DETAILED ACTION
Amendments filed September 19, 2025 have been entered.
Claims 1-22 remain pending;
Claims 13-22 have been withdrawn.
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 .
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.
Claim Objections
The previous objections to claims 2-7 and 9-12 have been withdrawn in light of applicant’s amendments made September 19, 2025.
Claims 2-7 are objected to because of the following informalities:
Claim 2, as amended, recites “includeenteric”. This is believed to be a typographical error as there should be a space between the two words “include” and “enteric”.
Claims 3-7 are included due to their dependency on claim 2.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection 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 of claim 1 due to it being unclear as to if the MTG is required or optional and to claim 4 for lacking antecedent basis for "the acetic acid bacteria" has been withdrawn in light of applicant’s amendments made September 19, 2025. The rejections below remain.
Claims 1-12 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 1 recites “the live probiotic cultures, B-vitamins, and kratom-derived alkaloids as cooperating to sooth stress in a beverage consumer”. It is unclear as to what “cooperate” means in terms of the claimed product. For example, it is unclear as to if the product simply requires said ingredients to all be present within the beverage, or if some specific amount of each ingredient is required, and what that amount would and would not encompass, or if some unknown interaction is required between said ingredients. Furthermore, it is noted that soothing of stress is relative and may be different from one person to another. Thus, the metes and bounds of the claimed limitation is unclear. For the purpose of prior art comparison, the claim will be considered in the broadest reasonable sense as only requiring said components together, within the beverage.
Claims 3 and 10 recite “lactic acid bacteria (Lactobacillus)”. As not all lactic acid bacteria are Lactobacillus, the claimed limitation is unclear. It is unclear as to if the parenthetical is limiting the lactic acid bacteria type to only Lactobacillus, or if the parenthetical is merely exemplary. It is suggested that the claim be amended to recite one term or the other.
Claim 8 recites in (b) that the beverage comprises alkaloids selected from the grouping including MTG, SPG, SPC, COR, 7HMG and PAY, and thus, the use of MTG is optional. However, the claim also recited in (c) that the MTG concentration is 1-3mg/fl oz, thus requiring the use of MTG. Therefore, the claim is unclear as it appears to conflict with itself. It is unclear as to if MTG is optional, but if included it is from 1-3mg/fl oz, or as to if MTG is required from 1-3mg/fl oz.
Claim 9 recites the limitation "the live probiotic cultures" in claim 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear as to if claim 9 is meant to depend from claim 8 which recites a live kombucha culture, or clam 1 which recites love probiotic cultures. It is noted that claims 10-12 also recite “the live probiotic cultures”, however, depend from claim 9.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Sloat et al (WO 2023/067509A1) in view of Buice (“DIY Kombucha and Fruit Fermentation Process”, pages 1-6, The Apothecary Fairy March 2021 https://theapothecaryfairy.com/blogs/news/diy-kombucha-and-fruit-fermentation-process?srsltid=AfmBOopdZtCnBy6fgTkqMVWiHLkjEF7T1-3nc5TCIIBuR_qft3D0x_5-).
Sloat et al (Sloat) teaches a kombucha beverage, which is a fermented beverage with live probiotic cultures in a sweetened aqueous solution (title and paragraphs 3, 4, 95, 96, 99). Sloat teaches that the beverage comprises 0.1-200mg/ml (about 3-600mg/fl oz) of one or more therapeutic agents selected from the group including kratom derived alkaloids including MTG, PAY, SPG, SPC, COR, 7HMG, and combinations thereof (paragraph 15-17, 111, 113, and 135).
