DETAILED ACTION
Claims 42, 50, 52, 55, 58, 60, 63-64, 75, and 90-96 are currently pending.
Claims 1-41, 43-49, 51, 53-54, 56-57, 59, 61-62, 65-71, 72-74, and 76-89 are cancelled.
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 II method claims 42, 50, 52, 55, 58, 60, 63-64 and 75 in the reply filed on November 3, 2025 is acknowledged.
Although claims 90-96 refer to the composition of claim 42, it is noted that claim 42 is directed to method claims and not composition claims. Applicant has elected the Group II method claims. Applicant has canceled the previous Group I invention directed to a pharmaceutical composition (canceled claims 1-5, 7-13, 15, 18-24, 28-29, 33-34, 38-39 and 88). Claims 90-96 are directed to composition claims and are therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 3, 2025.
Priority
This application claims benefit as a CON of 16/252,369 (filed 1/18/2019; ABN) which claims benefit from U.S. Application No.15/365,239 (filed 11/30/2016; ABN) which claims benefit from provisional U.S. Application No. benefit of 62/261, 169 (filed 11/30/2015) and claims benefit of 62/261,157 (filed 11/30/2015) and claims benefit of 61/261,170 (filed 11/30/2015).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/3/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
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.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located at pages 144 and 166 (forward and reverse primers).
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see page 82. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 42, 50, 52, 55, 58, 60, 63-64 and 75 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 42, 52, 55, and 60 require contacting cells or tissue with the chondrisome composition, and as currently written the claims encompass delivering any amount or concentration of chondrisomes, e.g., 2 chondrisomes.
Upon review of the specification, the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of delivering any amount or concentration of the claimed chondrisomes. Possession of an invention may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998).
In the instant case the references in the specification to the amount or concentration of the chondrisomes delivered to target cells or tissues are disclosed at Example F-2 (page 173), Example F-5 (page 177), Example F-12 (page 184), or Example F-13 (page 185). Example F-2 discloses delivering 4 or 16 µg of chondrisomes to 12,500 fibroblast cells. Example F-5 is directed to delivery of the chondrisome cargo and discloses delivering 8 µg of chondrisomes to 25,500 fibroblast cells. Example F-12 discloses delivering 2 µg of chondrisomes to 40,000 cells. Example F-13 discloses delivering 8 and 32 µg of chondrisomes to 80,000 cells.
A review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession delivering any amount or concentration of chondrisomes to target cells or tissues.
Furthermore, claims 50, 58, 63-64 and 75 require administering the chondrisome composition to a subject, i.e., in-vivo, and as currently written the claims encompass any amount or concentration of chondrisomes, e.g., 2 chondrisomes.
However, upon review of the specification, the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of administering to the subject any amount or concentration of the claimed chondrisomes. Possession of an invention may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998).
In the instant case the references in the specification to the amount or concentration of the chondrisomes delivered to the subject indicate unit doses include between 2 ug/kg to 10 mg/kg (pages 129-130). Specifically, Example F-15 discloses injection the chondrisomes at a concentration of 6ug/kg +/- 2ug/kg (page 188) and Example F-16 discloses injection the chondrisomes at a concentration of 36ug/kg +/- 5ug/kg (page 191).
Thus, a review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession administering to a subject any amount or concentration of chondrisomes.
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
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.
Claims 42, 52, 55 and 60 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Yivgi-Ohana et al. (US 2014/0193511, published 10 July 2014; IDS 11/3/2025).
Based upon the applicant’s specification and knowledge of a person of ordinary skill in the art, “chondrisome,” is equivalent to “mitochondrion.” The current application defines chondrisome as “subcellular apparatus derived and isolated or purified from the mitochondrial network of a natural cell or tissue source” (page 128). Merriam-Webster defines a chondriosome as a mitochondrion (IDS 11/3/2025).
