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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 23 June 2026.
.
CLAIMS UNDER EXAMINATION
Claims 1-15 and 17 are pending. Claim 15 has been examined on the merits. Claims 1-14 and 17 are withdrawn.
PRIORITY
The Applicant claims priority to KR10-2013-0055158, filed on 15 May 2013.
NEW GROUNDS OF REJECTIONS
Claim 15 has been amended to recite the stem cell composition is “free of aspirin”. New grounds of rejection have been necessitated by claim amendment.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ra et al. (previously cited; Culture of multi-potential stem cells originating in adipose tissue and a cosmetic composition containing protein extracted therefrom. WO2010008219 A2) in view of Furcht et al. (previously cited; Multipotent Adult Stem Cells And Methods For Isolation. US2018/0110806 with benefit of 11/238234 filed on 29 September 2005), Solchaga et al. (previously cited FGF-2 enhances the mitotic and chondrogenic potentials of human adult bone marrow-derived mesenchymal stem cells. Journal of Cellular Physiology 203:398–409 (2005), Yamaza et al. (Pharmacologic stem cell based intervention as a new approach to osteoporosis treatment in rodents. PLoS One. 2008 Jul 9;3(7):e2615) and Muraki et al. (Technical Report: Assessment of Viability and Osteogenic Ability of Human Mesenchymal Stem Cells After Being Stored in Suspension for Clinical Transplantation. Tissue Engineering. 2006;12(6):1711-1719).
Ra teaches method of culturing of adult adipose stem cells derived from human adipose tissue (Example 1, page 8). Adipose stem cells are cultured in “keratinocyte-SFM” containing 5% FBS, 2 mM NAC, 0.2 mM ascorbic acid, 0.09 mM calcium, 5 ng/ml rEGF, 5 μg/ml insulin and 74 ng/ml hydrocortisone. Multipotent mesenchymal stem cells are isolated (see Example 1, section (1), page 8). Adipose tissue-derived multipotent mesenchymal stem cells can be passaged for 3, 5, 8 or 10 (see Example 1, section (2), page 8).
Ra teaches the medium can contain components found in most preservative media, including selenium (see page 3, middle of page). Ra teaches cultures containing bFGF (see page 4, about fourth line). The art teaches the medium can contain bFGF (916.15 pg/ml) (see page 4, middle of page).
Ra teaches stem cells attached to a culture vessel can be treated with trypsin to recover the cells (see page 3, fifth section of Detailed Description of the Invention and Specific Embodiments).
The deficiencies of Ra are:
Ra is silent regarding the amount of selenium.
Ra does not explicitly teach the claimed amount of bFGF.
Ra is silent regarding the cell diameter following culture.
Ra does not teach suspending the stem cells in a solution containing the claimed amount of aspirin for 12-24 hours.
Ra does not teach preparing the cells at a concentration of 1x107 to 5x108 cells/ml.
Furcht et al. disclose a method of culturing multipotent stem cells in medium (Abstract; [0026]). The art teaches “selenium may be present at a concentration of about 0.1 to about 5 μg/ml” ([0026]).
Solchaga expands mesenchymal stem cells in FGF-2 (hence, bFGF) supplemented medium (Abstract). Treated cells are smaller and proliferate more rapidly than hMSCs expanded without FGF-2 (Abstract; see page 401, left column, first paragraph of Results). The art uses a dose of 10 ng FGF-2 per ml (see Figure 2, see page 401, left column first two lines).
Yamaza treats mesenchymal stem cells with 2.5 µg/ml (0.0025 mg/ml) aspirin for 3 days (page 3, right column, second paragraph). The art teaches cell viability is significantly improved with treatment (see text of Figure 3).
Muraki et al. investigate the viability of MSCs in suspension for clinical transplantation (see Title and Abstract). The art teaches viability of MSCs is dependent on temperature and time (Figure 1). Figure 1 discloses viability decreases after suspension/storage for 24 hours, but is maintained above 80% at 4°C (see Figure 1; also see page 1716, left column, first paragraph).
Muraki also teaches the following: cells are cultured on tissue culture plates, released by trypsin digestion and suspended at a concentration of 1x106 cells/ml in PBS (see page 1712, right column, third paragraph). A suspension is interpreted to be a formulation suitable for intravenous administration. This concentration of suspended/stored cells is used for animal administration (see page 1714, right column, first paragraph).
It would have been obvious to combine the teachings of the prior art by culturing the stem cells taught by Ra in a medium containing 1 ng/ml selenium. Ra teaches selenium can be used to culture multipotent adult stem cells and Furcht et al. teach about 0.1 to about 5 μg/ml selenium can be used to culture multipotent adult stem cells. One would have been motivated to use the amount taught by Furcht since the reference teaches it can be used to culture stem cells. The claimed amount is obvious because it lies inside the range taught by Furcht See MPEP 2133.03. One would have had a reasonable expectation of success since Furcht teaches selenium can be used in the claimed range.
It would have been obvious to optimize the amount of bFGF in the medium taught by Ra. Solchaga teaches a dose of 10 ng bFGF per ml produces MSCs which are smaller and proliferate more rapidly. The skilled artisan would optimize the amount of bFGF based on the desired cell number and cell size. See MPEP 2144.05. One would have had a reasonable expectation of success using bFGF since Ra teaches the use of additives that promote proliferation. One would have expected similar results since each reference is directed to therapeutic MSCs. Because the claimed culture media is rendered obvious, it would be expected to produce cells having the claimed diameter.
It would have been obvious to culture cells to passage 4 since Ra teaches culturing cells up for 3 or more days. The claimed stem cell increase is a result of culturing cells in the claimed culture medium. Because the claimed culture medium is rendered obvious, it follows that the stem cells taught by Ra would increase in number as claimed. It would have been obvious to treat the cultured cells taught by Ra with trypsin. One would have been motivated to do so to detach the cells from the culture dish as taught by Ra. One would have expected success since Ra teaches cells cultured in tissue cultured dishes are treated with trypsin to harvest the cells.
It would have been obvious to combine the teachings of the prior art by suspending the MSCs taught by Ra in a solution containing aspirin. One would have been motivated to do so since Yamaza treats mesenchymal stem cells with 2.5 µg/ml (0.0025 mg/ml) aspirin to improve stem cell viability. One would have had a reasonable expectation of success since Yamaza teaches stem cells can be treated with aspirin. One would have been motivated to optimize the treatment time since Muraki teaches stem cell viability can be maintained by limiting storage time to 24 hours. One would have expected similar results since both references are directed to methods of maintaining mesenchymal stem cell viability.
It would have been obvious to prepare the treated cells at a concentration of 1x107 . One would have been motivated to optimize the concentration taught by Muraki based on the desired number of cells for administration. The skilled artisan would suspend the cells in PBS (a solution which does not contain aspirin) since Muraki teaches cells are prepared in PBS when used for administration. One would have expected similar results since each reference is directed to maintaining stem cells. Therefore claim 15 is rendered obvious.
APPLICANT’S ARGUMENTS
The arguments made in the response field on 23 June 2026 are acknowledged. New grounds of rejection are set forth above to address the amended claims.
CONCLUSION
No Claims Are Allowed
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the APIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights