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 1-5, 7, 9, 11-17, 19-20, 22-24, and 30-34, of record 2/25/2025, are pending and subject to prosecution. Claims 1-5, 7, 9, 11-12, 14-15, 17, 19, 22-24, 30, 32, and 34 are amended.
Status of Prior Rejections/Response to Arguments
RE: Objection to the specification:
The amendment to the specification is effective to obviate the objection. The objection is withdrawn.
RE: Objection to claims 1-3, 9, and 11:
The amendment to claims 1-3, 9, and 11 is effective to obviate the objection. The objection is withdrawn.
Rejection of claims 1-5, 7, 9, 11-17, 19-20, 22-24, and 30-34 under 35 U.S.C. 112(b):
The amendment to claims 1-4, 7, 9, 15, 19, 22-24, and 30 is effective to obviate the rejection over claims 1-5, 7, 9, 11-13, 15-17, 19-20, 22-24, and 30-34. The rejection over those claims is withdrawn. The rejection over claim 14 is maintained because PiggyBac is a trademarked term.
RE: Rejection of claims 32 and 34 under 35 U.S.C. 112(a):
The amendment to claims 32 and 34 is effective to obviate the rejection. The rejection is withdrawn.
RE: Rejection of claims 1-5, 7, 9, 11-12, 17, 19, and 31-34 under 35 U.S.C. 103 over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020) in view of Minagawa et al. (Cell Stem Cell, 2018) and Suzuki et al. (Cancer Science, 2011):
RE: Rejection of claims 1-5, 7, 9, 11-14, 17, 19, and 31-34 under 35 U.S.C. 103 over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020) in view of Minagawa et al. (Cell Stem Cell, 2018) and Suzuki et al. (Cancer Science, 2011), further in view of Yelensky et al. (US 20200363414 A1):
RE: Rejection of claims 1-5, 7, 9, 11-12, 15-17, 19, and 31-34 under 35 U.S.C. 103 over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020) in view of Minagawa et al. (Cell Stem Cell, 2018) and Suzuki et al. (Cancer Science, 2011), further in view of Nakauchi et al. (EP 2853590 B1):
RE: Rejection of claims 1-5, 7, 9, 11-12, 17, 19-20, and 31-34 under 35 U.S.C. 103 over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020) in view of Minagawa et al. (Cell Stem Cell, 2018) and Suzuki et al. (Cancer Science, 2011), further in view of Giannoni et al. (Molecular Therapy, 2013) and Vodyanik et al. (Blood, 2006):
RE: Rejection of claims 1-5, 7, 9, 11-12, 17, 19, 22-24, and 30-34 under 35 U.S.C. 103 over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020) in view of Minagawa et al. (Cell Stem Cell, 2018) and Suzuki et al. (Cancer Science, 2011), further in view of Healy et al. (Human Pluripotent Stem Cells, 2011):
The applicant asserts that:
The prior art references use different and non-analogous processes to produce regenerative T cells and one of ordinary skill would not have arrived at the claimed invention based upon their teachings (Applicant Remarks, page 25-26).
Nagano et al. teach “their process to create regenerative T cells is superior to iPSCs transduced to exogenous TCR gene” (Applicant Remarks, page 25”).
Minagawa et al. do not teach active steps for generating TCRαβ chains and introducing them into iPSCs (Applicant Remarks, page 25).
Suzuki et al. do not teach the making or selection of peptide-specific CTL clones, introduction of CTL clone cDNA into iPSCs, or the making of regenerative T cells (Applicant Remarks, page 26).
The applicant’s arguments have been considered but are not found entirely persuasive.
The teachings of Nagano et al. and Minagawa et al. are, like the instant claims, drawn to the production of regenerated antigen-specific T cells. While prior art references in a 103 rejection are not individually required to teach every claimed limitation, characterization of the process of Nagano et al. as “drastically different” from the instant claims is not entirely accurate. The method of independent claim 1 differs from the method of Nagano et al. in two respects—the preparation and analysis of exogenous TCR cDNA and its introduction into iPSCs—and Nagano et al. do note the use of exogenous TCR genes as an alternative (See page 132, col. 1, full ¶). Nonpreferred and alternative embodiments constitute prior art under MPEP 2123(II). Minagawa et al. teach and provide motivation for the transduction of TCR genes into iPSCs during T cell regeneration (See page 851, col. 1, full ¶2 and page e3, ¶1). The combined teachings of Nagano et al. and Minagawa et al. render obvious much of the claimed invention, as a whole.
