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.
Information Disclosure Statement
The Information Disclosure Statement filed on June 25th 2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 102 & 103 Rejections Overcome by Amendment
Applicant’s amendments in the response filed on June 25th 2026 are acknowledged. Applicant has amended claim 1 to define a dosage of pelabresib at 50-300 mg/day. As Quisel does not teach a particular dosage of pelabresib, applicant has overcome all 102 rejections, and the rejections are thereby withdrawn. As the 103 rejections were dependent on the 102 rejections, they are withdrawn for the same reasons.
35 U.S.C. § 103 Rejections Necessitated by Amendment
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Quisel (WO 2021/062163 A1 effectively filed on September 27th 2019) in view of Mascarenhas (Mascarenhas et al., MANIFEST, a Phase 2 Study of CPI-0610, a Bromodomain and Extraterminal Domain Inhibitor (BETi), As Monotherapy or “Add-on” to Ruxolitinib, in Patients with Refractory or Intolerant Advanced Myelofibrosis, Blood, Volume 134, Supplement 1, 2019, Page 670)
Applicant’s arguments in the response filed on June 25th 2026 are acknowledged. Applicant argues that Quisel is not applicable as art, because Quisel does not suggest that pelabresib alone would be useful in the treatment of anemias, but only in combination with hepcidin antagonists. Applicant’s argument is found not persuasive.
Applicant’s method of claim 1 is directed towards a method of treatment comprising administration of pelabresib. Thus, applicant’s method necessarily encompasses combination treatments such as the treatment presented in Quisel.
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).
Quisel does not explicitly teach a particular dosage of pelabresib. However, one of ordinary skill in the art would have had a reasonable expectation of success in choosing a pelabresib dose already known in the art. For example, see Mascarenhas, who teaches administration of 125 mg/day pelabresib alongside ruxolotinib (Mascarenhas, pg. 2). Applicant’s dosage range, and claims 1, 3, and 4 are thereby prima facie obvious.
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 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), and claim 5 is 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.
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), and claim 7 is prima facie obvious.
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), and claim 8 is prima facie obvious.
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]). Claims 9-10 are thereby prima facie obvious.
Conclusion
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.
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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