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 20, 2026 is received.
Claims 16, 17, 19-24, 26-29 and 33-35 are previously canceled by Applicant.
Claims 1-15, 18, 25, 30 and 32 are pending in this application, claims 14, 15, 18, 25, 30 and 32 are withdrawn from further consideration, and claims 1-13 are being examined (Also, see Restriction/Election below).
Restriction/Election:
Applicant’s election of, Group I claims 1-13, in the reply filed on 03/20/2026 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Claims 14, 15, 18, 25, 30 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Group II), there being no allowable generic or linking claim.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 03/20/2026.
Objection(s):
Claims 1, 3-7 and 10-13 are objected to because of the following informalities:
In claim 1, replace “Bacillus coagulans” and “Lactobacillus paracasei” with --Bacillus coagulans-- and --Lactobacillus paracasei--.
In claim 3, replace “Bacillus coagulans” with --Bacillus coagulans--.
In claim 4, replace “Lactobacillus paracasei” with --Lactobacillus paracasei--.
In claim 5, replace “Bacillus coagulans” with -- Bacillus coagulans --.
In claim 6, replace “Lactobacillus paracasei” with --Lactobacillus paracasei--.
In claim 7, replace “Bacillus coagulans” and “Lactobacillus paracasei” with --Bacillus coagulans-- and --Lactobacillus paracasei--.
In claim 10, replace “Lactobacillus paracasei” with --Lactobacillus paracasei--.
In claim 11, replace “Bacillus coagulans” with -- Bacillus coagulans --.
In claim 12 , replace “Lactobacillus paracasei” and “Bacillus coagulans” with --Lactobacillus paracasei-- and --Bacillus coagulans--.
In claim 13, replace “Bacillus coagulans” with -- Bacillus coagulans --.
Appropriate correction is required.
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 and 4 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 SNZ 1969®. Lactobacillus paracasei MCC1849.
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(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 3 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.
Claims 2 and 3 contain the trademark/trade names Livaux® and SNZ 1969®, respectively. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe gold kiwifruit powder and Bacillus coagulans, respectively, accordingly, the identification/description is indefinite.
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 2-4 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 SNZ 1969” 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 Lactobacillus paracasei comprises MCC1849.” 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 §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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ying (AU 2022203588 A1) in view of Brutscher et al. (Microorganisms. 2022 May 17;10(5):1038, p. 1-21) in view of Arai et al., PLoS ONE, 2018, 13(6): e0199018, p. 1-15) and Metlakunta et al. (Regulatory Toxicology and Pharmacology, Volume 110, 2020, p. 1-6).
Regarding claims 1 and 2, Ying teaches an orally ingestible composition comprising: an amount of gold kiwifruit powder, an amount of Bacillus coagulans, and the gold kiwifruit powder is Livaux® (e.g., a chewable composition, comprising gold kiwifruit powder is Livaux®, a probiotic Bacillus coagulans, etc.) (see for example, p. 20 lines 3-7 and 21-33, and p. 21 lines 1-4).
Regarding claim 8, Ying teaches 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 9, Ying teaches the individual oral dosage form is a gummy (a chewable composition, tablet, capsule, etc.) (See for example, p. 20 lines 29-30 and p. 41 claim 2).
Regarding claim 11, Ying teaches the oral dosage form comprises between about 100 million CFUs and 4 billion CFUs Bacillus coagulans (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 13, Ying teaches the oral dosage form comprises about 500 million CFUs Bacillus coagulans (an amount of probiotic in the range of from 500 million to 4 billion CFU) (See for example, p. 20 lines 1-8).
Ying does not teach an amount of heat-treated Lactobacillus paracasei (claim 1), the Bacillus coagulans comprises SNZ 1969 (claim 3), the Lactobacillus paracasei comprises MCC1849 (claim 4), the ratio of the amount of gold kiwifruit powder: the amount of Bacillus coagulans is between 15:1 and 35:1 (claim 5), the ratio of the amount of gold kiwifruit powder: the amount of Lactobacillus paracasei is between 5:1 and 20:1 (claim 6), the ratio of the amount of Lactobacillus paracasei: the amount of Bacillus coagulans is between 1.5:1 and 3:1 (claim 7), the oral dosage form comprises between 75 mg and 700 mg gold kiwifruit powder; between 5 mg and 80 mg heat-treated Lactobacillus paracasei, and between 1 mg and 40 mg Bacillus coagulans (claim 10), and the oral dosage form comprises about 125 mg gold kiwifruit powder; about 10 mg Lactobacillus paracasei; and about 5 mg Bacillus coagulans (claim 12).
