compositions comprising Bacillus strains that are not captured within the cited claims. Applicant argues that the outstanding obviousness-type double patenting rejections over claims 16-20, 24 and 34 of 18/471658-now issued as U.S. Patent No. 12,364,720-is improper and founded upon an apparent misreading of the claims, which do not even mention Bacillus subtilis DSM 29870.
In response to the argument, patent claims of US 11,473,052 recite Bacillus subtilis DSM 29870 (i.e. Bacillus strain having 100% sequence identity to SEQ ID NO: 2), which reads on the instant claim limitation of Bacillus strain having a 16S rDNA with more than 99.5 % sequence identity to SEQ ID NO: 2. Patent claims of US 12,364,720 recite Bacillus subtilis DSM 29871 (i.e. Bacillus strain having 99.93% sequence identity to SEQ ID NO: 2), which reads on the instant claim limitation of Bacillus strain having a 16S rDNA with more than 99.5 % sequence identity to SEQ ID NO: 2. The instant claims and the patent claims have an overlapping scope.
Regarding the comments to withdraw the terminal disclaimers, Applicant filed on 09/19/2025 a TD for US 11,331,551. US 11,331,551 patent is not related to the instant application and does not recite a common assignee or inventors. Contrary to what Applicant is arguing, the TD filed on 09/19/2025 is for US 11,331,551 and not US 11,331,351. On 06/06/2023, Applicant filed a TD for US 11,166,989 and US 11,331,351.
Applicant argues the pending claims are patentably distinct from the claims of U.S. Patent No. 11,166,989 because the instant claims do not require a flowability
agent comprising calcium carbonate and/or sodium aluminum silicate and require a pelleted animal feed.
The TD for US 11,166,989 was filed to overcome the rejection (mailed on 03/20/2023) to the claims filed on 5/17/2022, which did not recite pelleted composition. The instant claims recite “composition comprises”. Thus the instant claims do not exclude the presence of other components such as those recited in claims of US 11,166,989. Applicant is advised that if the TD for US 11,166,989 filed on 06/06/2023 is withdrawn, the instant claims would be rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 11,166,989 in view of prior art references cited in previous rejection as well as this rejection that teach pelleted animal feed prior to the effective filing date of this application. Applicant may consider refiling TD for US 11,166,989 and US 11,331,351 with the correct information.
Conclusion
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699