DETAILED ACTION
This action is in reply to papers filed 8/18/2026. Claims 1-6, 8, 10-11, 13-14 and 24-33 are pending with claims 1-6 and 13-14 examined herein. Note that this application has been transferred to Examiner Titilayo Moloye, AU 1632.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20220396774A1, Published 12/15/2022.
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(s) 1-6 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mirani et al. (PgPub US20180371407A1, Published 12/27/2018), Rieck et al. (PgPub US20170362572A1, Published 12/21/2017) and Wang et al. (Exp Ther Med. 2014 Sep 22;8(5):1389–1396.).
Regarding claim 1, Mirani teaches a method comprising: (i) a devitalized, acellular, lung tissue-derived three dimensional scaffold (as in claim 1 (a) and claim 13 (a)); and (ii) beta cells selected from beta cells isolated from pancreatic islets and beta cells differentiated in-vitro from stem and/or progenitor cells, wherein the beta cells are seeded and cultured on said acellular three dimensional scaffold (as further in claim 1 (a) and claim 13 (a)) and maintain glucose-responsive insulin secretion for at least 7 days of culture on said scaffold (Pg. 2, para. 22; Pg. 3, para. 44; Pg. 4, para. 64). Mirani teaches expression of insulin and Glut2 was concentrated in clusters of cells (as further in claim 1 (b) and claim 13 (b)) (Pg. 5, para. 87).
And although Mirani teaches the micro-organ matrix scaffolds seeded with the cells can be cultured in a culture medium, Mirani fails to teach a stepwise differentiation protocol comprising sequentially applying a plurality of differentiation factors to the progenitor cells.
Before the effective filing date of the claimed invention, Rieck et al. teach a method of differentiating pancreatic endoderm cells (as in claim 3, as in claim 5 and claim 13) into functional beta cells using a stepwise differentiation protocol (as further in claim (1b) and claim 13 (b)) (Abstract). Rieck teaches the pancreatic endoderm cells are first differentiated from pluripotent stem cells in a 2D environment (air liquid interface) (as in claim 2 and claim 5) (Pg. 19, para. 163; Pg. 19, para. 166). In the method of deriving immature beta cells, and with respect to claim 4, Rieck teaches differentiating foregut endoderm cells into pancreatic endocrine precursor cells and then differentiating pancreatic endocrine precursor cells into the immature beta-cells (Pg. 20, para. 170). Rieck teaches these pancreatic beta cells exhibit glucose-dependent mitochondrial respiration and glucose-stimulated insulin secretion similar to islet cells (Abstract).
However, neither Mirani nor Rieck et al. teach co-culturing with MSCs (as in claim 6 and claim 14).
Before the effective filing date of the claimed invention, Wang et al. investigated the roles of the co-culture of human umbilical cord Wharton’s jelly-derived mesenchymal stem cells (hUC-MSCs) (as in claim 6 and claim 14) with rat pancreatic cells in the treatment of rats with diabetes mellitus. Wang teaches following co-culture with hUC-MSCs for 7 and 10 days, the rat pancreatic cells were strongly stained by pancreatic and duodenal homeobox-1 and human insulin. In fact, Wang teaches the insulin and C-peptide concentrations were increased significantly compared to the pure culture group (Abstract: Pg. 1390, Col. 2, ‘Differentiation’).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Mirani, wherein Mirani teaches a method of deriving insulin producing cells from progenitor pancreatic cells seeded and cultured on said acellular three dimensional lung scaffold, with the teachings of Rieck, wherein Rieck teaches a stepwise differentiating protocol for differentiating pancreatic endoderm cells into insulin producing beta cells, with a reasonable expectation of arriving at the claimed invention. A person of skill in the art would have been motivated to modify Mirani to include the protocol of Rieck et al., because Rieck teaches their derived pancreatic beta cells exhibit glucose-dependent mitochondrial respiration and glucose-stimulated insulin secretion similar to islet cells. Moreover, one of ordinary skill in the art would have found it prima facie obvious to co-culture the pancreatic endoderm cells with MSCs because Wang teaches the insulin and C-peptide concentrations of coculturing pancreatic progenitor cells with MSCs were increased significantly compared to the pure culture group.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the claimed invention, as a whole, was clearly prima facie obvious.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TITILAYO MOLOYE whose telephone number is (571)270-1094. The examiner can normally be reached Working Hours: 5:30 a.m-3:00 p.m. M-F. Off first Friday of biweek.
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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