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 .
Status
Applicant’s response dated 18 August 2026 to the previous Office action dated 19 May 2026 is acknowledged. Pursuant to amendments therein, claims 1, 7-9, 12-18, 20-21, 23, and 33-35 are pending in the application.
The drawing objections made in the previous Office action are withdrawn in view of applicant’s submission of acceptable replacement sheets.
The specification objections made in the previous Office action are withdrawn in view of applicant’s specification amendments.
The rejections under 35 U.S.C. 102 made in the previous Office action are withdrawn in view of applicant’s claim amendments.
The rejections under 35 U.S.C. 103 made in the previous Office action are withdrawn in view of applicant’s claim amendments, but new rejections under 35 U.S.C. 103 are made herein as set forth below in view of applicant’s claim amendments.
Election/Restrictions
Claims 14-16, 18, 20-21, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06 April 2026.
Claims 1, 7-9, 12-13, 17, and 33-35 are under current consideration.
Drawings
The drawings were received on 18 August 2026. These drawings are acceptable.
Response to Arguments
Applicant’s arguments, see remarks pages 7-9, filed 18 August 2026, with respect to the prior art rejections made in the previous Office action have been fully considered and are persuasive, in that the previously cited art does not disclose NSC-derived nanovesicles comprising recombinant CXCR4 as now claimed. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the prior art as discussed below.
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.
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.
Claim(s) 1, 7-9, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaige et al. (WO 2021/154888 A1; published 05 August 2021).
Gaige et al. discloses pharmaceutical compositions comprising modified extracellular vesicles with a payload in combination with one or more pharmaceutically or physiologically acceptable carriers, diluents, or excipients (paragraph [155]) wherein a payload is surrounded by the vesicle (paragraph [133]) wherein a payload can be a small molecule, nucleic acid, drug, or combination thereof such as two or more drugs or therapeutic biologics or RNAs (paragraph [135]) wherein modified extracellular vesicles comprise vesicle localization/targeting moieties (paragraph [21]) wherein the extracellular vesicle or exosome has vesical localization and targeting moiety thereon and is produced by a cell such as a neural stem cell (NSC) (paragraph [125]) wherein localization moieties can be CXCR4 (claim 12) wherein the vesicle localization with targeting moiety is displayed on the outer surface of the exosome (paragraphs [73], [75]) wherein the chimeric vesicle localization and targeting moiety is obtained using recombinant DNA methods (paragraphs [59], [80]) wherein the extracellular vesicle is an exosome (claim 25) wherein the exosome preferably has an average diameter of about 120 nm (paragraph [26]).
Although Gaige et al. does not disclose a specific example including all such elements as discussed above, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Gaige et al. as discussed above and to make the pharmaceutical composition of Gaige et al. as discussed above having all elements/constituents as discussed above, with a reasonable expectation of success.
Regarding claim 17, such is a product-by-process claim that is only limited to the structure implied by the steps per MPEP 2113(I), and here there is no additional structure implied by the steps not already discussed above.
Claim(s) 1, 7-9, 12-13, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaige et al. as applied to claims 1, 7-9, and 17 above, and further in view of Batrakova et al. (US 2020/0297631 A1; published 24 September 2020; of record).
Gaige et al. is relied upon as discussed above.
Gaige et al. does not disclose polymer-based nanoparticles as in claims 12-13.
Batrakova et al. discloses compositions comprising exosomes (i.e., a plurality of nanovesicles) and biological agents (abstract) wherein a composition for delivery of a biological agent to a cell comprises an exosome (i.e., a nanovesicle) comprising the biological agent (claim 1) wherein the exosome is isolated from a cell (i.e., the nanovesicles comprise cell membranes of a source cell) (claim 2) wherein the biological agent is a therapeutic agent (claim 6) wherein the exosomes have a size of 100-200 nm (i.e., encompasses a mean particle diameter from about 100-200 nanometers) (paragraph [0239]; Table 1) wherein one or more exosomes (i.e., a plurality of nanovesicles) are incorporated in the formulations of the invention (paragraph [0174]) wherein a targeting agent is attached to the surface of the exosome (claim 18) on a lipid group on the exosome (i.e., the cell membranes of the nanovesicles comprise a targeting agent on the external surface of the nanovesicles) (claim 21) wherein targeting agents include antibodies and cell surface binding proteins (i.e., binds to a ligand on the surface of a target cell) (paragraph [0133]) wherein antibodies (i.e., proteins) include recombinant antibodies/proteins (paragraph [0098]) wherein the biological/therapeutic agent may be a small molecule or polynucleotide (paragraph [0127]; claim 6) such as microRNA (paragraph [0131]) or small molecule doxorubicin (paragraph [0132]; Examples 2, 13; claim 6) wherein the exosomes are isolated from donor cells such as stem cells or dendritic cells (paragraph [0008]; claim 2) wherein nanoparticles comprising polymer and biological agent can be included in isolated exosomes (paragraphs [0161]-[0170]) wherein polymer may increase entrapment of biological agents into exosomes (paragraph [0165]) wherein nanoparticles can be PLGA (paragraph [0209]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gaige et al. and Batrakova et al. by making the pharmaceutical composition of Gaige et al. as discussed above wherein the biological agents therein are in nanoparticles comprising the agents and polymer such as PLGA as suggested by Batrakova et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to increase entrapment of the biological agents into the exosomes as suggested by Batrakova et al.
Claim(s) 1, 7-9, 17, and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaige et al. as applied to claims 1, 7-9, and 17 above, and further in view of Braeckmans et al. (US 2018/0372730 A1; published 27 December 2018; of record).
Gaige et al. is relied upon as discussed above.
Gaige et al. does not disclose coating as in claims 33-35.
Braeckmans et al. discloses characterizing extracellular vesicles (title; abstract) wherein extracellular vesicles are exosomes (claim 31) wherein vesicles are functionalized to advantageously avoid clustering such that they may be studied independently (paragraph [0013]) wherein subpopulations of exosomes can be analyzed and individual exosomes can be identified (paragraph [0016]) wherein functionalizing the extracellular vesicles comprises providing a coating of plasmonic material on the extracellular vesicles (claim 21) wherein the plasmonic material is metal based nanoparticles such as silver or carbon-based particles such as graphene particles (claims 29, 37) or gold (claims 33, 37-38) wherein the plasmonic nanoparticles may be functionalized with positively charged polymers (i.e., a polymeric coating) (paragraph [0088]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gaige et al. and Braeckmans et al. by coating the exosomes of Gaige et al. as discussed above with metal, gold, or silver nanoparticles functionalized with positively charged polymers (i.e., a polymeric coating) as suggested by Braeckmans et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to characterize the exosomes and to advantageously avoid clustering such that they may be studied independently wherein subpopulations of exosomes can be analyzed and individual exosomes can be identified as suggested by Braeckmans et al.
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 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 MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
