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 .
Election/Restrictions
Applicant’s election without traverse of Group 2, claims 7-17 and 20-22 in the reply filed on 24 October 2025 was previously acknowledged.
Claims 1-5 and 18-19 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 October 2025.
Claim Status
Claim 7 is currently amended, claim 6 was previously canceled, claims 13-16 and 22 have been newly canceled, claims 1-5 and 18-19 are currently withdrawn, and claims 7-12, 17, and 20-21 have been considered on their merits.
Priority
This application is a 371 of PCT/JP2021/032734 filed 06 September2021 which claims priority to JP 2020149447 filed 04 September 2020.
Withdrawn Objections/Rejections
The claim objection of claim 7 has been withdrawn due to Applicant’s amendment to the claim.
The rejection of the claims under 35 USC 112(b) have been withdrawn because Applicant has canceled the rejected claims.
The rejection of the claims under 35 USC 102 have been withdrawn due to Applicant’s amendments to the claims.
The non-statutory double patenting rejections of the claims have been withdrawn due to Applicant’s amendment to the claims.
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. 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 7-12, 17, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Yuasa et al. (US 2018/0298346 A1, published 18 October 2018, IDS ref., of record) as evidenced by Dodsworth et al. (Stem Cells, 2015, of record) in view of Banaszynski et al. (Cell 126, 08 September 2006, IDS ref.) and Tanaka et al. (Development 128, 2001).
This is a new rejection, necessitated by Applicant’s amendment to the claims. A response to any applicable traversal follow the rejection below.
Regarding claim 7, Yuasa teaches an agent for improving quality of an iPS cell, a method for producing an iPS cell, an iPS cell produced by such a method for production, and a composition for producing an iPS cell; wherein, the method for producing an iPS cell comprising introducing (a) a nuclear reprogramming substance and (b) an H1foo gene or a gene product thereof into a somatic cell (Abstract). The nuclear reprogramming substance and H1foo gene or a gene product read as the quality improvement agent. Yuasa teaches the introduction of the Oct3/4, Sox2, and Klf4 genes (OSK genes)+H1foo genes into murine fibroblasts results in marked increase of the number of alkaline phosphatase (ALP)-positive iPS cell colonies as compared with the introduction of the OSK genes alone (Fig. 2a and para. [0109]).
Yuasa is silent to the regulatory sequence including a nucleotide sequence encoding a destabilization domain.
However, Banaszynski teaches a technique to regulate the stability of specific proteins in mammalian cells using cell-permeable, synthetic molecules, such as, engineered mutants of the human FKBP12 protein that are rapidly and constitutively degraded when expressed in mammalian cells, and this instability is conferred to other proteins fused to these destabilizing domains (DD) (Abstract). Banaszynski teaches genetic fusion of the destabilizing domain to a gene of interest ensures specificity, and the attendant small-molecule control confers speed, reversibility, and dose-dependence to this method (Abstract). Banaszynski teaches fusion of an FKBP DD to the N terminus of YFP results in predictable and reversible small-molecule regulation of intracellular protein levels (Fig. 3 and p. 1002). Banaszynski teaches varying concentrations of Shld1 allow for dose-dependent control of protein expression, with expression reduced to almost zero percent within approximately three days (72 hours) and a fifty percent reduction within approximately two days (48 hours) (Fig. 3). This reads on the limitations of claim 7(a).
Tanaka teaches H1oo (later renamed H1foo) mRNA was only detected in the oocytes of follicles at all stages of development at or beyond the primary-secondary follicle stage and following fertilization, a substantial decrease was evident in H1foo expression (p. 661, Ontogenetic studies of H1oo mRNA and protein). Tanaka suggests possible functional role of H1foo is required in order to elucidate the mechanisms underlying its possible control of gene expression before, during or even after fertilization (p. 663, Discussion). The teachings of Tanaka suggest the controlled expression of the H1foo gene could be useful in the reprogramming of somatic cells but not required beyond modification of gene expression. Thus, regulatable expression of H1foo would be an advantage for reprogramming somatic cells, as reprogramming somatic cells in the method of Yuasa requires a modification in gene expression.
