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 is acknowledged.
Claims 1-5 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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
Claims 1, 4-5, 7, 9-11, 13, and 15-19 are currently amended, claim 6 has been canceled, claims 20-22 are new, claims 1-5 and 18-19 are currently withdrawn, and claims 7-17 and 20-22 have been considered on their merits.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.
Claim Objections
Claim 7 is objected to because the claim imparts limitations from a withdrawn claim. Appropriate correction is required.
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 13-16 and 22 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.
Claim 13 recites the limitation "the amount" in fourth line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 13 is an independent claim and does not disclose to what “the amount” is referring. Therefore, these limitations are unclear.
Claims 14-16 and 22 depend from claim 13 and do not remedy the issues, therefore, are included in this rejection.
Claim 15 recites the limitation "the gene family" in second line of the claim and “the at least one gene” in the fourth line of the claim. There is insufficient antecedent basis for these limitation in the claim.
Claim 15 depends from independent claim 13, which does not disclose a gene family nor more than one gene.
Additionally, it is unclear if “the gene family” and “the at least one gene” are the same gene or they are referring to different genes; or is “the at least one gene” referring to the H1foo gene of claim 13, from which claim 15 depends. Therefore, these limitations are unclear.
For the purposes of compact prosecution, “the gene family” is interpreted as referring to the nuclear reprogramming factors of claim 13, wherein, the gene families listed following “the gene family” are referring to the required nuclear reprogramming factors. The “at least one gene” is interpreted as referring to the H1foo gene of claim 13, therefore, reads as the H1foo gene encoded in the expression vector is capable of expressing said gene.
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.
Claims 7-17 and 20-22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Yuasa et al. (US 2018/0298346 A1, published 18 October 2018, IDS ref.) as evidenced by Dodsworth et al. (Stem Cells, 2015).
Regarding claim 7, Yuasa et al. teach 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 according to claim 1.
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 et al. (Abstract and introduction p. 3181). Therefore, the iPS cells of Yuasa et al. would be considered either naïve-type or prime-type iPS cells, absent evidence to the contrary.
Regarding claim 9, Yuasa et al. 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 et al. teach 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 et al. teach a vector comprising an Hlfoo gene can be also used as an agent for improving quality of an iPS cell (para. [0033]). Yuasa et al. teach 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 et al. teach 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 et al. teach the viral vector includes a Sendai virus vector (para. [0066]) (claim 12).
Regarding claim 13, Yuasa et al. teach 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 (expression regulator) that can function in the somatic cell to be a host may be used preferably (para. [0059]). Yuasa et al. teach 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.
The limitation of claim 13 following the wherein clause in the third line of the claim is interpreted as the H1foo protein expression is being regulated by the H1foo gene transduced into somatic cells. Therefore, the promoter in the expression vector comprising the H1foo gene reads as the H1foo gene has regulated expression of the H1foo protein.
Regarding claims 14 and 16, Yuasa et al. teach 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]). The expression vector containing a promoter that can function in the somatic cell host reads as being in a state capable of expressing the H1foo gene in cells (claim 14). Yuasa et al. teach the expression vector may be selected as appropriate depending on the purpose and include virus vectors (para. [0059]). Yuasa et al. teach the viral vector includes a Sendai virus vector (para. [0066]) (claim 16).
Regarding claim 15, Yuasa et al. 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]).
As indicated in the 112(b) rejection above, the limitation “the gene family” is interpreted as referring to the nuclear reprogramming factors of claim 13, wherein, the gene families listed following “the gene family” are referring to the required nuclear reprogramming factors. The “at least one gene” is interpreted as referring to the H1foo gene of claim 13, therefore, reads as the H1foo gene encoded in the expression vector is capable of expressing said gene.
Yuasa et al. teach 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]). This reads as the H1foo gene encoded in the expression vector is capable of expressing said gene.
Regarding claims 17 and 20-22, 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 et al. teach the limitations of method claims 7, 8, 10, and 13 to which claims 17 and 20-22 refer; as indicated above, therefore, Yuasa et al. teach the limitations of claims 17 and 20-22.
Thus, the reference anticipates the subject matter of claims 7-17 and 20-22.
