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
1. Applicant’s response filed on December 15, 2025 is acknowledged. Claims 5-9, 14, 17-23, and 25-29 have been amended. Claims 5-9, 13-14, 17-23 and 25-29 are currently pending.
Election/Restriction
2. REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 5-9 and 25-26, drawn to methods of controlling detrimental effects of Enterococcus.
Group II, claim(s) 13, 14, 17-23, and 27-29, drawn to a commercial package or feed additive with Bacillus.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Group I and II lack unity of invention because even though the inventions of these groups require the technical feature of bacillus strains as a feed additive, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Bernardeau- N&H Denmark APS, CN110087660; Published: 8/2/19 (submitted by Applicant). Bernardeau discloses methods for inhibiting or delaying growth of pathogenic Enterococcus cecorum administering an effective amount of a Bacillus-based direct fed microbial comprising one or more Bacillus bacterial strains including Bacillus amyloliquefaciens, Bacillus licheniformis, Bacillus pumilis, and Bacillus subtilis (see pages 1-5). Said Bacillus strains necessarily have the identifying characteristics as those recited in Groups I and II.
During a telephone conversation with John Breen on December 18, 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 5-9, 25 and 26. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13, 14, 17-23, and 27-29 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims 5-9 and 25-26 are currently under examination.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on June 11, 2025 and January 29, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Claim Rejections - 35 USC § 112
Deposit Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
4. Claims 5-9, 25 and 26 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Independent claim 5 is drawn to a method of controlling a detrimental effect of Enterococcus in an animal, the method comprising the steps of administering to an 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 A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275), a strain having all of the identifying characteristics of Bacillus strain A12 (NRRL No. B67516), a strain having all of the identifying characteristics of Bacillus strain 681 (NRRL No. B67515), a strain having all of the identifying characteristics of Bacillus strain 300 (NRRL No. B-50943), a strain having all of the identifying characteristics of Bacillus strain 101 (NRRL No. B-67218), a strain having all of the identifying characteristics of Bacillus strain 235 (NRRL No. B-67219), a strain having all of the identifying characteristics of Bacillus strain 86 (NRRL No. B-50944), a strain having all of the identifying characteristics of Bacillus strain 177 (NRRL No. B-67275), and combinations thereof.
Because it is not clear that cell lines possessing the properties of Bacillus strain A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275) are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims require the use of a suitable deposit for patent purposes a deposit in a public repository is required. Without a publicly available deposit of the above Bacillus strain A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275), one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the cell line is an unpredictable event.
Applicant’s referral to the deposit of Bacillus strain A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275) on page 34 of the specification is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR 1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by the International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application. These requirements are necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR 1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring: (a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request; (b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application; (c) the deposits will be maintained in the public repository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and (d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the repository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of biological material not made under the Budapest Treaty must be filed in the application and must contain: 1) The name and address of the depository; 2) The name and address of the depositor; 3) The date of deposit; 4) The identity of the deposit and the accession number given by the depository; 5) The date of the viability test; 6) The procedures used to obtain a sample if test is not done by the depository; and 7) A statement that the deposit is capable of reproduction. As well as a statement that removes restrictions to provide access to this strain upon granting of a patent has not made, either in the instant Specification, nor in Applicant's Remarks.
One of the critical conditions of Deposit is defined in 37 CFR 1.808 requires that the deposit of biological material be made under two conditions: (A) access to the deposit will be available during pendency of the patent application making reference to the deposit to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C. 122, and (B) with one exception, that all restrictions imposed by the depositor on the availability to the public of the deposited biological material be irrevocably removed upon the granting of the patent. Upon making this statement, the rejection under 35 USC 112, first paragraph will be withdrawn. This rejection can be obviated through perfection of the Deposit and amendment of the claims to clearly set forth the Deposited strains.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the Bacillus strain A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275) described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant’s possession at the time the application was filed.
Applicant’s attention is directed to In re Lundack, 773 F.2d.1216, 227 USPQ (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 112
Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 5-9 and 25-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of reducing pododermatitis, a detrimental effect of Enterococcus cecorum, in an animal, comprising the steps of administering to an animal a feed composition comprising an effective amount of Bacillus strains consisting of the combination of Bacillus strain A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), and 177 (NRRL No. B-67275), does not reasonably provide enablement for a method of controlling, reducing and preventing any detrimental effect of Enterococcus in an animal, comprising administering to an 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 A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275), a strain having all of the identifying characteristics of Bacillus strain A12 (NRRL No. B67516), a strain having all of the identifying characteristics of Bacillus strain 681 (NRRL No. B67515), a strain having all of the identifying characteristics of Bacillus strain 300 (NRRL No. B-50943), a strain having all of the identifying characteristics of Bacillus strain 101 (NRRL No. B-67218), a strain having all of the identifying characteristics of Bacillus strain 235 (NRRL No. B-67219), a strain having all of the identifying characteristics of Bacillus strain 86 (NRRL No. B-50944), a strain having all of the identifying characteristics of Bacillus strain 177 (NRRL No. B-67275), or combinations thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) states, “The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” “The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling” (MPEP 2164.03). The MPEP further states that physiological activity can be considered inherently unpredictable. Thus, Applicant assumes a certain burden in establishing that inventions involving physiological activity are enabled.
