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 .
The response filed on March 16, 2026 is received.
Claims 20-24, 26-31, and 33-43 are previously canceled by Applicant.
Claims 1-19, 25, 32, and 44 are pending in this application, claims 19, 25, 32 and 44 are withdrawn from further consideration, and claims 1-18 are being examined (Also, see Restriction/Election below).
Restriction/Election:
Applicant’s election of, Group I claims 1-18, in the reply filed on 03/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 19, 25, 32, and 44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Group II), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/16/2026.
Objection(s):
Claim(s):
Claims 1, 3-6, 9-11 and 14-17 are objected to because of the following informalities:
In claim 1, replace “Bacillus coagulans”, “Bacillus subtilis” and “Lactobacillus plantarum” with --Bacillus coagulans--, --Bacillus subtilis--, and --Lactobacillus plantarum--.
In claim 3, replace “Bacillus coagulans” with --Bacillus coagulans--.
In claim 4, replace “Lactobacillus plantarum” with --Lactobacillus plantarum--.
In claim 5, replace “Bacillus subtilis” with --Bacillus subtilis--.
In claim 6, replace “Bacillus coagulans” with --Bacillus coagulans--.
In claim 7, replace “Bacillus subtilis” with --Bacillus subtilis--.
In claim 8, replace “Lactobacillus plantarum” with --Lactobacillus plantarum--.
In claim 9, replace “Bacillus coagulans” with --Bacillus coagulans--.
In claim 10, replace “Bacillus subtilis” with --Bacillus subtilis--.
In claim 11, replace “Bacillus subtilis” with --Bacillus subtilis--.
In claim 14 , replace “Bacillus coagulans”, “Bacillus subtilis” and “Lactobacillus plantarum” with --Bacillus coagulans--, --Bacillus subtilis--, and --Lactobacillus plantarum--.
In claim 15, replace “Bacillus coagulans” and “Bacillus subtilis” with --Bacillus coagulans--, and --Bacillus subtilis--.
In claim 16, replace “Bacillus coagulans”, “Bacillus subtilis” and “Lactobacillus plantarum” with --Bacillus coagulans--, --Bacillus subtilis--, and --Lactobacillus plantarum--.
In claim 17, replace “Bacillus coagulans” and “Bacillus subtilis” with --Bacillus coagulans--, and --Bacillus subtilis--.
Appropriate correction is required.
Specification:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See pages 54 and 57). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term L-137®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejection - 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 3, 4 and 5 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ a specific strains: Bacillus coagulans Unique IS-2, Lactobacillus plantarum L-137, and Bacillus subtilis BS50.
It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit.
Further it is unclear if the starting materials were readily available to the public at the time of invention.
It is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Copy of deposit receipt is/are required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2, the phrase “gold kiwifruit powder comprises Livaux@” fails to further limit the subject matter of the claim 1 upon which it depends. Because, comprises is open-ended.
Suggestion to obviate the rejection: replace “comprise” with –is--.
Claim 3, the phrase “Bacillus coagulans comprises Unique IS-2” fails to further limit the subject matter of the claim 1 upon which it depends. Because, comprises is open-ended.
Suggestion to obviate the rejection: replace “comprise” with –is--.
Claim 4, the phrase “the heat-treated Lactobacillus plantarum comprises L-13” fails to further limit the subject matter of the claim 1 upon which it depends. Because, comprises is open-ended.
Suggestion to obviate the rejection: replace “comprise” with –is--.
Claim 5, the phrase “Bacillus subtilis comprises BS50” fails to further limit the subject matter of the claim 1 upon which it depends. Because, comprises is open-ended.
Suggestion to obviate the rejection: replace “comprise” with –is--.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejection - 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.
Claims 1-4, 12-13 and 15 are rejected under 35 U.S.C. 102(a(1) as being anticipated by Ying (AU 2022203588 A1, which is also cited in IDS filed on 03/14/2025).
Regarding claims 1 and 2, Ying discloses an orally ingestible composition comprising: an amount of gold kiwifruit powder, an amount of Bacillus coagulans, an amount of Bacillus subtilis, and an amount of heat-treated Lactobacillus plantarum, the gold kiwifruit powder is Livaux® (e.g., a chewable composition, comprising gold kiwifruit powder is Livaux®, a probiotic Bacillus coagulans, Bacillus coagulans Unique IS-2, Bacillus subtilis , and a heat-treated Lactobacillus plantarum, Lactobacillus plantarum HK-L) (see for example, p. 20 lines 3-7 and 21-33, and p. 21 lines 1-4).
Regarding claim 3, Ying discloses the Bacillus coagulans Unique IS-2 (See for example, p. 20 line 5).
