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 .
Applicant’s submission filed on July 13, 2026 has been entered and considered. Rejections and/or objections not reiterated from the previous action mailed January 13, 2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Applicant has amended claim 58 to include the limitations as recited in previously dependent claims 64 and 67 “…wherein the HPC of population thereof is derived from an inducible pluripotent stem cell (iPS) or a pluripotent stem cell; wherein the iPS is derived from a somatic fibroblast cell; and wherein the somatic fibroblast cell is reprogrammed to a iPS in vitro, ex vivo, or in vitro.”. Claims 64 and 67 have been canceled. Claims 65-66 and 68 have been amended for claim dependency. Claims 66 has been amended to properly define the acronym DBA. Claim 68 has been amended to correct matters of clarity by reciting “reprogrammed” and correcting typographical errors.
Claims 58-63, 65-66, and 68-70 are examined on the merits.
Election/Restrictions
Applicant’s election of Group I, claims 58-70, drawn to a method for inducing RBC differentiation via a nucleic acid encoding reprogramming factors HOXA9, ERG, RORA, SOX4, and MYB in the reply filed on September 24, 2025 is acknowledged. Applicant has not indicated traversal; therefore the election is being treated as without traverse.
Claims 71-77 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 24, 2025.
New Claim Objections
Claim 66 is objected to because of the following informalities: Claim 66 recites a mutation in the ribosomal protein “RSP19”. Applicant’s instant disclosure recites RPS19 mutations which is consistent with the nomenclature in the prior art. Therefore, Applicant’s recitation of “RSP19” in claim 66 appears to be a typographical error. Appropriate correction is required.
New Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 63 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 63, which depends from claim 58, recites “wherein the HPC or population thereof is derived from a inducible pluripotent stem cell (iPS) or a pluripotent stem cell and/or wherein the HPC or population thereof is isolated from a subject”. Claim 58, as amended, recites that the HPC or population thereof is derived from a inducible pluripotent stem cell (iPS) or a pluripotent stem cell wherein the iPS is derived from a somatic fibroblast…” Therefore, the limitations introduced by claim 63 are not considered to be further limiting nor does claim 63 include all the limitations of claim 58. As instantly claimed, claim 63 appears to broaden the scope of the HPC or population thereof. Appropriate correction is required. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained Claim Rejections - 35 USC § 102
Claims 58-70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doulatov et al. (2017). Drug discovery for Diamond-Blackfan anemia using reprogrammed hematopoietic progenitors. Sci. Trans. Med., 9(376), eaah5645, found in IDS dated 1/26/2024, hereafter “Doulatov 2017”).
With regard to claim 58, Doulatov 2017 discloses a transcription factor based method of expanding HPCs derived from iPSCs wherein HPCs were transduced with “5F” lentiviruses (i.e., CD34-5F cells), expanded for two weeks, and differentiated into RBCs (Pg. 2, right col., 1st full para. and Fig 1D). Doulatov 2017 discloses that the 5F lentiviral plasmids comprise HOXA9, ERG, RORA, SOX4 and MYB (Pg. 9, left col., Lentivirus and shRNA plasmids), which is considered to reasonably read on contacting HPCs with a nucleic acid encoding HOXA9, ERG, RORA, SOX4 and MYB for a sufficient time to induce a differentiated RBC.
With regard to claim 59, Doulatov 2017 discloses that HPCs were transduced with 5F lentiviruses and expanded for 2 weeks (Pg. 2, right col., 1st full para.).
With regard to claim 60, Doulatov 2017 discloses that HOXA9, ERG, RORA, SOX4 and MYB are expressed by a lentivirus (Pg. 9, left col., Lentivirus and shRNA plasmids).
With regard to claim 61, Doulatov 2017 discloses that CD34-5F cells exhibit erythroid progenitor maturation (Pg. 1, left col., 1st para.).
With regard to claim 62, Doulatov 2017 discloses that the HPCs transfected with 5F lentivirus (i.e., CD34-5F cells) (Pg. 2, right col., 1st full para.) are CD34+CD45+ (Pg. 9, left col., CD34-5F culture).
