DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of Group I, claims 49-58, in the reply filed on 20 August 2026 is acknowledged. Claims 59-68 have been withdrawn. Claims 49-58 are currently pending and under examination.
This application is a continuation of International Patent Application No. PCT/US2022/048196, filed October 28, 2022, which claims priority to U.S. Provisional Patent Application No. 63/272,940, filed October 28, 2021
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.
Claims 49-58 are rejected under 35 U.S.C. 103 as being unpatentable over Theunissen et al. (IDS; US 2017/0114323, Published 2017).
With regard to claims 49 and 54, Theunissen et al. teach a method for converting a pluripotent vertebrate cell to a more naïve state by contacting the cell with inhibitors in culture, including with an Src inhibitor (Abs.; Para. 127, 128). The Src inhibitor includes radicicol (Para. 124), wherein radicicol is an ATP citrate lyase (ACL) inhibitor (see Specification, p. 4, line 1-4). As Theunissen et al. expressly teach that the cell is contacted with an Src inhibitor, and that the Src inhibitor includes radicicol, it would have been obvious to one of ordinary skill in the art to contact the cell with radicicol, as expressly taught by Theunissen et al.
As radicicol cannot be separated from its properties, contacting the cell with radicicol as taught by Theunissen et al. would necessarily provide for blocking non-canonical tricarboxylic acid (TCA) cycle of the cell and maintaining the properties of pluripotency and self-renewal.
With regard to claims 50 and 55, Theunissen et al. teach that the Src inhibitor is radicicol (Para. 124), which is a natural ACL inhibitor (see Specification, p. 4, line 1-4).
With regard to claims 51 and 56, Theunissen et al. teach that the Src inhibitor is present at a concentration of about 0.5-1.5 µM (Para. 128). It is noted with regard to the term “about” that Applicant indicates:
The term "about" or "approximately" means within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined, i.e., the limitations of the measurement system. For example, "about" can mean within 3 or more than 3 standard deviations, per the practice in the art. Alternatively, "about" can mean a range of up to 20%, preferably up to 10%, more preferably up to 5%, and more preferably still up to 1% of a given value. Alternatively, particularly with respect to biological systems or processes, the term can mean within an order of magnitude, preferably within 5-fold, and more preferably within 2-fold, of a value. (Specification, p. 16, line 1-8).
Given this description, about 0.5-1.5 µM as taught by Theunissen et al. is interpreted to be encompassed within about 10 µM and about 100 µM. Alternatively, it would have been routine for an ordinary artisan to adjust the concentration of components in culture, including the radicicol, to optimize the naïve state of the contacted cell as desired.
With regard to claims 52, 53, 57, and 58, Theunissen et al. teach that the pluripotent vertebrate cell is maintained in culture for a time sufficient to change the pluripotency state to a more naïve state, including culturing for at least 1 day (Para. 136), which is fully encompassed within at least about 12 hours, and about 24 hours.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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