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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Acknowledgment is made of Applicants’ claim for benefit to foreign applications TW112148328 filed 12/12/2023.
Information Disclosure Statement
The IDS filed 12/06/2024 has been considered by the Examiner.
Status of Claims
Claims 1-9 are under examination.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1-3, 6, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lei et al. (Neurotoxicity Research, 2018).
Regarding claim 1, Lei et al. teach collection of pluripotent stem cells, inducing differentiation in the collected pluripotent stem cells to obtain a cell population comprising differentiated cells and undifferentiated stem cells. Lei et al. teach the administration of phthalide to the cells which would remove the undifferentiated cells by inducing differentiation (cover page, abstract).
Regarding claim 2, Lei et al. teach the phthalide compound is n-butyl phthalide (cover page, abstract).
Regarding claim 3, Lei et al. teach neural stem cell proliferation, migration, and differentiation to neurons, which are somatic cells (page 478, paragraph 3).
Regarding claim 6, Lei et al. teach concentration of the effective amount of the phthalide compound is 10 μM (page 481, Results: L-NBP Promoted NSC Proliferation In Vitro).
Regarding claim 8, Lei et al. teach administration of the phthalide compound for 2 days (page 481, Results: L-NBP Promoted NSC Proliferation In Vitro).
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lei et al. (Neurotoxicity Research, 2018) as applied to claim 1 above, and further in view of Gutiérrez-García (Cytotechnology, 2019).
Lei et al. teach administration of phthalide to the cells which would remove the undifferentiated cells by inducing differentiation (cover page, abstract).
Regarding claim 4, Lei et al. do not teach the differentiated cells do not include somatic cells.
Gutiérrez-García teach treating human hematopoietic stem cells with phthalates (cover page, abstract). Gutiérrez-García teach the presence of DBP, BBP and DEHP phthalates affects the in vitro expansion of human hematopoietic stem cells isolated from the umbilical cord blood (page 559, Conclusions).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the teachings of Lei et al. for the administration of phthalide to the cells with the teachings of Gutiérrez-García for phthalates exposed to human hematopoietic stem cells. Gutiérrez-García et al. provide motivation by teaching that HSCs exposed to phthalates opens new research horizons to investigate the effects of the endocrine disruptors on the transplantation of hematopoietic stem cells. One of skill in the art would have had a reasonable expectation of success at combining Lei et al. and Gutiérrez-García because both teach exposing stem cells to phthalates.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lei et al. (Neurotoxicity Research, 2018) as applied to claim 1 above, and further in view of Sadikoğullari et al. (Chemistry Select, 2022).
Lei et al. teach the administration of phthalide to cells (cover page, abstract).
Regarding claim 5, Lei et al. do not teach the effective amount of the phthalide compound is administered after a presence of somatic cells in the cell population.
Sadikoğullari et al. teach phthalides for cell treatments of somatic cells (cover page, abstract. Sadikoğullari et al. teach phthalides are of great interest in the scientific community due to the development of various phthalide-based drugs. Sadikoğullari et al. teach that phthalides have different biological properties which have led to the development of different research methodologies and strategies with various applications in drug manufacturers, academic research laboratories and phase research laboratories (page 27, 4.Conclusion).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the teachings of Lei et al. for administering phthalates to cells with the teachings of Sadikoğullari et al. for administering phthalates to somatic cells. Sadikoğullari et al. provide motivation by teaching that phthalides have different biological properties which have led to the development of different research methodologies and strategies with various applications. One of skill in the art would have had a reasonable expectation of success at combining Lei et al. and Sadikoğullari et al. because both teach treating cells with phthalates.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lei et al. (Neurotoxicity Research, 2018) as applied to claim 1 above, and further in view of Shi et al. (Chin Med J, 2013).
Regarding claims 7 and 9, Lei et al. do not teach the concentration of the effective amount of the phthalide compound is from 50 μM to 800 μM. Lei et al. do not teach the stem cells are embryonic stem cells or induced pluripotent stem cells.
Shi et al. teach treating embryonic stem cells with phthalate. Shi et al. teach the gene expression patterns of stem cell lines after their spontaneous differentiation (page 1714-1715). Shi et al. teach MEHP in low concentrations could change some differentiation gene expression pattern cell line specific (page 1719, left column). Shi et al. teach various phthalate concentrations which include 200 and 400 μM.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the teachings of Lei et al. for treating stem cells with phthalates with the teachings of Shi et al. for treating embryonic stem cells with phthalates. Shi et al. provide motivation by teaching that phthalates in low concentration could change some differentiation gene expression patterns. One of skill in the art would have had a reasonable expectation of success at combining Lei et al. and Shi et al. because both teach the interaction between differentiation and treating stem cells with phthalates.
Conclusion
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
