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 .
Status of the Claims
Claims 1-22 are pending (claim set as filed on 4/22/2026). Claims 23-24 are cancelled and withdrawn after restriction/election requirement.
Election/Restrictions
Claims 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected engineered probiotic, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/22/2026.
Priority
This application filed on 12/18/2023 claims benefit to a provisional application no. 63/223,126 filed on 7/19/2021. The claim to benefit is acknowledged and therefore, the effective filing date of the application is 7/19/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/26/2024 is 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.
Claim Objections
Claims 3 and 16 are objected to because of the following informalities: the bacterial species genus name “lactobacillus” is not capitalized, and there are no commas separating the bacterial species listed “ L. rhamnosus. L. acidophilus and L. plantarum”. 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 6, 11-12, and 20 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitations of glycol conjugates, phenolic acids, and stilbenes, and the claim also recites anthocyanin, proanthocyandins, isoflavones; ferulic acid, gallic acids and others; and resveratrol which are the narrower statements of the ranges/limitations respectively. The claim is considered indefinite because there is a question or doubt as to whether the features introduced by such narrower language are (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) required features of the claims.
Claim 11 uses the term “at least about” which is a relative term which renders the claim indefinite. The term “at least about” is not defined by the claim and the specification does not provide a standard for ascertaining the requisite degree. The claim recites “at least“ which limits the claim to the specified numerical value, but also recites “about” which includes the lower range of this value as well. The scope of the numerical range of the invention is then unclear as to when one would infringe on it.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 11-12 and 20 recite the broad recitation of the vacuum pressure, and the claims also recite (e.g. negative pressure) which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Regarding claims 11-12 and 20, the term "e.g." renders the claim indefinite because it is unclear whether the limitation of “negative pressure” following the phrase is part of the claimed invention. See MPEP § 2173.05(d). The exemplary language renders the claim indefinite as one could not ascertain if the vacuum pressure is limited to negative pressure or if it is merely suggested.
Claim Rejections - 35 USC § 102
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)(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 1-8 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao (Zhao et al., “Lactic acid bacterial fermentation modified phenolic composition in tea extracts and enhanced their antioxidant activity and cellular uptake of phenolic compounds following in vitro digestion”, 2015 Oct 26, Journal of Functional Foods, 20, pgs. 182-192) and as evidenced by Biological Principles (Biological Principles, “Fermentation, mitochondria, and regulation”, 2021 Apr 26, https://web.archive.org/web/20210426225759/https://bioprinciples.biosci.gatech.edu/07-fermentation-mitochondria-and-regulation/, accessed 2026 May 12, pgs. 1-3).
Zhao’s general disclosure relates to the ability of lactic acid bacteria to metabolize tea phenolics through fermentation (see abstract).
Regarding claim 1, Zhao anticipates a method of enhancing probiotic viability by providing a strain of live beneficial probiotic lactic acid bacteria (LAB) (see Zhao abstract) and a purified polyphenolic compound of catechins (see Zhao abstract). Zhao discloses that the bacteria metabolize the polyphenols (see Zhao abstract). As such, it is inherent that the polyphenols would be infused into the bacteria cell interiors as prokaryotic cellular metabolism takes place inside the cell in the cytoplasm (see Biological Principles pg. 3, ¶ 1). Limitations (d) and (e) are directed toward the intended result of the method steps (a)-(c) recited in the instant claim 1. It should be noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’". See MPEP 2111.04. Therefore, the limitations (d) and (e) of claim 1 hold no patentable weight as they merely recite intended result of the method steps and would be inherently true as the outcome of performing limiting method steps (a)-(c).
Regarding claims 2-8, Zhao anticipates the method of enhancing probiotic viability. However, the recitation of a “wherein” clause to describe the conditions of a step within the independent method claim does not necessarily further limit the claims. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. As the dependent claims are not steps required to carry out the inventive method, they have no patentable weight. See MPEP 2111.04.
Regarding claim 13, Zhao anticipates that the infusion process produced biologically active metabolites (see abstract).
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.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (Zhao et al., “Lactic acid bacterial fermentation modified phenolic composition in tea extracts and enhanced their antioxidant activity and cellular uptake of phenolic compounds following in vitro digestion”, 2015 Oct 26, Journal of Functional Foods, 20, pgs. 182-192), in view of Young (Young et al., “Vacuum facilitated infusion of bioactives into yeast microcarriers: Evaluation of a novel encapsulation approach”, 2017 Jul 31, Food Research International, 100, pgs. 99-111), and as evidenced by Biological Principles (Biological Principles, “Fermentation, mitochondria, and regulation”, 2021 Apr 26, https://web.archive.org/web/20210426225759/https://bioprinciples.biosci.gatech.edu/07-fermentation-mitochondria-and-regulation/, accessed 2026 May 12).
Zhao’s general disclosure has been set forth above.
Regarding claim 9, Zhao teaches the infusion process (see abstract).
Regarding claim 10, Zhao teaches the infusion process (see abstract).
Regarding claim 11, Zhao teaches the infusion process (see abstract).
Regarding claim 12, Zhao teaches the infusion process and the mixing of bacterial cells and polyphenolic compounds (see abstract).
Regarding claim 9, Zhao does not teach wherein said infusion takes place in an approximately 1 % to approximately 35% ethanol solution.
Regarding claim 10, Zhao does not teach wherein said infusion takes place in a vacuum or a combination of vacuum and positive external pressure environment.
Regarding claim 11, Zhao does not teach wherein the vacuum pressure is at least about 3 Torr.
