DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed July 24, 2026 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1-25 are pending.
Election/Restrictions
4. In the reply filed on January 26, 2026, applicant elected Group I, claims 2-9 with claim 1 as a linking claim with traverse.
5. Claims 10-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
6. Claims 1-9 are examined on the merits.
Claim Rejections - 35 USC § 102
7. Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hsu (US 6,383,525) for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues that the reference does not anticipate the claimed invention because the reference does not teach making an extract from the Adenostemma lavenia. However, the reference teaches that the powdered A. lavenia is mixed with the Ophiopogon filtrate resulting from extraction of the Ophiopogon with water (see column 3, lines 36-49 and Example 1). The filtrate is the liquid portion of the Ophiopogon extract; thus, the A. lavenia powder is mixed with a liquid at this point in the procedure taught by the reference. This mixture of the powder with the liquid would extract portions of the A. lavenia. Thus, the reference is considered to teach an “extract” as broadly claimed by applicant.
Applicant also argues that the reference does not anticipate the claimed invention because the reference does not teach using A. lavenia alone to treat dermatitis because the reference requires the presence of additional ingredient in the composition. However, applicant’s claims use the broad transitional phrase “comprising.” As discussed in MPEP section 2111.03, “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps…”. Thus, the reference properly anticipates the stated claims because applicant’s claims encompass unrecited elements.
Claim Rejections - 35 USC § 103
8. Claim(s) 2-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (US 6,383,525) in view of Liu (CN 102391106 – English translation) for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant reiterates the arguments against Hsu in regards to the teaching of the extract and the use of A. lavenia alone. The response to these arguments are as stated above.
In addition, applicant argues that Liu is not applicable to the present invention because “no efficacy verification trial are found in Liu.” However, efficacy trials are not required for a reference to be considered enabling especially in the absence of any evidence to the contrary. The reference is considered to provide enough information such that an artisan could make and use the A. lavenia extract to treat edema and other skin inflammations as taught by the reference. Thus, this argument is not persuasive.
Applicant also argues:
…in contrast to Liu, Examples in the specification of the present application has
clearly demonstrated the effect of treating dermatitis of the Adenostemma lavenia extract of the present application through the experiment for evaluation of IL-4 secretion inhibitory activity by EL4 cells, the experiment for animal model of 2,4-dinitrochlorobenzene (DNCB)-induced dermatitis and the experiment of atopic dermatitis model in NC/Nga mice.
Accordingly, the present application and Liu have significant differences.
Furthermore, the present application has clearly shown the unexpected effects, and has
inventive steps. Specifically, the Adenostemma lavenia extract of the present application has clearly demonstrated significant IL-4 secretion inhibitory activity, and significant efficacy in both DNCB-induced dermatitis model and NC/Nga atopic dermatitis model. Neither Hsu nor Liu discloses or suggests such therapeutic effects.
However, Liu teaches making the A. lavenia extract in the same manner as claimed by applicant. Thus, the A. lavenia extract taught by Liu would inherently result in the inhibition of IL-4 if applicant’s invention functions as claimed. Therefore, applicant’s argument is not persuasive.
9. 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 Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655