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 .
Claim Status
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101.
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 13 is 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.
Regarding claim 13, Attempts to claim a process without setting forth any steps involved in the process renders the claim indefinite. The word “use” in line 1 renders the claim indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 1 – 2 and 5 – 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (C.N. Patent Application Number 113462642; cited on IDS, claims are mapped to the machine translation attached, hereinafter Wu).
Regarding claims 1, 5 – 6, Wu discloses an invention claiming a fast inducing and differentiating method of mesenchymal stem cells (p. 18, Claim 1; p. 20, Claim 6, A mesenchymal stem cell) comprising: culturing pluripotent stem cells (p. 2, Background) in a medium comprising a BMP4 agonist.
Regarding claim 2, A chemical structure search rendered a match for Formula 1 of instant claim 2 (Top of p. 22 of STIC.SRCH in DAV) linked to Wu.
Regarding claim 7, Wu discloses experimental results that display CD90+, CD105+, and CD45- expression by the iPSC differentiation of the MSCs (p. 15, 2. Experimental Results Sect., FIG. 9).
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.
Claims 3 – 4 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Lu et al. (U.S. Patent Application Publication No. 2018/0055887 A.1.; cited on IDS, hereinafter Lu)
Regarding claim 3, Wu teaches all of the elements of the current invention as stated above except (p. 26, Claim 3) a medium containing inhibitors for MEK, p38, JNK, PKC, and GSK3. However, Lu discloses (p. 26, Claim 3) an invention that relates to a method for preparing induced mesenchymal stem cells (MSC), in which the inhibitors of instant claim 3 are used in the medium. Lu discloses that the motivation (para. [0011]) for the addition of the auxiliary agents of claim 3 were to enhance the efficacy of the protocol. Regarding claim 4, Wu does disclose an additional second stage mesenchymal stem cell inducing differentiation culture medium (p. 20, Top of the page) but does not include each inhibitor as stated above.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the medium of Lu in the mesenchymal stem cell generating protocol of Wu. Doing so would enhance the efficacy of the protocol, according to Lu.
Claims 8 – 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Konkuk et al. (K.R. Patent Application Publication No. 102319735; cited on IDS, claims are mapped to machine translation attached; hereinafter Konkuk).
Regarding claim 8, Wu teaches all of the elements of the current invention as stated above except an extracellular vesicle isolated from a culture solution of the MSCs. However, Konkuk discloses a method for obtaining extracellular vesicles from 3D-cultured MSCs (p. 1, Abstract; p. 9 – 11, Claims section). Regarding claims 9 – 13, Konkuk discloses (p. 10, Bottom of page) a composition for preventing or treating inflammation (multiple skin disorders, p. 10; Crohn’s disease, p. 11, Top of the page) comprising the stem cell-derived extracellular vesicles as an active ingredient. Regarding claim 11, Konkuk does not explicitly disclose the composition as a cosmetic but provides the motivation for one, by disclosing that the composition is useful for multiple skin disorders (including scleroderma). Konkuk discloses that the motivation for using the MSC-derived vesicles is because the exosomes are known to contain key factors related to anti-inflammation (p. 2, Background, 2nd para.).
It would have been prima facie obvious to one of ordinary skill in the art before effective filing date of the claimed invention to incorporate the MSC-derived extracellular vesicle producing teaching/motivation of Konkuk with the MSC-generating protocol of Wu. Doing so would generate and provide a therapeutic option for inflammatory diseases, according to Konkuk. Also, it would have been obvious to change an anti-inflammatory pharmaceutical composition into a cosmetic composition for the purpose of administering it to a subject for the treatment of a skin disorder.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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