DETAILED ACTION
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
Claims 1 and 6 are pending. Claims 2-5 and 7 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/IB2022/056868, filed on July 26, 2022. This application also claims the benefits of foreign priority to IN202141019126, filed on July 26, 2021.
Specification
The disclosure is objected to because of the following informalities:
The terms “5-flurouracil” and “cladibrine” are misspelled. As discussed below in the “Claim Objections” section, all instances of “5-flurouracil” and “cladibrine” in the instant specification should be corrected to “5-fluorouracil” and “cladribine.”
Appropriate correction is required.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant' s amendments and/or remarks.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites: “… A is an anticancer agent selected from the group consisting of 5-flurouracil, … cladibrine…”
According to Scifinder, “5-flurouracil” should be spelled as “5-fluorouracil” and “cladibrine” should be spelled as “cladribine” as shown in the search results reproduced below:
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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.
Claim 6 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 6 recites:
“A method of synthesizing the molecule of formula (I) of claim 1, synthesizing by esterification of the acid, the hormone derivative and the anticancer agent the molecule of formula (I).”
It is unclear from the language of claim 6 what is meant by “synthesizing by esterification of the acid, the hormone derivative and the anticancer agent the molecule of formula (I).” For example, the claim may be interpreted as requiring esterification of each of the acid, hormone derivative, and anticancer agent individually, thereby forming three separate esterified compounds. Under such an interpretation, however, it is unclear how the three separate esterified compounds are subsequently combined to form the single conjugate represented by the molecule of formula (I) of claim 1.
Alternatively, the claim may be interpreted as requiring esterification of an acid (B) with an anticancer agent (A) to form the A-B portion of the molecule of formula (I), followed by esterification of the resulting A-B intermediate with a hormone derivative (C) to form the molecule of formula (I) (i.e., A-B-C recited in instant claim 1).
Furthermore, the recited esterification reaction is inconsistent with at least certain embodiments disclosed in the specification. For example, instant figure 1 depicts an embodiment wherein citric acid is linked to 5-fluorouracil through an amide linkage, rather than an ester linkage:
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Thus, it is unclear how the recited “esterification of the acid, the hormone derivative and the anticancer agent the molecule of formula (I)” encompasses embodiments in which the linkage between the acid and the anticancer agent is an amide bond. As such, the scope of the claimed method is unclear.
The following is provided solely as an example of claim language that more clearly recites a method limitation. This example is not intended to suggest any particular reaction sequence or claim scope. Applicant may amend the claim in any manner, consistent with the disclosure, that clearly recites the intended synthetic step(s) required to form the molecule of formula (I) of claim 1:
“A method of synthesizing the molecule of formula (I) of claim 1, the method comprising esterifying an acid with a hormone derivative, wherein the acid and the hormone derivative are as defined in claim 1.”
Allowable Subject Matter
Claim 1 is objected to but would be allowable once appropriate corrections are made.
Conclusion
Claim 1 is objected to. Claim 6 is rejected.
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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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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