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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 3/5/2026 has been entered.
Applicant’s amendment and response filed on 1/16/2026 has been received and entered into the case.
Claims 19-41, 43-55, 57-63 have been canceled, claims 69-70 are newly added, claims 1-18 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 42, 56, 64-70 have been considered on the merits. All arguments have been considered.
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.
Claim(s) 42, 56 and 64-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Depaepe (US 2013/0156773) in view of Rahmo et al. (2013, Journal of Life Sciences and Technologies; IDS ref.), Rahmo (US 10,041,037 B2) and Patel et al. (US 2013/0216505A1)
Depaepe teaches a method of treating a subject suffering from COPD by administering hematopoietic stem cells (Abstract; para. 114-115) at a therapeutically effective amount (para. 7 and 105). Depaepe teaches that the cord blood derived hematopoietic stem cell administered to the lungs result in repair and regeneration of lung tissue (para. 57). Depaepe teaches the use of hUCB-CD34+ cells (para. 137 and 182).
Depaepe does not teach the SMS cells.
It is noted that the term “small mobile stem cells” is defined as a cell or a cell population characterized in that the cells are adherent cells of about 5 mm in diameter (para. [0155] of PGPub).
Rahmo teaches that SMS cells are CD34 positive cells and very small and strongly adherent (Abstract), and they can differentiate into osteogenic, adipogenic and neurogenic cells (see entire document). Rahmo teaches that the CD34+ SMS cells are isolated from umbilical cord blood (col. 1, Field of the Invention; col. 4, lines 3-8).
Rahmo et al. teaches SMS cells and the SMS cells are stem cells capable of giving rise to osteogenic, adipogenic, neurogenic lineage cells (Examples 2-4), and have the ability to reconstruct a whole complex set up of tissue-like structures in the absence of special stimuli or supporting agents (col. 4, lines 16-18).
It would have been obvious to a person skilled in the art to use the CD34+ SMS cells of Rahmo and Rahmo et al. for the method of repairing lung tissue of a subject suffering from COPD taught by Depaepe.
A person of ordinary skilled in the art would have reasonable expectation of success because the SMS cells of Rahmo and Rahmo et al. possess the ability to repair damaged tissue as hematopoietic stem cells of Depaepe. Furthermore, the CD34+ cells isolated from cord blood taught by Depaepe would inherently comprise CD34+ SMS cells, and considering their ability to repair a tissue or organ, one skilled in the art would reasonably expect that the CD34+ SMS cells isolated from cord blood would have comparable ability as CD34+ HSCs taught by Depaepe. In the absence of any evidence to the contrary, one skilled in the art would recognize that the SMS cells of Rahmo and Rahmo et al. are suitable alternative to the CD34+ HSCs of Depaepe for tissue repair and thus, treating COPD.
Regarding the SMS cells being aerosolized (claim 42), Depaepe in view of Rahmo and Rahmo et al. do not particularly teach the limitation.
Patel et al. teach a method of repairing COPD in a subject by administering stem cells (para. 4, 12), and the stem cells can be aerosolized (para. 103 and 106).
It would have been obvious to a person skilled in the art to aerosolize the SMS cells of Rahmo and Rahmo et al. for the method of Depaepe with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because it is known in the art that aerosolization of stem cells is a suitable delivery means for treating COPD in a subject.
Regarding the limitation of claims 64 and 67-68, the wherein clause is directed to the result of the claimed method. The combined teachings of the cited references meet the claimed method, the results are expected the same.
Regarding claim 65 directed to an antibiotic medication, Depaepe teaches that one or more other standard therapeutic agents can be combined including antibiotics (para. 140).
Regarding claim 66 directed to a pharmaceutically acceptable ingredients including carriers, excipients, diluents (para. 146-147).
Regarding claim 69, Depaepe teaches that the effective amount of hematopoietic stem cells comprise at least 9x106 (para. 121), and this teaching overlaps with the claimed 109 SMS cells.
Regarding claim 70, Depaepe in view of Rahmo, Rahmo et al. and Patel et al. do not particularly teach that the composition being administered at least three times. However, the dosage of the aerosolized SMS cells for treating COPD as contemplated by the combined teachings of Depaepe in view of Rahmo, Rahmo et al. and Patel et al. can be readily modified in order to obtain desired outcome of the method. Furthermore, it is well known in the art that aerosol delivery is carried out multiple times and thus, one skilled in the art would recognize that the aerosolized SMS cells would be administered multiple times with a reasonable expectation of success.
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 filed 1/16/2026 have been fully considered but they are not persuasive. The claim rejection under 35 U.S.C. 112(a) has been withdrawn.
It is noted that the above claim rejection is a new.
Conclusion
No claims are allowed.
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
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