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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/2026 has been entered.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119
(a)-(d). Acknowledgment is made of Applicants’ claim for benefit to foreign applications JP2020-071737 filed 04/13/2020.
This application claims the benefit of priority to Patent Application PCT/JP2021/015093.
Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application
Number PCT/JP2021/015093, filed on 04/09/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 10/12/2022, 12/07/2022, and 04/17/2024 have been considered by the Examiner.
Status of Claims
Claims 6 and 8-10 are under examination.
Claims 1-5 and 7 are cancelled.
Claim Rejections - 35 USC § 102
Rejection to claims 6 and 9-10 under 35 U.S.C. 102(a)(1) as being anticipated by Jin et al. (BioMed Research International, 2014) as evidenced by Tasso et al. (Invest Ophthalmol Vis Sci., 2012) have been withdrawn in view of the applicant’s amendments filed 04/28/2026.
Response to Arguments
Applicant's arguments and amendments filed 04/28/2026 have been fully considered and they are persuasive.
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.
Rejections necessitated by amendment:
Claims 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Jin et al. (BioMed Research International, 2014) as evidenced by Tasso et al. (Invest Ophthalmol Vis Sci., 2012) in view of Wang et al. (Cytotherapy, 2018).
Regarding claim 6, Jin teaches a method of administering mesenchymal stem cells to a subject in need thereof (page 2, section 2.1.1.). Jin teaches stem cell-based therapy for Glomerulonephritis is successful and postulate various reasons including immune modulatory functions of MSCs which may increase regulatory T cells in kidneys (page 9, Figure 1). Mesenchymal stem cells are known to have immunosuppressive properties and further can promote induction of CD25+ T regulatory cells as evidenced by Tasso et al (page 786, purpose).
Therefore, it is inherent that mesenchymal stem cells would increase CD25+ T regulatory cells because it is a known feature of mesenchymal stem cells. The MSCs administered to the kidney of a subject suffering from Glomerulonephritis would increase CD25+ T regulatory cells. Furthermore, the “increasing CD25-positive regulatory T cells in kidneys” is recited in the preamble and is an intended use. The claims do not recite limitations or active steps that reflect that intended use.
Jin does not teach administration of the mesenchymal stem cells in a cryopreservation solution.
Wang teaches administration of mesenchymal stem cells in a cryopreservation solution of 5% DMSO compared to DMSO-free controls (page S57, poster 159). Therefore, with association of DMSO to adverse side effects in transplant patients one would use 5% or less of DMSO in their injection to decrease the risk of side effects.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Jin et al. for administration of MSCs to increase CD25-positive regulatory T cells in kidneys with the teachings of Wang et al. for administration of MSCs to a subject in a cryopreservation solution. Wang et al. provide motivation by teaching that cryoprotectants are extensively used in blood and bone marrow stem cell transplantation and that 5% DMSO is not associated with adverse side effects in patients. One of skill in the art would have had a reasonable expectation of success at combining Jin et al. and Wang et al. because both teach the administration of stem cells to a subject.
Regarding claim 8, Wang teaches the use of DMSO (dimethyl sulfoxide) as a cryopreservation solution (page S57, poster 159).
Regarding claim 9, Jin teaches the subject is suffering from renal disease (page 1, abstract).
Regarding claim 10, Jin teaches the patient is suffering from renal disease and that renal disease is glomerulonephritis (page 1, abstract).
Response to Arguments
Applicant's arguments filed 04/28/2026 have been fully considered but they are not persuasive.
Applicant’s argument: Wang fails to cure the deficiencies noted above with respect to the teachings of Jin in view of Tasso. The alleged "known feature" of Tasso is with respect to in vitro results and does not necessarily and inevitably result in inducing an increase in CD25-positive regulatory T cells in the kidney. According to the teachings of Tasso, the induction of CD25-positive Tregs by MSCs was demonstrated only in vitro, and there is no disclosure of any in vivo increase, let alone in the kidney. Tasso does not disclose induction of CD25-positive Tregs by MSCs in vivo, or in the kidney. The combination of Jin in view of Tasso with Wang does not render claims 6 and dependent claim 8 obvious. Moreover, Wang does not disclose "wherein the infusion or the medium comprises a cryopreservation solution at a concentration of less than 5% (v/v)" as recited in claim 6.
Examiner’s response: Tasso et al. teach Mesenchymal stem/progenitor cells (MSCs) have regenerative and immunomodulatory properties. Tasso et al. teach MSCs promote the induction of CD25+ T lymphocytes with regulatory functions (Treg) (page 786, Purpose). For these reasons the authors further studied the induction of Tregs and the development of autoimmunity. Tasso et al. teach some of the animals were treated intraperitoneally with syngeneic MSCs. Tasso et al. also checked T-cell responses and in vitro Treg conversion by cell proliferation and blocking assays, in cell-cell contact and transwell settings (page 786, Methods). As recited above, Wang teaches administration of mesenchymal stem cells in a cryopreservation solution of 5% DMSO compared to DMSO-free controls (page S57, poster 159), which reads on wherein the infusion or the medium comprises a cryopreservation solution at a concentration of less than 5% (v/v).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
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