Factors to be considered in determining whether a disclosure would require undue experimentation have been reiterated by the Court of Appeals in In re Wands, 8 USPQ2d 1400 at 1404 (CRFC1988). The Wands factors have been considered in the establishment of this scope of enablement rejection. These factors include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and (8) the breadth of the claims.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: Independent claim 5 is drawn to a method of controlling a detrimental effect of Enterococcus in an animal, the method comprising the steps of administering to an 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 A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275), a strain having all of the identifying characteristics of Bacillus strain A12 (NRRL No. B67516), a strain having all of the identifying characteristics of Bacillus strain 681 (NRRL No. B67515), a strain having all of the identifying characteristics of Bacillus strain 300 (NRRL No. B-50943), a strain having all of the identifying characteristics of Bacillus strain 101 (NRRL No. B-67218), a strain having all of the identifying characteristics of Bacillus strain 235 (NRRL No. B-67219), a strain having all of the identifying characteristics of Bacillus strain 86 (NRRL No. B-50944), a strain having all of the identifying characteristics of Bacillus strain 177 (NRRL No. B-67275), and combinations thereof.
Dependent claim 6 is drawn to claim 5 wherein controlling said effects of Enterococcus comprises reducing or preventing Enterococcus in the animal.
Breadth of the claims: The claims are broadly drawn and encompass a method of controlling, reducing and preventing any detrimental effect caused by any Enterococcus in an animal. The breadth encompasses the administration of any isolated Bacillus strain. Said strain can be Bacillus strain A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275), as well as any strain having all of the identifying characteristics of Bacillus strain A12, any strain having all of the identifying characteristics of Bacillus strain 681, any strain having all of the identifying characteristics of Bacillus strain 300, any strain having all of the identifying characteristics of Bacillus strain 101, any strain having all of the identifying characteristics of Bacillus strain 235, any strain having all of the identifying characteristics of Bacillus strain 86, any strain having all of the identifying characteristics of Bacillus strain 177, or any combinations thereof.
Direction or guidance presented in the specification: The specification is enabling for a method of reducing the severity of pododermatitis, a detrimental effect of Enterococcus cecorum comprising administering to an animal a feed composition comprising an effective amount of Bacillus strains consisting of the combination of Bacillus strain A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), and 177 (NRRL No. B-67275). The specification appears to only enable the treatment of footpad lesions in broiler chickens comprising the specific combination of bacillus strains A12, 681, 300, 101, 235, 86, and 177.
The claims, however, are broadly drawn and encompass a scope well beyond said combination. Specifically, the specification does not provide enablement for controlling, reducing and preventing any detrimental effect of any Enterococcus in an animal. There is not an instance where any of the deposited strains singularly are administered and is effective in the manner that is claimed. Additionally, the specification does not make it clear which bacillus strains are encompassed and effective having the required “identifying characteristics”. Which specific bacillus strains are envisioned and deemed effective for the functions as claimed?
Furthermore, the specification has not enabled the prevention of any Enterococcus disease in an animal. Applicant is reminded that to be a prophylactic method and/or composition, said method must induce a protective immune response demonstrated by challenge experiments in an acceptable animal model. The specification does not provide substantive evidence that the claimed composition is capable of inducing protective immunity. This demonstration is required for the skilled artisan to be able to use the claimed method for their intended purpose of prevention. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the administration of the claimed composition, i.e. would not be able to accurately predict if protective immunity has been induced.
Presence or absence of working examples: There are no working examples provided to rectify the missing information in the instant specification pertaining to the claimed methods and use of bacillus strains having the ability to have the claimed efficacy.
State of the Prior Art: healthline.com, https://www.healthline.com/health/enterococcus-faecalis#prevention; accessed on January 20, 2026 teaches that when considering prevention of an enterococcus infection, one should do the following:
Wash your hands with warm water and soap throughout the day. Always wash after you use the bathroom and before you prepare or eat food. If you don’t have access to soap and water, use an alcohol-based hand sanitizer.
Don’t share personal items with anyone — especially people you know are sick. This includes forks and spoons, toothbrushes, or towels.
Wipe down shared items like TV remotes, doorknobs, and telephones with an antibacterial disinfectant.
When you’re in the hospital, make sure healthcare workers wash their hands or wear clean gloves when they care for you.
Ask that all thermometers, blood pressure cuffs, catheters, IVs, and other devices that are used in your treatment be disinfected.
If you have congenital heart disease or a prosthetic valve for cardiac valve repair, you’ll likely require antibiotics prior to dental or other surgical procedures as prophylaxis.
Quantity of experimentation necessary predictability in the art: The quantity of experimentation necessary would be undue as the claims encompass a composition capable of use in a method of preventing any enterococcus detrimental effect.
