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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 March 2026 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 30 March 2026 in response to the final rejection mailed 29 December 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 30 March 2026 replaces all prior versions and listings of the claims.
Claims 1, 3, 5-12, and 15 are pending. Claims 1, 8, and 12 are amended. Claims 1, 3, 5-12, and 15 are being examined on the merits.
Claim Objections
Claims 9 and 10 objected to because “subsp.” and “biovar.” should not be italicized in the scientific names. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 9 and 10 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.
Regarding Claims 9 and 10, the first instance of each genera should be spelled out in full. The specification at pages 5-6 indicates that, for example, there are multiple genera of intestinal beneficial bacteria which start with “L” and multiple genera of intestinal harmful bacteria which start with “E.” It is therefore unclear which specific bacteria are being claimed. Appropriate clarification is necessary.
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.
Claims 1, 3, 5-12, and 15 are rejected under 35 U.S.C. 103 as obvious over Marcq et al. (US 2014/0271999 A1) in view of Ahn et al. (Korea Science, 1999, 111-122), Zhang et al. (Chin Med, 2018, 26 pages), Sigma Aldrich (2018, 2 pages), and Jeong et al. (Front Microbiol, 2019, 13 pages).
The instant claims are as of record, drawn to a composition for improving intestinal microbial flora comprising a mixture of a ginseng extract and a column-purified fraction of an aqueous alcohol solution of a ginseng alcohol extract; and sodium propionate, wherein the weight ratio of the mixture to the sodium propionate is 4:1 to 1:2.
Marcq et al. teaches food and beverage compositions for human consumption comprising a functional ingredient (health functional food composition; pharmaceutical composition; Marcq et al., [0004]-[0005]; as required for instant Claim 11). The functional ingredient can be ginseng and compounds derived therefrom (broadly, a fraction thereof; ginseng extract; Marcq et al., [0032], page 4; as required for instant Claims 1 and 12). The composition additionally comprises other botanical extracts (plant extract) and preservatives such as sodium propionate to prevent the growth of bacteria (Marcq et al., [0032]-[0033], page 4; as required for instant Claims 1, 6, 12, and 15).
Marcq et al. do not teach wherein the composition comprises a fraction of a ginseng extract, ratios, growth/inhibition of particular species of bacteria, or wherein the aqueous alcohol solution of a ginseng alcohol extract is column purified.
Ahn et al. teach that water extracts of Panax ginseng facilitate growth of Bifidobacterium longum, B. breve (Ahn et al., Table 1, page 114), Lactobacillus casei, and L. gasseri (promoting growth of beneficial intestinal bacteria; Ahn et al., Table 5, page 116; as required for instant Claims 1, 8, and 9). Methanol extracts of P. ginseng (ginseng alcohol extract) inhibited the growth of Clostridium coccoides, and C. perfringens (inhibiting growth of intestinal harmful bacteria; Ahn et al., Table 6, page 117; as required for instant Claims 1, 8, and 10). Water extracts were obtained by further extracting residues of methanol extracts (broadly, fraction of ginseng extract; Ahn et al., Plant materials and sample preparation, page 112; as required for instant Claims 1 and 12). Additionally, solutions of the test material were prepared using methanol of distilled water (aqueous alcohol solution) as a solvent.
Jeong et al. teaches that sodium propionate inhibits the growth of Staphylococcus aureus, including multi-drug resistant strains and Sigma Aldrich teaches that sodium propionate is used in culture media to promote the growth of Bifidobacteria.
Zhang et al. teach that column chromatography is the main method used in natural product extraction to obtain pure natural products from a complex mixture (Zhang et al., Separation Methods, page 11; as required for instant Claims 1 and 12).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Marcq et al., Ahn et al., Zhang et al., Sigma Aldrich, and Jeong et al. to arrive at the instant invention. A skilled artisan could use column chromatography to obtain a purified fraction of the extract with a reasonable expectation of success because it is a well-known, commonly used method in the art. The ginseng extracts and fractions of Ahn et al. provide differential inhibition and growth promotion of different types of bacteria could readily be combined with the sodium propionate, which also has differential effects on different types of bacteria as taught by Jeong et al. and Sigma Aldrich, and additional herbal extracts of Marcq et al. provide additional health benefits and inhibition of bacterial growth that can affect shelf life (Marcq et al., [0032]-[0033], page 4). A skilled artisan would additionally be motivated to modify weight ratios of ginseng extract, ginseng extract fraction (Claim 3), and sodium propionate in order to arrive at the instant invention and could do so with a reasonable expectation of success.
