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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/25/2025 has been entered.
Claim 1 has been canceled, claim 14 is newly added, and claims 2-14 have been considered on the merits. All arguments have been considered.
Terminal Disclaimer
The terminal disclaimer filed on 8/25/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US PAT. 11,963,977 and 11,242,508 have been reviewed and is accepted. The terminal disclaimers have been recorded. The double patenting rejections have been withdrawn.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 15/269,077, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The instant claims require the population of cells expressing both pluripotent stem cell markers of Oct4, SSEA, Nanog and/or Sox2, and a differentiated mammalian somatic cell marker. As indicated below, the instant specification fails to provide support for the limitation and thus, the parent ‘077 application. The priority date for the claimed subject matter therefore is the filing date of the instant application, which is 11/15/2021.
Claim Interpretation
Claim 13 has been amended and the claim is directed to a population of isolated cells non-transformed, de-differentiated mammalian somatic cells expressing Oct4, SSEA, Nanog and/or Sox2, and the cells also express one or more markers of differentiated mammalian somatic cells; and claim 14 is directed to the marker being CD45.
The wherein clause of claim 13 directed to a product-by-process limitation, and the method steps of preparing the claimed cells do not provide any structural limitation to the claimed population of cells. Thus, the product-by-process limitation does not provide any weight in determining patentability of the claimed product. See MPEP2113.
Claims 2-6 disclose the limitations directed to the method step of claim 13, and thus, they do not provide any structure to the claimed product.
Thus, a cell population expressing Oct4/SSEA/Nanog/Sox2 and CD45 would meet the claimed subject matter of claims 2-6 and 13-14.
Claims 7-12 are directed to the cell population expressing Oct4/SSEA/Nanog/Sox2 and CD45 in a cell culture medium suitable for any of the claimed cell types.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 2-14 disclose the composition comprising the cells of claim 13 and a tissue specific culture medium for different types of cells including embryonic neural stem cells, skin cells, liver cells, muscle cells, lung cells or mesoderm cells.
Claim 13 upon the instant amendment discloses a population of cells expressing both pluripotent stem cell markers including Oct4, SSEA, Nanog and/or Sox2, and a differentiated somatic cell marker(s).
The limitations directed to the tissue specific media as claimed are not particularly disclosed in the instant specification. Rather the originally filed claims disclose the limitation. The originally filed claims (filed on 11/15/2021) disclose the population of cells expressing one or more of the pluripotent stem cell markers in tissue specific cell culture media and the claimed cells are derived from non-embryonic, non-transformed normal differentiated mammalian somatic cells by treating chemical stress and mechanical stress. There is no disclosure that the claimed cells expressing one or more of mammalian somatic cell markers. In the instant specification, CD45 positive cells are isolated from a Oct4-GFP mouse, and subjected to the claimed stress to de-differentiate the CD45-positive somatic cells (i.e. lymphocytes).
The specification discloses that the CD45-positive cells were treated with mechanical and/or chemical stress and the treated CD45-positive cells started to express the pluripotent stem cell markers. However, there is no indication in the instant specification that CD45 positive cells expressing any of pluripotent stem cell markers. According to para. [0201] of the instant specification, at day 1, most of cells still expressed CD45, but not Oct4. At day 3, marker expression transitioned to reveal CD45 negative cells or CD45 negative/Oct4positive (dim) cells. At day 7, CD45 expression disappeared, and Oct4 expressing cells were observed (FIG. 1D). This does not support the cells expressing both pluripotent stem cell markers and differentiated somatic cell markers. The specification fails to provide support for CD45 positive and Oct4 positive cells. Rather, CD45 expression appears to be lost when Oct4 expression starts to appear, i.e. CD45 negative/Oct4 dim cells. There is no disclosure that CD45+/Oct4+ cells in the specification. Thus, the instant amendment introduces new matter to the instant application.
Furthermore, the instant specification fails to provide sufficient written description to support the composition of claims 7-12 directed to the cells of claim 13 in a tissue specific culture medium. While the originally filed claims disclose the de-differentiated cells by the chemical and mechanical stress and expressing pluripotent stem cell markers are in a tissue specific culture medium, however, there is no support for the cells expressing both pluripotent stem cells markers and differentiated somatic cell markers in the tissue specific culture medium.
In amended cases, subject matter not disclosed in the original application is sometimes added and a claim directed thereto. Such a claim is rejected on the ground that it recites elements without support in the original disclosure under 35 U.S.C. 112, first paragraph, Waldemar Link, GmbH & Co. v. Osteonics Corp. 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). See MPEP § 2163.06 - § 2163.07(b) for a discussion of the relationship of new matter to 35 U.S.C. 112, first paragraph. New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.
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.
(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) 2-7 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang (US2009/0305413).
Regarding 2-6 and 13-14, Kang teaches a population of multipotent adult stem cells expressing Oct4 derived from umbilical cord blood and these cells also express CD45 (para. 13-16).
Regarding claim 7, Kang teaches that the umbilical cord blood-derived multipotent adult stem cell in a neural medium (para. 54).
Thus, the multipotent adult stem cells of Kang anticipate the claimed cell population.
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) 2-12 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang (supra) in view of Lee et al. (WO2012/121577A2; Eng. Translation attached).
Regarding claims 2-7 and 13-14, Kang anticipates the subject matter of the claims as above, and thus render them obvious.
Regarding claims 8-12 directed to a composition comprising the population of cells of claim 13 and a tissue specific medium for skin cells, liver cells, muscle cells, lung cells or mesoderm cells, Kang does not particularly teach the limitations.
However, it would have been obvious to a person skilled in the art to use a tissue specific culture medium for each claimed cell types with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because Kang teaches that the multipotent adult stem cells can differentiate into cells derived from mesoderm, ectoderm, and endoderm (para. 18), and one skilled in the art would utilize a differentiation medium for tissue specific lineages in order to obtain any one of desired lineages in the mesoderm, ectoderm or endoderm. The claimed cell types belong to any one of the mesoderm, ectoderm and endodermal lineage, and thus, one skilled in the art would utilize a differentiation medium suitable for the desired lineage cells with a reasonable expectation of success. In support, it is known in the art that a tissue-specific culture medium can be used for differentiation into specific tissues according to Lee et al. (p.5). Lee et al. teach a kit for tissue regeneration comprising a conjugate of plasmids PTEN and PTD, and stem cells, and the kit may further include a tissue-specific culture medium for inducing differentiation for differentiation into specific tissues. Still further, the use of the neural medium for differentiating into a nerve cell taught by Kang is considered as one example of such differentiation of the multipotent stem cells into any one of known cell types differentiated from the multipotent stem cells.
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.
Response to Arguments
Regarding the objection to the specification, applicant has pointed out that the instant specification does not disclose “for 15 mM” in para. [221]. It is acknowledged that the instant specification discloses a correct phrase of “for 15 min”. It is noted that somehow the PGPub version of the specification discloses para. [221] and this paragraph contains “15 mM”. The objection is withdrawn.
Regarding the 112(a) new matter rejection, the instant amendment overcome the rejection and the rejection has been withdrawn.
The instant amendment raised a new issue under 35 U.S.C. 112(a) and the new art rejections under 35 U.S.C. 102 and 103.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631