However, the amendment to require sorting of tumor-related antigen-reactive T cells on the basis of CD3/CD137 expression and preparation and analysis of TCRαβ chain cDNA prior to introduction into iPSCs is effective to obviate the rejections. The rejections are withdrawn.
RE: Provisional rejection of claims 1, 4-5, 7, 12-17, 20, 22-24, and 30-34 on the ground of nonstatutory double patenting over claims 1-2, 4, 7-8, 10, 12-16, 18, and 20-28 of co-pending Application No. 18/259687:
RE: Provisional rejection of claims 1-3, 5, 9, 11, 17, 19, 22-24, and 30-34 on the ground of nonstatutory double patenting over claims 1, 3-8, 14-15, 18-25, and 27-30 of co-pending Application No. 18/285023:
The amendment to require sorting of tumor-related antigen-reactive T cells on the basis of CD3/CD137 expression and preparation and analysis of TCRαβ chain cDNA prior to introduction into iPSCs is effective to obviate the provisional rejections. The provisional rejections are withdrawn.
New/Maintained Objections/Rejections
Claim Objections
Claims 1-5, 7, 12, 15, 17, 19, 22, and 24 are objected to because of the following informalities:
In claims 1-5, 7, 12, 15, 17, 19, 22, and 24, each instance of “step” or “steps” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-5, 7, 9, 11-17, 19-20, 22-24, and 30-34 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.
In claims 1-3, the term “significant reactivity” is a subjective term which renders the claims indefinite.
When a subjective term is used in the claim, the Examiner should determine whether the specification supplies some objective standard for measuring the scope of the term. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)). See MPEP 2173.05(b).
The term “significant reactivity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims 4-5, 7, 9, 11-17, 19-20, 22-24, and 30-34 are included in the rejection.
Claim 14 contains the trademark/trade name PiggyBac. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademarks/trade names are used to identify/describe cell editing and culture reagents and, accordingly, the identification/description is indefinite.
Claim 15 recites the limitations “the cell-binding domain”, “the heparin-binding domain”, and “the CS-1 sequence”. There is insufficient antecedent basis for these limitations in the claim. Dependent claim 16 is included in the rejection.
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.
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 1-2, 4-5, 7, 9, 12-13, 17, 19, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020), of record, in view of Schumacher et al. (US 20210040558 A1) and Minagawa et al. (Cell Stem Cell, 2018), of record.
Regarding claims 1, 5, 9, 12-13, 17, 19, and 31-34: Nagano et al. teach the production of T cells (which read on “regenerated T cells”) from T cell-derived iPSCs for (See Abstract). T cells were isolated from PBMCs obtained from a donor (See page 127, col. 1, full ¶1). The PBMCs were primed with a MART-1 peptide, and MART-1-tetramer-positive (which reads on “the T cell population in step (1) binds to MCH tetramer… that forms a complex with the tumor-related antigen peptide”) CD8 T cells were selected (See fig. 1). The T cells were transduced with Yamanaka factors to generate iPSCs (which reads on “initializing… T cells, to iPS cells”) (See page 133, col. 1, ¶1). Clones of iPSCs were induced for the T lineage, with all clonal lines yielding TCR-expressing T cells (which reads on “selecting… iPS cell clones that demonstrate high differentiation efficiency into T cells”) (See page 128, col. 1, v1). The iPSCs were differentiated to CD4+CD8+ T cells and expanded (which reads on “differentiating the iPSC cell clones… into mature T cells and proliferating the mature T cells”) (See page 133, col. 1, full ¶2).
Nagano et al. do not expressly teach the preparation of TCR cDNA or its introduction into iPSCs generated from antigen-specific T cells. However, Nagano et al. do note that TCR avidity of the clones varied widely and that the transduction of exogenous TCR genes may make it easier to produce a cell source for T cell therapy (See Abstract; page 129, col. 2, full ¶5; and page 132, col. 1, full ¶3).
