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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 4th of August 2026 has been entered.
Priority
This application was filed Oct. 6, 2021, and is a 371 application of PCT/KR2020/006574 filed on May 20, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
The certified copy has been filed in parent Application No. KR10-2019—0068929 filed on June 11, 2019, and makes reference to or appears to claim subject matter of Hyaluronic acid (see e.g. fig. 2), disclosed in Application No. KR10-2019—0068929 filed on June 11, 2019.
The disclosure of the prior-filed application, Application No. KR10-2019—0068929 filed on June 11, 2019, fails to provide adequate support or enablement in the manner for Lanifibranor provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The certified copy has been filed in parent Application No. KR10-2020-0001518 filed on January 6, 2020, and makes reference to or appears to claim subject matter of Lanifibranor (see e.g. fig. 2), disclosed in Application No. KR10-2020-0001518 filed on January 6, 2020.
Thus, the earliest priority date for the instant claims of the invention regarding Hyaluronic acid are accorded the filing date of June 11, 2019, and the instant claims of the invention regarding Lanifibranor are accorded the filing date of January 6, 2020.
Claim Status
In the response filed on the 4th of August 2026, Applicant has amended claim 10 and cancelled claims 1-9, 11 and 13.
Currently, claims 10, 12, and 14-17 are under examination in this Office Action.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
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.
Claims 10, 12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, et al. (WO2019/107939 A1, published June 6, 2019, hereinafter as “Kim”), Boubia, et al. (Journal of medicinal chemistry 61.6: 2246-2265, 2018, cited IDS 7/12/2024), and Nunez, et al. (Diabetes 67.Supplement_1: 1120-P, 2018).
This is a new rejection necessitated by amendment to the claims.
Regarding claim 10, Kim discloses a method for promoting production of stem cell-derived exosomes (see e.g. title, claims, p. 4, 7, 9-10). Kim discloses (a) culturing stem cells in a cell culture medium containing the pretreatment agent of pioglitazone (i.e. a pan-peroxisome proliferator-activated receptor (PPAR) agonist)(see e.g. p. 7-10, Examples).
Further, Kim discloses (b) washing the cultured stem cells and additionally culturing the washed stem cells in a cell culture medium (see e.g. p. 7); and (c) isolating stem cell-derived exosomes (see e.g. p. 7), wherein the production of the stem cell-derived exosomes is increased relative to stem cells cultured in the absence of the pretreatment agent (see e.g. p. 7).
Kim is silent regarding the pretreatment agent of lanifibranor.
However, the prior art of Boubia discloses the pan-peroxisome proliferator-activated receptor (PPAR) agonist pioglitazone (fig. 1) and lanifibranor (i.e. IVA337, compound 5)(see e.g. fig. 2). Further, Boubia discloses that lanifibranor is a potent agonist of PPARγ (see e.g. table 6 and 11) but overall, well balanced pan PPAR agonist, and has an excellent safety profile (see e.g. abstract). Further, the prior art of Nunez discloses that pioglitazone (i.e. PIO) altered the cargo composition of circulating exosomes (see e.g. abstract).
Accordingly, prior to the effective filing date of the instant claimed invention, it would have been prima facie to obvious for a person of ordinary skill in the art to have modified the method for promoting production of stem cell-derived exosomes as taught by Kim and substitute the pan-peroxisome proliferator-activated receptor (PPAR) agonist of pioglitazone (fig. 1) to incorporate the PPAR agonist of lanifibranor, as taught by Boubia, with a reasonable expectation of success because one of ordinary skill in the art would know that lanifibranor is a more potent agonist of PPARγ with an excellent safety profile (as taught by Boubia, see e.g. table 6 and 11). Furthermore, one of ordinary skill could have substituted one PPAR agonist for another and would have had a reasonable expectation of success since it is prima facie obvious to substitute one known element for another to obtain predictable results.
Regarding claim 12, Kim discloses wherein the cell culture medium contains fetal bovine serum free of exosomes (see e.g. p. 7).
Regarding claim 14, Kim discloses wherein the stem cell is an embryonic stem cell, an adult stem cell, or an induced pluripotent stem cell (iPSC)(see e.g. p. 2).
Regarding claim 15, Kim discloses wherein the adult stem cell is an adult stem cell of human or animal tissue origin, a mesenchymal stromal cell of human or animal tissue origin, or an induced pluripotent stem cell of human or animal tissue origin (see e.g. p. 2).
Regarding claim 16, Kim discloses wherein the human or animal tissue is selected from the group consisting of umbilical cord, umbilical cord blood, lipid, muscle, nerve, skin, amnion, and placenta (see e.g. p. 2).
Regarding claim 17, Kim discloses wherein the adult stem cell of human or animal tissue origin is selected from the group consisting of a hematopoietic stem cell, a mammary stem cell, an intestinal stem cell, a vascular endothelial progenitor cell, a neural stem cell, an olfactory neural stem cell, and a testicular stem cell (see e.g. p. 2).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Allowable Subject Matter/Closest Prior Art
The following is a statement of reasons for the indication of allowable subject matter: Hyaluronic acid a pretreatment agent.
The Art made of record but not relied upon for art rejection: Art cannot be applied to the claims as written without reading limitations into the claims. Nonetheless, the following prior art reference teaches many of the elements/steps inferred by the disclosure as filed.
Stice (US2018/0327714A1, published 2018, previously presented), Stice discloses a method for production of stem cell-derived exosomes from culturing mesenchymal stem cells with hyaluronan (i.e. hyaluronic acid, HA)(see e.g. abstract, and para. 3-8, 62, 85, page 8, claim 11). However, Stice is silent regarding using hyaluronan (i.e. HA) as a pretreatment agent for pretreating the stem cells in a cell culture medium.
Corradetti, et al. (Scientific reports 7.1: 7991, published 2017, prior art of record): Corradetti discloses culturing mesenchymal stem cells with a hyaluronic acid coating (see e.g. page 4-7, fig. 6). However, Corradetti, does not disclose obtaining stem cell-derived exosomes.
Darzynkiewicz Z, Balazs EA. (Aging (Albany NY). 2012 Feb;4(2):78-88), discloses hyaluronan (i.e. hyaluronic acid; HA), carries out numerous functions that are essential for survival, such as differentiation, proliferation, motility and intercellular communication of variety of cell types (see e.g. page 80), but does not disclose pre-treating stem cells and obtaining exosomes.
Arasu, et al. (Matrix Biology 64 (2017): 54-68; published 2017): Arasy discloses human bone-marrow derived MSCs secrete hyaluronan (HA)-coated extracellular vesicles (EV) and produce high levels of HA (see e.g. abstract, fig.3-4). Arasu discloses Lipopolysaccharide treatments and hypothesized that isolation steps results in partial shedding of the EV derived HA coat (see e.g. fig. 5-6, p. 65). Further, Arasu discloses that HA-coated EVs are potential mediators of MSC-mediated functions such as tissue healing and regeneration (see e.g. p. 66).
Conclusion
No claim is allowed.
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Josephine Gonzales PhD
Examiner
Art Unit 1638
/JOSEPHINE GONZALES/ Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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