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
Claims 1-2, 10, 15-16, 25-27, 31-37, 39-43, 46, 48-50 and 55 are pending.
Claims 10, 15-16, 31-37, 39-43, 46 and 48-50 are withdrawn.
Claims 1-2, 25-27 and 55 are rejected.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. As noted in the Non-Final Office Action mailed on 10 October 2025, this application is a 371 of PCT/KR2019/005020, filed 04/25/2019, and claims foreign priority to KR 10-2018-0048486, 04/26/2018.
Claims 1-2, 25-27 and 55 have the effective filing date of 26 April 2018.
Claim Objections
Claims 26-27 and 55 are objected to because of the following informalities:
Claim 26 recites: "...SEQ ID NO: 89 or 90..", which should read: "...SEQ ID NO: 89 or 90." That is, there appears to be two periods at the end of the claim, where there should be only one.
Claim 27 recites: "...the mitochondrial anchoring peptide .", which should read: "...the mitochondrial anchoring peptide." That is, the space between the last word in the claim "peptide" and the ending period should be removed.
Claim 55 recites: "..., wherein the scFv binds to any one selected from the group consisting of CD19, CD20,..., CEACAM, Nectin-3, or a combination thereof", which should read: "..., wherein the scFv binds to any one selected from the group consisting of CD19, CD20,..., CEACAM, and Nectin-3, or a combination thereof."
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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 1-2, 25-27 and 55 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.
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, claim 1 recites the broad recitation "a desired protein that functions inside and outside the cell", and the claim also recites "the desired protein is an scFv(single chain variable fragment antibody) for targeting a ligand or receptor present on the surface of a targeted cell" which is the narrower statement of the range/limitation. The claims 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.
Claim 1 further recites wherein the foreign protein is bound to the outer membrane of the mitochondria by the mitochondria anchoring peptide, wherein the foreign protein is bound in the following order: N terminal- desired protein- mitochondria anchoring peptide- C terminal. However, it is not clear if the mitochondrial anchoring peptide is binding to the outer membrane of the mitochondria (as recited in the claim) or if the desired protein (i.e., the N terminal of the desired protein) is binding to the outer membrane of the mitochondria, based on the purported binding order recited in the claim. The dependent claims are rejected for the same reason.
Claim 25 recites: The isolated modified mitochondria according to claim 1, wherein the mitochondria anchoring peptide comprises a C terminal region of any one selected from the group consisting of TOM5.
Claim 26 recites: "The isolated modified mitochondria according to claim 25, wherein the C terminal region of TOM5...; or the C terminal region of VAMP1B..."
However, it is not clear if the term “C terminal region” in claims 25 and 26 is a C-terminal fragment or located at the C-terminus. On the other hand, it appears that the term 'C terminal region' is broadening the scope of claim 1.
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 25 and 26 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.
Claim 25 recites: "The isolated modified mitochondria according to claim 1, wherein the mitochondria anchoring peptide comprises a C terminal region of any one selected from the group consisting of TOM5,..."
Claim 26 recites: "The isolated modified mitochondria according to claim 25, wherein the C terminal region of TOM5...; or the C terminal region of VAMP1B..."
Claim 1 recites a mitochondria anchoring peptide, not a C terminal region of a mitochondrial anchoring peptide. The term "C terminal region" in claims 25 and 26 is considered to encompass broader limitation than in claim 1.
The following amendment is suggested to obviate the above rejections:
An isolated modified mitochondria in which a foreign protein is bound to the outer membrane of the mitochondria, wherein the foreign protein is a fusion protein comprising a mitochondria anchoring peptide and a single chain variable fragment antibody (scFv),
wherein the scFv is at the N terminus of the fusion protein and is for targeting a ligand or receptor present on the surface of a targeted cell,
wherein the mitochondria anchoring peptide is at the C terminus of the fusion protein and comprises any one selected from the group consisting of TOM5, TOM7, TOM22, Fis1, Bcl-2, and VAMP1B, and
wherein the foreign protein is bound to the outer membrane of the mitochondria by the mitochondria anchoring peptide.
Cancel claim 25.
In claim 26, delete all limitations of “the C terminal region of” in lines 2-7.
27. The isolated modified mitochondria according to claim 1, wherein the foreign protein further comprises a linker between the scFv and the mitochondrial anchoring peptide.
Allowable Subject Matter
In the Non-Final Office Action mailed 17 October 2025, it was determined that claims 1-2, 25-27 and 55 recite subject matter that is free of prior art.
In order to place the instant application in better condition for allowance, Applicant may consider canceling claims 10, 15-16, 25, 32-37, 39-43, 46 and 48-50, and amending claims 1, 26 and 27 as suggested above.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON M PAPCIAK whose telephone number is (571)272-6235. The examiner can normally be reached M-F 8:30am-5:00pm.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/SMP/ Examiner, Art Unit 1657