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 .
As all rejections have been overcome in claims 1-11, 14-23, 28-39, 68, 69, 71, 74, 102 and 104 to the extent that they encompass elected species “C”, the next species has been examined : “(vi) free compound of claim 40”. Thus, claims 1-39, 68, 69, 71, 74, 102, 104 and 105, directed in part to non-elected species, are withdrawn from consideration. Claims 40, 70, 72, 101, 103 and 105 are under consideration. Claims 1, 40, 71, 72, 74, 104 and 105 have been amended.
The objection to claims 71, 72 and 105 because of the typographical error of “castrate-resistant prostrate cancer” is withdrawn in light of applicant’s amendment.
The rejection of claims 40, 70, 72, 101, 103 and 105 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendments.
The rejection of claims 40, 70, 72, 101, 103 and 105 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of applicant’s amendment.
The rejection of claims 40, 70, 72, 101, 103 and 105 under 35 U.S.C. 102(a)(1) as being anticipated by Gingipalli et al (WO2015/157594, reference of the IDS filed 3/02/2022). Is withdrawn in light of applicant’s amendment.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 40, 70 and 101 are rejected under 35 U.S.C. 102 (a)(1)as being anticipated by Richter et al (WO2008/138561, reference of the IDS filed 11/2/2021).
Richter et al disclose the compound
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(page 57) which meets the illimitations of claim 40 wherein when Q is CH2, then R2 is C5-C10 alkyl. Richter et al disclose that the molecules of the invention show an activity against several cancer cell lines between 0.03 to 60nM Specifically, the RD295 compound exhibits an IC50 of 0.43nM against a HT-29 cell line (page 57). Richter et al disclose pharmaceutical composition comprising the inventive compounds of formula I (page 12, second paragraph).
Claim 40 is rejected under 35 U.S.C. 102 (a)(1)as being anticipated by Vlahov et al (WO2017/031209, reference of the IDS filed 11/2/2021).
Vlahov et al disclose the compound
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(page 122) which meets the limitations of instant claim 40 for Q being CH2, and R2 being C5-C10 alkyl. Vlahov disclose that compounds which show cytotoxicity against cancer cell lines in the picomolar range are of interest as potential anti-cancer therapeutics.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 40, 70, 72, 101, 103 and 105 are rejected under 35 U.S.C. 103 as being unpatentable over Cong et al (US 2014/0227295, reference of the IDS filed 11/02/2021) in view of Richter et al (WO2008/138561).
Cong et al teach the specific compounds of
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which meet the limitations of claim 40 for R1= C1-C6 alkyl; Q= CH2; R2 is alkyl; R7 is NRaR7b, wherein R7a and R7b are hydrogen; R3 is -OC(O)N(H)C1-C10 alkyl; R4 is hydrogen, R5 is C1-C5 alkyl and R6 is -OH.
wherein for said specific compounds, Q is CH2 and R2 is CH2CH3. Cong et al also teach that R2 can be unsubstituted C1-C10 alkyl or C2-C10 alkynyl (claim 1, page 47, second column). Thus, it would be prima facie obvious to use longer alkyl or alkynyl chains of up to 10 carbons at the R2 position, rendering obvious an instant R2 of C5-C9 alkyl or C5-C9 alkynyl when Q was CH2.
Cong et al teach a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier (claim 19 of ‘295) which meets the limitation of claim 101. Cong et al disclose a method of treating a cancer in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a compound of claim 1 (claim 15 of ‘295) which meets the limitation of instant claims 70 and 72. Cong et al teach practice of the methods and use of compositions described herein will result in a reduction in the size or number of the cancerous growth and/or a reduction in associated symptoms (where applicable) (paragraph [0170]) which meets the limitations of claim 103. Cong et al teach that the cancer can be renal, lung, gastric, or ovarian cancer which meets the limitations of claim 105.
Cong et al teach that R2 can be unsubstituted C1-C10 alkyl or C2-C10 alkynyl (claim 1, page 47, second column).
Richter et al disclose the compound
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(page 57) which meets the illimitations of claim 40 wherein when Q is CH2, then R2 is C5-C10 alkyl and thus fulfills the limitation of claim 1 of Cong et al wherein R2. Richter et al teach that the RD295 compound exhibits an IC50 of 0.43nM against a HT-29 cell line (page 57). Richter et al disclose pharmaceutical composition comprising the inventive compounds of formula I (page 12, second paragraph).
Thus, it would be prima facie obvious to use longer alkyl or alkynyl chains of up to 10 carbons at the R2 position, rendering obvious an instant R2 of C5-C9 alkyl or C5-C9 alkynyl when Q was CH2. One of skill in the art would be motivated to do so because Cong et al teach that R2 can be unsubstituted C1-C10 alkyl or C2-C10 alkynyl and Richter et al teach that RD295 has an IC 50 of 0.43 nM against the HT-29 cell line. One of skill in the art would know that the HT-29 cell line is a colon cancer cell line .
Claims 40, 70, 72, 101, 103 and 105 are rejected.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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