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 .
DETAILED ACTION
Status of the Claims
Claims 1-11 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on November 10th 2025 and January 26th 2024 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
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)(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.
Claims 1, 3-5, and 7-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Quisel (WO 2021/062163 A1 effectively filed on September 27th 2019).
Claims 1, 3, and 4 are directed towards the treatment of iron deficiency anemia in a subject with myelofibrosis via administration of pelabresib. Quisel teaches the treatment of myelofibrosis and iron deficiency anemia via administration of CPI-0610 (also known as pelabresib) (Quisel, claims 1-2, claim 77), anticipating claims 1, 3, and 4.
Claim 5 is directed towards a method of increasing reticulocytes in a subject in need thereof via administration of pelabresib. Quisel teaches treatment of a subject with low reticulocyte count (Quisel, claim 49), anticipating claim 5.
Claim 7 requires that, in the method of claim 5 the subject has anemia. Quisel teaches treatment of a patient population with anemia (Quisel, claim 1), anticipating claim 7.
Claim 8 requires that, in the method of claim 5, the subject has myelofibrosis. Quisel teaches treatment of a patient population with myelofibrosis (Quisel, claim 1), anticipating claim 8.
Claims 9-10 require that, in the method of claim 1, the subject is also administered the JAK inhibitor, ruxolitinib. Quisel teaches administration of pelabresib (CPI-0610) alongside JAK-STAT antagonists (Quisel, paragraph [000196]), and teaches ruxolitinib as the JAK-STAT antagonist (Quisel, claim 89; Quisel, paragraphs [00033]-[00034]).
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.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Quisel (WO 2021/062163 A1 effectively filed on September 27th 2019).
Claim 2 further limits the method of claim 1 to a subject wherein the low reticulocyte count is less than about 0.5% of total erythrocytes in a subject. In other terms, wherein the reticulocytes (red blood cells newly produced by the bone marrow) are under 0.5% of the total red blood cell count. While Quisel does not explicitly quantify the reticulocyte count, Quisel does define a patient population wherein the anemia in myelofibrosis is caused by ineffective erythropoiesis due to bone marrow suppression (Quisel, paragraph [000168]). That is, Quisel defines a patient population wherein the bone marrow is not sufficiently producing new red blood cells (i.e. reticulocytes). As Quisel treats such a patient population with a low reticulocyte count (Quisel, paragraph [000168]; Quisel, claim 49), one of ordinary skill in the art would have a reasonable expectation of success in treating a patient population wherein the reticulocyte count is below the claimed 0.5% threshold. Claim 2 is thereby prima facie obvious.
Claim 6 similarly limits the method of claim 5 to wherein the subject has a reticulocyte count of less than about 0.5% of total erythrocytes. Claim 6 is prima facie obvious for the same reasons as claim 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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