Regarding claims 42, 52, and 55, it is noted that Example 4 ([0161]-[0162]) of Yivgi-Ohana discloses ex-vivo incubation (i.e., delivering) (claim 42) of mitochondria isolated from placenta with brain mouse endothelial cells (bEND3)(i.e., mammalian cells, target cells), wherein the mitochondria were modified by pretreatment with CGP37157 ((+) CGP) during the isolation process. As shown in FIG. 4 of Yivgi-Ohana, the ATP level was significantly increased (i.e., enhancing function of a target cell) (claims 46 and 55) in the bEND3 cells comprising exogenous mitochondria which were pretreated with CGP37157 ((+) CGP), as compared to control cells ((-) CGP).
It is further noted that paragraph [0120] of Yivgi-Ohana discloses that mitochondria delivered to cells is spontaneously transferred into the host cell which reads on “increasing mitochondrial content in a target cell.
Thus, Example 4 of Yivgi-Ohana anticipates claims 42, 52 and 55.
As to claim 60 and the limitation directed to increasing thermogenesis in a target cell or tissue, it is noted that although Example 4 of Yivgi-Ohana does not further comment on thermogenesis, it is noted that Yivgi-Ohana, at paragraph [0003], discloses that heat production is one of the numerous essential tasks performed by mitochondria and given that Yivgi-Ohana carries out the same method steps (delivering to a mammalian cell) as in the instant application means that any and all results of the method of Yivgi-Ohana, whether recognized at the time of publication or not, were inherently achieved by the reference method, thus anticipating claim 60. See In re Best, 562 F. 2d, 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) and Ex parte Novitski, 26 USPQ 2d 1389 (Bd. Pat. App. & inter. 1993). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of the invention, but only that the subject matter is in fact inherent in the prior art reference. See Schering Corp. v. Geneva Pharm. Inc, 339 F.3d 1373, 1377, 67, USPQ2d 1664, 1668 (Fed. Cir. 2003). See also Toro Co. v. Deere & Co. 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004). Thus, because Yivgi-Ohana teaches administering the same chondrisome composition by ex-vivo delivery to mammalian cells as the claimed method, Yivgi-Ohana necessarily meets the limitation of claim 60.
Claim Rejections - 35 USC § 103
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 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.
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) 50, 58, 64 and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Yivgi-Ohana, as applied to claims 42, 52, 55 and 60.
The teaching of Yivgi-Ohana is set forth above and anticipates claims 42, 52, 55 and 60.
Regarding claim 50 and the limitation directed to in-vivo delivery of the isolated chondrisomes to the subject, it is noted that Example 4 of Yivgi-Ohana is directed to ex-vivo delivery of the isolated chondrisomes to target cells. Example 4 does not further disclose in-vivo delivery/administration of the chondrisomes. However, Yivgi-Ohana (Abstract; [0017] and [0029]) teaches alternative treatments using therapeutically effective amounts of the chondrisome composition, wherein the pharmaceutical composition is administered to a subject (e.g., human) by intravenous, intraarterial, intramuscular, intralesional, transmucosal, subcutaneous, direct injection into a tissue or an organ or through inhalation.
Yivgi-Ohana at paragraph [0036] further teaches the in-vivo administered pharmaceutical composition comprises a plurality of modified mitochondria wherein the mitochondria are modified to harbor at least one exogenous pro-apoptotic protein.
Thus, Yivgi-Ohana does render obvious delivering modified chondrisomes by delivering the pharmaceutical composition to a subject in-vivo, that is, Yivgi-Ohana teaches the limitations required by the current claim and as said limitation is found in one reference it is held that a method of delivering a mitochondrial preparation to a subject in-vivo, comprising delivering a pharmaceutical preparation comprising isolated, modified chondrisomes derived from a cellular source of mitochondria, is within the scope of the teachings of Yivgi-Ohana, and thus renders the invention of claim 50 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to deliver modified chondrisomes by delivering the pharmaceutical composition to a subject in-vivo. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Yivgi-Ohana.