Therefore, it would have been obvious to one or ordinary skill in the art to combine the teachings of Yuasa with Banaszynski and Tanaka with a reasonable expectation of success because Banaszynski teaches the level of control could prove invaluable when the biological function of a protein of interest depends upon its intracellular concentration (pp. 998-999, Predictable Regulation of Intracellular Protein Levels). One would be motivated to combine the teachings of Yuasa with Banaszynski and Tanaka because the teachings of Tanaka suggest H1foo expression may not be required following modification of gene expression and Banaszynski teach a method of regulating gene expression.
Regarding claim 8 directed to the iPS cells are prime-type or naïve-type iPS cells, these types of iPS cells are not defined by the specification, however, the art describes naïve and prime as the two states of pluripotency, wherein the naïve, or ground state, as being the most pluripotent type and prime resembles that of a more developed stage of embryonic development, i.e., less pluripotent, as evidenced by Dodsworth (Abstract and introduction p. 3181). Therefore, the iPS cells of Yuasa would be considered either naïve-type or prime-type iPS cells, absent evidence to the contrary.
Regarding claim 9, Yuasa teach the method for producing an iPS cell according to further comprises the nuclear reprogramming substance comprises at least one selected from the group consisting of a gene of Oct gene family, a gene of Sox gene family, a gene of Klf gene family, a gene of Myc gene family, a gene of Lin gene family, a Nanog gene, and gene products thereof (para. [0038]).
Regarding claim 10, Yuasa teaches preferable nuclear reprogramming substances include an Oct3/4 gene or a gene product thereof, a Sox2 gene or a gene product thereof, and a Klf4 gene or a gene product thereof, a L-Myc gene (para. [0043]).
Regarding claims 11-12, Yuasa teaches a vector comprising an Hlfoo gene can be also used as an agent for improving quality of an iPS cell (para. [0033]). Yuasa teaches when the nuclear reprogramming substance is introduced into the somatic cell when the Hlfoo gene is introduced into the somatic cell, the expression vector obtained by incorporating the nuclear reprogramming substance or Hlfoo gene in a suitable expression vector containing a promoter that can function in the somatic cell to be a host may be used preferably (para. [0059]). Yuasa teaches the expression vector may be selected as appropriate depending on the purpose and include virus vectors (para. [0059]). The viral vector comprising a promoter that can function in the somatic cell reads as being capable of expressing in cells when the gene is transduced into the cell (claim 11). Yuasa teaches the viral vector includes a Sendai virus vector (para. [0066]) (claim 12).
Regarding claims 17 and 20-21, these claims all recite product-by-process limitations. Product-by-process limitations are considered only in as far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant case, Yuasa in view of Banaszynski and Tanaka teach the limitations of method claims 7, 8, and 10 to which claims 17 and 20-21 refer; as indicated above, therefore, Yuasa in view of Banaszynski and Tanaka teach the limitations of claims 17 and 20-21.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Traversal
Applicant’s arguments, see Remarks, filed 17 March 2026, with respect to the rejections of claims 7-17 and 20-22 under 35 USC 102 have been fully considered and are persuasive. Specifically, the arguments directed to Yuasa not teaching the limitations of amended claim 7 to include a nucleotide sequence encoding a destabilization domain. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Yuasa, Banaszynski, and Tanaka.
The arguments all appear to be directed to the Yuasa not teaching the limitations of amended claim 7, specifically a nucleotide sequence encoding a destabilization domain, which have been addressed in the rejection above.
Relevant prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eto et al. (US 2018/0051260 A1, published 22 February 2018)
Eto teaches a method for producing a stem cell clone, to include dedifferentiating somatic cells by introducing exogenous genes to include MYC family genes. Eto teaches since it is preferable to suppress the expression level of c-MYC, the c-MYC may be that which encodes a protein fused with a destabilizing domain.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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