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 .
This application is made special on the petition under 37 CFR 1.102(c)(1), granted December 03, 2025.
Claim Status
The claim set filed February 02, 2026 has been entered. Claims 1 and 8-10 are canceled. Thus, claims 2-7 as amended are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on January 22, 2026:
(I) The objection to claims 2-3, 7 and 9 is withdrawn in view of Applicant’s amendments to claims 2-3 and 7; and in view of the cancelation of claim 9 as discussed in the Claim Status section above.
(II) The rejection of claims 8-10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of Applicant canceling claims 8-10 as discussed in the Claim Status section above.
(III) The rejection of claims 3 and 5-7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of Applicant’s amendments to claims 3 and 5-7.
(IV) The rejection of claim 1 under 35 U.S.C. 103 is withdrawn in view of Applicant canceling claim 1 as discussed in the Claim Status section above.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4, pg. 6, line 9, depicts the second recited structure (e.g. Formula III) and the third recited structure (e.g. Formula IV) where both structures appear to be cut-off the depicted image on the right-hand side, for example Formula III in at least two places recites an oxygen atom having only one bonded group, which is inconsistent with the corresponding structure of Formula (III) recited within the specification on pg. 6, line 5.
The Examiner also respectfully notes within Formula (IV) it appears the CF3 group on the right-hand side of the phenyl ring is cut-off as the number “3” appears to be cut-off.
The Examiner encourages the Applicant to review the entire claim set to ensure all recited structures within each claim are complete, and if structures are incomplete to replace any structures according to and consistent with the specification.
Appropriate correction is required.
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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Suarato et al. (Published 28 April 1998, US-5744454-A, PTO-892).
Regarding claim 2-4, Suarato teaches anthracycline derivatives, see title. Suarato teaches an anthracycline of formula A, depicted as
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173
393
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, see Col. 1, lines 15-25.
Suarato teaches R1 represents H, hydroxy or a group of formula OR4, in which R4 is C1 alkyl, (e.g. R2 is -H, -OH, or -O-CH3, see claim 2, line 7; claim 3, pg. 4, line 2; and claim 4, pg. 6, line 4), see Col. 1, lines 25-30.
Suarato teaches R2 is hydroxy (e.g. -OH, required in formula (I) of claims 2-4), see Col. 1, lines 35-40.
Suarato teaches R3 is a group of formula YCH2R6, in which Y is CO and R6 is H or hydroxyl (e.g. R1 is -CH3 or -CH2OH, required in claim 2, line 6; claim 3, pg. 4, line 1; and claim 4, pg. 6, line 3), see Col. 1, lines 45-50.
Suarato teaches X represents a sugar residue of formula X1 depicted as,
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136
199
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, see Col. 2, lines 45-50.
Suarato teaches R11 and R12 are both H, see Col. 2, lines 60-65. Suarato teaches one of R14 and R15 is hydrogen and the other is OH, see Col. 3, lines 15-20.
Suarato teaches R13 represents NHCOR9, see Col. 2, lines 65-67; in which R9 is above defined, see Col. 3, lines 15-20; wherein R9 is selected from and including phenyl optionally substituted by one or more, for example 1, 2 or 3 substituents selected from and including CF3 (e.g. R3 is a trifluoromethyl-substituted benzoyl group, required in claim 2, lines 7-8; claim 3, pg. 4, lines 2-3; and claim 4, pg. 6, line 4-5), see Col. 1, lines 56-61.
The Examiner respectfully notes based on the anthracycline of formula A of the teachings of Suarato as discussed above, said formula A of Suarato corresponds to and includes the fluorobenzoyl anthracycline derivatives comprising a mono-, a di- or a tri-substituted triluoromethyl-substituted benzoyl group as recited and required within instant claims 2-4 as discussed above.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have chosen from the teachings of Suarato above and arrived at the fluorobenzoyl anthracycline derivatives required within instant claims 2-4 as within the scope of the artisan as combining prior art elements according to known compounds to yield predictable results. One of ordinary skill in the art would have been motivated to create the anthracycline of formula A as taught by Suarato above. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the fluorobenzoyl anthracycline derivatives required within instant claims 2-4, because Suarato teaches within the anthracycline of formula A of Suarato it includes and encompasses tri-fluoromethyl substituted benzoyl anthracyclines as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the teachings of the prior art.
Allowable Subject Matter
Claims 5-7 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Suarato teaches as set forth above. The Examiner respectfully notes Suarato teaches fluorobenzoyl anthracycline derivatives are within the scope of the anthracyclines of formula (A) of Suarato as discussed above.
The Examiner also respectfully notes Suarato further teaches the compounds of formula (A) may be prepared, depending on the nature of the substituents, starting from known anthracyclines by appropriate chemical modifications of the aglycone structure or the sugar moiety or both parts of the molecule, see Col. 7, lines 35-40.
However, the Examiner respectfully notes Suarato does not teach a method of preparing fluorobenzoyl anthracycline derivatives where Formula (1) is reacted with either Formula (2) or Formula (3), wherein Formulas (1), (2) and (3) are restricted as recited within independent claim 5. Thus, the teachings of Suarato do not anticipate nor render obvious why one of ordinary skill in the art would prepare a class of fluorobenzoyl anthracycline derivatives as recited within independent claim 5 wherein Formulas (1), (2) and (3) are restricted as recited within independent claim 5 as discussed above.
Claims 6-7 depend from the method of independent claim 5.
Conclusion
Claims 5-7 are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691