Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 7-13 are pending (claim set as filed on 10/5/2023).
Election/Restrictions
Claims 1-6 and 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/20/2026.
Applicant’s election without traverse of the species of claims 7-8, 10, and 12 in the reply filed on 2/20/2026 is acknowledged.
The election of species requirement for claim 10, as set forth in the Office Action mailed on 11/21/2025, has been reconsidered and is hereby withdrawn.
In view of the above noted withdrawal of the election of species requirement, applicant is advised that if any of the claim represented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claims may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP §804.01.
Priority
This application filed on 10/5/2023 claims benefit to a provisional application no. 63/413,412 filed on 10/5/2022. The claim to benefit is acknowledged and therefore, the effective filing date of the application is 10/5/2022.
Information Disclosure Statement
The two information disclosure statements (IDS) submitted on 3/27/2025 are considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the meaning of the values of the x-axis for Fig. 1A-Fig. 2C as described in the specification. Though the specification describes that the graphs show the relationship between Bacillus coagulans strains and inflammatory markers, there is not a unit of measure in the graphs to judge the proportion of inflammatory markers by. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claims 7-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contains 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.
The invention appears to employ novel biological materials, specifically a Bacillus coagulans strain deposited in the Agricultural Research Service Culture Collection (NRRL). Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to
the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon
granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5
years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made
(see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information; however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Although applicants have noted in pg.2, ¶ 2 of the Specification that the biological material was deposited according to the Treaty of Budapest, a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent is additionally required.
Claims 8-13 are rejected as being dependent on claim 7.
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.
Claim 8 is 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 8 recites the limitation "the animal" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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 7-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
With regards to Step 1, the Bacillus bacterial strain, dextrin carrier, and clay binder in claims 7-13 are compositions of matter.
With regards to Step 2A, prong one, claims 7 and 9 recite a commercial package comprising the deposited bacteria Bacillus coagulans NRRL No. B-67744. Dependent claims 10 and 12 recite additional elements such as the elected species dextrin carrier and a clay binder. Dependent claims 11 and 13 recite the form of the package, but claim 11 recites the two embodiments as a powder and a pellet, the powder form of the package is naturally occurring and is therefore not patent eligible. Dependent claim 8 recites the intended use of the package. The claimed deposited Bacillus species is considered to be a judicial exception. The specification does not indicate the source of the deposited Bacillus strain, and therefore there is nothing to indicate the deposited strain is an any way different from what would be found in nature. The additional claimed elements of dextrin, clay, the form of the package in its broadest embodiment claimed, and the intended use of the package are considered to be judicial exceptions as well as they are natural products with no modifications to make them more than what they would be naturally. Nor do these elements interact with each other to form a materially different structure, but are merely combined in the commercial package. It should be noted that the mere isolation of an bacterial organism from the natural environment and natural products such as dextrin and clay are not patent eligible.
With regards to Step 2A, prong two, claims 7-13 do not recite any additional elements to the commercial package to integrate into the instant application. Claim 8 recites the intended use of the application to improve the health of an animal, but it does not in any way change the natural structure or the inherent functionality of the deposited Bacillus bacteria or practically integrates it. Claims 10-13 recite additional components such as carriers, binders, and the physical form of the package, however it does not change the judicial exceptions themselves or practically integrate them. As such, there are no elements in addition integrated that apply or use the judicial exception in some other meaningful way.
With regards to Step 2B, claims 7-13 do not recite any elements other than the deposited Bacillus strain, dextrin carrier, clay binder, form of the package, and intended use of the package. As such, claims 7-13 do not recite additional elements that alone or together amount to significantly more than the judicial exception itself and therefore are not patent eligible.
For the following reasons, claim 7-13 are not deemed to encompass patent eligible subject matter under 35 USC § 101. Claims 8-13 are rejected for being dependent on claim 7.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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.
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.
Claims 7-13 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sandvang (Pre-Grant Publication No. US 2018/0296475 A1 – date of publication 10/18/2018).
Sandvang’s general disclosure relates to an animal feed composition (see abstract).
Regarding claims 7 and 9, Sandvang anticipates a composition comprising the bacteria Bacillus coagulans (see [0289]). Bacillus coagulans is immediately envisioned as it is a preferred embodiment of the bacterial species taught. Sandvang does not specify that the Bacillus strain was specifically NRRL No. B-67744, however it teaches a Bacillus coagulans species that has the same function to improve the health of the animal (see [0016]) as the B-67744 deposited strain does. Therefore, it appears the prior art teaches the same strain based on the function or an obvious variant.
