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 December 10, 2025 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 Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.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 9-14 and 17-21 are pending.
Claim Rejections - 35 USC § 112
4. Claim 11 is 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.
Claim 11 is indefinite because it requires the administration of a second therapeutic agent for viral hepatitis. However, claim 11 depends from claim 9 which requires the administration of a composition where the active component consists of 5,7,3',4'-tetrahydroxyflavan-3-ol C4-C8 dimer. Thus, claim 11 potentially conflicts with claim 9 unless claim 11 is clarified to require that the second therapeutic agent is a distinct composition from the therapeutic composition which consists of 5,7,3',4'-tetrahydroxyflavan-3-ol C4-C8 dimer as the active ingredient.
Claim Rejections - 35 USC § 103
5. Claim(s) 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 101632722 A (English translation) in view of Wang (CN 102755393 A — 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 argues:
One skilled in the art would not have been motivated to modify or combine these references to arrive at the claimed method, which specifically requires administration of a single active compound directed to viral inhibition, rather than general hepatoprotection. Both CN '722 and Wang focus on multi-component compositions involving numerous active ingredients, not on the use of Fagopyrum esculentum (or F. dibotrys) extract alone for treating viral hepatitis. Neither reference suggests that any single component would independently provide antiviral efficacy, nor would one of ordinary skill have had a reasonable expectation of success that the extract alone could yield equivalent therapeutic outcomes.
However, claim 17 does not require the administration of a 5,7,3',4'-tetrahydroxyflavan-3-ol C4-C8 dimer as the sole active ingredient. Claim 17 states that the method is drawn to administering a composition “containing” the dimer. “Containing” is considered synonymous with “comprising” (see MPEP section 2111.03) which allows for the inclusion of additional active ingredients in the composition. Thus, claim 17 does not exclude the additional active ingredients taught by the references. Therefore, this argument is not persuasive.
Applicant also argues that it would not be obvious to optimize the dosage of the dimer taught by CN ‘722 to arrive at the dosages claimed by applicant because “predicting the effective doses for botanical extracts is highly unpredictable due to variability in composition, bioavailability, and activity. Consequently, the claimed concentration cannot be considered a routine variation of the prior art and is not obvious.” However, applicant does not provide any evidence to support the assertion that the claimed dosages could not be achieved by an artisan without undue experimentation. CN ‘722 states that the procyanidin B2 is present in the extract at the concentration of about 2.84%. In addition, the reference teaches using the extract in a variety of dosages to create the pharmaceutical product (see pages 8 and 9 of the translation). Thus, the artisan would be motivated to optimize in and around the amounts taught by the reference in order to determine the most effective dosage for the dimer containing extract. Therefore, applicant’s argument is not persuasive.
Allowable Subject Matter
6. Claims 9, 10, and 12-14 are allowed.
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.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655