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 49-71, of record 10/15/2024, are pending and subject to prosecution.
Priority
The instant application is a CON of application 16/957918 (US patent 12060576, filed 6/25/2020), which is a national stage entry of PCT/US2019/012437 (filed 1/5/2019), which claims benefit to provisional application 62/614117 (filed 1/5/2018).
Drawings
The drawings are objected to because a petition for the acceptance of color photographs and color drawings has not been granted. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The use of the terms Essential 8, StemFlex, NutriStem, Matrigel, CryoStor, TrypLE, and DASbox, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 55, 63, 65, and 71 are objected to because of the following informalities:
In claims 55, 63, 65, and 71, parentheticals should not be used for abbreviations already written out in a preceding claim.
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 71 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bertolini et al. (Blood, 1997).
Regarding claim 71: Bertolini et al. teach the ex vivo generation of autologous megakaryocyte progenitors from CD34+ cells (See Abstract). The megakaryocyte progenitors were administered along with expanded CD34+ cells to patients with breast cancer or non-Hodgkin’s lymphoma, and prompt platelet recovery was observed (See Abstract and page 2683, col. 2, full ¶1). All members of the control group required platelet transfusion support, whereas two patients receiving megakaryocyte progenitors did not (which reads on “an effective amount to treat or ameliorate a condition in the subject to a patient not treated with the composition comprising the preMKs”) (See Abstract and page 2683, col. 2, full ¶1). The study taught by Bertolini et al. therefore anticipates the claimed method.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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. The 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.
Claims 49-70 are rejected under 35 U.S.C. 103 as being unpatentable over Vodyanyk et al. (WO 2017070337 A1), of record in IDS dated 10/16/2024, evidenced by Wang et al. (Genetics and Molecular Research, 2011), in view of Feng et al. (WO 2014100779 A1) (“Feng et al. (‘779)”), of record in IDS dated 10/16/2024, and Feng et al. (Stem Cell Reports, 2014) (“Feng et al. (2014)”), of record in IDS dated 10/16/2024.
Regarding claims 49-52, 58-64, and 67: Vodyanyk et al. teach the directed differentiation of pluripotent stem cells, such as human iPSCs, to hematopoietic precursor cells, which can be megakaryocyte progenitors (See ¶0063 and 0086). In Example 3, Vodyanyk et al. teach the formation of iPSC aggregates or embryoid bodies through suspension culture in ultra-low attachment flasks under continuous agitation on a rocker platform (which reads on “culturing pluripotent stem cells under continuous agitation such that the pluripotent stem cells form self-aggregating spheroids”) and that all subsequent culture steps are performed under continuous agitation (See ¶00183-00184). Vodyanyk et al. teach that 0.5-1 × 106 iPSCs/ml are used for making aggregates, indicating that the cells are dissociated for counting prior to addition to flasks (See ¶00183). The cell aggregates are transferred to a medium comprising BMP4, FGF2 (which reads on “bFGF”), and VEGF (which reads on “differentiating the self-aggregating pluripotent cell spheroids in a first culture medium”) (See ¶00184). The cells are further differentiated and expanded to hematopoietic progenitors, which can be megakaryocyte progenitors, in a medium comprising SCF, TPO, FLT3L, IL-3, and heparin (which reads on “differentiating the… cell spheroids in a second culture medium to produce megakaryocytic progenitors”) (See ¶0063 and 00184-00185). Vodyanyk et al. do not expressly teach the generation of iPSCs into hemogenic endothelial cells prior to the generation of megakaryocyte progenitors or the maintenance of hemogenic endothelial cell spheroids for subsequent megakaryocyte progenitor release.
