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 .
Applicant’s amendment and remarks filed on 9/18/2025 are acknowledged. Claims 1 and 13 are amended. Claims 2 and 11 are cancelled. Claims 1, 3-10, and 12-14 are pending.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 9/18/2025 is acknowledged. The traversal is on the ground(s) that claim 12 of Group II directly refers to claim 1 of Group I. Applicant argues that, if Group I is free of prior art, Group II would then be free of prior art; therefore, there would not be an undue burden the examine both groups. This is not found persuasive for the following reasons. First, the instant application was filed as a 371. Therefore, the propriety of restriction is determined under the rules for unity of invention. Second, examination burden includes more than just search. Third, as set forth below, the claims of Group I are not free of the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-6 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Claims 1, 3-4, 7-10, and 13-14 are currently under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome the rejection set forth below because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Information Disclosure Statement
The information disclosure statements filed on 4/4/2023 and 11/14/2025 have been considered. Signed copies are enclosed.
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.
Claims 7-8 and 13 are 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 pre-AIA the applicant regards as the invention.
Claim 7 is rendered indefinite by the phrase “in which an antibody specifically binding to a tumor-associated antigen is present in a cell.” It is not clear how the cell, the antibody, or the tumor-associated antigen fit into the invention.
Claim 8 recites the limitation "the tumor-associated antigen" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the isolated mitochondrion" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al (Mol. Pharmaceutics, 11:2640-2649, 2014; IDS filed 4/4/2023).
The instant claims are drawn to a modified anticancer agent in which TPP is bound to an anticancer agent and a method of preparing mitochondrion comprising an anticancer agent.
Han et al disclose doxorubicin conjugated to a lipophilic TPP (see abstract). Han et al disclose mixing of cells in vitro with TPP-DOX resulting in mitrochondrial uptake of TPP-DOX (see page 2645, column 1).
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.
Claims 1, 3-4, 7-10, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al (Mol. Pharmaceutics, 11:2640-2649, 2014; IDS filed 4/4/2023) in view of Han et al (CA3097108, 2019).
Han et al (Mol. Pharmaceutics) discloses TPP-doxorubicin conjugates which provide mitochondrial targeting of doxorubicin (see page 2648). These conjugates accumulate in mitochondria. Doxorubicin is an anticancer topoisomerase inhibitor which targets the cancers recited in claim 9. Han et al (Mol. Pharmaceutics) states that the issue with their anticancer agent is that it is nonselective for cancer cells.
Han et al (Mol Pharmaceutics) differs from the instant invention in that they do not disclose modified mitochondria comprising the anticancer agent.
Han et al (CA3097108) disclose modified mitochondria which can be effectively delivered to cancer cells (see abstract). These modified mitochondria can thus be used to deliver anticancer agents into cancer cells (see page 2, lines 9-15 and page 11, lines 31-40). The mitochondria are modified by minding a foreign protein to the outer membrane of the mitochondrion (see page 6). The foreign protein can be an antibody that targets ligands on the surface of a tumor cell, including the antigens recited in instant claim 8 (see page 8, lines 20-40).
It would have been obvious to one of ordinary skill in the art, at the time of invention, to use the modified mitochondria of Han et al (CA3097108) to deliver the TPP-DOX anticancer agent of Han et al (Mol. Pharmaceutics) because it allows selective delivery of the drug to cancer cells.
One would have had a reasonable expectation of success because Han et al (Mol Pharmaceutics) showed mitochondrial uptake of TPP-DOX and that it was a useful anticancer agent, while Han et al (CA3097108) showed that they could deliver anticancer agents specifically to cancer cells.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645