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 .
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I, wherein R1 is biotin and R2 is doxorubicin in the reply filed on 10/23/2025 is acknowledged. The traversal is on the ground(s) that the withdrawn claims 6 and 11 are method claims directed to mitochondrial-targeting peptides, which are both directly and indirectly dependent from the elected claim 1. This is not found persuasive because when the claimed process can be used to make a materially different product, as in the instant case, a restriction between the two groups is proper (see MPEP 806.05(f)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 6 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/23/2025.
Status of the Claims
Claims 1-7 and 9-21 are pending in this application.
Claims 6 and 11 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 1-5, 7, 9-10 and 12-21 are presently under consideration as being drawn to the elected species/invention.
Claim Objections
Claims 1-5, 7, 9-10 and 12-21 are objected to because of the following informalities: Claim 1 should be rewritten to recite “A mitochondria-targeted polypeptide (MTP)of Formula I…”. Claims 2-5, 7 and 9-10 should be rewritten to recite “…..MTP according to claim 1…..”. Claims 12-14 should be rewritten to recite “The drug carrier according….”. Claims 15-17 should be rewritten to recite “The cell-membrane-penetrating peptide according….”. Claims 18-21 should be rewritten to recite “The pharmaceutical composition according….”. Appropriate correction is required.
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 1-5, 7, 9-10 and 12-21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to claim 1, the phrase “drug groups” is not defined in the instant specification. One of ordinary skill in the art would not know what is encompassed by said phrase. Furthermore, claim 1 recites the phrase “at least one selected from the group”, which implies that R2 can also be something else. However, the specification does not teach what is encompassed by said R2.
Similarly, claims 2-5, 12-17 and 19 -21 recite the phrase “at least one selected from the group”.
With respect to claims 4-5, 14, 17 and 21, the word “derivatives” is not defined in the instant specification. One of ordinary skill in the art would not know what is encompassed by said word.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 5, 14, 17 and 21 recite the broad recitation “comprises a drug”, and the claims also recite “preferably, the drug is at least..” which is the narrower statement of the range/limitation. Similarly, claim 11 recites the broad recitation “wherein the amino protecting group is at least one selected…”, and the claim also recites “preferably, the tumor-targeting ligand is at least..” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-5, 7, 9-10 and 12-21, which depend from claim 1, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as these claims incorporate by dependency the indefiniteness of claim 1.
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 1-2, 4-5, 7, 9-10, 12, 14-15, 17-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiao et al. (Chem. Eur. J. 2021, 27, 12207-12214).
With respect to claims 1-2, 5, 7, 12 and 14, Xiao et al. teach the following mitochondria-targeted polypeptide (MTP) (Fig. 5A), which corresponds to the instantly claimed MTP wherein R1 is acyl and R2 is doxorubicin (Dox).
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Xiao et al. also teach that
Xiao et al. also teach that Dox emits fluorescence signals (page 12212, right column, 1st para). Therefore, Dox can be considered both a fluorescent group and a drug group.
With respect to claim 4, as discussed above under 35 U.S.C. 112(b), the word “derivatives” is not defined in the instant specification. Therefore, Doc can be considered a derivative of any of the fluorescent group claimed.
With respect to claim 9, Xiao et al. teach that “[U]pon effective cell uptake and endosome escape, we found the cytosolically released native cargo was predominantly localized inside the mitochondria” (page 12208, right column, 2nd para), thus implying that MTP is a cell-membrane-penetrating peptide.
With respect to claim 10, Xiao et al. teach that “[O]ur strategy thus paves the way for future mitochondrion-targeted therapy with a variety of biologically active agents (abstract). One of ordinary skill in the art would have at once envisaged a pharmaceutical composition comprising the MTP for administration.
With respect to claims 17 and 19, Xiao et al. teach that R1 is acyl and R2 is doxorubicin (Dox) (Fig. 5A).
With respect to claim 18, as discussed above, Xiao et al. teach that MTP is a cell-membrane-penetrating peptide targeting mitochondria (page 12208, right column, 2nd para).
With respect to claim 21, as discussed above, Xiao et al. teach that the drug is Dox (Fig. 5A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658