Regarding the beverage as comprising kratom derived alkaloids selected from the group consisting of SPG, SPC, COR, 7HMG and PAY and 0.1-10mg/fl oz MTG as recited in claim 1, as Sloat teaches that the beverage comprises 0.1-200mg/ml (about 3-600mg/fl oz) collectively, or individually, of one or more active therapeutic agents selected from the group including kratom extracts including MTG, PAY, SPG, SPC, COR, 7HMG (paragraph 4, 15-17, 20, 111-113, 120, and 135), the teachings of Sloat are considered to encompass or at least make obvious the product as claimed. Furthermore, as Sloat teaches the components as active therapeutic components, it would have been obvious to adjust each respective therapeutic agent within the disclosed range based upon the desired effect. For example, it would have been obvious for the beverage to comprise about 3-600mg/oz MTG for its known analgesic, antitussive, antidiarrheal, adrenergic, antimalarial, psychedelic, and/or antagonist effect and 3-600mg/oz of one or more kratom derived alkaloids including PAY for its smooth muscle relaxing effect, SPG for its smooth muscle relaxing effect, SPC for its smooth muscle relaxing effect, COR for its u-opioid antagonist effect, 7HMG for its analgesic, antitussive and antidiarrheal effect, and/or combinations thereof (Sloat paragraph 130). Sloat discloses overlapping ranges. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Sloat is not specific to the beverage as bottled, or the solution as including B-vitamins produced by the probiotic cultures as recited in claim 1.
Regarding the beverage as in a bottle as recited in claim 1, although Sloat is silent to bottling the beverage, the examiner takes official notice that bottling of beverages was a known means of storing and transporting them. It would have been obvious to one of ordinary skill in the art to bottle the beverage of Sloat in order to transport and/or store it after production and before consumption. To use a well-known means of transport and/or storage would have been obvious and routine for one of ordinary skill in the art.
Regarding the solution as including B-vitamins produced by the probiotic cultures as recited in claim 1, as discussed above Sloat teaches of Kombucha. Buice teaches that when making kombucha, yeast breaks down sugar creating vitamins, including B vitamins, which are good for the skin and maintaining and producing new and healthy cells (page 1). Thus, as evidenced by Buice, kombucha as taught by Sloat would contain B vitamins produced by the probiotic cutulures. Furthermore, it would have been obvious for the beverage of Sloat to specifically contain B vitamins for the benefit to the skin and cells as taught by Buice. Regardless, it is noted that the claimed limitation “produced by the probiotic cultures” is a product by process limitation and thus the process only considered as it affects the claimed product. In the instant case, the claimed process would impart B vitamins from the beverage.
Regarding the probiotic cultures, B-vitamins, and kratom-derived alkaloids as cooperating to sooth stress in a beverage consumer as recited in claim 1, as discussed above, the claimed limitation is unclear. Regardless, as the probiotic cultures, B-vitamins and kraton derived alkaloids are within the beverage of the prior art, the product of the prior art would encompass that as claimed. The position of the office is further supported as Sloat teaches the beverage is capable of reducing stress, wherein the amount of the active ingredient can be adjusted to achieve the desired effect (paragraphs 37 and 72).
Claims 2-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sloat et al (WO 2023/067509A1) in view of Buice (“DIY Kombucha and Fruit Fermentation Process”, pages 1-6, The Apothecary Fairy March 2021 https://theapothecaryfairy.com/blogs/news/diy-kombucha-and-fruit-fermentation-process?srsltid=AfmBOopdZtCnBy6fgTkqMVWiHLkjEF7T1-3nc5TCIIBuR_qft3D0x_5-), further in view of Yang et al (“Microbial and Chemical Profiles of Commercial Kombucha Products” Nutrients February 5 2022, pages 1-16).
As discussed above, Sloat teaches a kombucha beverage, which is a fermented beverage with live probiotic cultures in a sweetened aqueous solution. Sloat exemplifies the product as prepared by purchasing commercial kombucha beverages and adding the therapeutic ingredient(s) (paragraphs 354-357).
Regarding claims 2-6, Sloat is not specific to the live probiotic cultures as including enteric bacteria including Bacteroides thetaiotamicron, Escherischia coli, Enterococcus faecalis, Bacteroides fragilis, Enterobacter cloacae complex and Akkermansia muciniphilia as recited in claim 2; the live probiotic cultures as further including acetic acid bacteria and lactic acid bacteria (Lactobacillus) as recited in claim 3, wherein the acetic acid bacteria are selected from Gluconacetobacter and Acetobacter as recited in claim 4, and the live probiotic cultures further include yeast of both Zygosaccharomyces and Brettanomyces genera as recited in claim 5; and to the aqueous solution as including a sweetener selected from the group including agave, maple syrup, honey, cane sugar, date sugar, and combinations thereof as recited in claim 6.
