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 .
Election/Restrictions
Applicant’s election of the species VCAM-1 and mesenchymal stromal cell conditioned medium, without traverse, in the reply filed on is acknowledged.
Applicant has cancelled all claims to non-elected inventions/species.
Claims 1, 3 and 8 are pending and examined upon their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is the national stage entry of PCT/IB2021/061953 filed on 17 December 2021, and claiming the benefit of Republic of Colombia Application No. CONC2020/0015994, filed 18 December 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6 July 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 3 is objected to because of the following informalities: the unit of measure should be corrected from “Mg/mL” to “mg/mL”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hildago et al. Experimental Hematology, 29: 345-355, 2001.
Regarding Claim 1, the Hildago et al. prior art teaches an in vitro Transwell migration assay comprising
incubating an adhesion solution on a surface or adhesion compartment, wherein the adhesion solution comprises adhesion molecules, and wherein the adhesion molecules is vascular cell adhesion molecule-1 (VCAM-1), wherein it states, “For adhesion to VCAM-1, we used the soluble seven-extracellular domain recombinant human VCAM-1 (R&D Systems)” (pg. 346, Cell adhesion assays).
adding a migration buffer to a chemotactic compartment which comprises a chemotactic agent, wherein the chemotactic agent is mesenchymal stromal cell conditioned medium, wherein it states: “Before the adhesion assays, the cell lines were starved for 7 hours by incubation in adhesion medium (DMEM/BSA 0.5%)” (pg.346, Cell adhesion assays).
suspending a cellular phase of a source of HPC in a migration buffer and incubation thereof in a cellular compartment, wherein it states: CD34hi BM cells resuspended in adhesion medium …labeled for 20 minutes with the fluorescent dye BCECF-AM (pg.346, Cell adhesion assays) and “BM cells were placed in the upper chamber of Transwells (pg. 347, Chemotactic assays). The prior art teaches these cells are “hematopoietic progenitor cells” (see for example, Figure 1 legend).
And, recovering the content of the chemotactic compartment and count the cells which migrated; wherein the cellular compartment is separated from the chemotactic compartment by an adhesion surface or adhesion compartment; and wherein the cellular compartment and the chemotactic compartment are in mutual communication via a continuous solution which comprises a chemotactic gradient. Hildago and colleagues state: “600 mL of adhesion medium with or without 100 ng/mL of SDF-1 alpha was added to the lower chamber and transwells were incubated at 37 C for 3 hours. Viable migrated cells were counted in the flow cytometer by analyzing each sample in the same predetermined time and flow conditions” (pg. 347, Chemotactic assays).
Regarding Claim 3, Hildago et al. teach 1 µg/mL of sVCAM-1 is used (pg. 346, Cell adhesion assay). Thus, the prior art teaches the method wherein the concentration of the adhesion molecule (namely, VCAM-1) is of the order of pg/mL to mg/mL.
Regarding Claim 8, the methods of Hildago et al. prior art teach, in both the cell adhesion assays and the Chemotactic assays,wherein the HPC are incubated at 37oC for 3 hours (pg. 347, Chemotactic assays) and cells were maintained “in a humidified atmosphere at 37 8 C and 5% CO2” (pg. 347, lines 4-5). Therefore, the prior art teaches HPCs are incubated for 2 - 5 hours at 37°C with an atmosphere of between 3 and 5% of CO2.
Therefore, the method of the invention fails to distinguish over the methods disclosed in the prior art of record, and claims 1, 3 and 8 are rejected.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/Examiner, Art Unit 1675
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