DETAILED ACTION
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. Applicant’s Request for Continued Examination, Amendment and Arguments/Remarks received on 08 June 2026 have been entered. Claims 18 and 20-32 were previously pending in the application. Claim 26 has been cancelled, and no new claims have been added by Applicant. Claims 18, 20-25, and 27-32 are currently pending in the application. Claims 18, 24, 28, 30, 31, and 32 are independent claims.
The election of Group I, drawn to a method to obtain mesenchymal stem cells (MSC) with enhanced activity for the treatment of osteoarticular disease or trauma, remains in effect in the instant application.
The following election of species remains in effect in the instant application:
ATP-synthase inhibitors: a. Oligomycin.
Claims 24-25 and 27-32 remain withdrawn from consideration as being directed to a nonelected invention, there being no allowable generic or linking claim.
Claims 18 and 20-23 are currently pending and under examination in the instant application. An action on the merits follows.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/IB2020/061190, filed 26 November 2020, which claims priority to EPO 19211428.8, filed 26 November 2019. Filing of a certified copy of the EPO 19211428.8, filed 26 November 2019 is acknowledged.
Thus, the earliest possible priority for the instant application is 26 November 2019.
Claim Rejections - 35 USC § 102
The rejection of amended and previously presented claims 18, 20, and 23 under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. 2008, Stem Cells, 26, 960-968, is withdrawn in view of Applicant’s claims which now recite “wherein the induction media does not comprise an added differentiation-inducing factor other than the ATP-synthase inhibitor” in claim 18 lines 5-6.
Amended and previously presented claims 18 and 20-23 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mancini et al. [2018, Circulation Research, 122, 255-266].
Mancini discloses a method to obtain mesenchymal stem cells (MSC), wherein the method comprises: a) providing MSC; b) culturing the MSC in a media supplemented with 1 µM (i.e., 0.79 µg/mL) of the ATP-synthase inhibitor oligomycin, wherein the media does not comprise an added differentiation-inducing factor other than the ATP-synthase inhibitor; and c) removing the induction media to obtain the MSC [pg 256 col 2 ¶ 4, pg 257 col 2 ¶ 7- pg 258 col 1 ¶ 1, Figure 5].
Mancini additionally teaches wherein the oligomycin treatment of MSC (i.e., non ATH-MSC) increases production of IL-6, IL-8, and MCP-1 from the MSC [Figure 5]. Mancini does not explicitly teach wherein the MSC with increased production of IL-6, IL-8, and MCP-1 exhibit increased immunosuppressive activity, increased chondroprotective and chondrodifferentiation properties, increased cell migration and transmigration capacity, and increased ability to promote chondrocyte proliferation as compared to the MSC prior to performing the method. However, note that the method steps recited by Mancini are identical to the method steps recited in the instant claims. As such, the product generated thereby will necessarily and inherently have the same structural and functional properties, absent evidence to the contrary. “When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent.” See MPEP 2112.01 or In re Best, 195 USPQ 430, 433 (CCPA 1997). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
Mancini also discloses wherein the MSC are derived from adipose tissue [pg 256 col 2 ¶ 4].
Mancini additionally discloses wherein the method further comprises incubating the MSC for 24 hours in the media supplemented with the ATP-synthase inhibitor oligomycin [pg 257 col 2 ¶ 7- pg 258 col 1 ¶ 1].
Accordingly, by teaching all the limitations of amended and previously presented claims 18 and 20-23, Mancini anticipates the instant invention as claimed.
Claim Rejections - 35 USC § 103
The rejection of amended and previously presented claims 18 and 20-23 under 35 U.S.C. 103 as being unpatentable over Chen et al. [2008, Stem Cells, 26, 960-968] is withdrawn in view of Applicant’s claims which now recite “wherein the induction media does not comprise an added differentiation-inducing factor other than the ATP-synthase inhibitor” in claim 18 lines 5-6. Although Chen teaches that oligomycin has an inhibitory effect on osteogenic differentiation of hMSCs [Figure 7], thereby providing motivation to incubate MSCs in the presence of oligomycin to inhibit/prevent osteogenic differentiation, Chen does not teach that the inhibitory effect is relevant in the absence of added differentiation-inducing factors other than the ATP-synthase inhibitor.
Conclusion
No claim is allowed.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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