Yang et al (Yang) teaches that kombucha is a fermented drink which occurs by providing a culture of bacteria and yeasts to a sugary starter, wherein the yeast includes Zygosaccharomyces and Brettanomyces genera and the bacteria includes acetic acid bacteria Gluconacetobacter and Acetobacter and lactic acid bacteria Lactobacillus (page 1 introduction paragraph 1). Yang teaches that 9 kombucha products which account for manufactures of a high market share, with 86% of the commercial kombucha sales in the United States in 2021 were taken and analyzed for culture composition (page 2, section 2.1). Yang teaches that all samples were found to contain enteric bacteria including Bacteroides thetaiotamicron, Escherischia coli, Enterococcus faecalis, Bacteroides fragilis, Enterobacter cloacae complex and Akkermansia muciniphilia (pages 6-7 section 3.1). Yang teaches that in the products cane sugar was used as a sweetener (page 3 Table 1, samples A2-F).
Regarding the live probiotic cultures as including enteric bacteria including Bacteroides thetaiotamicron, Escherischia coli, Enterococcus faecalis, Bacteroides fragilis, Enterobacter cloacae complex and Akkermansia muciniphilia as recited in claim 2, as Sloat teaches of an enhanced kombucha beverage, wherein it is exemplified to take commercial kombucha products and enhance them, it would have been obvious to one of ordinary skill in the art to use the kombucha products of Yang as they were commercially available. Thus, the product of Sloat in view of Yang would comprise live probiotic cultures comprising enteric bacteria including Bacteroides thetaiotamicron, Escherischia coli, Enterococcus faecalis, Bacteroides fragilis, Enterobacter cloacae complex and Akkermansia muciniphilia. Furthermore, to have known components established to be within a known product would have been obvious and well within the purview of one of ordinary skill in the art.
Regarding the live probiotic cultures as further including acetic acid bacteria and lactic acid bacteria (Lactobacillus) as recited in claim 3, wherein the acetic acid bacteria are selected from Gluconacetobacter and Acetobacter as recited in claim 4, and the live probiotic cultures further include yeast of both Zygosaccharomyces and Brettanomyces genera as recited in claim 5, it would have been obvious for the kombucha of Sloat to comprise acetic acid bacteria Gluconacetobacter and Acetobacter, lactic acid bacteria Lactobacillus, and yeast of both Zygosaccharomyces and Brettanomyces genera as Sloat teaches of kombucha and kombucha was known to be made from yeast including Zygosaccharomyces and Brettanomyces genera and the bacteria including acetic acid bacteria Gluconacetobacter and Acetobacter and lactic acid bacteria Lactobacillus as taught by Yang. As Sloat is not specific to the method of making the kombucha to use known bacteria and yeast would have been particularly obvious to one of ordinary skill in the art.
Regarding the aqueous solution as including a sweetener selected from the group including agave, maple syrup, honey, cane sugar, date sugar, and combinations thereof as recited in claim 6, as Sloat teaches of an enhanced kombucha beverage, wherein it is exemplified to take commercial kombucha products and enhance them, it would have been obvious to one of ordinary skill in the art to use the kombucha products of Yang as they were commercially available. Thus, the product of Sloat in view of Yang, and the aqueous solution would comprise cane sugar in view of Yang. To have known components established to be within a known product would have been obvious and well within the purview of one of ordinary skill in the art.
