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 I, claims 1-20 in the reply filed on 12/17/2025 is acknowledged. The traversal is on the ground(s) that a search of Group I and II would not impose a search burden on the Examiner. This is not found persuasive because the method of Group II requires functional steps and limitations that are not required by the composition in Group I. Specifically, the method of Group II requires direct RPE cell differentiation (claim 21), the expression of 11 different factors (claim 23) and the lack of expression of 6 different factors (claim 24). A search of all of these factors, which are not recited in the composition of Group I, would necessitate a search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 21-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/17/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is unclear. Claim 1 recites in step (a)(ii) the optional use of a TGFβ family protein. In step (b) the TGFβ family protein is required for the culturing step, thus is it not clear how the TGFβ family protein can be an option in step (a)(ii) when it is a required limitation for the practice of step (b). A suggested amendment would be to remove the optional limitation in step (a)(ii).
Claim 8 is unclear. Claim 8 recites in line 4 the limitation “at least about 0.1 ng/ml of a TGFβ family protein”. However, it is not clear what the metes and bounds are of concentration of the TGFβ family protein since the recited limitation encompasses at least 0.1 ng/ml but also less than 0.1 ng/ml since the claim recites about 0.1 ng/ml. A suggested amendment would be to remove the “about” limitation.
Claim 10 is unclear. Claim 10 recites in line 2 the limitation “at least about 0.1 ng/ml TGFβ family protein”. However, it is not clear what the metes and bounds are of concentration of the TGFβ family protein since the recited limitation encompasses at least 0.1 ng/ml but also less than 0.1 ng/ml since the claim recites about 0.1 ng/ml. A suggested amendment would be to remove the “about” limitation.
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuroda et al. (WO 2018/164240 – English Translation Attached).
Regarding claims 1, 4 and 7, Kuroda et al. teach a method of generating RPE cells comprising:
contacting a culture of PSCs with a mixture of agents comprising the TGFβ inhibitor SB431542 (parags. 9 and 96); and
subsequently culturing the cells of (a) with Activin (a TGFβ family protein) in the absence of the TGFβ inhibitor to generate RPE cells (see claim 1 and paras. 47 and 96).
Regarding claim 2, Kuroda teaches that the PSCs were cultured in a adherent monolayer (paraga. 46 and 119).
Regarding claim 3, Kuroda teaches that the monolayer is grown in a two-dimensional culture system (parag. 120).
Regarding claim 5, Kuroda teaches that the BMP pathway signaling inhibitor is dorsomorphin (parag. 63).
Regarding claim 6, Kuroda teaches that the FGF/ERK pathway signaling inhibitor is PD0325901 (parag. 62).
Regarding claims 8 and 9, Kuroda teaches using about 1-5 μM of SB431542, about 0.25 μM of dorsomorphin, about 0.5-1.5 μM of PD0325901 and about 25 ng/ml Activin A (Fig. 13, 18, parag. 48, 57 and 66).
Regarding claims 10 and 11, Kuroda teaches contacting PSCs with at least 0.1 ng/ml of Activin A (parags. 48 and 57).
Regarding claim 12, Kuroda teaches contacting PSCs with the mixture of (a) is for about 2-7 days (parag. 72).
Regarding claim 13, Kuroda teaches contacting PSCs with a TGFβ family protein for 42 days (parag. 9, Fig. 1).
Regarding claim 14, Kuroda teaches that the monolayer is cultured on a surface comprising a laminin coating (parag. 27).
Regarding claims 15 and 16, Kuroda teaches that the PSCs are human ESCs (parag. 12).
Regarding claims 17-20, Kuroda’s method does not use a HIF pathway modulator, nicotinamide, hypoxic conditions or a three-dimensional culture system.
Thus, the teachings of Kuroda clearly anticipate the invention of claims 1-20.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