Feng et al. (‘779) teach the differentiation of iPSCs to hemogenic endothelial cells in medium comprising BMP4, bFGF, and VEGF, followed by differentiation of the hemogenic endothelial cells to megakaryocyte progenitor cells in a medium comprising SCF, TPO, FLT3L, IL-3, and heparin (See ¶94). Approximately 96% and 89% (which reads on “greater than 50%”) of the resulting megakaryocyte progenitors expressed CD43 and CD41, respectively, and 4.4% (which reads on “less than 10%”) expressed CD14 (See ¶398 and table 1).
Feng et al. (2014) teach the scalable differentiation of platelets from iPSCs (See Abstract). Human iPSCs were directly differentiated into hemogenic endothelial-like cells, which produced megakaryocyte progenitors (See page 818, col. 1, full ¶2 and col. 2, ¶1). Floating megakaryocyte progenitors were collected from the cultures each day for up to 5 days following the addition of expansion medium (which reads on “release the preMKs into suspension while maintaining the hemogenic cell… for subsequent production and release of the preMKs”) (See page 818, col. 2, ¶1-2 and fig. 1A).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Vodyanyk et al. to comprise collection of megakaryocyte precursors as they are released over consecutive days, such as is taught by Feng et al. (2014). One would be motivated to make this modification for determining surface marker characterization over time, as shown by Feng et al. (2014) (See page 818, col. 2, full ¶1), and such a modification could be readily made. Additionally, the teachings of Feng et al. (‘779) suggest that the hematopoietic cellular intermediates of Vodyanyk et al., since they are similarly formed from iPSCs in medium comprising BMP, FGF2, and VEGF, are in fact hemogenic endothelial cells, which are then further differentiated to megakaryocyte progenitors. As the megakaryocyte progenitors of Vodyanyk et al. and Feng et al. (‘779) are generated in media comprising SCF, TPO, FLT3L, IL-3, and heparin, similar expression patterns of CD41, CD43, and CD14 would also be expected.
Regarding claims 53-56 and 65: Following the discussion of claims 49-52, 58-64, and 67, Vodyanyk et al. teach a method for the production of megakaryocyte progenitors from iPSCs but do not teach further differentiation to megakaryocytes.
Feng et al. (‘779) teach the differentiation of iPSCs to hemogenic endothelial cells to megakaryocyte progenitor cells (See ¶94). The megakaryocyte progenitors can be further differentiated to megakaryocytes by seeding onto a non-adherent surface in a medium comprising SCF, TPO, IL-6, IL-9, and heparin (which reads on “seeding the preMKs onto a non-adherent surface in a culture medium before differentiating the preMKs into megakaryocytes” and “differentiating the preMKs in a third culture medium into megakaryocytes”) (See ¶95 and 402-404). The resulting matured megakaryocytes express CD42a, CD42b, and CD61 (See ¶161 and 398 and table 1). Feng et al. (‘779) teach that megakaryocyte progenitors can be cultured for platelet production under shear force conditions with deliberate and constant movement of the culture medium (which reads on “under continuous agitation”) (See ¶190).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Vodyanyk et al., modified by Feng et al. (‘779) and Feng et al. (2014), to further comprise a megakaryocyte differentiation step, such as is taught by Feng et al. (‘779). One would be motivated to make this modification because Feng et al. (‘779) teach that the megakaryocytes can be used to generate platelets for clinical applications (See ¶7-9). There would be a reasonable expectation of success because the megakaryocyte progenitors of Vodyanyk et al. could be readily differentiated by the culture methods of Feng et al. (‘779).
