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 .
Claims 57-80 are pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/9/2024 and 7/15/2024 has been considered by the examiner.
Claim Objections
Claims 57 is objected to because of the following informalities: it is suggested to spell out the full term Myelodysplastic syndromes when first mentioned in a claim (claim 57). Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 57, 58, 60-66, 68-72 is/are rejected under 35 U.S.C. 102(a1)(a2)as being anticipated by Bussolari (US20200171072, IDS).
Claim 57 recites a single step of “administering a telomerase inhibitor,” the wherein clause “wherein the subject received a first administration of the telomerase inhibitor and after the first administration of the telomerase inhibitor, 25% or more reduction in the variant allele frequence (VAF) was observed for one or more of the following genes: SF3B1, TET2, DNMT3A, CUX1 and ASXL1” is the intended result of the step that is positively recited, which does not require any additional step to be performed.
Claim 65 recites a method of treating MDS in a subject comprising first administering to the subject a telomerase inhibitor and continuing administering to the subject the telomerase inhibitor if, after the first administering of the telomerase inhibitor to the subject, 25% or more reduction in the variant allele frequency was observed for SF3B1, TET2, DNMT3A and ASXL1. Since the continuing administration is only performed if there is 25% reduction of the VAF, it is thus an optional step. The claim may be interpreted as comprise a single step of administering a telomerase inhibitor to a MDS patient.
Bussolari teaches a method of treating MDS comprising administering an effective telomerase inhibitor (paragraph [0013]). The teaching from Bussolari anticipates claims 57 and 65.
Regarding claims 58 and 66, the wherein clause “wherein 25% or more reduction in the variant allele frequence (VAF) was observed for one or more of the following genes: SF3B1, TET2, DNMT3A and ASXL1” is the intended result of the step that is positively recited, which does not require any additional step to be performed. Therefore, the teaching from Bussolari anticipates claims 58 and 66.
Regarding claims 60-62, 68-70, Bussolari teaches that the patient is transfusion dependent, relapsed or refractory to ESA and lenalidomide or HMA naive (page 18, paragraph [0183]-[0186]).
Regarding claims 63, 64, 71 and 72, the telomerase inhibitor is imetelstat sodium (paragraph [0105]).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 59, 67, 73-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bussolari.
Claim 73 is drawn to a method of treating a subject with MDS, comprising: assessing VAF for one or more genes selected from group consisting of SF3B1, TET2, DNMT3A, CUX2 and ASXL1 in a biological sample with MDS after a first administration of a telomerase inhibitor; and comparing the VAF to a baseline VAF for one or more genes prior to administration of the telomerase inhibitor; and identifying the subject having an increased likelihood of benefitting from treatment with the telomerase inhibitor if a 25% or more reduction in the VAF is observed for one or more genes; and continuing administering the telomerase inhibitor to the subject identified as having an increased likelihood of benefiting from the treatment with the telomerase inhibitor.
Claims 59, 67 and 75 are drawn to a method of treating MDS following first administration of a telomerase inhibitor and altering the dosage, frequency of dosing or course of therapy based on the observed VAF.
The teaching from Bussolari has been discussed above. Bussolari further teaches following administering imetelstat, various biomarkers were monitored and evaluated pre- and post-treatment (paragraph [0163]). Bussolari teaches there is a change in mutation variant frequency/variant allele frequency at a third data snap shot of SF3B1 and DNMT3A, wherein a reduction of SF3B1 mutation correlates with the longest transfusion independent (TI) duration, and DNMT3A reduction correlates reduction in bone marrow ringed sideroblasts (paragraph [0172]). Bussolari teaches at fourth data snap shot, a decrease of VAF of SF3B1 in 2/6 patient result in the longest TI duration on study (paragraph [0173] and [0207], and Table 20).
The only difference between the claimed invention of claim 73 and the teaching from Bussolari is that Bussolari does not specially teach continuing administering the telomerase inhibitor to the subject identified by assessing the VAF of one or more SF3B1, TET2, DNMT3A, CUX2 and ASXL1.
It would have been obvious to an ordinary skilled in the art reading Bussolari would recognize that reduction of the VAF following imetelstat sodium treatment of at least two mutation biomarker SF3B1 and DNMT3A would improve MDS by either a longer duration of TI or substantial reduction in bone marrow ringed sideroblasts. The ordinary skilled in the art would thus be motivated to continue to treat said patients that showed significant improvement with imetelstat sodium because such treatment improves MDS condition. Varying dosage, frequency and course of therapy would have been routine optimization and within the capability of an ordinary skilled in the art. Therefore, the claimed invention of claims 59, 67, 73-75 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claims 76-78, Bussolari teaches that the patient is transfusion dependent, relapsed or refractory to ESA and lenalidomide or HMA naive (page 18, paragraph [0183]-[0186]).
Regarding claims 79 and 80, the telomerase inhibitor is imetelstat sodium (paragraph [0105]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637
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