With regard to claim 63, Doulatov 2017 discloses that HPCs are derived from iPSCs (Abstract, Pg. 2, right col., 1st full para.).
With regard to claims 64-66, Doulatov 2017 discloses use of iPSCs derived from fibroblasts derived from a patient having an RPS19 mutation (Pg. 1, right col., last para.).
With regard to claim 67, Doulatov 2017 discloses wherein fibroblasts are differentiated to iPSCs in vitro (Pgs. 8-9, Patient samples and reprogramming).
With regard to claim 68, Doulatov 2017 discloses wherein iPSCs are differentiated to EBs in vitro (Pg. 9, Embryoid body differentiation) and wherein EBs are sorted into CD34+CD45+ progenitors, which is considered to reasonably read on HPCs, in vitro (Pg. 9, CD34-5F culture).
With regard to claims 69 and 70, Doulatov 2017 discloses that differentiated CD34-5F RBCs undergo engraftment and enucleation in vivo (Pg. 2, right col., 1st full para.).
Response to Declaration under 37 CFR 1.130(a)
The declaration under 37 CFR 1.130(a) filed by Dr. Sergei Doulatov on July 13, 2026 is insufficient to overcome the rejection of claims 58-70 based upon 35 U.S.C. 102 as being anticipated by Doulatov et al. (2017, Drug discovery for Diamond-Blackfan anemia using reprogrammed hematopoietic progenitors. Sci. Trans. Med., 9(376), eaah5645, found in IDS dated 1/26/2024, “Doulatov 2017”). Applicant has provided the declaration by Dr. Doulatov dated December 6, 2022 which was filed in the parent application 16/620,064. Dr. Doulatov declares that the prior art of Doulatov 2017 as cited against claims 1-4, 6-13, and 18-25 of the 16/620,064 is not available for use as prior art based on its exception under 35 U.S.C. 102(b)(1)(A) as being conceived by Dr. Doulatov and George Q. Daily and that all co-authors derived this information from Dr. Doulatov.
Applicant’s affidavit is acknowledged and has been fully considered but is not persuasive. Applicant’s affidavit from parent application 16/620,064 addresses art applied to claims 1-4, 6-13, and 18-25 of application ‘064 which are drawn to subject matter not described in the instant claims. Because the instant claims are drawn to different subject matter from parent application ‘064, the affidavit regarding subject matter derived from the inventor pertinent to application ‘064 is not considered pertinent to the subject matter of the instant claims.
New Claim Rejections - 35 USC § 103
This is a new rejection. However, this rejection is based on a similar interpretation as set forth in the non-final action dated January 13, 2026. The following new rejection provides additional interpretation of the claims which is necessitated by Applicant’s amendment in the response filed on July 13, 2026. Any aspect of Applicant’s traversal that pertains to the rejection as newly set forth will be provided following the new statement of rejection.
Claims 58-63, 65, and 68-70 are newly rejected under 35 U.S.C. 103 as being unpatentable over Doulatov 2013 in further in view of Garçon et al. (2013, Ribosomal and hematopoietic defects in induced pluripotent stem cells derived from Diamond Blackfan anemia patients. Blood, J. of Amer. Soc. of Hemat., 122(6), 912-921 and Supplemental Methods, hereafter “Garçon”).
With regard to claim 58, Doulatov 2013 teaches a method of induction of hematopoietic progenitor cells (HPCs) capable of multi-lineage potential and in vitro expansion which results in engraftment of blood progenitors in vivo (Abstract). Doulatov 2013 teaches that analysis of engraftment following transplantation of blood progenitors confirms RBC differentiation (Pg. 466, right col., 1st para.). Doulatov 2013 teaches a method comprising iPSCs differentiation into HPCs (i.e., CD34+CD45+ progenitors) (Pg. 460, right col., 2nd para., lines 1-6) and subsequent HPCs infection with SOX4, MYB, HOXA9, ERG, and RORA via lentiviral vectors and culture for 14 days (Pg. 463, right col., 1st para.). Doulatov 2013 further teaches the lentiviral vectors comprise the open reading frames of the transcription factors (Pg. 468, right col., Lentivirus Production and Lentiviral Gene Transfer), which is considered to reasonably read on contacting an HPC or population thereof with a nucleic acid encoding HOXA9, ERG, RORA, SOX4, and MYB for a sufficient time in order to induce RBC differentiation. Additionally, Doulatov 2013 teaches use of iPSC lines (Pg. 460, right col., top of 1st full para.), including BJ-IPS1 which are derived from foreskin fibroblasts (Pg. 464, right col., 1st para.), which is considered to reasonably read on an iPSC derived from a somatic fibroblast.
