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
Acknowledgement is made of the response filed on November 20, 2025. In that response, claims 1 and 3-6 were amended and claim 2was cancelled. Claims 1 and 3-6 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 and 3-6 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Bian (CN 113827682A; see attached machine translation by Google Patents, herein after “GP translation”).
Bian teaches a “green and healthy medicine combination for preventing and treating inflammatory bowel disease, characterized in that it comprises 15-25g of Codonopsis pilosula, 5-15g of fried Atractylodes Rhizoma, 15-25g of Poria cocos, 1-10g of glutinous rice, 1-10g of Rhizoma Coptidis, 1-10g of Turmeric ‑10g, 5‑15g of Chia vine, 5‑15g of Bletilla striata, 1‑10g of licorice” (GP translation, title; abstract). The “glutinous rice” is correctly translated as “Cornus officinalis” in other parts (p.3 sixth-tenth paras.). The “fried Atractylodes Rhizoma” is different than the “Atractylodes macrocephala Koidz.” in the claims here as Applicant point out. However given that the present application attempted to claim priority to Bian, the current claims appear to contain a translation error, rather than a genuine difference in the composition. Nonetheless a rejection under 35 U.S.C. 103 is issued below with prior art on “Atractylodes macrocephala Koidz.”, i.e., the non-fried, medicine.
Regarding the wt% in claims 1 and 3-6, these are argued as finding written description support in the Table on page 5 of the Specification. (Remarks, 5, November 20, 2025). The identical table appears in Bian (Description para.[0028]; see also GP translation p.4/7), wherein each of the First through the Fourth Preferred Embodiments contain the same components in the same weight concentrations, and hence the same wt% concentration ranges in claims 3-6. Claim 1 here recites simply the minimum and the maximum wt.% ranges of each medicine taken from the First through the Fourth Preferred Embodiments. For example for the roots of Codonopsis comprise 12.8 wt% of the First Preferred Embodiment and the 22.2 wt% of the Third Preferred Embodiment, which in claim 1 is taken as a range of “12.83-22.22 wt%”.
Response to Arguments
Applicant's arguments filed November 20, 2025 have been fully considered but they are not persuasive. Applicant argues that wt.% ranges of each component” further distinguishes the claims from Bian, which recites grams. (Remarks, 7, November 20, 2025.)
In response it is noted above that the identical table appears in Bian, therefore to the extent they are different concepts the present claims will raise written description issues under 35 U.S.C. 112(a).
Applicant further argues that Bian teaches the wrong preparations of Atractylodes macrocephala, Cornus officinalis, and Glycyrrhiza uralensis. (Remarks, 7, November 20, 2025.)
However Applicant attempted to claim priority to Bian and therefore cannot now argue the present claims comprise different herbs. As noted above in the rejection the differences appear to be translation discrepancies.
Claim Rejections - 35 USC § 103
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 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bian (CN 113827682A; see attached machine translation by Google Patents, herein after “GP translation”) in view of Han (Han, K.-Y., et al., Heme Oxygenase-1 Induction and Anti-inflammatory Actions of Atractylodes macrocephala and Taraxacum herba Extracts Prevented Colitis and Was More Effective than Sulfasalazine in Preventing Relapse, Gut and Liver, Vol. 11 (September 2017) 655-666).
Bian teaches a “green and healthy medicine combination for preventing and treating inflammatory bowel disease, characterized in that it comprises 15-25g of Codonopsis pilosula, 5-15g of fried Atractylodes Rhizoma, 15-25g of Poria cocos, 1-10g of glutinous rice, 1-10g of Rhizoma Coptidis, 1-10g of Turmeric -10g, 5-15g of Chia vine, 5-15g of Bletilla striata, 1-10g of licorice” (GP translation, title; abstract). The “glutinous rice” is correctly translated as “Cornus officinalis” in other parts (p.3 sixth-tenth paras.). Regarding the wt% in claims 1 and 3-6, these are argued as finding written description support in the Table on page 5 of the Specification. (Remarks, 5, November 20, 2025). The identical table appears in Bian (Description para.[0028]; see also GP translation p.4/7), wherein each of the First through the Fourth Preferred Embodiments contain the same components in the same weight concentrations, and hence the same wt% concentration ranges in claims 3-6. Claim 1 here recites simply the minimum and the maximum wt.% ranges of each medicine taken from the First through the Fourth Preferred Embodiments. For example for the roots of Codonopsis comprise 12.8 wt% of the First Preferred Embodiment and the 22.2 wt% of the Third Preferred Embodiment, which in claim 1 is taken as a range of “12.83-22.22 wt%”.
Bian does not teach “Atractylodes macrocephala Koidz.”, i.e., the non-fried Atractylodes macrocephala.
Han studied effects of Atractylodes macrocephala (AM) extract on murine intestinal epithelial IEC-6 cells with acute colitis induced from 7 days of dextran sulfate sodium (DSS) (title; abstract; pp.658-65). Anti-inflammatory activities occurred via inhibition of macrophage and T lymphocyte infiltrations (Figs.2-4 and accompanying text). Han concluded “AM or TH extracts were far superior in preventing DSS-induced colitis than sulfasalazine, AM or TH extracts can be considered natural agents that can prevent IBD relapse” and “promote additional regeneration” (abstract; see ).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Bian and Han and use Atractylodes macrocephala in place of the fried Atractylodes macrocephala as recited in the instant claim(s). Substituting equivalents known for the same purpose, where the equivalency has been recognized in the prior art, presents strong evidence of obviousness; an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. MPEP §2144.06 (II) (citations omitted). Here Bian also uses the prepared fried Atractylodes macrocephala, and Han teaches that non-fried Atractylodes macrocephala can be considered a natural agent that can prevent IBD relapse and “promote additional intestinal cell regeneration.
CONCLUSION
Applicant's amendment necessitated the 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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614