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 .
Priority
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional Application 63/041148, filed on 06/19/2020.
This application claims the benefit of priority to Patent Application PCT/US2021/037784. Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application Number PCT/US2021/037784, filed on 06/17/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 12/08/2022 and 07/18/2024 has been considered by the Examiner.
Status of Claims
Claims 1-4, 7-10, 17-18, 20-21, 23, 29, 31, 35-36, 38, 48, 52 and 56 are under examination.
Claim 5-6, 11-16, 19, 22, 24-28, 30, 32-34, 37, 39-47, 49-51, and 53-55 are cancelled.
Claim Rejections - 35 USC § 102
Rejection to claims 1-3, 9, 17-18, 20-21, 23, and 29 under 35 U.S.C. 102(a)(1) as being anticipated by Douay et al. (WO 2011/101468 A1) have been withdrawn in view of the applicant’s amendments filed 11/05/2025.
Rejection to claims 1-4, 7, 10, 17-18, 21, 29, 31, 35-36, 38, 48, and 52 under 35 U.S.C. 102(a)(2) as being anticipated by Turner et al. (US 2014/0255369 Al) as evidenced by Healio (Defining and recognizing different types of anemia common to the oncology practice, 2011) have been withdrawn in view of the applicant’s amendments filed 11/05/2025.
Claim Rejections - 35 USC § 103
Rejection to claim 8 under 35 U.S.C. 103 as being unpatentable over Douay et al. (WO 2011/101468 A1) as applied to claim 1 above and further evidenced by Conway et al. (Experimental Hematology, 2020) has been withdrawn in view of the applicant’s amendments filed 11/05/2025.
Rejection to claim 8 under 35 U.S.C. 103 as being unpatentable over Turner et al. (US 2014/0255369 Al) as evidenced by Healio (Defining and recognizing different types of anemia common to the oncology practice, 2011) as applied to claim 1 above and further evidenced by Conway et al. (Experimental Hematology, 2020) has been withdrawn in view of the applicant’s amendments filed 11/05/2025.
New rejections necessitated by applicant’s amendments filed 11/05/2025:
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 1-3, 9, 17-18, 20-21, 23, 29 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Douay et al. (WO 2011/101468 A1) in view of Liao et al (J Cent South University (Med, 2016).
Regarding claim 1, Douay et al. teach a medium for inducing red blood cells which includes insulin, heparin (page 7, lines 14-15), and iron saturated transferrin (holo-transferrin) (page 7, lines 5-6). Douay et al. teach the composition comprises plasma or serum and the serum of which is human serum (page 17, lines 26-27).
Douay et al. do not teach the composition contains AB plasma.
Liao et al. teach introduction of AB plasma for inducing red blood cells (page 1246, Results).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combine the teachings of Douay et al. for a medium for inducing red blood cells with the teachings of Liao et al. for introduction of AB plasma to induce red blood cells. Liao et al. provide motivation teaching the enucleation rate in the experimental group was higher than that in the control group. Liao et al. further provide motivation by teaching that AB serum can successfully differentiate CD34+ cells into enucleated red blood cells. One of skill in the art would have had a reasonable expectation of success at combining Douay et al. and Liao et al. because both teach compositions for inducing a red blood cells which include human plasma.
Regarding claims 2 and 3, Douay et al. teach the induction medium comprises growth factors IL-3, SCF, and EPO (page 17, lines 26-30).
Regarding claim 9, Douay et al. teach the composition comprises plasma or serum and the serum of which is human serum not bovine serum (page 17, lines 26-27).
Regarding claim 17, Douay et al. teach a method of inducing a red blood cell by contacting the cell with the induction medium contacting a stem cell for 25 days to induce RBC generation (pages 17&18, lines 26-33 & 1-6).
Regarding claim 18, Douay et al. teach the culture conditions induced generation of a maximum number of mature enucleated RBC (page 20, lines 15-17). Douay et al. teach the cultured RBCs generated strongly express both CD235a and CD71 (page 22, lines 10-11).
Regarding claim 20, Douay et al. teach a 25 day method of inducing a red blood cells (pages 17&18, lines 26-33 & 1-6), which is at least 18 days.
Regarding claim 21, Douay et al. teach the stem cell induced is an induced pluripotent stem cell (iPSC) or human hematopoietic stem cells (page 2, lines 5-10).
Regarding claim 23, Douay et al. teach culture of the hESCs on low attachment plates, which is Nunc’s version of ultra-low attachment plates preventing cell attachment to the plate.
Regarding claim 29, Douay et al. teach an RBC produced by the method of claim 17 above (pages 17&18, lines 26-33 & 1-6).
Regarding claim 52, Douay et al. teach the composition of claim 1 to induce differentiation and the method/instructions for inducing a red blood cell using the composition (page 20, lines 15-17), which could be a kit.
Claims 1-4, 7, 10, 17-18, 21, 29, 31, 35-36, 38, 48, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Turner et al. (US 2014/0255369 Al) in view of Liao et al (J Cent South University (Med, 2016) and as evidenced by Healio (Defining and recognizing different types of anemia common to the oncology practice, 2011).
Regarding claim 1, Turner et al. teach a culturing medium for inducing red blood cells which includes the antibiotics penicillin and streptomycin (page 30, paragraph 0311).
Turner et al. do not teach the composition includes human AB plasma.