Schumacher et al. teach methods for isolating antigen-specific and/or tumor-reactive TCR genes for immunotherapy (See Abstract and ¶0010, 0169, and 0179-0180). The T cells can be isolated from a subject, such as a patient with cancer (See ¶0010 and 0016). Cells can be separated on the basis of any CD marker or T cell activation marker or combinations of T cell activation markers, including CD137 (See ¶0010, 0246-0247, and 1150). Schumacher et al. teach isolation and activation of T cells using CD3/CD28 beads in one example (See ¶1051). TCR RNA can be isolated and converted to cDNA for preparation of an expression construct, which can be introduced into T cells by viral vectors or transposases (which read on “a transposon vector”) (See ¶0161-0163, 0819, and 0821). The TCRαβ gene products can be expressed in TCRαβ-null cells (which reads on “a TCR gene deficient T cell line”) to determine specificity to an antigen of interest following stimulation (which reads on “to select for cDNAs that exhibited significant reactivity”) (See ¶0008, 0016, 0129, and 0246-0247).
Minagawa et al. teach “rejuvenated” T cells produced from T cell-derived iPSCs and the transduction of TCR genes into non-T cell-derived iPSCs using a lentiviral vector (See Abstract and fig. 3). TCR genes were specific for WT-1 or the GPC3298-306 peptide (See page 854, col. 2, ¶1). GPC3 is overexpressed in cancers such as hepatocellular carcinoma, and iPSCs were generated from GPC3 peptide-vaccinated hepatocellular carcinoma patients (which reads on “the subjects in steps (1) and (2) are separate individuals and the subject in step (2) is a subject for cancer treatment” and “the subject in step (2) is a patient with hepatoma”) (See page 851, col. 1, full ¶4). The regenerated T cells reduced tumor size and increased survival in mice (which reads on “therapeutic agent for cancer”), “pharmaceutical composition”, and “method for… treating cancer”) (See fig. 4). Minagawa et al. also teach that exogenous gene transduction in iPSCs could prevent undesirable TCR rearrangement for obtaining antigen-specific T cells (See page 851, col. 1, full ¶2).
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 Nagano et al. to comprise transduction of the T cell-derived iPSC with exogenous TCR cDNA, such as that taught by Schumacher et al. and Minagawa et al., in the manner taught by Minagawa et al. One would be motivated to make this modification because Nagano et al. and Minagawa et al. suggest that transduction of T cell-derived iPSCs to express an exogenous TCR may improve the resulting regenerated T cells (See Nagano et al., page 132, col. 1, full ¶3 and Minagawa et al., page 852, col. 1, full ¶2). There would be a reasonable expectation of success in doing so because the iPSCs of Nagano et al. could be readily transduced with TCRαβ cDNA obtained from T cells positive for activation markers such as CD3 and CD137 and analyzed as taught by Schumacher et al.
Regarding claim 2: Following the discussion of claims 1, 5, 9, 12-13, 17, 19, and 31-34, Nagano et al., Schumacher et al., and Minagawa et al. do not expressly teach the TCR cDNA as derived from T cells contacted with a tumor-associated antigen after isolation. However, Schumacher et al. teach that TCRαβ pairs can be selected from reporter T cells modified to express the TCRs by stimulation with an antigen of interest (See ¶0010 and 0272).
It would have therefore been obvious to further modify the method of Nagano et al., modified by Schumacher et al. and Minagawa et al., to comprise contacting of T cells with an antigen post-isolation. The selection of any order of performing process steps is considered to be prima facie obvious in the absence of new or unexpected results. See MPEP 2144.04(IV)(C).
Regarding claim 4: Following the discussion of claims 1, 5, 9, 12-13, 17, 19, and 31-34, Nagano et al., modified by Schumacher et al. and Minagawa et al., render obvious the generation of regenerated T cells comprising exogenous TCRs but do not expressly teach preparation of the cDNA after or in parallel with initialization to iPSCs and selection of clones. However, the selection of any order of performing process steps is considered to be prima facie obvious in the absence of new or unexpected results. See MPEP 2144.04(IV)(C).