Doulatov 2013 is silent as to the method steps of in vitro, ex vivo, or in vivo reprogramming of the somatic fibroblasts into iPSCs but cites Garçon as teaching generation of iPSCs (Pg. 459, bridging para.).
Garçon teaches generation of iPSCs from skin fibroblasts (Pg. 913, Results, lines 1-5) wherein reprogramming of fibroblasts into iPSC lines was performed in vitro (Garçon Supplemental Methods, Creation and differentiation of iPSCs from DBA patients).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to apply the process of reprogramming somatic fibroblasts into iPSCs in vitro as taught by Garçon prior to use of Doulatov 2013’s method of inducing RBC differentiation comprising contacting HPCs with a nucleic acid encoding HOX9A, ERG, RORA, SOX4, and MYB wherein the HPCs are derived from iPSCs derived from somatic fibroblasts with a reasonable expectation of success. A skilled artisan would have been motivated to use in vitro reprogramming methods as the subsequent steps in the differentiation method as taught by Doulatov 2013, i.e., generation of HPCs from iPSCs, are also performed in vitro. Thus, performing both reprogramming of fibroblasts to iPSCs in vitro as well as differentiation of generated iPSCs to HPCs in vitro would decrease complexity by reducing additional method steps and allow for increased control over the experimental method. Further, in vitro fibroblast reprogramming methods are considered obvious as they are known in the art. One having ordinary skill in the art would have had a reasonable expectation of success as in vitro methods of reprogramming fibroblasts are known in the art.
With regard to claim 59, Doulatov 2013 teaches that HPCs are infected and cultured for 14 days prior to subsequent assays (Pg. 463, right col., 1st para.).
With regard to claim 60, Doulatov 2013 teaches that the nucleic acid is encoded by a lentiviral vector (Pg. 468, right col., Lentivirus Production and Lentiviral Gene Transfer).
With regard to claim 61, Doulatov 2013 teaches wherein transfected HPCs undergo erythroid maturation (Pg. 466, right col., 1st para.).
With regard to claim 62, Doulatov 2013 teaches that the HPCs are CD34+CD45+ (Pg. 460, right col., 2nd para., lines 1-6).
With regard to claim 63, Doulatov 2013 teaches that HPCs (i.e., CD34+CD45+ progenitors) were derived from iPSCs (Pg. 460, right col., 2nd para., lines 1-6).
With regard to claim 65, Doulatov 2013 teaches use of an iPSC line, BJ-IPS1 (Pg. 464, right col., 1st para.), derived from foreskin fibroblasts, which is considered to reasonably read on a mammalian somatic fibroblast.
With regard to claim 68, Doulatov 2013 teaches use of the fibroblast-derived iPSC line BJ-IPS1 in the method of differentiating iPSCs to HPCs (as detailed supra claim 58) and subsequent induction of HSCs derived from the BJ-IPS1 line contacted with SOX4, MYB, HOXA9, ERG, and RORA (Pg. 464, right col., 1st para.). Doulatov 2013’s methods of differentiation of iPSCs to HPCs, transfection of HPCs, and erythroid progenitor culture are all performed in vitro (see Experimental Procedures section), which is considered to reasonably read on differentiation of HPCs in vitro based on the disclosed methods.
With regard to claim 69, Doulatov 2013 teaches that transfected HPCs generate erythroid cells (Pg. 463, right col., 1st and 2nd paras.) but that erythroid maturation/RBC differentiation requires an additional process such as transplantation into the proper microenvironment (Pg. 466, left col. 1st para.) which results in in vivo engraftment, which is the naturally occurring ongoing process following the step of transplantation of the erythroid cells generated by transfected HPCs, of differentiated RBCs (Pg. 466, right col., 1st para.).