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 7-9, 17, and 20-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. US 10,544,396 B2 as evidenced by Dodsworth et al. (Stem Cells, 2015).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims.
Regarding claims 7 and 9, patented claim 1 recites a method for producing an iPS cell comprising introducing a nuclear reprograming substance consisting of a polynucleotide encoding an Oct3/4 protein, a Sox2 protein, a Klf4 protein, and a polynucleotide encoding an H1foo protein into a somatic cell.
The H1foo protein reads as the quality improvement agent of instant claim 7.
The polynucleotide encoding an Oct3/4 protein, a Sox2 protein, or a Klf4 protein read as at least one nuclear reprogramming factor from the group consisting of a gene of an Oct gene family, a gene of a Sox gene family, a gene of a Klf gene family, a gene of a Myc gene family, a gene of a Lin gene family, a Nanog gene; and the proteins expressed read as the gene products thereof of instant claim 9.
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 et al. (Abstract and introduction p. 3181). Therefore, the iPS cells of the patented claims would be considered either naïve-type or prime-type iPS cells, absent evidence to the contrary.
Regarding claim 10, patented claim 3 recites a method for producing an iPS cell in vitro, comprising: i) introducing (a) a nuclear reprogramming substance wherein the nuclear reprogramming substance consists of a polynucleotide encoding an Oct3/4 protein, a polynucleotide encoding a Sox2 protein, a polynucleotide encoding a Klf4 protein and a
Polynucleotide encoding an L-Myc protein, and (b)a polynucleotide encoding an Hlfoo protein into a somatic cell.
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, the patented claims recite the limitations of method claims 7, 8, and 10 to which claims 17 and 20-21 refer; as indicated above, therefore, the patented claims teach the limitations of claims 17 and 20-21.
Therefore, the patented claims 1 and 3 anticipate instant claims 7-10, 17, and 20-21 because the instant claims are broader.
Claims 11-16 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. US 10,544,396 B2 in view of Yuasa et al. (US 2018/0298346 A1, published 18 October 2018, IDS ref.).
The claims of U.S. Patent No. US 10,544,396 B2 anticipate the subject matter of claims 7-10, 17, and 20-21, and thus, also render them obvious.
Regarding claims 11-16, the patented claims 1 and 3 are silent to the expression vector transducing the cell, i.e., viral expression vector. However, the use of viral vectors to transduce cells for the purpose of reprogramming somatic cells to iPS cells is well known and obvious.
Yuasa et al. teach a vector comprising an Hlfoo gene can be also used as an agent for improving quality of an iPS cell (para. [0033]). Yuasa et al. teach 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 et al. teach 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 et al. teach the viral vector includes a Sendai virus vector (para. [0066]) (claim 12).
Yuasa et al. teach 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 (claim 13, expression regulator) that can function in the somatic cell to be a host may be used preferably (para. [0059]). Yuasa et al. teach 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.
Yuasa et al. teach 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]). The expression vector containing a promoter that can function in the somatic cell host reads as being in a state capable of expressing the H1foo gene in cells (claim 14). Yuasa et al. teach the expression vector may be selected as appropriate depending on the purpose and include virus vectors (para. [0059]). Yuasa et al. teach the viral vector includes a Sendai virus vector (para. [0066]) (claim 16).
Regarding claim 15, Yuasa et al. 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]). The limitation “the gene family” is interpreted as referring to the nuclear reprogramming factors of claim 13, wherein, the gene families listed following “the gene family” are referring to the required nuclear reprogramming factors. The “at least one gene” is interpreted as referring to the H1foo gene of claim 13, therefore, reads as the H1foo gene encoded in the expression vector is capable of expressing said gene.
Yuasa et al. teach 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]). This reads as the H1foo gene encoded in the expression vector is capable of expressing said gene.
Therefore, it would have been obvious to one of ordinary skill in the art to have used the Sendia virus vector to transduce the iPS cells of Yuasa et al. as the method of introducing the nuclear reprogramming factors and H1foo protein to the iPS cells of the patented claims as this technique is a well-known in the art.
Therefore, patented claims 1 and 3 in view of Yuasa et al. render obvious instant claims 7-17 and 20-22.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS A. HUMPHRIES whose telephone number is (703)756-5556. The examiner can normally be reached Monday - Friday, 7:30am - 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631