Regarding claims 57 and 66: Following the discussion of claims 49-56, 58-65, and 67, Vodyanyk et al. teach that the cells can be assessed for gene expression by RT-PCR (See ¶00167). PCR inherently requires a lysis step for nucleic acid extraction from cells (“which reads on “preparing lysates”) (See Wang et al., page 520, ¶1-2 and page 521, ¶1). Vodyanyk et al. do not expressly teach application of RT-PCR to megakaryocytes, however one of ordinary skill in the art would find it obvious to apply such a step to the megakaryocytes resulting from the combined methods of Vodyanyk et al., Feng et al. (‘779), and Feng et al. (2014), as Vodyanyk et al. teach that it enables phenotypic assessment (See ¶00167).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP 2159. See MPEP 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 49-55 and 62-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12060576. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 49: Patented claim 1 recites a method for megakaryocyte production comprising: culturing dissociated pluripotent stem cells in a matrix-independent culture and under continuous agitation such that the pluripotent stem cells form self-aggregating pluripotent cell spheroids; differentiating, under continuous agitation, the self-aggregating pluripotent cell spheroids in a first culture medium into hemogenic endothelial cell spheroids; and differentiating, under continuous agitation, the hemogenic endothelial cell spheroids in a second culture medium to produce megakaryocytic progenitors, causing the hemogenic endothelial cell spheroids to release the megakaryocytic progenitors into suspension while maintaining the hemogenic endothelial cell spheroids for subsequent production and release of the megakaryocytic progenitors. The patented claim anticipates the instant claim.
Regarding claim 50: Following the discussion of claim 49, patented claim 2 recites the method of patented claim 1 wherein the first culture medium comprises one or more of Bone morphogenic protein 4 (BMP4), Basic fibroblast growth factor (bFGF), and Vascular endothelial growth factor (VEGF). The patented claim anticipates the instant claim.
Regarding claim 51: Following the discussion of claim 49, patented claim 3 recites the method of patented claim 1 wherein the second culture medium comprises one or more of Stem cell factor (SCF), Thrombopoietin (TPO), Fms-related tyrosine kinase 3 ligand (Flt3-L), Interleukin-3 (IL-3), Interleukin-6 (IL-6) and Heparin. The patented claim anticipates the instant claim.
Regarding claim 52: Following the discussion of claim 49, patented claim 4 recites the method of patented claim 1 wherein the pluripotent stem cells are human induced pluripotent stem cells. The patented claim anticipates the instant claim.
Regarding claim 53: Following the discussion of claim 49, patented claim 5 recites the method of patented claim 1 further comprising the step of seeding the megakaryocytic progenitors onto a non-adherent surface in a culture medium before differentiating the megakaryocytic progenitors into megakaryocytes. The patented claim anticipates the instant claim.
Regarding claim 54: Following the discussion of claim 49, patented claim 6 recites the method of patented claim 1 further comprising the step of differentiating the megakaryocytic progenitors in a third culture medium into megakaryocytes. The patented claim anticipates the instant claim.
Regarding claim 55: Following the discussion of claim 49, patented claim 7 recites the method of patented claim 6 wherein the third culture medium comprises one or more of Stem cell factor (SCF), Thrombopoietin (TPO), Interleukin-6 (IL-6), Interleukin-9 (IL-9) and Heparin. The patented claim anticipates the instant claim.
Regarding claim 62: Patented claim 8 recites a method for megakaryocyte production comprising: differentiating, in a matrix-independent culture, pluripotent stem cells in a first culture medium into hemogenic endothelial cells; and differentiating the hemogenic endothelial cells in a second culture medium into megakaryocytic progenitors, wherein each of the differentiating the pluripotent stem cells and the differentiating the hemogenic endothelial cells is carried out under continuous agitation to enable the pluripotent stem cells to self-aggregate and differentiate into hemogenic endothelial cell spheroids and the hemogenic endothelial cells in the hemogenic endothelial cell spheroids to differentiate into megakaryocyte progenitors, causing the hemogenic endothelial cell spheroids to release the megakaryocytic progenitors into suspension while maintaining the hemogenic endothelial cell spheroids for subsequent production and release of additional megakaryocytic progenitors. The patented claim anticipates the instant claim.
Regarding claim 63: Following the discussion of claim 62, patented claim 9 recites the method of patented claim 8 wherein the first culture medium comprises one or more of Bone morphogenic protein 4 (BMP4), Basic fibroblast growth factor (bFGF), and Vascular endothelial growth factor (VEGF) and the second culture medium comprises one or more of Stem cell factor (SCF), Thrombopoietin (TPO), Fms-related tyrosine kinase 3 ligand (Flt3-L), Interleukin-e (IL-3), Interleukin-6 (IL-6) and Heparin. The patented claim anticipates the instant claim.
