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 of Application
Receipt of Applicant’s remarks and amended claims filed on June 30, 2026.
Claims 1, 5-9 and 16 are pending in this application.
Claims 1, 5-9 and 16 have been amended.
Claims 2-4, 10-15 and 17-20 have been cancelled.
All claims are under examination in this application.
Withdrawn Rejections
Claim Rejections - 35 USC § 101
The rejection of claims 8-15 and 17-20 under 35 U.S.C. 101 because the claimed invention is not supported by either a specific asserted utility or a well-established utility has been withdrawn in view of the cancellation of claims 10-15 and 17-20, and the amendment to claims 8-9 to recite “the targeted carrier”.
Claim Rejections - 35 USC § 112
The rejection of claims 6-15 and 17-20 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 because:
claim 6 recites the limitation "the drug carrier" in line 1 and there is insufficient antecedent basis for this limitation in the claim has been withdrawn in view of the amendment to the claims to recite “the targeted carrier”;
claim 7 contains the trademark/trade name Temodal has been withdrawn in view of the amendment to the claim to recite temozolamide;
claims 8-15 and 17-20, as noted above, are drawn “the use” of the composition of claim 1 has been withdrawn in view of the cancellation of claims 10-15 and 17-20, and the amendment to claims 8-9 to recite “the targeted carrier”.
Claim Rejections - 35 USC § 102
The rejection of claims 1-7 and 16 under 35 U.S.C. 102(a)(2) as being 102(a)(2) by Chen et al. (EP 4190349) has been withdrawn in view of the amendment to claim 1 to recite a transmembrane protein CD 63 and a microRNA encapsulated within the extracellular vesicle, wherein the microRNA comprises miRNA-181.
Newly Applied Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Instant claim 8, depends from claim 1. The claims are drawn to a targeted carrier. Claim 8 does not further limit to the structural elements of claim 1 but rather recites functional properties which would necessarily be present in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claims 1, 5-9, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (EP 4190349) in view of Zeng et al (Current Strategies for Exosome Cargo Loading and Targeting Delivery, Cells, 2023, 12, 1416, Published 17 May 2023).
Chen discloses exosomes having an anti-HLA-G protein specific for cancer, and the exosome is used as a delivery vehicle to deliver therapeutic agents for treating cancer (abstract).
Chen discloses a polynucleotide, which comprises a sequence encoding a fusion protein, wherein the fusion protein comprises a targeting protein and an exosomal transmembrane protein, and the targeting protein comprises an anti-human leukocyte antigen G (HLA-G) protein (paragraph 0024). The exosomal transmembrane protein comprises CD 63 (paragraph 0026), for example.
Figure 9 shows an amount of miRNA and doxorubicin co-loaded into exosomes.
Regarding claim 5, as noted above, the exosomal transmembrane protein comprises CD 63 (paragraph 0026), for example.
Regarding claim 6, the exosome comprises an anti-cancer drug used to target glioblastoma (claims 5, 7). The anti-cancer agent is a chemotherapy agent or a microRNA for treating cancer (claim 8).
Regarding claim 7, chemotherapy agents include temozolomide (paragraph 0040).
Regarding claims 8-9, the instant claims recite functional properties of the targeted carrier recited in instant claim 1.
Regarding claim 16, the exosomes can be incorporated into a pharmaceutical composition to be administered for the treatment of cancer (paragraph 0050-0052).
Chen does not disclose the microRNA is miRNA-181.
Zeng discloses exosomes, due to their high biocompatibility, stability, and low immunogenicity, are favored as cargo carriers. They offer protection against cargo degradation (abstract).
Exosomes loaded with miRNA 181 and doxorubicin. Modifications, including the use of temozolamide into the exosomes is additionally disclosed (Advantages of Exosomes as Drug Carriers).
It would have been obvious to one of the ordinary skill in the art prior to the effective filing date of the invention to have used miRNA in the exosomes of Chen since Zeng discloses it is suitable for inclusion in exosomes and can be used in combination with exemplified doxorubicin and alternative temozolomide of Chen.
Conclusion
Applicants’ 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 MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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