DETAILED ACTION
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 1-4 and 6-21 are pending (claim set as filed on 11/17/2025).
Applicant’s election without traverse of Group I, method claims, in the reply filed on 09/21/2023 is acknowledged. Apparatus claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, only method claims 1-4, 6-7, and 21 are presented for examination.
Priority
This application is a CON of 15/318,557 (now U.S. Patent no. 11,491,480 B2), which is a
371 of PCT/US2015/035584, which has a PRO 62/012,045 filed on 06/13/2014.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 11/17/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Affidavit/Declaration
The Schueller declaration under 37 CFR 1.132 filed on 11/17/2025 is sufficient to overcome the previous rejections as indicated in the last office action.
Withdrawal of Rejections
The response and amendments filed on 11/17/2025 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
Briefly, the previous obviousness rejection over Millar in view of Coplan has been withdrawn necessitated by Applicant’s persuasive arguments. In particular, as reiterated from page 20 of the remarks, due to the harsh conditions of the cited references and lack of data, and thus, one of ordinary skill in the art would reasonably believe that the combination would further reduce and potentially eliminate the extremely low yield of mitochondria isolated using Millar’s methods and there is no reasonable expectation that the mitochondria would be viable. Furthermore, the previous anticipation rejection over Novak has been withdrawn for similar reasons.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Maintained Rejections - Double Patenting
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-7, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-7 of U.S. Patent no. 11,491,480 B2 (parent application no. 15/318,557). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘480 are the narrower claim set that anticipate the broader instant claims.
Regarding claims 1-2 and 21, ‘480 teaches “A method for isolating a viable and respiration-competent mitochondrion, the method comprising: providing a mammalian cell homogenate comprising a viable mitochondrion; passing the cell homogenate through a first filter having a pore-size of 30 μm to 50 μm, and subsequently passing the cell homogenate through a filter having a pore-size of 5 μm to 20 μm, to thereby form a filtrate; and collecting the filtrate, centrifuging the filtrate, and removing supernatant, thereby isolating the viable and respiration-competent mitochondrion, wherein the method of isolating a viable and respiration-competent mitochondrion from the cell homogenate does not comprise repetitive centrifugation steps, wherein the method takes less than 30 minutes to isolate the mitochondrion” (see claims 1-2 of ‘480).
Regarding claims 3-4, ‘480 teaches homogenizing a tissue in a solution comprising 300 mM sucrose, 10 mM K+HEPES, and 1 mM K+EGTA, to thereby provide the cell homogenate (see claims 3-4 of ‘480).
Regarding claims 6-7, ‘480 teaches the filtrate is centrifuged at 9000 x g and a sterile vessel (see claims 6-7 of ‘480).
Examiner’s note: the non-statutory double patenting rejection is being maintained in light of Applicant’s request to be held in abeyance until allowable subject matter has been reached.
Conclusion
Claims 1-4, 6-7, and 21 are free over the prior arts.
Claims 1-4, 6-7, and 21 stand rejected under non-statutory double patenting.
Claims 8-20 are withdrawn as being directed to the non-elected invention.
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.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653