Additionally, it would have been obvious to a person of ordinary skill in the art to modify the weight ratios of ginseng extract to sodium propionate (Claim 5) and ginseng extract to plant extract (Claim 7) as taught by Marcq et al. to arrive at the instant invention. Sodium propionate is a preservative that prevents the growth of bacteria, and thus a skilled artisan could modify the amount present in order to obtain the desired intended use of the composition as claimed. Active agents such as ginkgoflavonoids, tea tannins, anthocyanosides, and polyphenols which can be extracted from plant sources also provide various nutraceutical effects, such as delaying the aging process (Marcq et al., [0032], page 3), and thus their proportion within the claimed composition could be modified by a skilled artisan to achieve desirous effects with a reasonable expectation of success.
If not expressly taught by Marcq et al., Ahn et al., or Zhang et al., based upon the overall beneficial teaching provided by this reference with respect to compositions disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable weight ranges in which to make such a composition), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
With respect to the USC 103 rejections above, please note that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 30 March 2026 have been fully considered but they are not persuasive.
Applicant argues that the specific ratio of 4:1 to 1:2 is critical to the invention and results in a significant and unexpected effect of selective promotion of the growth of beneficial intestinal bacteria relative to harmful bacteria.
Regarding the specific ratio claimed by applicant, a skilled artisan would be at least motivated to try various combinations of water and methanol extracts of Panax ginseng and sodium propionate based upon the teachings of the prior art regarding their differential effects on different bacteria. The instant claims are also drawn broadly to extracts of unknown concentrations comprising various components of unknown concentrations, and the broad “ginseng extract” without any further delineation (e.g., a specific solvent such as water) renders the claimed ratio equally broad. Finally, the examples in the specification are drawn to red ginseng and the specification also indicates (pg. 8-9) that any extract mixture with a weight ratio of 1:(0.01-1) increases the effect of promotion of intestinal beneficial bacteria or inhibiting growth of intestinal harmful bacteria. The extract mixture and sodium propionate in a ratio of (8-1):(1-8) also is excellent in the effect of promotion of intestinal beneficial bacteria or inhibiting growth of intestinal harmful bacteria (pg. 9). Since the specification indicates that wide ranges of ratios of the two extracts to one another and the extract mixture to the sodium propionate, as well as broad concentrations of the extracts (e.g., 0.1 to 100 mg/mlL, pg. 9), have the effect of differential promotion/inhibition of beneficial/harmful bacteria, and therefore the criticality of the claimed ranges as presented in the instant claims is not persuasive over the prior art.
Additionally, not only was it known in the art that sodium propionate is a preservative used for preventing bacterial growth (Marcq et al., [0032]-[0033], page 4), but also that ginseng extracts provide selective enhancement/inhibition of bacterial growth depending on the solvent used. Water extracts of Panax ginseng facilitate growth of the beneficial bacteria Bifidobacterium longum, B. breve, Lactobacillus casei, and L. gasseri (Ahn et al., Table 1, page 114; Table 5, page 116), whereas methanol extracts of P. ginseng inhibited the growth of the harmful bacteria Clostridium coccoides, and C. perfringens (Ahn et al., Table 6, page 117). Additionally, it is known in the art that sodium propionate may be used in culture media to promote the growth of beneficial Bifidobacteria (Sigma Aldrich, Principle and Interpretation, page 2) and can also be used to inhibit the growth of the harmful bacterium Staphylococcus aureus (Jeong et al., Abstract, page 1). Taken together, it is unsurprising that combining an extract of ginseng with an alcoholic fraction of an extract of ginseng and then adding sodium propionate would have selective enhancement of beneficial bacterial growth.
Conclusion
No claims are presently allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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