Regarding claim 4, Ying discloses the heat-treated Lactobacillus plantarum comprises L-137 (See for example, p. 20 lines 22-24, and p. 37 1st table 4th row).
Regarding claim 12, Ying discloses the orally ingestible composition is in the form of a gummy, a tablet, a capsule, a liquid, a suspension, a powder, or a chew (a chewable composition, tablet, capsule, etc.) (See for example, p. 20 lines 29-30 and p. 41 claim 2).
Regarding claim 13, Ying discloses the orally ingestible composition is in the form of an individual oral dosage form (dosage form) (See for example, p. 4 lines 7-10).
Regarding claim 15, Ying discloses the oral dosage form comprises between about 500 million CFUs and 9 billion CFUs Bacillus coagulans, and between about 500 million CFUs and 9 billion CFUs Bacillus subtilis (an amount of probiotic in the range of from 500 million to 4 billion CFU) (See for example, p. 20 lines 1-8).
Ying therefore anticipate the claimed composition of claims 1-4, 12-13 and 15.
Claim Rejection - 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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ying (AU 2022203588 A1, which is also cited in IDS filed on 03/14/2025) as applied to claim 1-4, 12-13 and 15 above, and further in view of Brutscher et al. (Microorganisms. 2022 May 17;10(5):1038, p. 1-21).
The teachings of Ying with respect to the limitations of claims 1-4, 12-13 and 15, are discussed above in details.
Ying does not teach the Bacillus subtilis comprises BS50 (claim 5). However, before the effective filing date of the invention, Brutscher et al. teach probiotic strain Bacillus subtilis BS50 is safe and has health benefits and can be used as dietary (See for example, p. 14 paragraph “4. Discussion” – Continued on p. 15-16, and “5. Conclusions”).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been capable of substituting Bacillus subtilis BS50 taught by the prior art to be a safe probiotic for the Bacillus subtilis in the composition taught by Ying with a reasonable expectation of success in providing the claimed composition of claim 5. Because, substitution of one Bacillus subtilis for another would have been obvious and, because Ying discloses/teaches an orally ingestible composition comprising: an amount of gold kiwifruit powder, an amount of Bacillus coagulans, an amount of Bacillus subtilis, and an amount of heat-treated Lactobacillus plantarum, and because Brutscher et al. teach Bacillus subtilis BS50.
Regarding claim 17, Ying teaches the oral dosage form comprises about 1 billion CFUs Bacillus coagulans, and about 1 billion CFUs Bacillus subtilis (an amount of probiotic in the range of from 500 million to 4 billion CFU) (See for example, p. 20 lines 1-8).
Regarding claim 18, Ying teaches oral dosage form of a gummy , i.e., a chewable composition (See for example, p. 20 lines 29-30 and p. 41 claim 2).
Moreover, regarding the limitations of claims 6-11, 14 and 16, the ratios gold kiwifruit powder: the amount of Bacillus coagulans is between 5:1 and 20:1, the ratio of the amount of gold kiwifruit powder: the amount of Bacillus coagulans is between 5:1 and 20:1, the ratio of the amount of gold kiwifruit powder: the amount of Lactobacillus plantarum is between 3:1 and 7:1, the ratio of the amount of Lactobacillus plantarum: the amount of Bacillus coagulans is between 1.5:1 and 3.5:1, the ratio of the amount of Lactobacillus plantarum the amount of Bacillus subtilis is between 1.5:1 and 3.5:1, the ratio of the amount of Bacillus coagulans: the amount of Bacillus subtilis is between 0.5:1 and 1.5:1, the oral dosage form comprises between about 75 mg and 700 mg gold kiwifruit powder; between about 5mg and 140 mg heat-treated Lactobacillus plantarum; between about 5 mg and 90 mg Bacillus subtilis; and between about 5 mg and 90 mg Bacillus coagulans, the oral dosage form comprises about 125mg gold kiwifruit powder; about 25 mg heat- treated Lactobacillus plantarum, about 10mg Bacillus subtilis; and about 10 mg Bacillus coagulans.
In this case, Ying teaches gold kiwifruit powder in the range of from 1% to 30% and in an amount of from 75 mg to 300mg per unit dosage form (See for example, p. 21 lines 1-7), and the composition comprises up to 1 wt% of probiotic (See for example, p. 20 line 12), and the oral dosage form comprises about 1 billion CFUs Bacillus coagulans, and about 1 billion CFUs Bacillus subtilis (an amount of probiotic in the range of from 500 million to 4 billion CFU) (See for example, p. 20 lines 1-8).
Therefore, the ratios and the amounts of claimed ingredients in the orally ingestible composition would have been optimized by a person of ordinary skill in the art before the effective filing date of the invention depend on the results to be achieved and intended use and subject.
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571)272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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