DETAILED ACTION
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 .
Claims 1-15, 29, 31, 33, 39 and 55 are pending. Claims 15, 29, 31, 33, 39 and 55 are withdrawn. Claims 1-14 are under examination.
Election/Restrictions
Applicant’s election of Group I, claims 1-14 in the reply filed on 04/09/2026 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Claims 15, 29, 31, 33, 39 and 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/09/2026.
Information Disclosure Statement
The information disclosure statement filed 06/27/2025 has been considered and an initialed copy is enclosed.
Claim Objections
Claims 5-7 are objected to because of the following informalities:
In claim 5: “the ratio of the amount of gold kiwifruit powder: the amount of Bacillus coagulans” should be written as “the ratio of the amount of gold kiwifruit powder to the amount of Bacillus coagulans”.
In claim 6: “the ratio of the amount of gold kiwifruit powder: the amount of Lactococcus lactis” should be written as “the ratio of the amount of gold kiwifruit powder to the amount of Lactococcus lactis”.
In claim 7: “the ratio of the amount of Bacillus coagulans: the amount of Lactococcus lactis” should be written as “the ratio of the amount of Bacillus coagulans to the amount of Lactococcus lactis”.
Colons (:) in a sentence is used to introduce clauses or phrases that serve to describe, amplify, or restate what precedes them. In claims 5-7, it appears the colon between the phrases is used to express a ratio, however, ratios are expressed in numbers with a colon between the numbers. Appropriate correction is required.
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.
Claims 2-4, 8 and 12-14 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 2 contains the trademark/trade name LIVAUX.
Claim 3 contains the trademark/trade name UNIQUE IS-2
Claim 4 contains the trademark/trade name IMMUSE.
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 name is used to identify/describe LIVAUX is used to identify a powdered formulation from cold-processed Actinidia chinensis var. chinensis ‘Zesy002’ gold-fleshed kiwifruit (see paragraph 84 of the specification); UNIQUE IS-2 is used to identify a specific strain of Bacillus coagulans i.e. Bacillus coagulans ATCC PTA-11748 (example 5 of the specification) and IMMUSE is used to identify a particular heat-treated Lactococcus lactis strain known as Lactococcus lactis strain Plasma (“LC-Plasma”) (see paragraph 86 of the specification), accordingly, the identification/description is indefinite.
Claims 12-14 recite “about”. The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not define the term “about”. Therefore, the metes and bounds of the lower limit and upper limit of “about” is vague and indefinite.
In claim 8, the recitation of “other solution” is vague and indefinite. The metes and bounds of what is encompassed by “other solution” is not clear as recited in the claim and “other solution” is not defined in the specification.
Claim Rejections - 35 USC § 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thakkar et al. WO 2022/115709 02-06-2022 cited in IDS as evidenced by Ansell et al US 2017/0326190 11/16/2017 cited in IDS in view of Kang et al. Probiotics Antimicrob Proteins. 2021 Dec;13(6):1530-1538.
Claims 1-4: Thakkar et al disclose an orally ingestible composition (see paragraph 3 disclosing dietary fiber composition) comprising: an amount of gold kiwifruit powder (see paragraph 3 and 28 disclosing the composition comprises yellow kiwi fruit extract), an amount of Bacillus coagulans (see paragraph 3 and paragraph 29) and an amount of Lactococcus lactis ( see p. 56-57 Table 2, probiotics panel selection list comprising Lactococcus lactis and paragraph 153 disclosing the composition comprises one or more microbes from table 2 ).
Regarding the recitation of the trademarks in claims 2-4, Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding claim 2: LIVAUX is interpreted as gold kiwifruit powder.
Regarding claim 3: UNIQUE IS-2 is interpreted as Bacillus coagulans.
Regarding claim 4: IMMUSE is interpreted as Lactococcus lactis.
Claim 8: Thakkar et al disclose the orally ingestible composition is in the form of a gummy, tablet, capsule, liquid, powder blend and nutritional bars. See paragraph 33.
Claims 9-10: Thakkar et al disclose the orally ingestible composition is in the form of an individual oral dosage form such as a gummy, tablet, capsule, liquid, powder blend and nutritional bars.
As evidenced by Ansell et al, yellow kiwi fruit extract can be prepared in powder form and corresponds to gold kiwifruit powder. See paragraphs 165 and 231.
Thakkar et al does not disclose that the Lactococcus lactis is heat-treated.
Kang et al disclose heat treatment of lactic acid bacteria (LAB) strains including Lactobacillus Lactis strains. See abstract and table 2 on p. 1533. Kang et al disclose that heat treating the LAB maintains their bio-functionality, elongates their shelf-life and provides high stability. Kang et al disclose that heat-killed LAB perform immunomodulatory functions and are advantageous as probiotics considering their long product shelf-life and easy storage. See abstract and p. 1537 under conclusion.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have heat treated the Lactococcus lactis of Thakkar et al as taught by Kang et al, resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Kang et al disclose that heat treating the LAB maintains their bio-functionality, elongates their shelf-life and provides high stability and that heat-killed LAB perform immunomodulatory functions and are advantageous as probiotics considering their long product shelf-life and easy storage.
Claims 5-6: Thakkar et al disclose the amount of a probiotic in the composition and the amount of yellow kiwifruit extract. For instance, yellow kiwifruit extract is 15% by weight and a probiotic is 3% by weight that is a ratio of 5: 1 or yellow kiwifruit extract is 60% by weight and a probiotic is 10% by weight that is a ratio of 6:1 See paragraphs 153 and 154 for different amounts of probiotic and yellow kiwi fruit extract. The ratio of between 2:1 and 15:1 and between 5:1 and 20:1 of the amount of yellow kiwi fruit extract: the amount of Bacillus coagulans would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention based on the amounts disclosed in paragraphs 153-154.
Claim 7: Thakkar et al disclose the amount of a probiotic in the composition and the composition can comprise at least one or more probiotic. Thus, based on the amounts of bacteria the ratio amount of B. coagulans : the amount of Lactococcus lactis being between 1:1 to 5:1 would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention.
Regarding the oral dosage e.g. a gummy form of claims 11-14, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Thakkar et al disclose the amounts by weight (percent) of each bacteria and the yellow kiwifruit extract that can be in an oral dosage form. See paragraphs 153-154. It would not have been inventive to arrive at the optimum or workable amounts of the yellow kiwifruit extract (gold kiwifruit powder), heat treated Lactococcus lactis and Bacillus coagulans in an oral dosage form by routine experimentation as disclosed in claims 11-14. The general conditions of claims 11-14 are disclosed by Thakkar et al.
See paragraphs 153-154 disclosing various of amounts of a probiotic and yellow kiwifruit extract (corresponding to gold kiwifruit powder as evidenced by Ansell et all) in the composition (e.g. gummy as disclosed elsewhere as referenced above) expressed as percent by weight.
In some cases, the composition comprises an amount of a probiotic from about 5% to 95%, from about 5% to about 90%, from about 5% to about 80%, from about 10% to about 50%, from about 10% to about 40%, from about 10% to about 30%, or from about 20% to about 25% by weight etc.
In some cases, the composition comprises an amount of yellow kiwi fruit extract from about 5% to 95%, from about 5% to about 90%, from about 5% to about 80%, from about 10% to about 50%, from about 10% to about 40%, from about 10% to about 30%, or from about 20% to about 25% by weight etc..
Status of Claims
Claims 1-14 are rejected. Claims 15, 29, 31, 33, 39 and 55 are withdrawn.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
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