Regarding claim 12, Zhao does not teach wherein a mixture of probiotic bacterial cells and polyphenolic compounds are exposed to 99% vacuum pressure for about 4 seconds to about 7 seconds.
Young’s general disclosure relates to a vacuum-infusion method to encapsulate bioactives into a microbe (see abstract).
Regarding claim 9, Young teaches that the infusion takes place in ethanol in the range of 5-35% ethanol which falls within the claimed range of “approximately” 1-35% (see pg. 103, Table 1).
Regarding claim 10, Young teaches that the infusion takes place in a vacuum (see abstract).
Regarding claim 11, Young teaches a vacuum pressure of “at least about” 3 Torr where the vacuum pressure disclosed is 1 kPa (see Young abstract), which converts to 7.5 Torr. Applicant defines the range of “about” in the specification to mean less than or equal to +/- 0.05%-10% of that claimed numerical value (see specification [00192]), and so 7.5 Torr is within the range of the claimed numerical value.
Regarding claim 12, Young teaches the cells and the curcumin polyphenols were exposed to 99% vacuum pressure for 5 seconds (see pg. 103, ¶ 2), which is within the claimed range of “about” 4-7 seconds. However, Young does not specify that the cells used in this method were probiotic bacteria.
It would have been obvious though to the ordinary artisan at the time of the effective filing date to combine the vacuum infusion step as taught in Young with the probiotic bacteria-polyphenol infusion method as taught in Zhao. One would be motivated to do so because Young teaches that this vacuum infusion step is a more rapid alternative to conventional incubation encapsulation methods (see Young pg. 101, ¶ 2). The addition of a quicker vacuum pressure step would be advantageous in Zhao which uses the incubation method instead and tests for the shortest optimal fermentation time achievable (see Zhao pg. 183, ¶ 7). Therefore, the ordinary artisan could improve upon the timing of Zhao’s infusion process by combining such methods and would have a reasonable expectation of success in doing so.
Claims 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (Zhao et al., “Lactic acid bacterial fermentation modified phenolic composition in tea extracts and enhanced their antioxidant activity and cellular uptake of phenolic compounds following in vitro digestion”, 2015 Oct 26, Journal of Functional Foods, 20, pgs. 182-192) and in view of Young (Young et al., “Vacuum facilitated infusion of bioactives into yeast microcarriers: Evaluation of a novel encapsulation approach”, 2017 Jul 31, Food Research International, 100, pgs. 99-111).
Zhao’s general disclosure has been set forth above.
Regarding claim 14, Zhao teaches a method of enhancing probiotic viability by providing a strain of live beneficial probiotic Lactobacillus bacteria (see pg. 183, ¶ 4) and extracting polyphenolic compounds from a green tea extract that includes catechins (see pg. 183, ¶ 5-6). Zhao also teaches mixing the probiotic bacteria and the polyphenolic extract (see pg. 183, ¶ 7). Zhao does not teach applying vacuum pressure to infuse the polyphenols into the probiotic bacteria cells.
Young’s general disclosure has been set forth above.
Regarding claim 14, Young teaches applying vacuum pressure to the mixed solution of polyphenols and cells (see pg. 101, ¶ 9). However, Young does not specify that the cells used in this method were probiotic bacteria.
It would have been obvious though to the ordinary artisan at the time of the effective filing date to combine the vacuum infusion step as taught in Young with the probiotic bacteria-polyphenol infusion method as taught in Zhao. One would be motivated to do so because Young teaches that this vacuum infusion step is a more rapid alternative to conventional incubation encapsulation methods (see Young pg. 101, ¶ 2). The addition of a quicker vacuum pressure step would be advantageous in Zhao which uses the incubation method instead and tests for the shortest optimal fermentation time achievable (see Zhao pg. 183, ¶ 7). Therefore, the ordinary artisan could improve upon the timing of Zhao’s infusion process by combining such methods and would have a reasonable expectation of success in doing so.
Regarding claims 15-16 and 18-19, Zhao and Young teach the method of enhancing probiotic viability. However, the recitation of a “wherein” clause to describe the conditions of a step within the independent method claim does not necessarily further limit the claims. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. As the dependent claims are not steps required to carry out the inventive method, they have no patentable weight. See MPEP 2111.04.
Regarding claim 17, Zhao and Young teach the polyphenolic compounds are extracted from the encapsulating cells with organic solvents (see Young pg. 103, ¶ 3), of which ethanol is one of the extracting solvents disclosed (see Young pg. 103, ¶ 10).
Regarding claim 20, Zhao and Young teach the mix of cells and the curcumin polyphenols were exposed to 99% vacuum pressure for 5 seconds (see Young pg. 103, ¶ 2), which is within the claimed range of “about” 4-7 seconds.
Regarding claim 21, Zhao and Young teach the mixture is subject to multiple iterations of vacuum pressure as all experimental samples were conducted triplicate (see Young pg. 101, ¶ 10).
Regarding claim 22, Zhao and Young teach collecting infused bacterial cells (see Young pg. 190, ¶ 4) and extracting a second polyphenolic compound as both fisetin and curcumin are disclosed (see Young pg. 103, ¶ 10). Zhao and Young also teach the mixing of a second polyphenol compound with an infused cell and applying vacuum pressure to it, as Young discloses a second polyphenol is mixed and vacuum-infused into a cell simultaneously with a first polyphenol (see Young pg. 105, ¶ 3).
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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/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
/E.R.W./Examiner, Art Unit 1653
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