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 application
Claims 30-37, 52-54 and 56 are pending. The IDS is in compliance with 37 CFR 1.97 and 1.98 and has been considered. A new listing of the claims has been submitted which does not present any claim amendments.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Prior rejections
The rejection of claims 30-35, 37, 52-56 under 35 U.S.C. 103 as being unpatentable over Frezza et al., in view of Wieckowski et al., and Islam et al. is withdrawn in view of applicant’s arguments. New rejections are set forth below.
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 54 is 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 54 depends from claim 30 and recites the further limitation “wherein the isolated donor mitochondria comprises mitochondria isolated from fibroblasts;” Claim 30 requires that the isolated mitochondria are MSC. While fibroblast and MSC are both mesenchymal stromal cells they differ in origin and function. The specification does not teach that fibroblast cells are or can be derived from MSCs, it does not teach a process for obtaining fibroblast cells from MSC and fails to teach that fibroblast cells are a subset of MSCs (see paragraph 0083, 0088, 0118-0119 of the specification). Accordingly claim 54 fails to include all the limitation of claim 30 and thus is improperly dependent from claim 30.
In response to this rejection applicants may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Art Rejections
Claims 30-35, 37, 52-53, and 56 are rejected under 35 U.S.C. § 103 as being unpatentable over Frezza et al. in view of Bozidis et al. ("Isolation of Endoplasmic Reticulum, Mitochondria, and Mitochondria-Associated Membrane Fractions from Transfected Cells and from Human Cytomegalovirus-Infected Primary Fibroblasts"), Nzigou Mombo et al. ("MitoCeption: Transferring Isolated Human MSC Mitochondria to Glioblastoma Stem Cells"), and Ishii et al. ("An improved method for isolation of mitochondria from cell lines that enables reconstitution of calcium-dependent processes"), as applicable.
Frezza et al. teaches the isolation of functional mitochondria from cultured cells and tissues using mitochondrial isolation buffers comprising a buffering agent, a chelating agent, a sugar, and an agent that acts as a membrane stabilizer and/or oxygen radical scavenger and/or binder of Ca2+ and/or binder of free fatty acid. Frezza et al. discloses mitochondrial isolation buffer components including Tris/MOPS, EGTA/EDTA, sucrose, and BSA.
Bozidis et al. teaches the use of a serine protease inhibitor in mitochondrial isolation, specifically phenylmethylsulfonyl fluoride (PMSF). Bozidis et al. lists a 100 mM PMSF stock among the materials and expressly instructs at step 10 to add fresh PMSF to 1× MTE to a final concentration of 1 mM during mitochondrial isolation. Thus, Bozidis et al. teaches the serine protease inhibitor limitation recited in claim 35.
Nzigou Mombo et al. teaches isolated human MSC mitochondria and a protocol for transferring isolated human MSC mitochondria to target cells by MitoCeption. Accordingly, Nzigou Mombo et al. teaches the donor mitochondria source recited in claim 30 and in claim 56.
Ishii et al. teaches HEPES-based mitochondrial isolation and assay buffers, including HEPES-containing buffers and HEPES-KOH. Accordingly, Ishii et al. teaches the HEPES and K-HEPES limitations recited in claims 52 and 53.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the mitochondrial isolation buffer of Frezza et al. with the PMSF-containing mitochondrial isolation teachings of Bozidis et al. in order to protect mitochondria from proteolytic damage during isolation. It also would have been obvious to use isolated human MSC mitochondria as taught by Nzigou Mombo et al. in view of the known mitochondrial transfer applications discussed in the art. Further, it would have been obvious to use HEPES or HEPES-KOH buffering as taught by Ishii et al. as a predictable buffering variant for mitochondrial handling and isolation.
Claim 31 depends from claim 30 and further recites a zwitterionic sulfonic acid buffering agent. Frezza et al. teaches MOPS-containing buffering systems, which are zwitterionic sulfonic acid buffering agents used in mitochondrial isolation buffers.
Claim 32 depends from claim 30 and further recites ethylene glycol-bis(ß-aminoethyl ether)-N,N,N',N'-tetraacetic acid (EGTA) or a salt thereof. Frezza et al. teaches EGTA in mitochondrial isolation buffers.
Claim 33 depends from claim 30 and further recites sucrose. Frezza et al. teaches sucrose in mitochondrial isolation buffers.
Claim 34 depends from claim 30 and further recites bovine serum albumin (BSA). Frezza et al. teaches fatty-acid-free BSA in mitochondrial isolation buffers as a membrane stabilizer and free-fatty-acid binder.
Claim 35 depends from claim 30 and further recites PMSF. Bozidis et al. expressly teaches PMSF in the mitochondrial isolation buffer, rendering this limitation obvious.
Claim 37 depends from claim 30 and recites that the composition does not comprise an antibiotic. The mitochondrial isolation buffer teachings of record do not require an antibiotic, and omission of an antibiotic would have been an obvious and routine choice in view of the mitochondrial isolation art.
Claim 52 depends from claim 30 and further recites HEPES or salt thereof. Ishii et al. teaches HEPES-containing mitochondrial buffers, rendering this limitation obvious.
Claim 56, recites a kit that recites all the limitation of claim 30 with the addition of 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.
Where the printed matter provide does not have a functional relationship the instructions are given no patentable weight. See Ex parte Gwinn, 112 USPQ 439, 446-47 (Bd. Pat. App. & Int. 1955), in which the invention was directed to a set of dice by means of which a game may be played. The claims differed from the prior art solely by the printed matter in the dice.
For the reasons set forth above, claims 30-35, 37, 52-53, and 56 would have been obvious over the combined teachings of Frezza et al., Bozidis et al., Nzigou Mombo et al., and Ishii et al. The cited references collectively teach or suggest each of the material limitations of the pending claims, and the proposed combination would have involved only the predictable use of prior art elements according to their established functions. Accordingly, claims 30-35, 37, 52-53, and 56 are unpatentable under 35 U.S.C. § 103.
Response to applicants’ arguments
Applicants assert that none of the prior art cited teach or suggest all that they are purported to teach and there would have been no motivation to combine the teaching. Applicant arguments are persuasive. Accordingly, the new ground of rejection addressing all the elements identified by the applicants are address above.
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, 9am to 5pm.
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GARY BENZION, Ph.D.
Supervisory Patent Examiner
Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681
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