DETAILED ACTION
This action is in reply to papers filed 7/8/2026.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230285470A1, Published 9/14/2023.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 84-87, 89-91, 94-95 and 98-102 in the reply filed on 7/8/2026 is acknowledged.
Claims 103-108 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/8/2026.
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 89, 91 and 94 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.
Each of claims 89, 91 and 94 recite the term ‘preferably’. The use of this language creates an ambiguity as to whether the feature that follows is a required limitation of the invention or just an optional preference.
Claim 94 depends on a cancelled claim. See below.
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The metes and bounds of claim 94 are unclear in view of its dependency on a cancelled claim.
Appropriate correction is requested.
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.
Prior Art Rejection 1
Claim(s) 84-87, 90, 95 and 100-102 are rejected under 35 U.S.C. 103 as being unpatentable over Pei et al. (CN101984050B, Published 3/9/2011; English translation attached), Chen et al. (US20120202291A1, Published 8/9/2012) and Phan, T. (PgPub US20180127721A1, Published 5/10/2018; Ref. 3 in IDS filed 4/6/2023).
Pei et al. teach cell types derived from placental tissue that have wide application prospects in allogeneic transplantation and can be effectively induced into induced pluripotent stem cells (iPS), are amniotic mesenchymal cells , chorionic mesenchymal cells and umbilical cord mesenchymal cells (as in claim 84, in-part and as in claim 85) (Abstract). Towards this end, Pei teaches a method for inducing reprogramming to efficiently induce pluripotency from these cell types by introducing cDNAs containing pluripotent stem cell factors such as OCT4, Sox2, Klf4 and c-Myc (as in claim 84, in-part) (Pg. 5). Pei teaches these cells are then cultured on the culture medium and the quality of iPS is optimized on a suitable medium after the initial iPS is obtained, and pluripotent stem cell clones can also be preliminarily identified. Pei teaches the means of introducing comprises electroporation (as in claim 90) (Pg. 5).
However, Pei et al. fails to teach the suitable medium comprises a compound for suppressing inflammatory response and enhancing cell survival (as further in claim 84).
Before the effective filing date of the claimed invention, Chen et al. taught a fully defined media that support pluripotent cell viability, proliferation, cloning, and derivation (as in claim 84, in-part )(Abstract; Pg. 4, para. 50). Chen teaches the medium comprises hydrocortisone (as further in claim 84 and as in claim 100 and claim 101) (Pg. 2, para. 24). In one teaching, Chen teaches when hydrocortisone, its derivatives, and dexamethasone were added to DF5SFe- an expansion medium- to replace FBS (as in claim 95), cell growth was improved significantly (Pg. 8, para. 86).
And although Chen teaches hydrocortisone, Chen fails to teach the concentration of hydrocortisone in the media (as in claim 102).
Before the effective filing date of the claimed invention, Phan taught a method of isolating a mesenchymal stem cell population from the amniotic membrane of the umbilical cord, the method comprising cultivating umbilical cord tissue in a culture medium comprising, inter alia, hydrocortisone (Abstract; Pg. 5, para. 51). In one embodiment, Phan teaches the hydrocortisone is provided at a concentration of about 1 μg/ml hydrocortisone. It is noted that although Phan does not teach the hydrocortisone is added to the medium at an amount as claimed, MPEP 2144.05 states that "generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical”. ” [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). Experimentation to determine the optimum concentration of hydrocortisone to be added to the medium in order to obtain a desired effect in vivo was well known in the art of wound cell culture. Thus, obtaining the resulting medium to function as claimed would require only routine experimentation for one of ordinary skill in the art (as in claim 102).
Phan also teaches at least about 90% or more cells of the stem cell population express each of the following markers: CD73, CD90 and CD105 and lack expression of the following markers: CD34, CD45 and HLA-DR (as in claim 86 and claim 87) (Abstract).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Pei et al., wherein Pei teaches a method of reprogramming mesenchymal stem cells derived from amniotic tissue into pluripotent stem cells, with the teachings of Chen et al., wherein Chen teaches a fully defined media that support pluripotent cell viability, proliferation, cloning, and derivation with the teachings of Phan, wherein Phan teaches a method isolating mesenchymal stem cells derived from amniotic.
