Notice of Pre-AIA or AIA Status
The present application, 18568061, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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
The filing receipt, mailed 5/14/2024, states that this application was filed 12/07/2023, and claims domestic priority benefit as a 371 of PCT/JP2021/022314, filed 06/11/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/25/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
In regards to interpretation of the claim term “exosome production promoter”, it is noted that the Specification does not appear to provide a limiting definition. The Specification states:
[0015] An exosome production promoter according to the present invention is an exosome production promoter that promotes production of exosomes from adipose-derived mesenchymal stem cells cultured in a serum-free medium, and contains EGF.
Specification at para [0015].
Furthermore, the Specification states:
[0050] The exosome production promoter can be used for the production of exosomes.
Specification at para [0050].
Thus, the instant Specification does not provide a limiting definition of “exosome production promoter”, such that “exosome production promoter” is confined to a substance used only in cell culture media.
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.
Claim 1 and claims 2, 4, 5, 7, 8, 10, 11, and dependent claims, 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.
The claims state abbreviations for EGF, IL-1beta, SCGF and TNF alpha, but should provide the spelled out words in their first instance.
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.
1. Claim(s) 1-3, 5-9, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanagita, US 20230172992, Yi, US 20200121723 A1, and Kanaki, 20200040304.
Yanagita, US 20230172992, throughout the publication and abstract, and at para 103, 178, 277, 285, 296, 296, 535. Yanagita teaches culturing mesenchymal cells in medium from mesenchymal cell culture, in order to increase production of exosomes.
Yanagita, at para [0102], [104], [0180], teaches serum-free culture medium, especially for cultured cells and culture medium used for therapeutic applications, such as treatment of disease and regenerative medicine; and containing EGF (epidermal growth factor) to promote proliferation of stem cells
Yanagita, teaches at para [0004] that mesenchymal are known to secrete exosomes and, at para [0277], teaches producing exosome from mesenchymal stem cell culture; at, e.g., at para [0295]-[0296], teaches culture supernatant that contains IL-1b, as in claim 2.
Yanagita, at para [0062], states:
[0295] Each of the culture supernatant according to the first embodiment and the culture supernatant according to the second embodiment preferably contains at least one of IL-1α (interleukin-1α), IL-1β (interleukin-1β), or TNF-α (tumor necrosis factor-α) in an amount of 0 to 15 pg/mL (see FIGS. 30 to 32). Each of the culture supernatant according to the first embodiment and the culture supernatant according to the second embodiment more preferably contains each of IL-1α, IL-1β, and TNF-α in an amount of 0 to 15 pg/mL. Since these cytokines are known as factors causing inflammatory symptoms, it is desirable that the culture supernatant does not contain them in large amounts.
Yanagita, at para [0062].
Yanagita does not teach trehalose, an exosome production promoter that does not contain TNFa, a nonwoven scaffold for culturing cells.
Yi, US 20200121723 A1, at para [0032], Figure 1, and claim 2, teaches the obtaining of exosomes, as in claim 3, by adding trehalose to conditioned media for obtaining exosomes. Yi, at para [0033], Fig.s 6A to 6E, states that adding trehalose to the buffer for diafiltration results in exosomes having a uniform particle size distribution and high purity.
Kanaki, 20200040304, throughout the publication and abstract and e.g., at para [0004], [0103], teaches exosomes extracellularly secreted by mesenchymal stem cells; [0011], teach a nanofiber carrier, composed of polysaccharides such as chitin, which is suspended in medium, for mesenchymal cells to adhere to; Kanaki teaches that cells adhered to the nanofibers showed long-term survivability under suspension culture. Kanaki thus teaches a nonwoven scaffold for culturing cells.
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined trehalose, an exosome production promoter that does not contain TNFa, a nonwoven scaffold for culturing cells in the methods for using an exosome production promoter for production of exosomes from adipose-derived mesenchymal stem cells in a serum-free medium, wherein the promoter contains EGF, or method thereof.
One of ordinary skill in the art would have been motivated to have combined trehalose in the exosome production promoter, because Yi taught that adding trehalose to the buffer for diafiltration results in exosomes having a uniform particle size distribution and high purity. It is noted that the “exosome production promoter” is not limited to cell culture, (see, above claim interpretation).
One of ordinary skill in the art would have been motivated to have combined an exosome production promoter that does not contain TNFa, because it was suggested by Yanagita to reduce its use, and one of ordinary skill in the art would be motivated to remove it as a design choice, after routine testing.
One of ordinary skill in the art have used a nonwoven scaffold for culturing cells in the methods for using an exosome production promoter for production of exosomes from adipose-derived mesenchymal stem cells in a serum-free medium, wherein the promoter contains EGF, or method thereof, because Kanaki teaches that cells adhered to the nanofibers showed long-term survivability under suspension culture. Kanaki thus teaches a nonwoven scaffold for culturing cells.
2. Claim(s) 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanagita, US 20230172992, Yi, US 20200121723 A1, and Kanaki, 20200040304 as applied to claims 1-3, 5-9, 11-12 above, and further in view of Cao, 2020, Stem Cell Research & Therapy, Volume 11, 329, pages 1 to 15.
The prior art of Yanagita, US 20230172992, Yi, US 20200121723 A1, and Kanaki, 20200040304, are relied upon as applied to claims 1-3, 5-9, 11-12 above.
Yanagita, US 20230172992, Yi, US 20200121723 A1, and Kanaki, 20200040304, do not teach or suggest a exosome production promoter that does not contain SCGF.
Cao, throughout the publication and abstract, teach use of stem cell factor (SCF), which reads on SCGF, in mesenchymal stem cell media. Cao, p. 14 of 15, indicates that SCF is a key factor in maintaining the stemness of stems cells from human exfoliated deciduous teeth.
results-affecting variable.
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have used a exosome production promoter that does not contain SCGF.
One of ordinary skill in the art would have been motivated to have used a exosome production promoter that does not contain SCGF because combined trehalose in the exosome production promoter, because Cao demonstrates that SCGF is a results-effective variable, and one of ordinary skill in the art would be motivated to remove it as a design choice, after routine testing.
Conclusion
2. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark L Shibuya whose telephone number is (571)272-0806. The examiner can normally be reached M-F, 9AM-4:30PM.
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MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/Primary Patent Examiner, Art Unit 1631