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 .
Status of the claims
Claims 38-51, 55 have been canceled. Claims 30-37, 52-54 and 56 are currently pending. Of the claims pending claim 30, 54 and 56 are currently amended.
The examiner and art unit assigned to this application has been changed. Currently the application is assigned to art unit 1681 to SPE Gary Benzion.
The election of BSA as a membrane stabilizer, made on 9/3/2025 is again acknowledge. The restriction requirement is still deemed proper and final.
The objections to claims 30 and 52 is withdrawn in view of applications amendment.
Prior Art
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 30-35, 37, 52-56 are rejected under 35 U.S.C. 103 as being unpatentable over Frezza et al., “Organelle isolation: functional and morphological analysis of mitochondria,” Nature Protocols 2:287–295 (2007). In view of Wieckowski et al., “Isolation of mitochondria-associated membranes and mitochondria from tissues and cells,” Nature Protocols 4:1582–1590 (2009) and Islam et al. Nat. Med: (18(5) 759-765. Mitochondrial transfer from bone marrow-derived stromal cells to pulmonary alveoli protects against acute lung injury.
Claim 30 (currently amended) broadly requires the following element to comprise the mitochondrial isolation buffer comprising:
(a) buffering agent;
(b) a chelating agent;
(c) a sugar;
(d) an agent that acts as a membrane stabilizer and/or oxygen radical scavenger and/or binder of Ca+ and/or binder of free fatty acid; and
(e) a serine protease inhibitor; and
(f) isolated donor mitochondria from mesenchymal stromal cells (MSCs).
Freeze et al. teach a mitochondria isolation buffer comprising mM TRIS-MOPS as a zwitterionic sulfonic-acid buffering agent, including EGTA in mitochondrial isolation buffers, a sugar, the use of fatty‑acid‑free bovine serum albumin (BSA) as a membrane stabilizer and free‑fatty‑acid binder (e.g., IBm1 contains 2 mL of 10% BSA per 100 mL. Additionally, the authors recommend including 0.1% fatty‑acid‑free albumin in EB to prevent uncoupling by fatty acids). Frezza et al.'s buffer recipes (IBc, IBm1, IBm2, EBc, EBm) contain sucrose, Tris/MOPS, EGTA/EDTA, KCl, MgCl2, and BSA, and do not list antibiotics in the isolation or experimental buffers. Freeza et al. do not teach the use of a serine protease inhibitor, but do acknowledge that proteases can damage mitochondria and suggest that isolation should be done at 40C. In this regard, Wieckowski et al. teach the use of PMSF in the isolation buffer for mitochondria from tissue and cells. Thus, the teachings of Freeza et al. and Wieckowski et al. are appropriately combinable as they both teach buffers that are used in the isolation of mitochondria. Neither reference teach the isolation of donor mitochondria from mesenchymal stromal cells (MSCs). However, Islam et al. teaches isolation of mitochondria from mesenchymal stromal cells (MSCs) using a phosphate-buffered saline IPBS) is routine. Thus, Islam teach that MSC cells were known to contain mitochondria which can be isolated.
With regard to claim 56, drawn to a kit comprising:
instructions for administration of a donor mitochondria composition to a subject; and a mitochondrial isolation buffer composition for use in mitochondrial organelle transplantation, said composition comprising: (a) a buffering agent; (b) a chelating agent; (c) a sugar; a membrane stabilizer; and (e)a serine protease inhibitor; and (f) isolated donor mitochondria from mesenchymal stromal cells (MSCs).
The claim comprises the elements of claim 30 with the further limitation of written instruction; Where a product merely serves as a support for printed matter, no functional relationship exists. In this instance the “written instruction” is given no patentable weight. According to the MPEP, the first step of the printed matter analysis is the determination that the limitation in question is in fact directed toward printed matter. See In re DiStefano, 808 F.3d 845, 848, 117 USPQ2d 1265, 1267 (Fed. Cir. 2015). Once it is determined that the limitation is directed to printed matter, the examiner must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." Id. at 850, 117 USPQ2d at 1268. Since the instruction in claim 56 are drawn to instructions for administration of a donor composition to a subject it is given no patentable weight and the limitations of claim 56 are subsumed by the prior art of record.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Gary Benzion whose telephone number is (571)272-0782. The examiner can normally be reached M-F, 7 am to 4pm.
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/GARY BENZION/ Ph.D.Supervisory Patent Examiner, Art Unit 1681