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 .
Applicant’s amendment and response filed on 10/17/2025 has been received and entered into the case.
Claims 2-5 have been canceled, claims 6-8 are newly added, and claims 1 and 6-8 have been considered on the merits. All arguments have been considered.
The claim rejections under 35 USC 112(a), 102 and 103 have been withdrawn due to the instant amendment. The instant amendment necessitates new ground of rejection (see 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.
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.
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.
Claim(s) 1 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al. (of record).
Kato et al. teach a method of administering a repair agent for damaged tissue, and the repair agent comprises MSCs that have been cultured in a serum-free medium to a target (paras. 10-11, 102-103). Kato et al. teach that the damaged tissue is tissue damage that accompanies spinal cord damage, multiple sclerosis, myocardial infarction, stroke, Alzheimer’s disease, etc. (para. 12, 111 and 126) and the tissue to be treated with the repair agent includes spinal cord, a brain (para. 125).
Kato et al. teach that the MSCs are derived from various known sources including a synovial membrane (para. 109).
It would have been obvious to a person skilled in the art to administer synovial membrane derived mesenchymal stem cells cultured in a serum-free medium for treating central nervous system disease including spinal cord damage, multiple sclerosis, myocardial infarction, stroke, or Alzheimer’s disease as taught by Kato et al. with a reasonable expectation of success.
Regarding claim 6, Kato et al. teach that the method of administration of the repair agent include an intravenous injection (para. 115).
Regarding the concentration of MSCs (claim 7), Kato et al. teach the amount of administration of the repair agent of an embodiment of the present invention is 1x104 mesenchymal stem cells to 1x1010 mesenchymal stem cells (para. 117).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al. as applied to claim 1 above, and further in view of Yang et al. (US 2011/0262393; of record).
Regarding claim 8 directed to the synovial membrane-derived MSCs being cryopreserved and tawed prior to administration, Kato et al. do not particularly teach the limitation.
It is extremely well known in the art that stem cells for therapeutic applications can be cryopreserved. For example, Yang et al. teach a method of treating neural disease including Alzheimer's disease, Parkinson's disease, depression, epilepsy, multiple sclerosis (para. 66) by using MSCs derived from various sources including synovial membrane (para. 106). Yang et al. teach that the cells can be preserved in a frozen form (para. 75). Thus, it would have been obvious to a person skilled in the art to cryopreserve the synovial membrane-derived MSCs of Kato et al. prior to the administration with a reasonable expectation of success. Furthermore, one skilled in the art would recognize that the cryopreserved cells would require to be thawed prior to the administration.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
Applicant’s arguments have been fully considered and are persuasive in view of the instant amendment. Therefore, the rejections under 112(a), 102 and 103 have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made (see above). In view of the new claim rejection under 35 U.S.C. 103, applicant’s argument is moot as Kato et al. is not relied as an 102 art, and it is now cited as a primary ref. for the 103 rejection.
Applicant argued that Kato et al. briefly mention “synovial membrane” and there is no example in which synovial membrane-derived MSCs were used actually. As argued, Kato et al. disclose “synovial membrane” as one of various sources of the MSCs utilized in the therapeutic application. Thus, while Kato et al. do not particularly show any example of using the synovial membrane-derived MSCs, however, it would have been obvious to a person skilled in the art to use synovial membrane-derived MSCs for the method of Kato et al. with a reasonable expectation of success as Kato et al. recognize that the synovial membrane-derived MSCs as one of MSCs suitable for the method.
The actual reduction to practice is not a requirement for the obviousness rejection. Rather, the requirement is a reasonable expectation of success. As Kato et al. teach MSCs can be used in treating various CNS diseases including those claimed, and the MSCs can be from any sources including synovial membrane, there is a reasonable expectation of success in the absence of any evidence to the contrary. Furthermore, obviousness does not require absolute predictability but at least some degree of predictability is required (MPEP2143.02). The teachings of Kato et al. as well as Yang et al. cited in the claim rejections above would provide a reasonable expectation of success in using the synovial membrane-derived MSCs in treating CNS diseases.
Applicant alleged that it would have been difficult for a person skilled in the art to conceive that synovial membrane-derived MSCs cultured in a serum-free medium yield an excellent therapeutic effect on a CNS disease. There is no evidence to support the allegation that the claimed method provides “excellent” therapeutic effect on a CNS disease in the instant specification, or the claims do not require such “excellent” therapeutic effect.
Applicant is advised to provide factual evidence, if there is any, showing that the synovial membrane-derived MSCs would provide superior and unexpected results in comparison to any other known MSCs in treating the CNS diseases as claimed in order to obviate the 103 rejections presented above.
Conclusion
No claims are allowed.
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 TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631