DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 73-85 in the reply filed on 6/01/2026 is acknowledged.
Claims 86-88 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 6/01/2026.
Claims 73-85 are under consideration on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 73-85 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 73-85 are rejected as indefinite for incorporating by reference Tables 1, 2, and/or 3 of the specification. See M.P.E.P. § 2173.05(s), in that incorporation by reference is a necessity doctrine and not for applicant’s convenience. In this case and as evidenced by the phrasing of dependent claims 79-81 and 83-85, the data of Tables 1-3 of the specification can clearly and unambiguously be directly recited in the claims. Correction is required.
In so much that claims 74-85 depend from claim 73 and do not resolve the point of confusion, these claims must be rejected with claim 73 as indefinite.
Claim Rejections - 35 USC § 102
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)(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 73-85 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cortes et al. (US 2024/0360411; Reference A).
The applied reference has a common Applicant and common Inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Cortes teaches a method of identifying a candidate perturbation for promoting the transition of a starting population of progenitor cells into erythrocytes comprising HbF (i.e. fetal hemoglobin) or HbF-expressing progenitors thereof, the method comprising: exposing the starting population of progenitor cells to a perturbation; identifying a perturbation signature for the perturbation, the perturbation signature comprising one or more cellular-components and a significance score associated with each cellular-component, the significance
score of each cellular-component quantifying an association between a change in expression of the cellular component and a change in cell state of the cells in the
population of progenitor cells into erythrocytes comprising HbF or HbF-expressing progenitors thereof following exposure of the population of cells to the perturbation; and identifying the perturbation as a candidate perturbation for promoting the transition of a population of progenitor cells into erythrocytes comprising HbF or HbF-expressing
progenitors thereof based on the perturbation signature, wherein the perturbation signature is an increase in expression and/or activity in the progenitor cell of one
or more genes selected from the genes designated as an "up" gene in the gene directionality column of Tables 1-3, and/or a decrease in expression and/or activity in the progenitor cell of one or more genes selected from the genes designated as a "down" gene in the gene directionality column of Tables 1-3 (claims 60-62), wherein Tables 1-3 of Cortez are identical to Tables 1-3 of the instant Application, anticipating claim 73, 75-77, 79-81, and 83-85, and claims 78 and 82 with sufficient specificity (see M.P.E.P. § 2131.03; i.e. “one or more” of the specific entries of Tables 1-3 is sufficiently specific for all possible 98 entries of Table 1, all possible 103 entries of Table 2, and all possible 49 entries of Table 3 of Cortez and combinations thereof). Cortez teaches the method of any one of claims 60 to 62, wherein the perturbation signature is an increase in expression and/or activity in the progenitor cell of a network module designated in the network module column of Table 1, Table 2, and/or Table 3, including combinations of the foregoing (claim 63), anticipating claim 74.
Claims 73-85 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Verhelle et al. (WO 2007/139939; provided in the IDS dated 2/28/2024).
Regarding the gene expression patterns of claims 73-85, the claims are read in light of the specification that methods of contacting CD34+ hematopoietic stem cells in vitro with a composition comprising an effective dosage of hydroxyurea (as a species of perturbation candidate) such as to increase fetal hemoglobin (HbF) expression (e.g. the perturbation signature and significance score) inherently yields the various gene expression combinations of claims 73-85. See Example 2 and Figure 2 of the disclosure. Therefore, any treatment of CD34+ hematopoietic stem cells in vitro with a composition comprising an effective dosage of hydroxyurea such as to increase fetal hemoglobin (HbF) expression is reasonably presumed to inherently generate/yield the various gene expression patterns of claims 73-85 absent any showing to the contrary. See M.P.E.P. § 2112(V) and 21112.01(I); when the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established, and the USPTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Verhelle teaches methods of expanding CD34+ hematopoietic stem cells in vitro with a composition comprising an effective dosage of hydroxyurea such as to increase fetal hemoglobin (HbF) expression ([29] and Figure 15), anticipating or reading on claims 73-85.
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 73-85 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 65-76 of copending Application No. US 17/901,371 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive to methods of a method of identifying a candidate perturbation for promoting the transition of a starting population of progenitor cells into erythrocytes comprising fetal hemoglobin (HbF) or HbF-expressing progenitors thereof, the method comprising: (a) exposing the starting population of progenitor cells to a perturbation; (b) identifying and measuring a perturbation signature for the perturbation, the perturbation signature comprising one or more cellular-components and a significance score associated with each cellular-component, the significance score of each cellular-component quantifying an association between a change in expression of the cellular-component and a change in cell state of the cells in the starting population of progenitor cells into erythrocytes comprising HbF or HbF-expressing progenitors thereof following exposure of the starting population of cells to the perturbation; and (c) identifying the perturbation as a candidate perturbation for promoting the transition of the starting population of progenitor cells into erythrocytes comprising HbF or HbF-expressing progenitors thereof based on the perturbation signature, wherein the perturbation signature is an increase in expression and/or activity in the starting population of progenitor cells of one or more genes selected from the genes designated as an "up" gene in the gene directionality column of Table 1a and/or Table 2, and/or a decrease in expression and/or activity in the starting population of progenitor cells of one or more genes selected from the genes designated as a "down" gene in the gene directionality column and wherein Tables 1a, 1b, and 2 recited in claim 65 of the copending ‘371 Application are the narrower embodiment of instant Tables 1-3 incorporated by reference into instant claim 73.
Dependent claims 66-76 of the copending ‘371 Application read on the narrower combinations of additional genes and specific genes as set forth in instant dependent claims 74-85.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner Comments
Claims 73-85 are directed towards the natural phenomena correlating gene expression profiles in hematopoietic progenitors under generic before-and-after generic treatment conditions to drive differentiation to blood cell types or to drive HbF expression. However and while generic, the claimed methods of screening generic compounds to drive hematopoietic differentiation into blood cells or to drive fetal hemoglobin (HbF) expression is a practical application of the judicial exception whose eligibility is self-evident. See M.P.E.P. § 2106.06.
Conclusion
No claims are free of the art. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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