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 6/24/2026 has been received and entered into the case.
Claims 3-4 and 7-18 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-2 and 5-6 have been considered on the merits. All arguments have been considered.
The claim rejection under 35 USC 103 based on Daley et al. has been withdrawn due to the instant amendment.
Claim Rejections - 35 USC § 103 (New Rejection)
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(s) 1-2 and 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Menasche et al. (US 2019/0255219; IDS ref.) in view of Burridge et al. (2011, PLoS ONE) and Sagaradze et al. (2019, Int. J. Mol. Sci.; of record)
Regarding claim 1, step (a), Menasche et al. teach a method of culturing cardiac progenitor cells derived from induced pluripotent cells (iPS) in a serum-free medium comprising FGF2 (Example 1, para. 112). This method is for proliferating the cardiac progenitor cells.
Menasche et al. do not particularly teach the use of human serum albumin (HSA).
Burridge et al. teach the method of differentiating hPSC into cardiomyocyte, and the method includes steps of hEB formation and mesoderm induction and then cardiac specification (Phase 2 and 3) (see Fig. 1A), and one skilled in the art would recognize that the cells in Phase 2 and 3 of the Burridge et al. are cardiac progenitor cells as they would differentiate into cardiomyocytes. According to Burridge et al., Phases 2 and 3 involve the culture medium comprising a basal medium (RPMI medium), BMP4 and FGF2 (growth factors) for Phase 2; and RPMI+FBS or RPMI+HSA (human serum albumin) for Phase 3. Burridge et al. teach the use of human serum albumin is required for serum-free medium to maintain cardiac differentiation (Table 1).
It would have been obvious to a person skilled in the art to use HSA taught by Burridge et al. as a supplement to a serum-free medium of Menasche et al. with a reasonable expectation of success.
Regarding the steps (b)-(c), Menasche et al. teach the step of producing EVs by the cardiac progenitors cultivated in serum-free medium (para. 112). However, they do not teach the serum-free medium without HSA or growth factors.
It would have been obvious to a person skilled in the art to prepare the conditioned medium and subsequently EVs from the cells cultivated in a serum-free medium without any supplements. For example, Sagaradze et al. teach that the conditioned medium is collected using basal medium, DMEM-LG (low glucose) or DMEM with NutriStem XF Basal Medium (p.10, 4.3. Collection of MSC conditioned medium). Sagaradze et al. teach that it is important to note that only basal media without nutrimental supplement (FBS or NutriStem supplement) were used for MSC conditioning because of high-risk influence on the biosafety of a final product in clinical application (p.2 and 8).
It would have been obvious to a person skilled in the art to use the serum-free medium of Menasche et al. without comprising any supplement, i.e. HSA and FGF2, as the additional supplements are not desired for preparing therapeutic composition comprising the secretome, i.e. EVs and other factors secreted from the cells.
Regarding claim 2 directed to the step of concentrating or enriching for a small extracellular vesicle-enriched fraction (sEV) from the medium, Menasche et al. teach the isolation of EVs (para. 112), and this step is understood that the EVs are isolated from the conditioned medium obtained by culturing the cardiac progenitors in a serum-free medium. By doing so, Menasche et al. would inherently meet the step of concentrating or enriching sEV from the medium.
Regarding claims 5-6 directed to the therapeutic composition suitable for administration to a patient comprising producing a secretome-containing composition of claim 1 or sEV of claim 2, the combined teachings of the cited references would meet the step of producing a secretome-containing composition (i.e. conditioned medium obtained from culturing cardiac progenitor) or an sEV-containing composition (i.e. enriched exosomes from the conditioned medium) as discussed above.
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 with respect to claim rejection under 35 U.S.C. 103 based on Daley et al. in view of Mintz et al., Sagaradze et al., Vallee et al. and Sahoo et al. have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument due to the instant amendment.
The new claim rejection based on Menasche et al. in view of Burridge et al. and Sagaradze et al. is presented above due to the instant amendment limiting the progenitor cells being cardiac progenitor cells.
Relevant Prior Art
The following prior art is relevant to the subject matter of the instant claims but not cited in the claim rejection(s).
Cornwell et al. (2018, Stem Cell Research): Cornwell et al. teach that cardiac progenitor/stem cell, cardiac colony forming unit-fibroblasts (cCFU-F) are cultured in a serum-free medium comprising growth factors for self-renewal.
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
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