With regard to claim 70, Doulatov 2013 teaches wherein differentiated RBCs are CD235a+ CD71+ and enucleated (Pg. 466, right col., 1st para.). CD235a+ is considered to reasonably read on GlyA+.
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Doulatov 2013 as applied to claims 58 above in further in view of Garçon et al. (2013, Ribosomal and hematopoietic defects in induced pluripotent stem cells derived from Diamond Blackfan anemia patients. Blood, J. of Amer. Soc. of Hemat., 122(6), 912-921 and Supplemental Methods, hereafter “Garçon”).
With regard to claim 66, as detailed above, Doulatov 2013 teaches method of induction of hematopoietic progenitor cells (HPCs) capable of multi-lineage potential and in vitro expansion and which results in engraftment of blood progenitors in vivo (Abstract). Doulatov 2013 teaches that analysis of engraftment following transplantation of blood progenitors confirms RBC differentiation (Pg. 466, right col., 1st para.). Doulatov 2013’s method comprises differentiation of iPSCs into HPCs (i.e., CD34+CD45+ progenitors) (Pg. 460, right col., 2nd para., lines 1-6) and subsequent HPC infection with lentiviral vectors comprising SOX4, MYB, HOXA9, ERG, and RORA (Pg. 463, right col., 1st para.) and Doulatov 2013 teaches wherein an iPSC line derived from somatic fibroblasts (i.e., BJ-IPS1) is used in the method (Pg. 464, right col., 1st para.). Doulatov 2013 also teaches that iPSCs have been generated from patients having Diamond Blackfan anemia (DBA) and cites Garçon (Pg. 459, Introduction, 1st para.). Further, Doulatov 2013 teaches that iPSC lines from patients with diseases such as DBA have the potential to generate improved models of diseases and platforms for screening of therapeutic drugs, however, existing systems are unable to generate large numbers of transplantable cells from human pluripotent stem cells (Pg. 459, left col. 1st para.), result in cells exhibiting limited engraftment, and generate only small numbers of transplantable cells which cannot be expanded (Pg. 459, left col., 2nd para.).
Doulatov 2013 does not reduce to practice the generation of iPSCs from fibroblasts isolated from patients having a ribosomal disorder, DBA, or a mutation in RPS19 but cites Garçon.
Garçon teaches generation of iPSCs from fibroblasts isolated from DBA patients having mutations in RPS19 (Abstract). Additionally, Garçon teaches that somatic cells which are reprogrammed into iPSCs provide new opportunities for studies of DBA and a potential strategy for cellular therapy (Pg. 912, right col., 2nd para.).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to use somatic fibroblasts from a patient having DBA and/or a mutation in RPS19 which can be reprogrammed into iPSCs as taught by Garçon in the method of inducing RBC differentiation comprising contacting HPCs with a nucleic acid encoding HOX9A, ERG, RORA, SOX4, and MYB wherein the HPCs are derived from iPSCs derived from somatic fibroblasts as taught by Doulatov 2013 with a reasonable expectation of success. A skilled artisan would have been motivated to make this combination in order to generate DBA-specific HPCs which are capable of being expanded and transplanted thereby providing an improved model for the study of DBA and therapeutic DBA treatments.
Response to Arguments
Applicant's arguments filed July 13, 2026 are acknowledged and have been fully considered but are not persuasive.
Claims 58-65 and 68-70 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doulatov 2013.
Applicant asserts that claim 58, as amended; which recites “…wherein the HPC of population thereof is derived from an inducible pluripotent stem cell (iPS) or a pluripotent stem cell; wherein the iPS is derived from a somatic fibroblast cell; and wherein the somatic fibroblast cell is reprogrammed to a iPS in vitro, ex vivo, or in vitro” which are limitations not disclosed by Doulatov 2013 (Pg. 9, 4th para.).
Applicant has canceled claim 64 rendering the rejection of claim 64 moot. Applicant’s arguments are considered persuasive and, as such, a new grounds of rejection has been supplied above.
