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
This action is in response to the claims filed on June 29, 2024. Claims 1 – 12 are pending.
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, 3, 4, 8, 9, 11 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guo et al. (C.N. Patent Application Publication No. 108210518 A; hereinafter Guo). The claims are mapped to the machine translation of CN108210518.
Regarding claims 1, 3, 4, 8, 9, 11 and 12 Guo discloses a DMEM/F12 (p. 4, bottom of page) basal culture medium and a method for the culturing of umbilical cord mesenchymal stem cells that comprises adding 0.2 – 9 mg/ml of Salvia miltiorrhiza extract (p. 5, bottom of page) to the medium.
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 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Kapalavavi et al. (Subcritical Water Extraction of Salvia miltiorrhiza. Molecules. 2021; 26(6):1634; hereinafter Kapalavavi).
Regarding claims 2 and 10, Guo teaches all of the elements of the current invention as stated above except explicitly stating the method of extraction for Salvia miltiorrhiza. However, Kapalavavi discloses that the traditional way to take the herbal medicine is to cook (decoction) the medicinal herbs in boiling water (Introduction) at 100 ⁰ C (Table 1.). The motivation would be to use the most efficient extraction method for a root.
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 have utilized the traditional extraction method of Kapalavavi for Salvia miltiorrhiza in the mesenchymal stem cell culture protocol of Guo. Doing so would employ one of the best isolation methods for a root extract, in order for the extract to be added (mixed) to a cell culture medium.
Claims 5 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Guo and Kapalavavi as applied to claims 2 and 10 above, and in further view of Esser et al. (Evaporation from Cell Culture Plates, Thermo Fisher Scientific TILSPNUNCBU02 0111, (2011); hereinafter Esser)
Regarding claims 5 – 7, Guo and Kapalavavi teach all of the elements of the current invention as stated above except the relative humidity (RH) of the stem cell culturing environment. Furthermore, Guo (p. 4, bottom) discloses/suggests a 5% CO2 level and a culturing temperature range of 35 ⁰ C to 38 ⁰ C. However, Esser discloses (p.2, Environmental humidity) the “ideal” RH for cell culture is 100%. Esser provides motivation for utilizing relatively high humid culturing environments by disclosing that the high humidity helps to avoid significant medium evaporation from culture plates. This evaporation may cause problems due to the medium components potentially reaching harmful concentrations that could damage the cells (p. 1, 1st paragraph). Esser further discloses/suggests that the highest obtainable humidity in practice would normally be about 95% and to use a humidity control (p. 4, Summary, 1st point) that secures the highest possible RH (i.e. 90% to 99%).
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 combine the traditional extraction method of Kapalavavi for Salvia miltiorrhiza and the RH of Esser with the mesenchymal stem cell culture conditions of Guo. Doing so would provide for the best cell culturing conditions to avoid significant medium evaporation from mesenchymal stem cell culture plates.
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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