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 .
Response to Amendments
This office action is in response to the amendment filed on March 02, 2026. Claims 7 and 11 have been cancelled. Claims 1-6 and 8-10 are currently pending and are under examination.
Any objections or rejections not reiterated below are hereby withdrawn.
Withdrawal Rejection(s)
The rejection of claims 1-11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn based on the remarks and the amendment to the claims filed March 2, 2026.
The rejection of claims 7 and 11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement is withdrawn based on the cancellation of the claims.
Pending Rejection(s)
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 8-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The rejection was explained in the office action mailed on December 29, 2025 and still applies to the pending claims. The claims are rejected for failing to describe a method for lead detoxification by administration of a composition comprising a therapeutically effective amount of Crassocephalum rabens extracts from the different aqueous solvents and a process, wherein the method prevents lead poisoning and any related diseases thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Response to Remarks
Applicant’s respond to the 35 U.S.C. 112(a), first paragraph rejection and state that one of ordinary skill in the art would be able to make and/or use the invention based on the amemdment to the claims.
Claims 1-4 have been amended to recite, a method for lead detoxification by Crassocephalum rabens extract, comprising administering to a mammal a composition comprising a therapeutically effective amount of Crassocephalum rabens extract to decrease a lead concentration in blood-and restore the liver function, and thereby to treat and/or prevent lead poisoning and the related disease thereof; Crassocephalum rabens extract is a mixture rich in 1,2-di-O-linolenoyl-3-0-p-galactopyranosyl- sn-glycerol (dLGG); the composition is used to inhibit an increase of reduce an aspartate aminotransferase (AST) level and an alanine aminotransferase (ALT) level in blood. Applicant's arguments filed March 2, 2026 have been fully considered but they are not persuasive.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The claims are drawn to a method for lead detoxification by Crassocephalum rabens extract, comprising administering to a mammal a composition comprising a therapeutically effective amount of Crassocephalum rabens extract to decrease a lead concentration in the blood and restore the liver function, and thereby to treat and/or prevent lead poisoning and the related disease thereof. The breadth of preventing and treating any lead poisoning and any related disease thereof is broad. Since the method for lead poisoning and the related diseases thereof remains largely unsolved as explained in the prior rejection when referencing the state of the prior art and the predictability or unpredictability of the art, means for preventing lead poisoning and the releated diseases thereof is highly unpredictable. Olusola and Shyur were discussed to provide the art and the unpredictability of the art, and along with the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention for the scope claimed. One skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation.
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.
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/ALPA NILESH AMIN/Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655