That is, one of ordinary skill in the art would have found it prima facie obvious to use the isolation method of Phan to obtain mesenchymal stem cells derived from amniotic, reprogram said mesenchymal stem cells using the method of Pei et al. and culture said reprogramming cells in the medium of Chen, with a reasonable expectation of arriving at the claimed invention.
A person of skill in the art would have been motivated to make such modifications in order to derive iPS cells from mesenchymal stem cells derived from amniotic membrane.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the claimed invention, as a whole, was clearly prima facie obvious
Prior Art Rejection 2
Claim 89 is rejected under 35 U.S.C. 103 as being unpatentable over Pei et al. (CN101984050B, Published 3/9/2011; English translation attached), Chen et al. (US20120202291A1, Published 8/9/2012) and Phan, T. (PgPub US20180127721A1, Published 5/10/2018; Ref. 3 in IDS filed 4/6/2023) as applied to claim 84-87, 90, 95 and 100-102 and further in view of Noguchi (JP2020089313A, Published 6/11/2020;English translation attached)
The teachings of Pei et al., Chen et al. and Phan are relied upon as detailed above. However, none of these references teach the exogenous nucleic acids encoding
the proteins OCT3/4, SOX2, KLF4, LIN28 and L-MYC and the p53-shRNA are provided by one,
two or three vectors (as in claim 89).
Before the effective filing date of the claimed invention, Noguchi et al. teach an experimental example in which OCT4, p53 shRNA, SOX2, KLF4, L-MYC, and LIN28 (Pg. 117) can be used as reprogramming factors in somatic cells, using a singular plasmid vector (as in claim 89). Noguchi teaches the human somatic cells are not particularly limited as long as they can be collected from humans. In one embodiment, Noguchi teaches the cells are derived from amniotic tissue (Abstract; Pg. 3).
When taken with the teachings of Pei et al., Chen et al. and Phan, wherein the combination teaches a method of reprogramming mesenchymal stem cells derived from amniotic membrane, wherein said method comprises introducing reprogramming factors into an isolated mesenchymal stem cell using electroporation, one of ordinary skill in the art would have found it prima facie obvious to introduce OCT4, p53 shRNA, SOX2, KLF4, L-MYC, and LIN28 as reprogramming factors in somatic cells using a singular plasmid vector into the mesenchymal stem cells of the combination. The skilled artisan would have found it prima facie obvious to do because Noguchi teaches these reprogramming factors can be used in amniotic membrane derived cells.
Prior Art Rejection 3
Claim 91 is rejected under 35 U.S.C. 103 as being unpatentable over Pei et al. (CN101984050B, Published 3/9/2011; English translation attached), Chen et al. (US20120202291A1, Published 8/9/2012) and Phan, T. (PgPub US20180127721A1, Published 5/10/2018; Ref. 3 in IDS filed 4/6/2023) as applied to claim 84-87, 90, 95 and 100-102 and further in view of Jiang et al. (CN110951785A, Published 4/3/2020; English translation attached.)
The teachings of Pei et al., Chen et al. and Phan are relied upon as detailed above. However, none of these references teach the mesenchymal stem cell of the amniotic membrane of the umbilical cord is subjected to electroporation with 1 pulse having a duration time of 15-25ms and a voltage of 1550-1650V (as in claim 91).
Before the effective filing date of the claimed invention, Jiang et al. taught introducing a nucleic acid into mesenchymal stem cells, wherein the pulse voltage is 1300-1700V, the pulse time interval is less than 30ms, and the pulse frequency is at least once (as in claim 91) (Abstract).
When taken with the teachings of Pei et al., Chen et al. and Phan, wherein the combination teaches a method of reprogramming mesenchymal stem cells derived from amniotic membrane, wherein said method comprises introducing reprogramming factors into an isolated mesenchymal stem cell using electroporation, one of ordinary skill in the art would have found it prima facie obvious to use the electroporation method of Jiang et al. The skilled artisan would have found it prima facie obvious to do so because Jiang observed success when using introducing a nucleic acid into mesenchymal stem cells, wherein the pulse voltage is 1300-1700V, the pulse time interval is less than 30ms, and the pulse frequency is at least once.
Thus, for this reason, the modification would have been prima facie obvious.
Allowable Subject Matter
Claims 98-99 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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