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 .
Response to Amendment
Applicant's amendment and argument filed 06/29/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-21 are pending of which claims 10-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/04/2025.
Claims 1-9 and 21 are being examined on the merits.
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.
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 1-9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Zhonhliang Jiang et. al. (From IDS, Comparative cytocompatibility of multiple candidate cell types to photoencapsulation in PEGNB/PEGDA macroscale or microscale hydrogels, Biomed Mater, 2018, October 2nd; 13(6):065012) and Wei Aiqi et. al. (CN119876013A).
Regarding claims 1 and 5, Jiang discloses both polyethylene glycol diacrylate (PEGDA) and polyethylene glycol norbornene (PEGNB) photopolymerized hydrogels having thiol-ene linkages for the PEGNB for encapsulating cells to act as cell carriers (see page 4, 1st para.) and further discloses wherein “The initiator species was synthesized in accordance with previously published procedures [88,94,97]. Briefly, 3.0 g of 2,4,6-trimethylbenzoyl chloride (Sigma Aldrich, USA) was added dropwise to a 250 mL round bottom flask containing an equimolar amount of dimethyl phenylphosphonite and stirred at room temperature under nitrogen overnight” (see page 5, materials and methods).
Regarding claim 3, Jiang discloses wherein the PEGNB microgels were ranging in diameter from 50 um to 160 um (see page 9, results and discussion).
Regarding claim 4, Jiang discloses that after 14 days (336 hours) there were viable cells with encapsulation from PEGNB of about 80% (see figure 6).
Regarding claims 6-7, Jiang discloses that the PEGNB hydrogel is in a final concentration of 10 mM dithiol linker (Mn ≈1500 Da, Sigma Aldrich, USA) (see hydrogel forming solution, page 6).
Regarding claim 9, Jiang discloses that the composition is for controlled cell interactions through microfluidic-based droplet forming techniques (see right column, page 2).
Jiang does not specifically teach that the mesenchymal stem cells exhibit increased expression of one or more secretome factors relative to monolayer stem cells after culture.
Aiqi teaches of culture methods for improving proliferation activity and factor secretion of mesenchymal stem cells, which is characterized in that the mesenchymal stem cells are cultured in a low-oxygen environment (see claim 1) and teaches wherein the factors comprise expression products of one or more of multipotency-related genes Sox2, nanog and Klf4, angiogenesis-related genes VEGF, TGF- β1, VEGF-A and BMP4, immunoregulatory-related genes IL-10, IL-6 and iNOS (see claim 5). Aiqi teaches that therefore, the characteristics of various tissue sources of the mesenchymal stem cells make the mesenchymal stem cells become a brand-new and abundant seed cell for cell therapy, gene therapy and bone or cartilage tissue engineering, and have wide clinical application prospects. However, the number of primary mesenchymal stem cells just isolated is too small to meet the requirements in clinical treatment and research. Therefore, a large number of mesenchymal stem cells need to be cultured in vitro, which requires a good cell culture method as a basis for growth and proliferation of cells and secretion of related factors (see background 1st para.).
At the same time, the expression of pluripotency-related genes, angiogenesis-related genes and immune regulation-related genes by the mesenchymal stem cells was improved, and the secretion of related factors was increased, without affecting the specific surface marker genes of the mesenchymal stem cells, and without affecting the heterogeneity and homogeneity of the cell group (see abstract).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use the culturing methods taught by Aiqi in the composition taught by Jiang so that one could create a composition in which the MSC’s proliferated and had increased expression of TGF- β1, VEGF-A for reasons of improving expression of pluripotency-related genes, angiogenesis-related genes and immune regulation-related genes by the mesenchymal stem cells. It would have been obvious to optimize the MSCs which can be released from the hydrogels within 48 hours after encapsulation or dispersion within the hydrogel or 14 days after culture because there are available techniques for doing so as discussed by Jiang and it appears to be a matter of mere judicious selection.
Response to Arguments
Applicant’s arguments filed 06/29/2026 have been fully considered but they are not persuasive. The applicant argues that the relied upon art does not teach the new amendment of controlling release of the secretome production of the MSC. The Office relies on new art by Aiqi which teaches the newly amended limitations as can be appreciated from the above rejection.
Conclusion
Currently 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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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