However, regarding an amount of heat-treated Lactobacillus paracasei, the Lactobacillus paracasei comprises MCC1849 (claims 1 and 4), before the effective filing date of the invention, Arai et al. teach probiotic strain heat-treated Lactobacillus paracasei, the Lactobacillus paracasei comprises MCC1849 is safe and has health benefits, etc. (See for example, p. 8 “Discussion” – Continued on p. 12). Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been capable of include an amount of heat-treated Lactobacillus paracasei, i.e., Lactobacillus paracasei comprises MCC1849, taught by the prior art to be a safe probiotic having health benefits in the composition taught by Ying with a reasonable expectation of success in providing the claimed composition. Because, Arai et al. teach probiotic Lactobacillus paracasei comprises MCC1849 is safe and has health benefits.
Moreover, regarding claim 3, Bacillus coagulans comprises SNZ 1969®, Metlakunta et al. teach Bacillus coagulans comprises SNZ 1969® to be a safe probiotic with health benefits (See for example, p. 4 right-hand column “4. Discussion” and p. 7 left-hand column “5. Conclusion”). Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been capable of substituting Bacillus coagulans comprises SNZ 1969®, taught by the prior art to be a safe probiotic for the Bacillus coagulans 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 coagulans for another would have been obvious and, because Ying teaches an orally ingestible composition comprising: an amount of gold kiwifruit powder, an amount of Bacillus coagulans, and because Metlakunta et al. teach Bacillus coagulans comprises SNZ 1969®.
In addition, regarding the limitations of claims 5-7, 10 and 12, the ratio of the amount of gold kiwifruit powder: the amount of Bacillus coagulans is between 15:1 and 35:1 (claim 5), the ratio of the amount of gold kiwifruit powder: the amount of Lactobacillus paracasei is between 5:1 and 20:1 (claim 6), the ratio of the amount of Lactobacillus paracasei: the amount of Bacillus coagulans is between 1.5:1 and 3:1 (claim 7), the oral dosage form comprises between 75 mg and 700 mg gold kiwifruit powder; between 5 mg and 80 mg heat-treated Lactobacillus paracasei, and between 1 mg and 40 mg Bacillus coagulans (claim 10), and the oral dosage form comprises about 125 mg gold kiwifruit powder; about 10 mg Lactobacillus paracasei; and about 5 mg Bacillus coagulans (claim 12).
Ying further 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, etc. (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.
Double Patenting Rejection:
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.
A)
At least, claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18544233 (reference application) in view of Arai et al. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of copending Application No. 18544233 disclose 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.
Moreover, Arai et al. teach probiotic strain heat-treated Lactobacillus paracasei, the Lactobacillus paracasei comprises MCC1849 is safe and has health benefits, etc. (See for example, p. 8 “Discussion” – Continued on p. 12). Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been capable of substituting an amount of heat-treated Lactobacillus paracasei for the Lactobacillus in the composition taught by claim 1 of instant application with a reasonable expectation of success in providing the claimed composition of at least claim 1 of instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
B)
At least, claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18584809 (reference application) in view of Arai et al. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of copending Application No. 18584809 disclose an orally ingestible composition comprising: an amount of gold kiwifruit powder, an amount of Bacillus coagulans, and an amount of heat-treated Lactobacillus casei.
Moreover, Arai et al. teach probiotic strain heat-treated Lactobacillus paracasei is safe and has health benefits, etc. (See for example, p. 8 “Discussion” – Continued on p. 12). Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been capable of substituting an amount of heat-treated Lactobacillus paracasei for the Lactobacillus in the composition taught by claim 1 of instant application with a reasonable expectation of success in providing the claimed composition of at least claim 1 of instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
C)
At least, claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18621753 (reference application) in view of Arai et al. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of copending Application No. 18621753 disclose an orally ingestible composition comprising: an amount of gold kiwifruit powder, an amount of Bacillus coagulans, and an amount of heat-treated Lactobacillus lactis.
Moreover, Arai et al. teach probiotic strain heat-treated Lactobacillus paracasei is safe and has health benefits, etc. (See for example, p. 8 “Discussion” – Continued on p. 12). Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been capable of substituting an amount of heat-treated Lactobacillus paracasei for the Lactobacillus in the composition taught by claim 1 of instant application with a reasonable expectation of success in providing the claimed composition of at least claim 1 of instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion(s):
No claim(s) is allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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