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 .
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.
Claim Status
Claims 31-45 are currently pending and examined on the merits.
Claim Objections
Claim 32 is objected to because of the following informalities. Appropriate correction is required.
Claim 32 appears to contain a typographical error and should read “GF109203X, and any”.
Claim Rejections - 35 USC § 102
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) 31-38, 40-42, 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishikawa, KI., Nonaka, R., Akamatsu, W. (2021). Differentiation of Midbrain Dopaminergic Neurons from Human iPS Cells. In: Imai, Y. (eds) Experimental Models of Parkinson’s Disease. Methods in Molecular Biology, vol 2322. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-1495-2_8 (hereinafter Ishikawa).
Regarding claims 31-38, 40-41, Ishikawa discloses methods of producing dopaminergic cells for therapeutic applications (Abstract). Ishikawa discloses retinal pigment epithelial (RPE) cells in a neural differentiation media comprising Neurobasal® medium supplemented with B27, 2 mM l-glutamine, 1mM sodium pyruvate, 0.1 mM 2-mercaptoethanol, 100 nM LDN193189, 10 μM CHIR99021, 10 μM SB431542, and 4 μM Y-27632 (Induction of dopamine-producing cells from RPE cells).
Regarding claim 42, Ishikawa discloses that the media does not comprise either FGF8 or FGF2 (Induction of dopamine-producing cells from RPE cells).
Regarding claim 45, Ishikawa discloses that the culture media is composed of Neurobasal® medium supplemented with chemically defined components (Induction of dopamine-producing cells from RPE cells).
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.
Claim(s) 43-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa as applied 31-38, 40-42, 45 above.
Regarding claim 43, Ishikawa does not disclose that the glutamine is present at a concentration of about 0.1% to about 5% by volume. However, Ishikawa discloses that l-glutamine in utilized in the culture media at a concentration of about 2mM. Generally differences in concentration will not support the patentability in the absence of evidence demonstrating criticality. MPEP § 2144.05. Therefore, the claimed concentrations are considered to be obviated by Ishikawa.
Regarding claim 44, Ishikawa does not disclose that the antioxidant is present at a concentration of about 5 µg/mL to about 200 µg/mL. However, Ishikawa discloses that the media comprises sodium pyruvate at a concentration of about 1 mM. Generally differences in concentration will not support the patentability in the absence of evidence demonstrating criticality. MPEP § 2144.05. Therefore, the claimed concentrations are considered to be obviated by Ishikawa.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa as applied 31-38, 40-42, 45 above and in view of B-27 Supplement (50X). Datasheet [online]. Gibco, 2018 [retrieved on 2016-06-13]. Retrieved from the Internet:<URL: https://documents.thermofisher.com/TFS-Assets/LSG/manuals/B27_Supplement_man.pdf> (hereinafter B27).
Regarding claim 39, Ishikawa does not disclose that the B27 is present at a concentration of about 0.1% to 20% by volume. However, Ishikawa discloses that culture media comprises B27. As evidenced by B27, the supplement is routinely utilized at a concentration of about 2% by volume for neuronal cultures. Therefore, a skilled artisan would understand that B27 could be utilized in the methods of Ishikawa at well-known concentrations for neuronal cultures.
Conclusion
No claims are allowed.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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