DETAILED ACTION
Claims 42, 46, 52 and 55 are currently pending. Claims 1-41, 43-45, 47-51, 53-54 and 56-141 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 Invention Group IV (claims 42, 46, 52 and 55) in the reply filed on September 12, 2025 is acknowledged.
Priority
This application claims benefit as a DIV of 15/779,736 (now U.S. Patent No. 11,903,974, filed 5/29/2018) which claims benefit from PCT/US2016/064238 (filed 11/20/2016), which claims benefit from provisional U.S. Application No. 62/261,170 (filed 11/30/2015) and claims benefit of 62/261,169 (filed 11/30/2015) and claims benefit of 62/261,157 (filed 11/30/2015).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 16, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are 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.
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, 46, 52 and 55 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Yivgi-Ohana et al. (US2014/0193511, published 10 July 2014; IDS 8/16/2024, 16 pages).
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 (see PTO-892).
Regarding claims 42 and 55, it is noted that Example 4 ([0161]-[0162]) of Yivgi-Ohana discloses ex-vivo incubation (i.e., delivering) of mitochondria isolated from placenta with brain mouse endothelial cells (bEND3)(mammalian 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 in the bEND3 cells comprising exogenous mitochondria which were pretreated with CGP37157 ((+) CGP), as compared to control cells ((-) CGP). Thus, Example 4 of Yivgi-Ohana anticipates claims 42 and 55.
Regarding claim 46, claim 46 is directed to a method of enhancing function of a target cell or tissue, comprising delivering to the target cell or tissue a pharmaceutical preparation comprising isolated, modified chondrisomes derived from cultured cells.
Yivgi-Ohana teaches claims 11 and 13:
11. A method of treating a condition which benefits from increased mitochondrial function, said method comprising: providing a pharmaceutical composition comprising a plurality of partially purified functional mitochondria, said partially purified functional mitochondria having an intact outer membrane, wherein the total amount of mitochondrial proteins does not exceed 80% of the total amount of cellular proteins within said composition, and wherein the composition is devoid of exogenous protease inhibitors; and administering to a subject in need thereof a therapeutically effective amount of said pharmaceutical composition.
13. The method of claim 11, wherein said partially purified functional mitochondria are derived from a cell or a tissue selected from the group consisting of: placenta, placental cells grown in culture and blood cells.
Yivgi-Ohana’s partially purified mitochondria read on “modified” chondriosomes.
Therefore, based upon claims 11 and 13, Yivgi-Ohana anticipates a method of enhancing function of a target cell or tissue, comprising delivering to the target cell or tissue a pharmaceutical preparation comprising isolated, modified chondrisomes derived from cultured cells.
Regarding claim 52, it is noted that, Yivgi-Ohana’s claim 11 teaches administering to a subject in need thereof a therapeutically effective amount of said pharmaceutical composition comprising a plurality of partially purified functional mitochondria derived from a blood cells. Thus, based upon claims 11 and 13, Yivgi-Ohana anticipate a method of increasing mitochondrial content 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.
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 46, 52 and 55 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 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 claim 52.
As to instant claim 46 and the limitation regarding enhancing function of a target cell or tissue, it is noted that claim 22 of US ‘975 claims the method of claim 1, wherein the composition is administered in an amount and for a time sufficient to enhance the metabolic function of the target cell or tissue, thus claim 22 of US ‘975 anticipates instant claim 46.
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, 46, 52 and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 42, 46 and 52 of copending Application No. 17/651,056 (“copending application ‘056”) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 42, claim 7 of copending application ‘056 claims the following:
7. A pharmaceutical preparation comprising isolated, modified chondrisomes derived from a cellular source of mitochondria.
42. A method of delivering a chondrisome preparation to a mammalian cell or tissue ex vivo, comprising contacting the cell or tissue with the pharmaceutical preparation of claim 7.
Claim 42 of copending application ‘056 anticipates instant claim 42.
Regarding claim 46, claim 46 of copending application ‘056 claims the following:
46. A method of enhancing function of a target cell or tissue, comprising delivering to the target cell or tissue the pharmaceutical preparation of claim 7.
Claim 46 of copending application ‘056 anticipates instant claim 46.
Regarding claim 52, claim 52 of copending application ‘056 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 the pharmaceutical preparation of claim 7.
Claim 52 of copending application ‘056 anticipates instant claim 52.
As to instant claim 55 and the limitation directed at increasing tissue ATP levels, it is noted copending application ‘056 (page 5) evidences that the delivered chondriosomes are taken up by the recipient cells and increase ATP levels in the recipient cells. Thus, the limitation directed to increasing tissue ATP levels seems to be an outcome of practicing the method of claims 42, 46 and 52 of copending application ‘056.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed. No claim is free of prior art.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHRISTOPHER BABIC can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633