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 without traverse of Group I (claims 1-13, 17, and 33-36) in the reply filed on 06 April 2026 is acknowledged.
Claims 14-16 and 18-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 1-13, 17, and 33-36 are under current consideration.
Drawings
The drawings are objected to because FIGS. 18A-18F are depicted on sheet 21 and then different depictions on sheet 22 are also labeled as 18A-18F. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the Brief Description of the Drawings section discusses FIG. 18, rather than FIG. 18A, FIG. 18B, etc., but the drawings depict FIG. 18A, FIG. 18B, etc.; and the Brief Description of the Drawings section discusses FIGS. 11A-11D, rather than FIG. 11, but the drawings depict FIG. 11.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 and 10-13 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Batrakova et al. (US 2020/0297631 A1; published 24 September 2020).
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 nanoparticles can be PLGA (paragraph [0209]).
Regarding claims 4-6, such claims further limit the antibody/affibody/peptide, but such is not required as claim 2 specifies that an alternative is protein, which Batrakova et al. discloses as discussed above.
Claim(s) 33 and 35 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by John et al. (WO 2019/094679 A1; published 16 May 2019).
John et al. discloses synthetic exosomes (SE’s) also called deformable nanoscale vehicles (DNVs) encapsulating an antibody (abstract) wherein the antibodies are therapeutic molecules (paragraph [0167]) wherein the DNVs and therapeutic agents are in a pharmaceutical composition (paragraph [0250]) wherein the DNVs are about 100 or 150 nm average diameter (claim 66) wherein the DNVs further include a surface coating of a hydrophilic polymer chain (paragraph [0216]).
Claim Rejections - 35 USC § 103
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) 1-13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Batrakova et al.
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 nanoparticles can be PLGA (paragraph [0209]).
Regarding claims 4-6, such claims further limit the antibody/affibody/peptide, but such is not required as claim 2 specifies that an alternative is protein, which Batrakova et al. discloses as discussed above.
Regarding claim 9, although Batrakova et al. does not specifically disclose about 500-800 copies of the nucleic acid as claimed, 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 optimize the therapeutic effectiveness of the composition of Batrakova et al. as discussed above by varying the amount/dose of the micro-RNA therein through routine experimentation per MPEP 2144.05(II), 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 because active/therapeutic agent amount/dose is a known result-effective variable that is a matter of routine optimization. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"); Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'").
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 the only additional structure implied other than that already discussed above is a mean particle diameter of about 90-150 nanometers, which overlaps the disclosed range of about 100-200 nanometers as discussed above, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Claim(s) 1-13, 17, and 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Batrakova et al. as applied to claims 1-13 and 17 above, and further in view of Braeckmans et al. (US 2018/0372730 A1; published 27 December 2018).
Batrakova et al. is relied upon as discussed above.
Batrakova et al. does not disclose a coating as in claims 33-36.
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 Batrakova et al. and Braeckmans et al. by coating the exosomes of Batrakova 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.
Further regarding claim 36, as discussed above Batrakova et al. discloses that the exosomes are isolated from donor cells such as dendritic cells (i.e., the nanovesicles are obtained from dendritic cell membranes).
Conclusion
No claims are allowed.
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
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