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 Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 3/11/2026 are acknowledged. Claims 22 and 24 are amended; claims 1-21 are canceled; no claims are withdrawn; claim 25 is new; claims 22-25 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement submitted on 2/24/2026 has been considered by the examiner.
Drawings
The replacement drawings received 2/24/2026 are accepted.
Claim Interpretation
The limitation “Lactobacillus derived from Artemisia indica var. maximowiczii” is interpreted to mean any Lactobacillus associated with any amount, part or fraction of any Artemisia indica var. maximowiczii, i.e., Artemisia princeps, plant at any time including in the fermentation because Lactobacillus are a separate biological organism which are not derived from Artemisia in any real biological sense.
Claim Objections
The objection to claims 22 and 24, as set forth at pp. 3-4 of the previous Office Action, is withdrawn in view of the amendment of the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al., JP 2010126484 (cite N, PTO-892, 11/25/2025; herein “Lee”) in light of Shimono et al., 2013 (cite V, PTO-892, 11/25/2025; herein “Shimono”).
Lee teaches an antimicrobial composition, i.e., agent, to be topically administered (i.e., cosmetic), wherein administering the antimicrobial provides an antiseptic effect [0009] wherein the antimicrobial composition comprises a fermentation product of Artemisia princeps (Abst.; [0010]) which comprises Lactobacillus derived from Artemisia princeps ([0010], [0015], [0017]) wherein the agent is a cream [0023] anticipating claims 22-23.
Shimono discloses that Artemisia indica var maximowiczii is synonymous with Artemisia princeps (p. 830, ¶3). Thus, Lee discloses a method for providing an antiseptic effect, i.e., reducing microbial disease, comprising administering an antimicrobial agent to a subject, i.e. topically administering the antimicrobial composition to a subject, the agent comprising Lactobacillus derived from Artemisia indica var. maximowiczii, i.e., Artemisia princeps, or a secretion from the Lactobacillus derived from Artemisia indica var. maximowiczii, i.e., Artemisia princeps, wherein the agent is a fermentation product of Artemisia indica var. maximowiczii, i.e., Artemisia princeps, wherein the agent is a cream anticipating claims 22-23.
The Lactobacillus derived from Artemisia princeps would necessarily comprise parafarraginis, parabuchneri, buchneri, and harbinensis anticipating claim 24.
Response to Arguments
Applicant's arguments filed 3/11/2026 have been fully considered but they are not persuasive. Arguments of the Applicant’s Response on p. 4 regarding the claim objections are moot as the objections have been withdrawn.
Regarding the rejection of claims 22-24 under 35 U.S.C. 102(a)(1) over Lee in light of Shimono, Applicant argues 1) that the Lactobacillus in Lee are not derived from Artemisia indica var. maximowiczii but are derived from nature (pp. 4-6), then argues 2) that it is impossible that the Lactobacillus are derived from Artemisia indica var. maximowiczii because Lactobacilli are added to the ferment (p. 6, ¶2), then argues 3) that because solids are filtered the compositions in Lee must be sterile and not comprise Lactobacillus at all (pp. 6-7, spanning ¶), and finally argues that Lee does not state that the Lactobacillus derived from Artemisia indica var. maximowiczii are the active ingredient; therefore, Lee does not teach every limitation of the claims.
Claims 22-25 are drawn to a generic method of reducing microbial disease by administering an antimicrobial agent to a subject; hence, the focus is on the composition of the antimicrobial agent.
The antimicrobial composition is defined in the claims with the product-by-process limitation that the agent is a fermentation product of Artemisia indica var. maximowiczii (claims 22-24) or a fermentation product of Artemisia indica var. maximowiczii and soymilk, i.e., BRI is that the fermentation comprises soybean;
The antimicrobial composition further comprises a secretion from Lactobacillus and/or the Lactobacillus themselves wherein the Lactobacillus are defined by the product-by-process limitation that the Lactobacillus are extracted from Artemisia indica var. maximowiczii and that the secretion or the Lactobacillus themselves are the active ingredient.
As explained in the previous Office action and reiterated above, the limitation “Lactobacillus derived from Artemisia indica var. maximowiczii” is interpreted to mean any Lactobacillus associated with any amount, part or fraction of any Artemisia indica var. maximowiczii, i.e., Artemisia princeps, plant at any time including in the fermentation because Lactobacillus are a separate biological organism which are not derived from Artemisia in any real biological sense.
