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 .
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 6-10 are under examination.
Claim 1-5 are cancelled.
Response to Arguments
Applicant's arguments filed 11/03/2025 have been fully considered but they are not persuasive.
Applicant’s arguments: Claims 6 and 9-10 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Jin et al. (2014) as evidenced by Tasso et al. (2012). Amended claim 6 recites: "A method of increasing CD25-positive regulatory T cells, comprising: administering mesenchymal stem cells to a subject in need thereof; and inducing an increase in CD25-positive regulatory T cells in the kidney." Jin discloses a method for treating glomerulonephritis by administering stem cells (including MSCs) and describes their anti-inflammatory and immunomodulatory functions (Section 4.2.1). Figure 1 lists "Anti-inflammatory/immunomodulation" among the functions of stem cells and mentions "T regulatory cells." The Examiner considers that "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)." Notably, Jin does not disclose that administration of MSCs results in an increase in CD25-positive Tregs in the kidney. Tasso, at page 786 describes that MSCs exhibit immunosuppressive activity and can induce CD25-positive Tregs (p. 786, Purpose). The Examiner recognizes that MSCs are known to promote proliferation of CD25-positive Tregs. However, 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. "The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic.... In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." MPEP 2112.IV. Jin does not describe that administration of MSCs necessarily results in an increase in CD25-positive Tregs. Tasso does not disclose induction of CD25-positive Tregs by MSCs in vivo, or in the kidney. Jin, in view of Tasso, does not expressly or inherently anticipate the as- amended claims.
Claims 7-8 are rejected under 35 U.S.C. § 103 as being unpatentable over Jin as evidenced by Tasso, and further in view of Wang et al. (2018). The Examiner contends that "Jin teaches a method of increasing CD25-positive regulatory T cells in kidneys, comprising: administering mesenchymal stem cells to a subject in need thereof." Office Action at page 5. Applicant respectfully disagrees. As noted above, Jin, in view of Tasso, does not teach all of the limitations of amended claim 6. The Examiner acknowledges Jin does not teach administration of the mesenchymal stem cells in a cryopreservation solution, and relies on Wang, which mentions that administration of MSCs suspended in a solution containing 5 % DMSO is non-problematic. Wang does not cure the deficiency that Jin, in view of Tasso, fails to disclose that MSC administration increases CD25-positive Tregs in the kidney.
Examiner’s response: Jin teaches a method of administering mesenchymal stem cells to a subject in need thereof (page 2, section 2.1.1.). The effect of the administration of the mesenchymal stem cells to the subject in need is immune modulation which can increase regulatory T cells in kidneys (page 9, Figure 1). Jin does not specifically state the increase of CD25 in the kidney as a result of the treatment, but the identification of a feature of the cells provide does not separate the method of the present application from Jin. Jin teaches the administration of cells to modulate the immune cells which would inherently have the same results as administration of MSCs as taught by the present application.
Rejections maintained:
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.
Claims 6 and 9-10 are rejected 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).
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 have the ability to 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.
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).
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.
Claims 7-8 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) as applied to claim 6 above, and further in view of Wang et al. (Cytotherapy, 2018).
Jin teaches a method of increasing CD25-positive regulatory T cells in kidneys, comprising: administering mesenchymal stem cells to a subject in need thereof.
Jin does not teach administration of the mesenchymal stem cells in a cryopreservation solution.
Regarding claim 7, Jin teaches the limitations of claim 6, but does not teach the administration of MSCs 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.
Regarding claim 8, Wang teaches the use of DMSO (dimethyl sulfoxide) as a cryopreservation solution (page S57, poster 159).
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.
Conclusion
THIS ACTION IS MADE FINAL. 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
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638