Regarding claim 58 and the limitation directed at delivering a payload to a subject by administering to the subject the pharmaceutical preparation comprising the isolated, modified chondrisomes, wherein the chondrisomes comprise the payload, it is noted that Yivgi-Ohana, at paragraphs [0032]-[0034], teaches the modified chondrisomes delivered to the subject comprise at least one exogenous pro-apoptotic protein. Thus, Yivgi-Ohana’s method does render obvious delivering a payload, that is, Yivgi-Ohana teaches the limitations required by the current claim and as said limitation is found in one reference it is held that a method of delivering a mitochondrial preparation to a subject in-vivo, comprising delivering a pharmaceutical preparation comprising isolated, modified chondrisomes derived from a cellular source of mitochondria, is within the scope of the teachings of Yivgi-Ohana, and thus renders the invention of claim 50 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to deliver modified chondrisomes by delivering the pharmaceutical composition to a subject in-vivo. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Yivgi-Ohana.
Further regarding claim 64 and the limitation directed to decreasing triglyceride or serum cholesterol levels, it is noted that although Yivgi-Ohana does not further comment on the administering of the modified chondrisomes further decreasing triglyceride or serum cholesterol levels, Yivgi-Ohana carries out the same method steps of in-vivo delivery of the modified chondrisomes, as in the instant application, and thus means that any and all results of the method of Yivgi-Ohana, whether recognized at the time of publication or not, were necessarily achieved by the reference method, thus meeting the limitation of claim 64. See In re Best, 562 F. 2d, 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) and Ex parte Novitski, 26 USPQ 2d 1389 (Bd. Pat. App. & inter. 1993). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of the invention, but only that the subject matter is in fact inherent in the prior art reference. See Schering Corp. v. Geneva Pharm. Inc, 339 F.3d 1373, 1377, 67, USPQ2d 1664, 1668 (Fed. Cir. 2003). See also Toro Co. v. Deere & Co. 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004). Thus, because Yivgi-Ohana teaches administering the same chondrisome composition by in-vivo delivery as the claimed method, Yivgi-Ohana necessarily meets the limitation of claim 64.
Regarding claim 75 and the limitation directed to treating a subject for a disease or condition, it is noted as set forth above regarding the rejection of claim 50, Yivgi-Ohana teaches delivering modified chondrisomes by delivering the pharmaceutical composition to a subject in-vivo. Yivgi-Ohana, at paragraph [0028], further teaches a variety of conditions and disorders are associated with nonfunctional or dysfunctional mitochondria and further teaches treating diseases caused by damage to mtDNA by delivering the disclosed modified chondrisomes ([0028] and claim 11).
Thus, Yivgi-Ohana does render obvious treating a subject for a disease or condition caused by damage to mtDNA, that is, Yivgi-Ohana teaches the limitations required by the current claim and as said limitation is found in one reference it is held that a method of treating a subject for a disease or condition by delivering the pharmaceutical composition comprising modified chondrisomes to a subject, is within the scope of the teachings of Yivgi-Ohana, and thus renders the invention of claim 75 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to treat a subject for a disease or condition by delivering the modified chondrisomes to a subject in-vivo. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Yivgi-Ohana.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 50, 52, 58 and 75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6 and 13-15 of U.S. Patent No. 10,370,458 (“US ‘458”). Although the claims at issue are not identical, they are not patentably distinct from each. Claims 1, 5-6 and 13 of US ‘458 claims the following:
A method of delivering an agent to a target site of a human subject, the method comprising administering to the subject a composition comprising isolated viable mitochondria and an agent, to thereby deliver the agent to the target site of the subject, wherein the agent is linked to, attached to, embedded in, or encapsulated by the mitochondria, and the composition is administered into a blood vessel that carries blood to the target site, wherein the agent is 18F-Rhodamine 6G or iron oxide nanoparticle.
5. The method of claim 1, wherein the mitochondria are autogeneic to the subject.
6. The method of claim 5, wherein the autogeneic mitochondria have exogenous mitochondrial DNA (mtDNA).
13. A method of delivering an agent to a target site of a human subject, the method comprising administering to the subject isolated viable mitochondria and an agent, to thereby deliver the agent to the target site of the subject, wherein the agent is .sup.18F-Rhodamine 6G or iron oxide nanoparticle and the agent is linked to, attached to, embedded in or encapsulated by the mitochondria.
Thus claims 1, 5-6 and 13 of US ‘458 anticipate claims 50, 52, 58 and 75.