Hence, to address Applicant’s point 1, that the Lactobacillus in Lee are not derived from Artemisia indica var. maximowiczii but are derived from nature, and point 2, that it is impossible that the Lactobacillus are derived from Artemisia indica var. maximowiczii because Lactobacilli are added to the ferment; it would appear that the natural ferment of Artemisia princeps, i.e., Artemisia indica var. maximowiczii, disclosed in Lee would comprise Lactobacillus derived from Artemisia indica var. maximowiczii regardless of whether additional Lactobacillus are added to the ferment or not; hence, points 1) and 2) are clearly unpersuasive.
Regarding 3), that solids are filtered from the compositions of Lee means that the compositions do not comprise Lactobacillus derived from Artemisia indica var. maximowiczii, is completely unpersuasive because filtering solids from a ferment is not sterile filtration.
Lastly, the allegation that Lee not stating that the Lactobacillus derived from Artemisia indica var. maximowiczii or a secretion from the Lactobacillus derived from Artemisia indica var. maximowiczii is the active ingredient means that Lee does not teach every limitation of the claims is incorrect. Patentability does not depend on the opinions or statements of anyone; rather, it depends on the method steps and the compositions in the method. Applicant has not shown that the active ingredient in Lee is NOT secretions from the Lactobacillus derived from Artemisia indica var. maximowiczii or the Lactobacillus derived from Artemisia indica var. maximowiczii themselves; hence, Applicant’s implicit allegation that the active ingredient is different from the instant invention has not been shown with any evidence and is unpersuasive.
Thus, the anticipation of claims 22-24 by Lee is maintained.
Claims 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuwaki et al., 2012 (cite U, PTO-892, 11/25/2025; herein “Kuwaki”) in light of Shimono et al., 2013 (cite V, PTO-892, 11/25/2025; herein “Shimono”).
Kuwaki teaches a plant-based fermented paste, i.e. plaster, with demonstrated anti-bacterial activities for use as a functional food (Abst.) wherein the ferment comprises Artemisia princeps fermented with Lactobacillus buchneri (p. 22, “Preparation of plant-based paste”; Table 1) anticipating claims 22-24.
The ferment further comprises soybean; thus, under a broadest reasonable interpretation (BRI) the ferment comprises soymilk and Artemisia princeps, anticipating claim 25.
Shimono discloses that Artemisia indica var maximowiczii is synonymous with Artemisia princeps (p. 830, ¶3). Thus, Kuwaki discloses a method for providing an antibacterial activity, i.e., reducing microbial disease, comprising administering an antimicrobial agent to a subject, i.e. orally administering the functional food comprising the antimicrobial agent to a subject, the agent comprising Lactobacillus buchneri derived from Artemisia indica var. maximowiczii, i.e., Artemisia princeps, or a secretion from the Lactobacillus buchneri derived from Artemisia indica var. maximowiczii, i.e., Artemisia princeps, wherein the agent is a fermentation product of Artemisia indica var. maximowiczii, i.e., Artemisia princeps, wherein the agent is a plaster anticipating claims 22-24.
Response to Arguments
Regarding the rejection of claims 22-24 under 35 U.S.C. 102(a)(1) over Kuwaki in light of Shimono, Applicant argues Kuwaki does not state that the Lactobacillus derived from Artemisia indica var. maximowiczii is the active ingredient; therefore, Kuwaki does not teach every limitation of the claims.
Firstly, a secretion from Lactobacillus derived from Artemisia indica var. maximowiczii or Lactobacillus derived from Artemisia indica var. maximowiczii can be the active ingredient.
The allegation that Kuwaki not stating that the Lactobacillus derived from Artemisia indica var. maximowiczii or a secretion from the Lactobacillus derived from Artemisia indica var. maximowiczii is the active ingredient means that Kuwaki does not teach every limitation of the claims is incorrect. Patentability does not depend on the opinions or statements of anyone; rather, it depends on the method steps and the compositions in the method. Applicant has not shown that the active ingredient in Kuwaki is NOT secretions from the Lactobacillus derived from Artemisia indica var. maximowiczii or the Lactobacillus derived from Artemisia indica var. maximowiczii themselves; hence, Applicant’s implicit allegation that the active ingredient is different from the instant invention has not been shown with any evidence and is unpersuasive.
Thus, the anticipation of claims 22-24 by Kuwaki is maintained and amended to include claim 25 because the ferment in Kuwaki comprises soybean.
Double Patenting
The rejection of claims 22-24 on the ground of nonstatutory double patenting over claims 1-2 of U.S. Patent No. 11944651, as set forth on pp. 6-11 of the previous Office action is withdrawn in view of the filing and approval of a terminal disclaimer over 11944651 on 2/24/2026.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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