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 .
Claims 1-3 are under examination.
Response to Applicants Amendments
Applicants have significantly amended the claims. As a result of the claim amendments, the former rejection is withdrawn and a new rejection is put forward. Although AURKA expression was originally the type of expression chosen in the species election, the examiner has decided to rejoin DOCK2 with AURKA as a species of gene expression based on the recent claim amendment and additional searching completed by examiner. The 112(b) rejection is withdrawn because of the recent claim amendment.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Chai (US 20200392454) in view of Riordan (US 20180214489)
Chai teaches producing mesenchymal stem cells with therapeutic purposes (Abstract). Chai teaches that therapeutic mesenchymal stem cells can be generated by culturing mesenchymal stem cells in induction/selective medium (Abstract). Chai teaches that mesenchymal stem cells cultured in a specific medium, Medium D, have an excellent therapeutic value because they promote: tissue development (proliferation), cell signaling, and localization (Paragraph 44 of Chai). Such a culture medium induces the cells to express genes (such as DOCK2) that are related to tissue development (proliferation), cell signaling, and/or localization (Claim 8) as in instant Claims 1 and 3.
Chai does not teach an additional purification step in which the cells are further purified/sorted using their expression markers. Riordan teaches that mesenchymal stem cells can be selected based on the expression or lack of expression of various markers (Paragraph 14 of Riordan). Paragraph 15 of Riordan states that, “in one embodiment, the invention teaches the selection of MSC, a desired population can be purified/selected for based on markers found in specific donors which naturally possess higher levels of markers associated with activity, or selecting for cells which have higher expression of MSC markers associated with activity.”
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have further purified the mesenchymal stem cells. An artisan would have been motivated to have purified therapeutic cells based on gene/protein expression because it can isolate a desired population of cells which have the ability to inhibit unwanted clinical progression, stabilize disease activity, or reverse disease activity (Paragraph 15 of Riordan). Since DOCK2 is expressed in the desired cell population, it would have been obvious to have used it to select for cells as taught in Riordan as in instant Claim 1.
Dependent Claims taught by Chai
Chai teaches that the mesenchymal stem cells can be from umbilical cord (Paragraph 3) as in instant Claim 2.
Chai teaches a preferred therapeutic population of mesenchymal stem cells that have increased expression for DOCK2. DOCK2 is a recognized marker in this desired population. Chai does not state specifically that the cells can be purified by choosing them based on the expression level or activity level of DOCK2 being higher when compared to a control group of mesenchymal stem cells having low self-maintenance ability. However, an artisan would have been motivated to have used a recognized marker to purify a desired cell population because Riordan teaches that such a method can better isolated a desired therapeutic cell population (Paragraphs 14-15 of Riordan). Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yield predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology and placental implant preparation. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
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 LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