Claims 50, 52, 55, 58 and 75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 21-23 of U.S. Patent No. 11,903,974 (“US ‘974”). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of claim 1 of US ‘974 claims in-vivo delivering to the target cell or tissue a pharmaceutical composition comprising isolated chondrisomes derived from cultured cells and claims 21-23 of US ‘974 claims the chondriosomes are modified by genetic engineering or by loading with a heterologous cargo agent. Thus, claims 21-23 of US ‘974 anticipates instant claims 50, 52, 58 and 75.
As to instant claim 55 and the limitation directed at increasing tissue ATP levels, it is noted US ‘974 (col 4, lines 30-40) evidences that the delivered chondriosomes are taken up by the recipient cells and increase ATP levels in the recipient cells. The limitation directed to increasing tissue ATP levels seems to be an outcome of practicing the method of claim 1 of US ‘974.
Claims 50, 52, 55, 58 and 75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19-21 of U.S. Patent No. 11,903,975 (“US ‘975”). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of claim 1 of US ‘975 claims in-vivo delivering to the target cell or tissue a pharmaceutical composition comprising isolated chondrisomes derived from blood or a blood product and claims 19-21 of US ‘975 claims the chondriosomes are modified by genetic engineering or by loading with a heterologous cargo agent. Thus, claims 19-21 of US ‘975 anticipate instant claims 50, 52, 58 and 75.
As to instant claim 55 and the limitation directed at increasing tissue ATP levels, it is noted US ‘975 (col 4, lines 22-35) evidences that the delivered chondriosomes are taken up by the recipient cells and increase ATP levels in the recipient cells. The limitation directed to increasing tissue ATP levels seems to be an outcome of practicing the method of claim 1 of US ‘975.
Claims 42, 52, and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42, 52 and 55 of copending Application No. 18/403,586 (“copending application ‘586”) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 42, Claim 42 of copending application ‘586 claims the following:
42. A method of delivering a chondrisome preparation to a mammalian cell or tissue ex-vivo, comprising contacting the cell or tissue with a pharmaceutical preparation comprising isolated, modified chondrisomes derived from cultured cells.
Thus claim 42 of copending application ‘586 anticipates instant claim 42.
Regarding claim 52, claim 52 of copending application ‘586 claims the following:
52. A method of increasing mitochondrial content and/or activity in a target cell or tissue, comprising delivering to the target cell or tissue a pharmaceutical preparation comprising isolated, modified chondrisomes derived from cultured cells.
Thus claim 52 of copending application ‘586 anticipates instant claim 52.
Regarding claim 55, claim 55 of copending application ‘586 claims the following:
55. A method of increasing tissue ATP levels, comprising delivering to a target cell or tissue a pharmaceutical preparation comprising isolated, modified chondrisomes derived from cultured cells.
Thus claim 55 of copending application ‘586 anticipates instant claim 55.
Claims 42, 52, and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42, 52 and 55 of copending Application No. 18/404,389 (“copending application ‘389”) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 42, Claim 42 of copending application ‘389 claims the following:
42. A method of delivering a chondrisome preparation to a mammalian cell or tissue ex-vivo, comprising contacting the cell or tissue with a pharmaceutical preparation comprising isolated, modified chondrisomes derived from blood or a blood product.
Thus claim 42 of copending application ‘389 anticipates instant claim 42.
Regarding claim 52, claim 52 of copending application ‘389 claims the following:
52. A method of increasing mitochondrial content and/or activity in a target cell or tissue, comprising delivering to the target cell or tissue a pharmaceutical preparation comprising isolated, modified chondrisomes derived from blood or a blood product.
Thus claim 52 of copending application ‘389 anticipates instant claim 52.
Regarding claim 55, claim 55 of copending application ‘389 claims the following:
55. A method of increasing tissue ATP levels, comprising delivering to a target cell or tissue a pharmaceutical preparation comprising isolated, modified chondrisomes derived from blood or a blood product.
Thus claim 55 of copending application ‘389 anticipates instant claim 55.
Conclusion
Claim 63 appears to be free of prior art.
No claim is allowed.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633