Alternatively, regarding claims 7 and 9, if the strains are not the same but are obvious variants, it would be obvious to one of ordinary skill in the arts before the effective filing date to use any Bacillus coagulans strain with the same function including instant B-67744 in the composition taught by Sandvang. One would be motivated to do so because Sandvang teaches that the Bacillus strain in the composition has the same function of improving the health of the animal (see [0016]) as the deposited Bacillus strain in the commercial package. So it would be prima facie obvious to do a simple substitution of one Bacillus strain for another as they are functionally the same and one would have had a reasonable expectation of success in doing so.
Regarding claim 8, Sandvang teaches that the Bacillus composition (see [0289]). Since the recitation of intended use does not impart a structural limitation ,the prior art is capable of performing the intended use. See MPEP 2111.02.
Regarding claim 10, Sandvang teaches the composition contains a carrier of a salt and a sugar (e.g. a dextrin) (see [0252]).
Regarding claim 11, Sandvang teaches that the composition is in powder form (see [0253]) or in pellet form (see [0252]).
Regarding claim 12, Sandvang teaches the composition comprises a preferred embodiment of a clay binder (see [0255]).
Regarding claim 13, Sandvang teaches the same structure as claimed and therefore it reads on ” dietary nutrient composition.”
Claims 7-13 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Johnson (Pre-Grant Publication No. WO 2019/147799 A1 – date of patent 8/1/2019).
Johnson’s general disclosure relates to a Bacillus composition for administration to animals (see pg. 1 – “Field”).
Regarding claims 7 and 9, Johnson anticipates a feed comprising Bacillus coagulans (see pg. 62, claim 1). Johnson recites a composition “comprising” several listed Bacillus species, of which includes Bacillus coagulans. Johnson does not specify that the Bacillus strain was specifically NRRL No. B-67744, however it teaches Bacillus coagulans species that has the same function to improve the health of the animal (see pg. 6, ¶ 4) as theB-67744 deposited strain does. Therefore, it appears the prior art teaches the same strain based on the function or an obvious variant.
Alternatively, regarding claims 7 and 9, if the strains are not the same but are obvious variants, it would be obvious to one of ordinary skill in the arts before the effective filing date to use any Bacillus coagulans strain with the same function including instant B-67744 in the composition taught by Johnson. One would be motivated to do so because Johnson teaches that the Bacillus strain in the feed has the same function of improving the health of the animal (see pg. 6, ¶ 4) as the deposited Bacillus strain in the claimed commercial package. So it would be prima facie obvious to do a simple substitution of one Bacillus strain for another as they are functionally the same and one would have had a reasonable expectation of success in doing so.
Regarding claim 8, Johnson teaches that the Bacillus composition (see pg. 62, claim 1). However, in the body of the claim wherein the Bacillus strain causes an effect of improving the health of the animal merely recites the intended use of the commercial package rather than any distinct definition of the claimed invention limitations. Therefore since the prior art teaches the structure of the claimed invention, the prior art is capable of performing the intended use. See MPEP 2111.02.
Regarding claim 10, Johnson teaches the carrier comprises a salt, a sugar, and a maltodextrin (see pg. 59, Statement 21). Maltodextrin is a type of dextrin and so reads on the dextrin carrier as claimed by the applicant.
Regarding claim 11, Johnson teaches the composition is in powder form or in pellet form (see pg. 35, ¶ 1).
Regarding claim 12, Johnson teaches the composition of a clay binder (see pg. 35, ¶ 1).
Regarding claim 13, Johnson teaches the same structure as claimed and therefore it reads on ” dietary nutrient composition.”
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 7-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-7 of copending Application No. 18/481,999.
This is a provisional nonstatutory double patenting rejection. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed towards:
a commercial package comprising an isolated Bacillus strain NRRL No. B-67744 (claims 7-13)
a commercial package further comprising a dextrin carrier and a clay binder (claims 10 and 12)
a commercial package formed as a powder or a pellet (claim 11)
a commercial package in the form of a dietary nutrient composition (claim 13)
Copending Application No. 18/481,999 claims are directed towards:
a commercial package comprising an isolated Bacillus strain NRRL No. B-67744 (claims 1 and 3)
a commercial package further comprising a dextrin carrier and a clay binder (claims 4-6)
a commercial package formed as a powder or a pellet (claim 5)
a commercial package in the form of a dietary nutrient composition (claim 7)
The claims of both the instant application and the copending application are directed towards a composition of a Bacillus bacteria strain and excipients of dextrin and clay. As such, both applications are claiming similar compositions as they contain the same structural components. Although the copending application claims additional Bacillus strains in the composition, the instant application recites comprising language in claim 1 which allows for the inclusion of additional Bacillus strains into the instant composition.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.R.W./ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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