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 claims
Claims 1-4, 6-9, and 12 are pending. Claims 6-9, and 12 are withdrawn. Claims 1-4 are under exam.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/29/2025 has been entered.
Claim Rejections - 35 USC § 103
Claims 1-4 were rejected under 35 U.S.C. 103 as being unpatentable over Mooney et al (WO2013025763A2, published 2013-02-21; hereinafter "Mooney"); and Caliari et al., Nat Methods. 2016 Apr 28; hereinafter "Caliari", as evidenced by Mafi et al (Open Orthop J. 2011; hereinafter "Mafi").
The rejection is withdrawn following Applicant arguments and amendments. New rejections are set forth below.
NEW REJECTIONS
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over KR1020130124074 (published Nov 13, 2013, hereinafter "'074 Application;" See IDS 3/25/2021; English translation in PTO-892) in view of Lee et al (Connect Tissue Res. 2011 Jun; hereinafter "Lee;" See PTO-892).
Regarding claim 1: ‘074 application taught a method of “culturing at least one tissue selected from the group consisting of gastrointestinal mucosal tissues, peripheral nerve outer membrane tissues, and blood vessel outer membrane tissues in a hydrogel; and recovering mesenchymal stem cells (MSCs) grown and grown into the hydrogel from one or more tissues selected from the group consisting of gastrointestinal mucosal tissues, peripheral nerve outer membrane tissues, and blood vessel outer membrane tissues by decomposing only the hydrogel.” (‘074 Application English translation, p. 7, para 7). It is pointed out that the cells from encapsulated tissues migrate into the hydrogel (See ‘074 Figure 3). It is noted that ‘074 application did not use a synovial tissue for recovering MSCs.
Lee was directed to “a nonenzymatic explant technique” to isolate MSCs. Lee isolated MSCs from “small pieces of synovial membrane which were put into a 100-mm diameter culture dish. “After incubation for 1 day, all explants were discarded and the attached cells were transferred to fresh MSCBM medium for culture, with medium changed twice weekly.” (Lee p. 227, last para). Lee indicated that “only MSCs capable of migration survived during the cultivation period of the synovial explants, contamination by other cells was minimal compared with MSCs generated enzymatically” (Lee p. 233, first para). Lee also pointed out that “MSCs isolated by the explant technique may behave more similarly to MSCs involved in cartilage repair in vivo than MSCs isolated enzymatically.” (Lee p. 233, first para).
It would have been obvious for a person of ordinary skill in the art to apply the hydrogel encapsulation of the tissue of ‘074 application and harvest of MSC to synovium as taught by Lee. Lee expressly states that the MSCs migrating from synovial explants possess desirable characteristics for cartilage repair and ‘074 application provides a generalizable technique for harvesting migratory MSCs from tissue encapsulation in hydrogel and degradation of hydrogel to recover the cells. A person of ordinary skill will be motivated combine these teachings to facilitate the culture and recovery of synovial derived MSCs. It is also noted that ‘074 taught variety of connective tissue and membrane-derived tissues support hydrogel encapsulation, MSC migration and MSC harvest. Thus a person would have reasonable expectation of success of obtaining MSCs from synovium as required by the claim. As such the claim is obvious.
Regarding claim 2: ‘074 application taught that the hydrogel of the present invention is not particularly limited, but may be one or more selected from the group consisting of collagen, gelatin, chondroitin, hyaluronic acid, alginic acid among others (‘074 application p. 3, para 5)
Regarding claim 3: ‘074 application taught that the hydrogel degrading enzyme can be selected from urokinase, streptokinase, and plasm in to decompose only the fibrin hydrogel (‘074 application p. 3, para 6)
Regarding claim 4: ‘074 application taught that the mesenchymal stem cells obtained by the culturing method may contain immunological characteristics that are positive to one or more marker groups selected from the group consisting of CD29, CD44, CD73, CD90. (‘074 application p. 3, para 7)
Conclusion
No claim is free of art. No claim is allowed.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633