Regarding claim 7: following the discussion of claims 1, 5, 9, 12-13, 17, 19, and 31-34, Nagano et al. teach the assessment of alloreactivity in the regenerated T cells and selection of clones with low alloreactivity (See fig. 4). Such a step could readily be included in the method of Nagano et al., modified by Schumacher et al. and Minagawa et al., for selecting allogeneic or autologous regenerated T cells to avoid an alloreactive response in subjects receiving the cells.
Claims 1-5, 7, 9, 11-13, 17, 19, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020), of record, in view of Schumacher et al. (US 20210040558 A1) and Minagawa et al. (Cell Stem Cell, 2018), of record, further in view of Suzuki et al. (Cancer Science, 2011), of record.
The teachings of Nagano et al., Schumacher et al., and Minagawa et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claims 3 and 11: Following the discussion of claims 1-2, 4-5, 7, 9, 12-13, 17, 19, and 31-34, Nagano et al., modified by Schumacher et al. and Minagawa et al., render obvious the generation of regenerated T cells comprising exogenous TCRs but do not expressly teach isolation of T cell TCR genes from a subject administered a tumor-related antigen.
Suzuki et al. teach the generation of antigen specific T cell clones from which TCR cDNA was prepared (See page 1622, col. 2, full ¶1). Hepatocellular carcinoma patients were vaccinated with a GPC3 peptide, and cytotoxic T cells were isolated from patient PBMCs (which reads on “T cells obtained from a subject to whom a tumor-related antigen has been administered”) (See page 1622, col. 2, full ¶1). Suzuki et al. teach that the GPC3 peptide comprises the sequence FVGEFFTDV, which is identical to instant SEQ ID NO 2 (See page 1622, col. 1, ¶3 and alignment below).
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It would have been obvious to one having ordinary skill in the art to modify the method rendered obvious by Nagano et al., Schumacher et al., and Minagawa et al. to comprise isolation of TCR genes from cancer patients vaccinated with a HLA-restricted antigenic peptide, as taught by Suzuki et al. One would have been motivated to make this modification because Suzuki et al. teach that peptide-specific CTL clones could recognize and were active against GPC3-expressing cancer cell lines (See Abstract and fig. 1-2). There would be a reasonable expectation of success in doing so because TCR genes could be readily isolated from T cells of liver cancer patients vaccinated in such a manner.
Claims 1-2, 4-5, 7, 9, 12-14, 17, 19, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020), of record, in view of Schumacher et al. (US 20210040558 A1) and Minagawa et al. (Cell Stem Cell, 2018), of record, further in view of Yelensky et al. (US 20200363414 A1), of record.
The teachings of Nagano et al., Schumacher et al., and Minagawa et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 14: Following the discussion of claims 1-2, 4-5, 7, 9, 12-13, 17, 19, and 31-34, Nagano et al., modified by Schumacher et al. and Minagawa et al., render obvious the generation of regenerated T cells comprising introduction of exogenous TCRs via transposon but do not expressly teach the use of PiggyBac transposons.
Yelensky et al. teach the PiggyBac transposon as an exemplary vector for introducing TCRs into cells (See ¶0641-0642).
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 Nagano et al., modified by Schumacher et al. and Minagawa et al., to comprise the use of a PiggyBac transposon for expressing exogenous TCRs in iPSCs. One would be motivated to make this modification because Yelensky et al. teach such a vector as exemplary for this purpose (See ¶0641-0642). There would be a reasonable expectation of success in doing so because a PiggyBac system could be readily used for gene transfer.
Claims 1-2, 4-5, 7, 9, 12-13, 15-17, 19, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020), of record, in view of Schumacher et al. (US 20210040558 A1) and Minagawa et al. (Cell Stem Cell, 2018), of record, further in view of Nakauchi et al. (EP 2853590 B1), of record.
The teachings of Nagano et al., Schumacher et al., and Minagawa et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claims 15-16: Following the discussion of claims 1-2, 4-5, 7, 9, 12-13, 17, 19, and 31-34, Nagano et al., modified by Schumacher et al. and Minagawa et al., render obvious the generation of regenerated T cells comprising exogenous TCRs but do not expressly teach differentiation of the iPSCs and expansion of the resulting T cells on PBMC feeder cells.
