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 (claims 6-8) in the reply filed on 8/6/2026 is acknowledged. The traversal is on the ground(s) that the product and the process of making are not directed to separate and unrelated inventions. This is not found persuasive because the inquiry of the claims in different categories of invention under 35 USC 121 is whether they are independent or distinct, not about related or not. The restriction requirement clearly stated how they are different (i.e. product and process of making the product). Applicant’s argument on “technical concept involving producing a blood vessel organoid from iPSCs, establishing a tissue-specific vascular endothelial cel line therefrom and subsequently using the resulting cell line to efficiently produce a blood vessel organoid” appears to direct a restriction practice under the national stage. The claims have clearly different categories, method of making, method of using and product, and the discussion in the restriction requirement addressed that they are distinct.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5 and 9-11 have been canceled, claims 12-19 are newly added, claims 12-19 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 6-8 have been considered on the merits.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “A method for generating endothelial cell line from organoid”.
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.
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) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meijer et al. (2023, Advanced Biology; published online on 10/27/2022; IDS ref.) in view of Bouis et al. (2001, Angiogenesis), Basma et al. (2014, Am. J. Physiol. Lung Cell Mol. Physiol.) and Haase et al. (2009, Cell Stem Cell).
Meijer et al. teach that 3D human iPSC blood vessel organoids can be a source of functional vascular cells including organoid-derived endothelial cells (ODECs) (Abstract). Meijer et al. teach that human iPSC-derived blood vessel organoids were generated, and vascular organoid-derived, cell type-specific population including ECs were purified by dissociating into single-cell solution, sorted and culturing the cells from the organoids (p.7, Results).
Meijer et al. do not teach the vascular endothelial “cell line”. The term “cell line” refers to a clone of cultured cells that may continue to divide and proliferate through cell culture and pass on genetic characteristics to subsequent generations, that is, a series of cell lines that maintain their genetic characteristics even when subcultured (para. 49 of the specification).
However, it is well known in the art that cells obtained from dissociated tissue can be clonally expanded for a pure population.
Bouis et al. teach that endothelial cells (EC) are used as in vitro model systems for various physiological and pathological processes, especially in angiogenesis research (Abstract). Bouis et al. pointed out drawbacks of primary EC that there is a limited lifespan and display characteristics that differ from batch to batch due to their multidonor origin (Abstract). Bouis et al. teach that truly immortalized cell lines are generally better characterized and more stable in their endothelial traits than EC that were given an extended life span, and discussed EC lines known in the art (Tables 1-2) including those generated from HUVEC.
It would have been obvious to a person skilled in the art to produce EC lines from the blood vessel organoids produced by the method of Meijer et al. as immortalized EC lines are useful in various applications and one with skill in the art would utilize the iPSC derived blood vessel organoid as a source of the immortalized ECs. As the process of preparing immortalized cell line from primary cells is well known in the art, one skilled in the art would recognize that producing EC cell lines from the blood vessel organoids has reasonable expectation of success.
Regarding claim 7 directed to the culturing in an endothelial growth medium (EGM), the term is interpreted as any medium suitable for culturing endothelial cells. Meijer et al. teach ODECs were cultured on EGM2 medium (Lonza) (p.4, 1st col. 1st para.).
Regarding the wherein clause of claim 8 directed to the source of the induced pluripotent stem cells, the limitation does not require any active step to be carried out, rather the structure of the induced pluripotent stem cells is not required in the claimed method of producing the endothelial cell line. Thus, the source of the induced pluripotent stem cells does not limit the claimed method. Nevertheless, it is extremely well known in the art that any somatic cells can be reprogrammed to iPSCs. Basma et al. teach iPSCs have been generated using COPD or non-COPD lung fibroblasts (see entire document). Haase et al. teach umbilical cord blood as a source of iPSC reprogramming (see entire document). Thus, it would have been obvious to a person skilled in the art to use any somatic cells including lung cells or cord blood cells for reprogramming into the iPSCs with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Relevant Prior Art
The following prior art is relevant to the claimed subject matter but not cited in the claim rejection.
Vargas-Valderrama et al. Journal of Biomedical Science (2020) 27:67, p.1-13
Ariyashinghe et al. Physiol Genomics 55: 324–337, 2023
Penninger et al. WO2018/229251A1
Conclusion
No claims are allowed.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631