Claims 66 and 67 were rejected under 35 U.S.C 103 as being upatentable over Doulatov 2013 as applied to claims 58, 63, and 64 in further view of Garçon. Regarding the rejection of claim 66, Applicant traverses the Office’s assertion of obviousness based on the combination of Doulatov 2013 and Garçon. Applicant traverses that the amendment of claim 58 to recite “…wherein the HPC of population thereof is derived from an inducible pluripotent stem cell (iPS) or a pluripotent stem cell; wherein the iPS is derived from a somatic fibroblast cell; and wherein the somatic fibroblast cell is reprogrammed to a iPS in vitro, ex vivo, or in vitro” is novel over Doulatov 2013 and that the teachings of Garçon do not cure the deficiencies of Doulatov 2013 (Pg. 10, 2nd full para.)
Applicant further asserts that the teachings of Garçon related to reprogramming of somatic fibroblasts from subjects having DBA and/or mutation in RPS19 do not provide a reasonable expectation of success as Garçon’s methods of reprogramming of DBA and/or RPS19 fibroblasts had low reprogramming efficiency and limited success. Applicant traverses that Garçon discloses that DBA fibroblasts are resistant to reprogramming methods used by Garçon and that a skilled artisan, based on the disclosure of Garçon would not expect to successfully reprogram fibroblasts using Garçon’s methods (Pg. 10, 2nd to last para, and Pgs. 10-11, bridging para.). Applicant asserts that a skilled artisan, based on the disclosure of Garçon, would not have a reasonable expectation of success and therefore one having ordinary skill in the art would not be motivated to combine the teachings of Doulatov 2013 and Garçon to arrive at the instantly claimed method.
Applicant’s traversal has been fully considered but is not persuasive.
Applicant has canceled claim 67, rendering the rejection of claim 67 moot. Regarding applicant’s traversal related to expectation of success, as detailed supra, Doulatov directly points to Garçon as an example of pluripotent stem cells which have been generated from patients with hematological diseases, in this case DBA, and discloses that these pluripotent cells “have the potential to become powerful models to gain insight into the molecular basis of disease and platforms for drug screens”. Doulatov further discloses that in order to investigate diseases, these disease-derived IPSCs must be differentiated into hematopoietic stem and progenitor cells (HPSCs) and that current systems do not generate large numbers of differentiated transplantable cells which limits further investigation and experimentation related to hematologic diseases (Pg. 459, bridging para.). Doulatov subsequently discloses a method for inducing red blood cell differentiation comprising contacting HPCs with “5F” lentiviruses as detailed supra. Garçon also discloses the utility of iPSCs derived from reprogramming of fibroblasts from a DBA patient having and RPS19 mutation as a model which recapitulates the disease phenotype and provides a renewable source of human DBA cells for further investigation related to gene therapeutics and drug screening (Pg. 918, left col., 1st para.). Thus, both Doulatov and Garçon provide support for use of iPSCs derived from DBA patients.
Although Applicant traverses that the reprogramming method of Garçon is inefficient, it is noted that the instant claims do not require any specific efficiency related to the reprogramming of fibroblasts from DBA patients to iPSCs. Additionally, absolute certainty is not required for a reasonable expectation of success. MPEP 2143.02(I) states “Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute"))”.
Further, as the instant claims are drawn to generation of stem cells from a fibroblast cell, a skilled artisan would recognize that once at least one iPSC was generated, any inefficiency would be overcome because that cell could be expanded in culture to generate many iPSCs. Although Garçon discloses low reprogramming efficiency using their method, Garçon also discloses that iPSC were ultimately able to be obtained from a DBA patient having an RPS19 mutation (Pgs. 912-913, bridging para.) and that the generated iPSC clone from a DBA patient having an RPS19 mutation proliferated normally and retained stable characteristics in “prolonged” culture. (Pg. 913, right col., 1st para.). Thus, based on Garçon, a skilled artisan would have a reasonable expectation of success in at least generating a single iPSC clone from a DBA/RPS19 patient which could generate large numbers of iPSCs for use in the instantly claimed method.
Conclusion
No claims are allowed.
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 ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
