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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 response filed March 23, 2026 has been received and entered into the application file. All arguments have been fully considered.
Claims 1-6 and 8-21 from the claim set filed March 12, 2026 are pending. Claim 7 is cancelled. Claims 15-21 are withdrawn. Thus claims 1-6 and 8-14 are being examined on the merits herein.
Rejection(s) Withdrawn
Claim Rejections - 35 USC § 102
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.
RE: Claims 1, 6, 7, 9, 10, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mader.
Applicant amended claim 1 to now require infection of the MSCs while said cells are in the pelleted state. Mader does not teach said limitation. As such, the previously filed rejections are withdrawn. However, Applicant amendment has necessitated new grounds of rejection as set forth below.
Claim Rejections - 35 USC § 103
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.
RE: Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mader, as applied to claims 1, 6, 9, 10 and 14 above.
Claims 2-4 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mader in view of Ra.
For the reasons discussed above, the anticipation rejection over Mader is withdrawn, and thus the obviousness rejections that are based on the same basis are likewise withdrawn. However, Applicant amendment has necessitated new grounds of rejection as set forth below.
New ground(s) of Rejection, necessitated by Amendment
Claim Rejections - 35 USC § 102
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 1-6, 8-11 and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by RA (WO 2019240559 A1, published 12/19/2019, EFD 6/17/2019; PTO 892).
The rejection over RA discussed below is reliant upon the English Translation of RA (RA, WO 2019240559 A1, published 12/19/2019, EFD 6/17/2019, English Translation; PTO 892).
The applied reference has a common Applicant (R BIO CO; NATURECELL CO) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
RA teaches (p1, Claims (18)):
(RA claim 1): A method for producing mesenchymal stem cells containing anticancer virus (i.e., oncolytic virus) with improved cell viability, including the following steps:(a) preparing mesenchymal stem cells in a pellet state;(b) infecting an anticancer virus (i.e., measles virus) to the mesenchymal stem cells in the pellet state;(c) centrifuging the mesenchymal stem cells infected with the anticancer virus; and (d) obtaining mesenchymal stem cells into which the anticancer virus is introduced (and thus have improved cell viability) (i.e., instant claim 1).
(RA claim 2): The method of claim 1, wherein the mesenchymal stem cells of step (a) are cultured in a medium containing aspirin (i.e., instant claim 2).
(RA claim 3): The method of claim 2, wherein the medium further contains vitamin C (i.e., instant claim 3).
(RA claim 4): The method of claim 1, wherein the mesenchymal stem cells of step (a) are pretreated with vitamin C (i.e., instant claim 4).
(RA claim 5): The method according to claim 1, wherein the mesenchymal stem cells of step (b) are 1 x 10 ^5 to 1 x 10^ 6 cells (i.e., instant claim 5).
(RA claim 6): The method of claim 1, wherein the mesenchymal stem cells are derived from a tissue selected from the group consisting of fat, uterus, bone marrow, muscle, placenta, umbilical cord blood, urine, hair follicles and skin (i.e., instant claim 6).
(RA claim 7): The method of claim 1, wherein the anticancer virus is a measles virus (incorporated into instant claim 1).
(RA claim 8): The method according to claim 1, wherein the anticancer virus of step (b) is 1 x 10 5 to 1 x 10 7 TCID50 (i.e., instant claim 8).
(RA claim 9): The method of claim 1, wherein the anticancer virus of step (b) is an attenuated anticancer virus (i.e., instant claim 9).
(RA claim 10): The method of claim 1, wherein the infection of step (b) is carried out for 30 minutes at 36 ~ 37 ℃ (i.e., instant claim 10). T
(RA claim 11): The method according to claim 1, wherein the anticancer virus of step (c) is treated with natural products to the mesenchymal stem cells.
(RA claim 12): The method of claim 11, wherein the natural product is an anticancer agent or an antioxidant.
(RA claim 13): The method of claim 12, wherein the anticancer agent is aspirin or paclitaxel (i.e., instant claim 11).
(RA claim 14): The method according to claim 12, wherein the antioxidant is alder extract or vitamin C.
(RA claim 15): The method of claim 1, wherein the mesenchymal stem cells of step (d) are not cultured further after the anticancer virus is introduced (i.e., instant claim 14).
Thus, RA anticipates claims 1-6, 8-11 and 14 and therefore said claims are properly rejected.
Claim Rejections - 35 USC § 103
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.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over RA in view of Mader (previously cited).
In regards to claim 12, Ra anticipates the method of claim 11. Ra does not teach wherein the treatment with aspirin is performed using a vehicle containing autologous serum.
As discussed in the previously filed OA, Mader teaches MSCs as carriers to deliver measles virus (Abstract). Mader teaches the use of autologous patient derived MSC to deliver oncolytic MV for a phase I clinical trial in ovarian cancer (Title, Abstract, p10, 1st column, 1st paragraph). Mader additionally teaches autologous MSCs can be safely administered and tolerated in humans (p10, 1st column, 1st paragraph).
As noted supra, RA does not teach autologous serum nor does RA teach autologous MSCs. RA does teach the method discussed above relates to a cell therapy product for treating cancer (Abstract). Thus, both Mader and RA teach the use of MSCs as carriers for measles virus for the treatment of cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to do a simple substitution of one known element for another to obtain predictable results. It would have been obvious to substitute the autologous MSCs of Mader in the place of the MSCs of RA for the treatment of cancer.
The skilled artisan would have had a reasonable expectation of successfully substituting said cells due to both Mader and RA studying MSCs as carriers of oncolytic virus for the treatment of cancer. Substitution of one element for another known in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Further, as Mader teaches the use of autologous patient derived MSC to deliver oncolytic MV, it would thus be a matter of obvious design choice to use a vehicle containing autologous serum for the aspirin treatment. It would have been obvious to a POSITA, before the effective filing date of the claimed invention, to perform the aspirin treatment via a vehicle containing autologous serum, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Thus, the claim is obvious and is properly rejected.
In regards to claim 13, Mader and Ra make obvious the method of claim 12. Ra does not teach a specific temperature for treating the MSCs with aspirin. However, Mader teaches virus infected MSCs were incubated overnight at 4 degrees Celsius (p11, Virus infection). Thus, this reads on the treatment taking place between 0.1 to 10 degrees Celsius. Therefore, it would be obvious to treat with aspirin at 4 degrees Celsius.
Thus, the claim is obvious and is properly rejected.
Conclusion
No claim is allowed. No claim is free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE R SMALL whose telephone number is (703)756-4783. The examiner can normally be reached Monday - Friday 8:30am-4pm.
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/KATHERINE R SMALL/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
