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 .
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 12/16/2025 is acknowledged. The traversal is on the ground(s) that any search of the prior art and examination of involving claims of Group II will co-extend with the search and examination of the claims of Group I and be made without serious burden on the examiner and the Office.
This is not found persuasive because the method of Groups I and II start with entirely distinct cells (particularly the embryonic fibroblasts used in Group II) and the cells of Group I do not require reprogramming through the introduction of exogenous factors such as Oct 3/4. While iPS cells and ES cells may be both pluripotent, iPS cells are structurally distinct from ES cells and a search of Group II would not result in a search of Group I as Applicant argues.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 2, 6, 14-24 and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/16/2025.
Claims 25, 26, 30, 31, 35, 45 and 47-50 are examined in the instant application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 25, 26, 30, 31, 35, 45, 47 and 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mendlein et al. (US 2012/0207744 A1).
Regarding claims 25, 26 and 30, Mendlein et al. teach a method of producing formative iPSCs comprising obtaining a population of embryonic fibroblasts, culturing the embryonic fibroblasts in a first medium comprising a nucleic acid encoding the reprogramming gene Oct ¾ and then culturing the population of embryonic fibroblasts in a second medium that comprises a FGF activator, a TGFβ activator and a WNT activator (parags. 20, 46, 55, 203, 257, 575, 1030 and 1251).
Regarding claim 31, Mendlein teaches that the nucleic acid interfering RNA that targets the reprogramming gene (parag. 91, 95 and 96).
Regarding claim 35, Mendlein teaches that the activators are FGF protein, Activin A protein and WNT protein (parags. 513 and 947).
Regarding claims 45 and 47, Mendlein teaches further culturing the formative iPSCs with FGF and noggin (parag. 364).
Regarding claim 49, Mendlein teaches that the TGFβ inhibitor can ben SB431542 (parag. 1316).
Thus the teachings of Mendlein clearly anticipate the invention of claims 25, 26, 30, 31, 35, 45, 47 and 49.
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.
Claim(s) 25, 45, 48 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mendlein et al. (US 2012/0207744 A1) in view of Hanna et al. (WO 2016/016894 A1).
Regarding claim 25, Mendlein et al. teach a method of producing formative iPSCs comprising obtaining a population of embryonic fibroblasts, culturing the embryonic fibroblasts in a first medium comprising a nucleic acid encoding the reprogramming gene Oct ¾ and then culturing the population of embryonic fibroblasts in a second medium that comprises a FGF activator, a TGFβ activator and a WNT activator (parags. 20, 46, 55, 203, 257, 575, 1030 and 1251).
Regarding claim 45, Mendlein teaches further culturing the formative iPSCs with FGF and noggin (parag. 364).
While Mendlein teaches that their claimed method can be practiced with WNT and JNK inhibiters, Mendlein does not teach:
the species of WNT and JNK inhibitors, IWP2 and SP600125, respectively.
Regarding the WNT and JNK inhibitors, IWP2 and SP600125, Hanna et al. teach
a method of reprogramming somatic cells into iPSCs (pg. 1 lines 4-19) using the WNT inhibitor IWP2 (pg. 46 line 27 bridge pg. 47 line 4) and the JNK inhibitor SP600125 (pg. 60 lines 3-7).
Thus at the time of filing it would have been prima facie obvious to combine the teachings of Mendlein regarding a method of reprogramming somatic cells into iPSCs with the teachings of Hanna regarding using specific WNT and JNK inhibitor in a method of reprogramming to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since Mendlein teaches that WNT and JNK inhibitors can be used in their method of reprogramming and Hanna teaching specific species of inhibitors for WNT and JNK.
There would have been a reasonable expectation of success that IWP2 and SP600125, respectively would inhibit WNT and JNK since Hanna teaches that both are specific inhibitors to their related proteins.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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