Reasonable correlation must exist between the scope of the claims and scope of enablement set forth, and it cannot be predicted from the disclosure how to make/use the claimed method. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention. Thus, for all these reasons, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, the lack of guidance and working examples provided in the specification and the high degree of unpredictability as evidence by the state of the prior art, attempting the construct and test variants of the claimed invention would constitute undue experimentation.
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.
6. Claims 5-9, 25 and 26 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 5 is rendered vague and indefinite by the use of the phrase “having all the identifying characteristics”. It is unclear what is meant by said phrase, as it is not explicitly defined in the specification. What constitutes or is defined by “all the identifying characteristics”? What core features/structures must be maintained? As written, it is impossible to determine the metes and bounds of the claimed invention.
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.
7. Claim(s) 5-7, 9, 25 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernardeau -N&H Denmark ApS, CN110087660; Published 8/2/19 (provided by Applicant).
Independent claim 5 is drawn to a method of controlling a detrimental effect of Enterococcus in an animal, the method comprising the steps of administering to an 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 A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275), a strain having all of the identifying characteristics of Bacillus strain A12 (NRRL No. B67516), a strain having all of the identifying characteristics of Bacillus strain 681 (NRRL No. B67515), a strain having all of the identifying characteristics of Bacillus strain 300 (NRRL No. B-50943), a strain having all of the identifying characteristics of Bacillus strain 101 (NRRL No. B-67218), a strain having all of the identifying characteristics of Bacillus strain 235 (NRRL No. B-67219), a strain having all of the identifying characteristics of Bacillus strain 86 (NRRL No. B-50944), a strain having all of the identifying characteristics of Bacillus strain 177 (NRRL No. B-67275), and combinations thereof.
Bernardeau discloses a method for inhibiting or retarding the growth of all or part of a pathogenic Enterococcus species in an animal, the method comprising administering to the animal an effective amount of Bacillus-based direct-fed selected from the group consisting of Bacillus amyloliquefaciens, Bacillus licheniformis, Bacillus pumilis and Bacillus subtilis. Said Bacillus-based component can be administered to an animal in a form selected from the group consisting of feedstuffs, feed additive compositions, premixes, or in a liquid such as water (see page 1; meets claims 5-7 and 25-26). Further, Bernardeau discloses that the Bacillus based DFM may inhibit or delay all or part of the growth of E. cecorum, which causes pododermitis (see page 6, meets claim 9).
Lastly, in view of the 112 as set forth above, the Office takes the position that, absent evidence to the contrary, the bacillus strains of the prior art has the identifying characteristics of the claimed deposited Bacillus strains. Said strains are administered in an identical manner and are effective for controlling, inhibiting or treating an effect of Enterococcus in an animal, therefore, absent evidence to the contrary, they’re one in the same.
8. Claim(s) 5-7, 9 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koshchaev et al., E3S Web of Conferences, 2020; 210(06023): 1-9.
Independent claim 5 is drawn to a method of controlling a detrimental effect of Enterococcus in an animal, the method comprising the steps of administering to an 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 A12 (NRRL No. B-67516), 681 (NRRL No. B-67515), 300 (NRRL No. B-50943), 101 (NRRL No. B-67218), 235 (NRRL No. B-67219), 86 (NRRL No. B-50944), 177 (NRRL No. B-67275), a strain having all of the identifying characteristics of Bacillus strain A12 (NRRL No. B67516), a strain having all of the identifying characteristics of Bacillus strain 681 (NRRL No. B67515), a strain having all of the identifying characteristics of Bacillus strain 300 (NRRL No. B-50943), a strain having all of the identifying characteristics of Bacillus strain 101 (NRRL No. B-67218), a strain having all of the identifying characteristics of Bacillus strain 235 (NRRL No. B-67219), a strain having all of the identifying characteristics of Bacillus strain 86 (NRRL No. B-50944), a strain having all of the identifying characteristics of Bacillus strain 177 (NRRL No. B-67275), and combinations thereof.
Koshchaev discloses methods of administering probiotic cultures to treat the development of pododermatitis in broiler chickens. The poultry received diets of the Starter, Rost, Finisher brands (which includes dry mash; meeting claim 25). Features of feeding broiler chickens were as follows: 1 - Control group (Standard diet); 2 - Experienced group (Low protein diet); 3 - Experienced group (Standard diet + probiotic Bacillus amyloliquefaciens); 4 - Experienced group (Low protein diet + probiotic Bacillus amyloliquefaciens) (see page 5; meeting claims 5-7).
Moreover, Koshchaev discloses that as a result of the studies carried out to assess the degree of pododermatitis, it was observed that the quality of the paws increases or decreases, depending on the composition of the feed consumed and it was concluded that the use of probiotics in low-protein diets of broilers reduces the degree of manifestation of pododermatitis (see page 7-8; meets claim 9).
Lastly, in view of the 112 as set forth above, the Office takes the position that, absent evidence to the contrary, the bacillus strains of the prior art has the identifying characteristics of the claimed deposited Bacillus strains. Said strains are administered in an identical manner and are effective for controlling, inhibiting or treating an effect of Enterococcus in an animal, therefore, absent evidence to the contrary, they’re one in the same.
Conclusion
9. No claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 January 22, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645