DETAILED ACTION
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 election with traverse of Group I, claims 5-7 in the reply filed on 11 May 2026 is acknowledged. In view of Applicant’s amendments, the restriction requirement is withdrawn, and claims 8-10 are rejoined and examined on the merits.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 11 March 2026 is hereby withdrawn. It is noted that once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim 5-10 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/KR2023/006022, filed May 3, 2023, which claims priority to Korean Patent Application Nos.: 10-2023-0024598, filed February 23, 2023, and 10-2022-0109087, filed August 30, 2022.
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 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (IDS; WO 2021/034164, Published 25 February 2021; US 2022/0339198, Published Oct. 27, 2022 utilized as an English translation, and referred to hereafter), in view of Brodie et al. (US 2020/0188440; Published 2020).
With regard to claims 5 and 8, Chang et al. teach treating a subject having Alzheimer’s disease by administering a composition comprising glia-like cells differentiated from a human mesenchymal stem cell (hMSC) to the subject, the benefits of administration including reducing the expression of inflammasomes, and improving long-term memory with respect to spatial perception ability and enhancing spatial cognitive ability (Abs.). As the glia-like cells are administered to the subject, administration provides for regeneration of glial cells in the subject.
Chang et al. do not specifically teach that the subject has vascular dementia.
Brodie et al. teach the treatment of aging-associated diseases, including Alzheimer’s disease and vascular dementia, by administering a composition comprising modified MSC, including MSC differentiated to astrocyte-like cells (Abs.; Para. 23, 102; Ex. 12).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Chang et al. and Brodie et al., because both teach the treatment of age-related dementias by administration of a composition comprising MSCs that have been differentiated to glia-like cells. The treatment of vascular dementia by administration of a composition comprising MSCs that have been differentiated to glia-like cells is known in the art as taught by Brodie et al. The treatment of a subject with vascular dementia using the method of Chang et al. amounts to the simple substitution of one known type of age-related dementia for another that is also known to be treatable with glia-like cells, and would have been expected to predictably and successfully provide treatment for the additional disease type. Further, the treatment of an additional type of age-related dementia, including vascular dementia as taught by Brodie et al., would have been expected to predictably improve the method of Chang et al. by allowing for the treatment of an additional type of dementia, thus rendering the method more useful for a wider population.
With regard to claims 6 and 9, Chang et al. teach that the hMSCs are derived from bone marrow, adipose tissue, blood, or skin (claim 4).
With regard to claims 7 and 10, Chang et al. teach that the hMSCs are passaged 10 to 15 times (claim 3), which is fully encompassed with in twice to 15 times.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 11 of copending Application No. 17/615575 (reference application), in view of Brodie et al. (US 2020/0188440; Published 2020). Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a method of treating an age-related dementia in a subject by administering glia-like cells induced from late-passaged hMSCs, including 13 to 15 passages, the hMSCs derived from bone marrow, adipose tissue, blood, or skin (Instant claims: 5-10; Reference application claims 1, 4, 11). The reference application does not specifically teach that the subject has vascular dementia.
Brodie et al. teach the treatment of aging-associated diseases, including Alzheimer’s disease and vascular dementia, by administering a composition comprising modified MSC, including MSC differentiated to astrocyte-like cells (Abs.; Para. 23, 102; Ex. 12).
It would have been obvious to one of ordinary skill in the art to combine the teachings of the reference application and Brodie et al., because both teach the treatment of age-related dementias by administration of a composition comprising MSCs that have been differentiated to glia-like cells. The treatment of vascular dementia by administration of a composition comprising MSCs that have been differentiated to glia-like cells is known in the art as taught by Brodie et al. The treatment of a subject with vascular dementia using the method of the reference application amounts to the simple substitution of one known type of age-related dementia for another that is also known to be treatable with glia-like cells, and would have been expected to predictably and successfully provide treatment for the additional disease type. Further, the treatment of an additional type of age-related dementia, including vascular dementia as taught by Brodie et al., would have been expected to predictably improve the method of the reference application by allowing for the treatment of an additional type of dementia, thus rendering the method more useful for a wider population.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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