Regarding the beverage as comprising kratom derived alkaloids selected from the group consisting of SPG, SPC, COR, 7HMG and PAY and/or 1-5mg/fl oz MTG as recited in claim 7, as discussed above, as Sloat teaches that the beverage comprises 0.1-200mg/ml (about 3-600mg/fl oz) of one or more therapeutic agents selected from the group including kratom extract including MTG, PAY, SPG, SPC, COR, 7HMG, and combinations thereof (paragraph 15-17, 111, 113, and 135), the teachings of Sloat are considered to encompass or at least make obvious the product as claimed. Sloat discloses overlapping ranges. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sloat et al (WO 2023/067509A1).
Sloat et al (Sloat) teaches a kombucha beverage, which is a fermented beverage with live probiotic cultures in a sweetened aqueous solution (title and paragraphs 3, 4, 95, 96, 99). Sloat teaches that the beverage comprises 0.1-200mg/ml (about 3-600mg/fl oz) of one or more therapeutic agents selected from the group including kratom derived alkaloids including MTG, PAY, SPG, SPC, COR, 7HMG, and combinations thereof (paragraph 15-17, 111, 113, and 135).
Regarding the beverage as comprising kratom derived alkaloids selected from the group consisting of MTG, SPG, SPC, COR, 7HMG and PAY and/or 1-3mg/fl oz MTG as recited in claim 8, as discussed above, the claimed limitations are unclear. Regardless, as Sloat teaches that the beverage comprises 0.1-200mg/ml (about 3-600mg/fl oz) of one or more therapeutic agents selected from the group including kratom extract including MTG, PAY, SPG, SPC, COR, 7HMG, and combinations thereof (paragraph 15-17, 111, 113, and 135), the teachings of Sloat are considered to encompass or at least make obvious the product as claimed. Sloat discloses overlapping ranges. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Sloat is not specific to the beverage as bottled as recited in claim 8.
Regarding the beverage as in a bottle as recited in claim 8, although Sloat is silent to bottling the beverage, the examiner takes official notice that bottling of beverages was a known means of storing and transporting them. It would have been obvious to one of ordinary skill in the art to bottle the beverage of Sloat in order to transport and/or store it after production and before consumption. To use a well-known means of transport and/or storage would have been obvious and routine for one of ordinary skill in the art.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sloat et al (WO 2023/067509A1) in view of Yang et al (“Microbial and Chemical Profiles of Commercial Kombucha Products” Nutrients February 5 2022, pages 1-16).
As discussed above, Sloat teaches a kombucha beverage, which is a fermented beverage with live probiotic cultures in a sweetened aqueous solution. Sloat exemplifies the product as prepared by purchasing commercial kombucha beverages and adding the therapeutic ingredient(s) (paragraphs 354-357).
Regarding claims 2-12, Sloat is not specific to the live probiotic cultures as including enteric bacteria including Bacteroides thetaiotamicron, Escherischia coli, Enterococcus faecalis, Bacteroides fragilis, Enterobacter cloacae complex and Akkermansia muciniphilia as recited in claim 9; the live probiotic cultures as further including acetic acid bacteria and lactic acid bacteria (Lactobacillus) as recited in claim 10, wherein the acetic acid bacteria are selected from Gluconacetobacter and Acetobacter as recited in claim 11, and the live probiotic cultures further include yeast of both Zygosaccharomyces and Brettanomyces genera as recited in claim 12.
Yang et al teaches that kombucha is a fermented drink which occurs by providing a culture of bacteria and yeasts to a sugary starter, wherein the yeast includes Zygosaccharomyces and Brettanomyces genera and the bacteria includes acetic acid bacteria Gluconacetobacter and Acetobacter and lactic acid bacteria Lactobacillus (page 1 introduction paragraph 1). Yang teaches that 9 kombucha products which account for manufactures of a high market share, with 86% of the commercial kombucha sales in the United States in 2021 were taken and analyzed for culture composition (page 2, section 2.1). Yang teaches that all samples were found to contain enteric bacteria including Bacteroides thetaiotamicron, Escherischia coli, Enterococcus faecalis, Bacteroides fragilis, Enterobacter cloacae complex and Akkermansia muciniphilia (pages 6-7 section 3.1).