Regarding claim 64: Following the discussion of claim 62, patented claim 10 recites the method of patented claim 8 wherein the pluripotent stem cells are human induced pluripotent stem cells. The patented claim anticipates the instant claim.
Regarding claim 65: Following the discussion of claim 62, patented claim 11 recites the method of patented claim 8 further comprising the step of differentiating the megakaryocytic progenitors in a third culture medium into megakaryocytes, the third culture medium comprising one or more of Stem cell factor (SCF), Thrombopoietin (TPO), Interleukin-6 (IL-6), Interleukin-9 (IL-9) and Heparin. The patented claim anticipates the instant claim.
Claims 49, 52, 54, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 6-11 of U.S. Patent No. 12403161. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 49-52, 54-55, and 57-58: Patented claim 1 recites a method for differentiating induced pluripotent stem cells (iPSC) to prepare a composition, the method comprising: expanding induced pluripotent cells in a matrix independent culture using single cell passaging; dissociating the expanded pluripotent cells into a single cell suspension; differentiating the dissociated pluripotent cells in a first culture medium into hemogenic endothelial cells; differentiating the hemogenic endothelial cells in a second culture medium into megakaryocytic progenitors; differentiating the megakaryocytic progenitors in a third culture medium into megakaryocytes; and lysing the megakaryocytes so as to obtain a lysate composition comprising one or more of Interleukin 1-beta, Interleukin 16, Interleukin 12P40, TNF-beta, BCA-1, IP-30, Fractalkine, GCkine, MCP-4, MIP-1alpha, MIP-1beta, SDF-1alpha, SDF-1beta, or a combination thereof. Patented claim 8 recites the method of patented claim 1, wherein one or more of the dissociated pluripotent cells, the hemogenic endothelial cells or the megakaryocytic progenitors are differentiated under continuous agitation in a matrix independent culture. Patented claim 9 recites the method of patented claim 1, wherein the dissociated pluripotent cells are cultured so as to form self-aggregating pluripotent cell spheroids in a matrix independent culture. Patented claim 10 recites the method of patented claim 9, wherein the self-aggregating pluripotent cell spheroids are differentiated so as to form hemogenic endothelial cell spheroids. Patented claim 11 recites the method of patented claim 10, wherein the hemogenic endothelial cell spheroids are differentiated so as to produce the megakaryocytic progenitors, causing the hemogenic endothelial cell spheroids to release the megakaryocytic progenitors into suspension while maintaining the hemogenic endothelial cell spheroids for subsequent production and release of the megakaryocytic progenitors. The combined limitations of the patented claims render obvious the instant claims.
Regarding claim 50: Following the discussion of claims 49, 52, 54 and 57-58, patented claim 3 recites the method of patented claim 1, wherein the first culture medium comprises one or more of Bone morphogenic protein 4 (BMP4), Basic fibroblast growth factor (bFGF), and Vascular endothelial growth factor (VEGF). The combined limitations of the patented claims render obvious the instant claim.
Regarding claim 51: Following the discussion of claims 49, 52, 54 and 57-58, patented claim 6 recites method of patented claim 1, wherein the second culture medium comprises one or more of Stem cell factor (SCF), Thrombopoietin (TPO), Fms-related tyrosine kinase 3 ligand (Flt3-L), Interleukin-3 (IL-3), Interleukin-6 (IL-6) and Heparin. The combined limitations of the patented claims render obvious the instant claim.
Regarding claim 55: Following the discussion of claims 49, 52, 54 and 57-58, patented claim 7 recites the method of patented claim 1, wherein the third culture medium comprises one or more of Stem cell factor (SCF), Thrombopoietin (TPO), Interleukin-6 (IL-6), Interleukin-9 (IL-9) and Heparin. The combined limitations of the patented claims render obvious the instant claim.
