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 .
Status of Claims
Claims 1, and 6-8 were cancelled. Claims 2-5 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements is being considered by the examiner.
WITHDRAWN REJECTIONS
Claim Rejections - 35 USC § 112
Claims 1-8 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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The rejection is withdrawn following cancellation of claims 1 and 6-8 and claim amendments to claim 2.
Claim Rejections - 35 USC § 102
Claims 1-2 were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ameri et al (US 2012/0135519A1; published May 31, 2012, hereinafter "Ameri", See PTO-892).
The rejection is withdrawn following claim amendments and cancellation of claim 1.
Claim Rejections - 35 USC § 103
Claims 2-3 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ameri et al (US 2012/0135519A1; published May 31, 2012, hereinafter "Ameri", See PTO-892) in view of Olmer et al (Tissue Eng Part C Methods. Published 2012 Oct, hereinafter "Olmer", See PTO-892).
The rejection is withdrawn following cancellation of claims and claim amendments.
Claims 4-5 and 8 were rejected under 35 U.S.C. 103 as being unpatentable over Ameri et al (US 2012/0135519A1; published May 31, 2012, hereinafter "Ameri", See PTO-892) in view of Olmer et al (Tissue Eng Part C Methods. Published 2012 Oct, hereinafter "Olmer", See PTO-892) and Fernandez et al (Plant Methods, 2018, hereinafter "Fernandez", See PTO-892).
The rejection is withdrawn following cancellation of claims and claim amendments.
NEW REJECTIONS NECESSITATED BY CLAIM AMENDMENTS
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.
Claims 2-5 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Amit et al (WO2012032521; Published Mar 15, 2012; Hereinafter "Amit"; See PTO-892)..
Regarding claims 2-3: Amit taught methods of culturing pluripotent stem cells in a suspension culture as single cells devoid of clumps (See Amit Abstract). Claim 52 of Amit taught that “culture conditions comprise a culture medium which comprises basic fibroblast growth factor (bFGF) at a concentration of at least 50 ng/ml and an IL6RIL6 chimera.” Amit taught that “the concentration of the bFGF is selected from the range of between 50 ng/ml to 150 ng/ml.” (See Amit [0062]). Amit also at [0272] indicated that bFGF can be added at higher concentrations, “…the culture medium which comprises … bFGF at a concentration of at least about 50 ng/ml to about 1 μg, e.g., from about 60 ng/ml to about 1 μg/ml…”
Amit provided a range for concentration of bFGF in suspension cell culture necessary to maintain pluripotency. Amit provided various ranges of FGF from 50 ng/ml to 1µg/ml. Based on the disclosure of Amit it is submitted that determination of appropriate bFGF concentration would be readily optimizable for one having ordinary skill in the art by routine experimentation. Where 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. See MPEP 2144.05. FGF concentration suggested by Amit would be expected to maintain undifferentiated state (See Amit claim 52). While the application does not explicitly disclose at least 150 ng/ml concentration of bFGF, Amit does disclose higher concentrations such as up to 1µg/ml. As such it is submitted that it is not obvious to generate workable ranges of bFGF
Regarding claims 4-5: Amit taught that “to initiate a suspension culture on 58 mm Petri dishes the pluripotent stem cells are seeded at a cell density of 1×106-5×106 cells/dish.” (See Amit [0190]. Amit further taught that “[w]hen a bioreactor is used, the concentration of cells seeded in the bioreactor can be from about 1×104 to about 106 cells per ml.” (See Amit [0186]). As such it is submitted that Amit taught a suspension culture with a cell density of not less than 6.0x105 cells/ml. It is again reiterated that where 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. See MPEP 2144.05. Amit taught a method of culturing pluripotent cells with bFGF of at least 50 ng/ml. Amit also indicated that the concentration of FGF can be optimized up to 1µg/ml. Amit also taught seeding pluripotent cells at a cell density of 1×106-5×106 cells/dish. As such it is submitted that it is not obvious to generate workable ranges of cell density.
Conclusion
No claim is free of art.
No claim is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M. Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633
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