Liao et al. teach introduction of AB plasma for inducing red blood cells (page 1246, Results).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Turner et al. for a culturing medium for inducing red blood cells which includes antibiotics penicillin and streptomycin with the teachings of Liao et al. for introduction of AB plasma to induce red blood cells. Liao et al. provide motivation by teaching that the enucleation rate in the experimental group was higher than that in the control group. Liao et al. provide motivation by teaching that AB serum can successfully differentiate CD34+ cells into enucleated red blood cells. One of skill in the art would have had a reasonable expectation of success at combining Turner et al. and Liao et al. because both teach compositions for inducing a red blood cell.
Regarding claims 2 and 3, Turner et al. teach the induction medium comprises growth factors IL-3, SCF, a corticosteroid dexamethasone and EPO (page 35, paragraph 0366).
Regarding claim 4, Turner et al. teach the corticosteroid is dexamethasone (page 35, paragraph 0366).
Regarding claim 7, Turner et al. teach a culturing medium for inducing red blood cells includes the antibiotics penicillin and streptomycin (page 30, paragraph 0311).
Regarding claim 10, Turner et al. teach a pharmaceutical composition comprised of induced red blood cells and further includes pharmaceutically acceptable excipients (page 43, claim 80).
Regarding claim 17, Turner et al. teach a method of inducing a red blood cell by contacting the cell with the induction medium contacting a stem cell for a time period in order to induce RBC generation (page 30, paragraph 0315).
Regarding claim 18, Turner et al. teach the culture conditions allowed to obtain mature enucleated RBC (page 30, paragraph 0304).
Regarding claim 21, Turner et al. teach the stem cell induced is an induced pluripotent stem cell (iPSC) or human hematopoietic stem cells (page 6, paragraph 0045).
Regarding claim 29, Turner et al. teach an RBC produced by the method of claim 17 above (page 43, claim 78).
Regarding claim 31, Turner et al teach an in vitro differentiated RBC and a pharmaceutical composition comprising the in vitro differentiated mature red blood cells (page 43, claim 80).
Regarding claim 35, Turner et al. teach HSCs isolated from any source may be used to produce, without limitation, universal donor red blood cells, red blood cells of a rare blood type, red blood cells for personalized medicine like an autologous transfusion (page 6, paragraph 0045). Turner et al. teach a method of treatment, prevention, or diagnosis of a disease or disorder characterized by a deficiency of anucleated red blood cells comprising: providing to a subject in need thereof the population of in vitro differentiated mature red blood cells (page 43, claim 80).
Regarding claim 36, Turner et al. teach the subject in need of a transfusion refers to a subject that has an amount of red blood cells that is from about 10 times to about 1,000 times lower than the amount of red blood cells in a subject having a normal amount of red blood cells (page 24, paragraph 0257). Turner et al. teach the deficiency of red blood cell could be caused by various disorders including various types of anemia, Gaucher's disease, hemolysis, neutropenia, thrombocytopenia, granulocytopenia, hemophilia, Hodgkin's lymphoma, Non-Hodgkin's lymphoma, B cell chronic lymphoma, Burkitt' s lymphoma, Follicular-like lymphoma, diffused large B-cell lymphoma, multiple myeloma, acute myeloid leukemia, pre-B acute lymphocytic leukemia, pre-T acute lymphocytic leukemia, acute promyelocytic leukemia, refractory leukemia, or combinations thereof (pages 24 & 25, paragraph 0258).
Regarding claim 38, Turner et al. teach the method of claim 35 and further teach the patient in need of treatment has a type of anemia (pages 24 & 25, paragraph 0258). Anemia is classified and diagnosed by the level of hemoglobin, low Hb level may be the first indication of anemia as evidenced by Healio (page 2, Hemoglobin). Grade 1 mild anemia is classified by 10 g/dL, grade 2 moderate anemia is Hb from 8 to less than 10 g/dL, and grade 3 severe anemia is below 8 g/dL as evidenced by Healio (page 2, Hemoglobin). Therefore, the patients treated would have hemoglobin of 10 g/dL or lower.
Regarding claim 48, Turner et al. teach HSCs isolated from any source may be used to produce, without limitation, universal donor red blood cells, red blood cells of a rare blood type, red blood cells for personalized medicine like an autologous transfusion (page 6, paragraph 0045). Turner et al. teach a method of treatment, prevention, or diagnosis of a disease or disorder characterized by a deficiency of anucleated red blood cells comprising: providing to a subject in need thereof the population of in vitro differentiated mature red blood cells (page 43, claim 80). Turner et al. teach the subject in need of a transfusion refers to a subject that has an amount of red blood cells that is from about 10 times to about 1,000 times lower than the amount of red blood cells in a subject having a normal amount of red blood cells (page 24, paragraph 0257). Turner et al. teach the deficiency of red blood cell could be caused by various disorders including various types of anemia, Gaucher's disease, hemolysis, neutropenia, thrombocytopenia, granulocytopenia, hemophilia, Hodgkin's lymphoma, Non-Hodgkin's lymphoma, B cell chronic lymphoma, Burkitt' s lymphoma, Follicular-like lymphoma, diffused large B-cell lymphoma, multiple myeloma, acute myeloid leukemia, pre-B acute lymphocytic leukemia, pre-T acute lymphocytic leukemia, acute promyelocytic leukemia, refractory leukemia, or combinations thereof (pages 24 & 25, paragraph 0258).
Regarding claim 52, Turner et al. and Liao et al. teach the composition of claim 1 to induce differentiation (page 30, paragraph 0311) and the method/instructions for inducing a red blood cell using the composition (page 30, paragraph 0304), which are the components of a kit.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 11/05/2025, with respect to claim 8 have been fully considered and are persuasive. The rejection of claim 8 has been withdrawn.
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.
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
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