Regarding the live probiotic cultures as including enteric bacteria including Bacteroides thetaiotamicron, Escherischia coli, Enterococcus faecalis, Bacteroides fragilis, Enterobacter cloacae complex and Akkermansia muciniphilia as recited in claim 9, as Sloat teaches of an enhanced kombucha beverage, wherein it is exemplified to take commercial kombucha products and enhance them, it would have been obvious to one of ordinary skill in the art to use the kombucha products of Yang as they were commercially available. Thus, the product of Sloat in view of Yang would comprise live probiotic cultures comprising enteric bacteria including Bacteroides thetaiotamicron, Escherischia coli, Enterococcus faecalis, Bacteroides fragilis, Enterobacter cloacae complex and Akkermansia muciniphilia. Furthermore, to have known components established to be within a known product would have been obvious and well within the purview of one of ordinary skill in the art.
Regarding the live probiotic cultures as further including acetic acid bacteria and lactic acid bacteria (Lactobacillus) as recited in claim 10, wherein the acetic acid bacteria are selected from Gluconacetobacter and Acetobacter as recited in claim 11, and the live probiotic cultures further include yeast of both Zygosaccharomyces and Brettanomyces genera as recited in claim 12, it would have been obvious for the kombucha of Sloat to comprise acetic acid bacteria Gluconacetobacter and Acetobacter, lactic acid bacteria Lactobacillus, and yeast of both Zygosaccharomyces and Brettanomyces genera as Sloat teaches of kombucha and kombucha was known to be made from yeast including Zygosaccharomyces and Brettanomyces genera and the bacteria including acetic acid bacteria Gluconacetobacter and Acetobacter and lactic acid bacteria Lactobacillus as taught by Yang. As Sloat is not specific to the method of making the kombucha to use known bacteria and yeast would have been particularly obvious to one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed September 19, 2025 have been fully considered but they are not persuasive.
Applicant argues that the recitation of “the live probiotic cultures, B-vitamins, and kratom-derived alkaloids as cooperating to sooth stress in a beverage consumer” in claim 1 is broad and not indefinite because: the specification provides guidance on how to achieve a soothing effect and the range of 0.1-10mg/fl oz.of kratom derived MTG provides the claimed result. This argument is not convincing. First it is noted that applicant’s argument is not commensurate in scope with the claims. The claims do not recite an amount of MTG to sooth stress, but rather, a cooperation of ingredients to provide the claimed results. Second, the rejection is not based on enablement, but rather lack of clarity. What one person considers soothing, another may not, and it is unclear as to how the recited components must “cooperate” to achieve such an arbitrary result. As stated above, it is unclear as to if the recite components need just be present, or if some kind of coaction, i.e. cooperation between them is required.
Applicant argues that Sloat (WO ‘509) teaches of a cannabinoid focused system and thus it would not have been obvious to use kratom derived MTG or alkaloids and to do so would present unique challenges. This argument is not convincing. As stated in the rejection, Sloat teaches a kombucha beverage comprising 0.1-200mg/ml (about 3-600mg/fl oz) of one or more therapeutic agents selected from the group including kratom derived alkaloids including MTG, PAY, SPG, SPC, COR, 7HMG, and combinations thereof. Applicant is specifically directed to cited paragraphs 4 and 135 which states the therapeutic agents (including MTG, PAY, SPG, SPC, COR, 7HMG, and combinations thereof) are kratom derived, and is additionally referred to claims 16 and 22.
Applicant argues that the prior art does not recognize the synergy and the claimed cooperation of ingredients. This argument is not understood as in the remarks applicant argues that only the recited range of 0.1-10mg/fl oz. MTG is required to achieve the claimed effect, and as stated above, the reference teaches of an overlapping amount. Thus. The prior art would achieve the claimed results.
Applicant further argues unexpected results as described in paragraphs 5 and 6. This argument is not convincing as it does not lay out any evidence that can be evaluated, such as so that it can be compared to the scope of the claims and/or the closest prior art of record.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Applicant's amendment necessitated any new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELLY BEKKER whose telephone number is (571)272-2739. The examiner can normally be reached Monday-Friday 8am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792