Nakauchi et al. teach methods for producing antigen-specific T cells from T cell-derived iPSCs (See 0001). The maturing T cells can be stimulated with one or more of PHA, an anti-CD3 antibody, and an anti-CD28 antibody and can be co-cultured with allogeneic or autologous PBMCs (which reads on “autologous or cross peripheral blood mononuclear cells”) (See ¶0056-0058, 0065, 0139-0140, and 0142 and fig. 24).
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 Nagano et al., modified by Schumacher et al. and Minagawa et al., to comprise differentiation and expansion of the iPSC-derived T cells using antibodies against CD3 and CD28 or PHA and PBMCs, as taught by Nakauchi et al. One would be motivated to make this modification because Nakauchi et al. teach these agents as suitable for stimulation of the differentiating T cells (See ¶0056-0058 and 0065). There would be a reasonable expectation of success in doing so because Nakauchi et al. demonstrate these discrete combinations as supporting T cell maturation and expansion (See ¶0139-0140 and 0142).
Claims 1-2, 4-5, 7, 9, 12-13, 17, 19-20, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020), of record, in view of Schumacher et al. (US 20210040558 A1) and Minagawa et al. (Cell Stem Cell, 2018), of record, further in view of Nakauchi et al. (EP 2853590 B1), of record.
The teachings of Nagano et al., Schumacher et al., and Minagawa et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 20: Following the discussion of claims 1-2, 4-5, 7, 9, 12-13, 17, 19, and 31-34, Nagano et al., modified by Schumacher et al. and Minagawa et al., render obvious the generation of regenerated T cells comprising exogenous TCRs but do not expressly teach transduction of the TCRs into CD34+/CD43+ hematopoietic stem cells.
Giannoni et al. teach the transduction of TCR genes into Human hematopoietic stem/progenitor cells for generating transgenic T cells (See Abstract and fig. 1).
Vodyanik et al. teach that CD34 and CD43 are early markers of hematopoietic progenitors (See Abstract and fig. 1 and 3).
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 Nagano et al., modified by Schumacher et al. and Minagawa et al., to comprise transduction of the TCRs into CD34+/CD43+ hematopoietic stem cells differentiated from the iPSCs. One would be motivated to make this modification because Giannoni et al. demonstrate that TCR cDNA can be successfully introduced into hematopoietic stem cells for the generation of mature, antigen-specific T cells (See Abstract). One would also be motivated to use CD34+/CD43+ cells because Vodyanik teach those markers as indicative of hematopoietic progenitor cells (See Abstract). Such a modification could be readily made.
Claims 1-2, 4-5, 7, 9, 12-13, 17, 19, 22-24, and 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Nagano et al. (Molecular Therapy: Methods & Clinical Development, 2020), of record, in view of Schumacher et al. (US 20210040558 A1) and Minagawa et al. (Cell Stem Cell, 2018), of record, further in view of Healy et al. (Human Pluripotent Stem Cells, 2011), of record.
The teachings of Nagano et al., Schumacher et al., and Minagawa et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claims 22-24 and 30: Following the discussion of claims 1-2, 4-5, 7, 9, 12-13, 17, 19, and 31-34, Nagano et al., modified by Schumacher et al. and Minagawa et al., render obvious the generation of regenerated T cells comprising exogenous TCRs but do not expressly teach the construction of a master cell bank.
Healy et al. teach that the establishment of a cryopreserved master cell bank is a key part of assuring well-characterized, high-quality cells for research and industry (See page 17, full ¶1).
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 Nagano et al, modified by Schumacher et al. and Minagawa et al., to comprise the cryopreservation of at least some of the iPSC clones and/or regenerated T cells. One would be motivated to make this modification because Healy et al. teach the creation of a master cell bank to be good practice for cell culture applications (See page 17, full ¶1). There would be a reasonable expectation of success in doing so because the cells could be readily cryopreserved and stored for later differentiation and/or expansion.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M Babic, can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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