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 .
Status of Application, Amendments and/or Claims
The amendment of 23 October 2025 has been entered in full. Claims 1, 6-10, 12-17, and 20 are amended. Claims 2-5, 11, 18, and 19 are cancelled.
Claims 1, 6-10, 12-17, and 20 are under consideration in the instant application.
Oath/Declaration
It is noted to Applicant that as stated in the Communications of 20 June 2023 and 10 March 2023, a properly executed inventor’s oath or declaration has not been received for the inventors of the instant application. Although no time period for reply is set forth in the instant Office Action, Applicant must submit the inventor’s oath or declaration in compliance with 37 CFR 1.63, or a substitute statement in compliance with 37 CFR 1.64, executed by or with respect to each actual inventor no later than the expiration of the time period set forth in the “Notice of Allowability” to avoid abandonment (see 37 CFR 1.53(f)).
Withdrawn Objections and/or Rejections
1. The objections to claims 12-17, 19, and 20 as set forth at pages 2-3 of the previous Office Action of 10 September 2025 are withdrawn in view of the amended and cancelled claims (23 October 2025).
2. The rejection of claims 1-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (enablement) as set forth at pages 3-9 of the previous Office Action of 10 September 2025 is withdrawn in view of the amended claims and the declaration of Dr. Amit Patel under 37 CFR 1.132 filed 23 October 2025 (in its entirety).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
3. Claims 6 and 13-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 6 recites the method of claim 1, wherein said mesenchymal stem cell population derived from umbilical cord tissue expresses two or more of the following markers: a) CD73; b) CD90; c) CD105; and d) SSEA3 or SSEA4.
Claim 13 recites the method of claim 8, wherein said umbilical cord tissue derived mesenchymal stem cell population expresses two or more of the following markers: a) CD10; b) CD13; c) CD44; d) CD73; e) CD90; f) PDGRr-alpha; g) PD-L2; and h) HLA-A,B,C.
Claim 14 recites the method of claim 8, wherein said umbilical cord tissue derived mesenchymal stem cell population does not express two or more of the following markers: a) CD31; b) CD34; c) CD45; d) CD80; e) CD86; f) CD117; g) CD141; h) CD178; i) B7-H2; j) HLA-G and k) HLA-DR,DP,DQ.
Claim 15 recites the method of claim 8, wherein said umbilical cord tissue derived mesenchymal stem cell population secretes two or more factors selected from the group consisting of: a) MCP-1; b) MIP1beta; c) IL-6; d) IL-8; e) GCP-2; f) HGF; g) KGF; h) FGF; i) HB-EGF; j) BDNF; k) TPO; l) RANTES; and m) TIMP1.
Claim 16 recites the method of claim 8, wherein said umbilical cord tissue derived mesenchymal stem cell population expresses one or more markers selected from a group consisting of: a) TRA1-60; b) TRA1-80; c) SSEA3; d) SSEA4; and e) NANOG.
The specification as originally filed does not provide adequate written description for (i) an umbilical cord tissue derived mesenchymal stem cell population that expresses two or more markers (claim 6, 13); (ii) an umbilical cord tissue derived mesenchymal stem cell population that does not express two or more markers (claim 14); (iii) an umbilical cord tissue derived mesenchymal stem cell population that secretes two or more factors (claim 15); and (iv) an umbilical cord tissue derived mesenchymal stem cell population that expresses one or more markers (claim 16).
The “two or more” and “one or more limitations” as recited in claims 6 and 13-16 are not expressly asserted, nor do they flow naturally from the specification. At the top of the Remarks section of the Response of 23 October 2025, Applicant states that support for the amended claims may be found throughout the specification, non-exclusively including [0011], [0024], [0047], [00110], and original claim 2. Upon the Examiner’s independent review, the specification only teaches:
Preferred methods include embodiments wherein said cord tissue derived mesenchymal stem cell expresses a marker selected from a group of markers comprised of: a) CD10 b) CD13; c) CD44; d) CD73; e) CD90; f) PDGFr-alpha; g) PD-L2; and h) HLA-A,B,C (page 12, [0039]);
Preferred methods include embodiments wherein said cord tissue mesenchymal stem cells does not express one or more markers selected from a group comprising of; a) CD31; b) k) CD34; c) CD45; d) CD80; e) CD86; f) CD117; g) CD141; h) CD178; i) B7-H2; j) HLA-G and k) HLA-DR,DP,DQ (page 12, [0040]);
Preferred methods include embodiments wherein said umbilical cord tissue-derived cell secretes factors selected from a group comprising of: a) MCP-1; b) MIP1beta; c) IL-6; d) IL- 8; e) GCP-2; f) HGF; g) KGF; h) FGF; i) HB-EGF; j) BDNF; k) TPO; 1) RANTES; and m) TIMP1 (page 12, [0042]); and
Preferred methods include embodiments wherein said umbilical cord tissue derived cells express markers selected from a group comprising of: a) TRA1-60; b) TRA1-81; c) SSEA3; d) SSEA4; and e) NANOG (page 12, [0043]).
Therefore, the Examiner is unable to locate where the specification provides adequate written description of (i) an umbilical cord tissue derived mesenchymal stem cell population that expresses two or more markers (claim 6, 13); (ii) an umbilical cord tissue derived mesenchymal stem cell population that does not express two or more markers (claim 14); (iii) an umbilical cord tissue derived mesenchymal stem cell population that secretes two or more factors (claim 15); and (iv) an umbilical cord tissue derived mesenchymal stem cell population that expresses one or more markers (claim 16).
It is noted that the Examiner attempted to contact Applicant’s representative on 13 February 2026 and 17 February 2026 to discuss a proposed Examiner’s amendment to place the instant application in condition for allowance. However, Applicant’s representative could not be reached because no one answered the phone and the voicemail box was too full to leave a message.
Conclusion
Claims 6 and 13-16 are rejected. Claims 1, 7-10, 12, 17, and 20 are allowable.
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 BRIDGET E BUNNER whose telephone number is (571)272-0881. The examiner can normally be reached Monday-Friday 9:00 am-6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BEB
Art Unit 1647
17 February 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647