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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 02/16/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/31/2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 06/03/2026 is acknowledged.
Claims 1-10 and 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/31/2024.
Claims 15-20 are being examined on the merits.
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 19 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. The claim recites an additional step of enhancing and this could mean many things. Although the specifications give preferred embodiments of what this can mean the specifications are not to be read into the claims for interpretation because the term “enhancing” is not defined and so the limitations metes and bounds are indefinite.
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 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andrew Hoffman (From IDS, WO2018208670A1).
Regarding claims 15 and 18, Hoffman discloses a method “of isolating mesenchymal stromal cell (MSC)-derived extracellular vesicles (EV) having membrane-tethered TGF-β (MSC-derived, membrane-tethered TGF-β EV), the method comprising: culturing MSC, or a cell or tissue source of MSC, in cell culture or conditioned medium; and isolating the MSC-derived, membrane-tethered TGF-β EV from the cell culture or conditioned medium; and optionally, quantifying the amount of MSC-derived, membrane-tethered TGF-β EV from the cell or tissue source” (see claim 26). Here Hoffman discloses a secretory cell (MSC) and culturing in medium that allows for EVs having membrane-tethered TGF- β, and isolating (sorting) on the presence of TGF- β which means there would inherently be a population which does not have the TGF- β marker because Hoffman teaches “the EV lacking membrane- tethered TGF-β can be negatively selected by immune affinity techniques” (see page 49, lines 24-25).
Regarding claims 16 and 20, Hoffman teaches “In an embodiment, such dendritic cells, and, in turn, the EV derived therefrom, can be recombinantly modified to express certain tumor associated antigens to enhance immune cell response against tumors” (see page 49, lines 21-23). This implies genetic manipulation.
Regarding claim 17, Hoffman discloses “In other embodiments, for therapeutic applications, MSC-derived EV with membrane tethered TGF-~ can be separated from the total EV population using immune affinity techniques, e.g., affinity chromatography” (see page 54, lines 20-23).
Regarding claim 19, Hoffman discloses “An in vitro method of enhancing production of mesenchymal stromal cell (MSC) derived extracellular vesicles (EV) comprising membrane-tethered TGF-~ (MSC-derived, membrane-tethered TGF-~ EV)” comprising culturing MSC ins conditioned mediator molecules selected from the group consisting of interferon-gamma (IFNy), tumor necrosis factor (TNF), lipopolysaccharide (LPS) and interleukin-17 (IL-17) for a time sufficient for the MSC to produce an enhanced amount of MSC-derived, membrane-tethered TGF-~ EV, wherein the MSC are immortalized or native MSC. (see claim 59, pages 105-106).
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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