Claims 49-51, 54-55, 57, 62-63, and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63, 65-66, and 69-76 of co-pending Application No. 19271628 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 49, 57, 62, and 66: Co-pending claim 63 recites a method for preparing a lysate composition, the method comprising: differentiating induced pluripotent stem cells (iPSCs) into megakaryocytes; and lysing the megakaryocytes so as to obtain the lysate composition comprising one or more of Interleukin 1-beta, Interleukin 16, Interleukin 12P40, TNF-beta, BCA-1, IP-10, Fractalkine, GCkine, MCP-4, MIP-1alpha, MIP-1beta, SDF-1alpha, SDF-1beta, or a combination thereof. Co-pending claim 65 recites the method of claim co-pending 63, wherein the step of differentiating the iPSCs into megakaryocytes comprises: expanding induced pluripotent cells in a matrix independent culture using single cell passaging; and dissociating the expanded pluripotent cells into a single cell suspension; and differentiating the dissociated pluripotent cells in a first culture medium into hemogenic endothelial cells. Co-pending claim 69 recites the method of co-pending claim 65, wherein the step of differentiating the iPSCs into megakaryocytes comprises differentiating the hemogenic endothelial cells in a second culture medium into megakaryocytic progenitors. Co-pending claim 73 recites the method of co-pending claim 69, wherein one or more of the dissociated pluripotent cells, the hemogenic endothelial cells or the megakaryocytic progenitors are differentiated under continuous agitation in a matrix independent culture. Co-pending claim 74 recites the method of co-pending claim 65, wherein the dissociated pluripotent cells are cultured so as to form self-aggregating pluripotent cell spheroids in a matrix independent culture. Co-pending claim 75 recites the method of co-pending claim 74, wherein the self-aggregating pluripotent cell spheroids are differentiated so as to form hemogenic endothelial cell spheroids. Co-pending claim 76 recites the method of co-pending claim 75, wherein the hemogenic endothelial cell spheroids are differentiated so as to produce megakaryocytic progenitors, causing the hemogenic endothelial cell spheroids to release the megakaryocytic progenitors into suspension while maintaining the hemogenic endothelial cell spheroids for subsequent production and release of the megakaryocytic progenitors. The combined limitations of the co-pending claims render obvious the instant claims.
Regarding claims 50-51 and 63: Following the discussion of claims 49, 57, 62, and 66, co-pending claim 66 recites the method of co-pending claim 65, wherein the first culture medium comprises one or more of Bone morphogenic protein 4 (BMP4), Basic fibroblast growth factor (bFGF), and Vascular endothelial growth factor (VEGF). Co-pending claim 70 recites the method of claim 69, wherein the second culture medium comprises one or more of Stem cell factor (SCF), Thrombopoietin (TPO), Fms-related tyrosine kinase 3 ligand (Flt3-L), Interleukin-3 (IL-3), Interleukin-6 (IL-6) and Heparin. The combined limitations of the co-pending claims render obvious the instant claims.
Regarding claim 54: Following the discussion of claims 49, 57, 62, and 66, co-pending claim 71 recites the method of co-pending claim 69, wherein the step of differentiating the iPSCs into megakaryocytes comprises differentiating the megakaryocytic progenitors in a third culture medium into megakaryocytes. The combined limitations of the co-pending claims render obvious the instant claim.
Regarding claim 55: Following the discussion of claims 49, 57, 62, and 66, co-pending claim 72 recites the method of co-pending claim 71, wherein the third culture medium comprises one or more of Stem cell factor (SCF), Thrombopoietin (TPO), Interleukin-6 (IL-6), Interleukin-9 (IL-9) and Heparin. The combined limitations of the co-pending claims render obvious the instant claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JENNIFER S SPENCE/Examiner, Art Unit 1633
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