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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/12/26 has been entered.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 102 rejections are withdrawn:
Claim(s) 1, 3, and 4 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohana et al. (WO 2020/021534, published Jan 30th, 2020);
The following 35 U.S.C § 103 (a) rejections are withdrawn:
Claim(s) 1-12 were rejected under 35 U.S.C. 103 as being unpatentable over Ohana et al. (WO 2020/021534, published Jan 30th, 2020) in light of support by Medline Plus (Acute tubular necrosis), Gil et al. (Chest, 2005), and Cho et al. (Korean J Pediatr 2010);
The Applicant’s amendments limiting the composition to comprise isolated mitochondria and is cell-free necessitated the above withdrawals. All arguments drawn to these rejections are now considered moot.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3, 4, 9, 10, 11, 13 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCully et al. (WO 2017/124037) in light of support by Glas et al. (J. Cell Biol. 1966, previously presented).
These claims contain product-by-process limitations on how the mitochondria for the composition are isolated. MPEP 2133 is clear that it is the final structure of the composition is examined and the method of making is only considered when it imparts structural limitations to the claims. In this case the homogenization buffer is not a limitation that appears to add a structural component since the buffer is removed by centrifugation when the mitochondria are isolated as a precipitate. Therefore art reading on the structure of the composition of claim 1 will also read on claims 13 and 14 since the buffer is not considered part of the final composition.
McCully et al. teach administering a composition comprising cell-free mitochondria (to treat ischemia/reperfusion injury in a kidney (McCully, pg. 29, lines 30 to pg. 30, line 5). McCully et al. teach ischemia/reperfusion injuries result in inflammation in to the tissue (McCully, pg. 29, lines 23-25) and is associated with mitochondrial injury and dysfunction (McCully, pg. 29, lines 31-32). They teach the amount of mitochondria injected ranges from 1x 102 to 1x 1014 mitochondria (McCully, pg. 29, lines 5-20) and this amount is administered in multiple or single injections. Glas et al. teach mitochondria have a mass of 51.8 x 10-14 g or more specifically . This converts the mass of mitochondria administered by McCully et al. to 51.8 x 10-12 to 51.8 g. The upper amount exceeding 5 and 40 μg limited in claims 10 and 11. McCully et al. teach the mitochondria are isolated from animal tissue with a homogenization buffer and centrifugation to obtained a mitochondrial pellet (see Fig. 1, pg. 46-47).
Therefore the invention as a whole is anticipated by the reference.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 3, 4, and 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCully et al. (WO 2017/124037) in light of support by Glas et al. (J. Cell Biol. 1966, previously presented).
These claims contain product-by-process limitations on how the mitochondria for the composition are isolated. MPEP 2133 is clear that it is the final structure of the composition is examined and the method of making is only considered when it imparts structural limitations to the claims. In this case the homogenization buffer is not a limitation that appears to add a structural component since the buffer is removed by centrifugation when the mitochondria are isolated as a precipitate. Therefore art reading on the structure of the composition of claim 1 will also read on claims 13 and 14 since the buffer is not considered part of the final composition.
McCully et al. teach administering a composition comprising cell-free mitochondria (to treat ischemia/reperfusion injury in a kidney (McCully, pg. 29, lines 30 to pg. 30, line 5). McCully et al. teach ischemia/reperfusion injuries result in inflammation in to the tissue (McCully, pg. 29, lines 23-25) and is associated with mitochondrial injury and dysfunction (McCully, pg. 29, lines 31-32). They teach the amount of mitochondria injected ranges from 1x 102 to 1x 1014 mitochondria (McCully, pg. 29, lines 5-20) and this amount is administered in multiple or single injections. Glas et al. teach mitochondria have a mass of 51.8 x 10-14 g or more specifically . This converts the mass of mitochondria administered by McCully et al. to 51.8 x 10-12 to 51.8 g. The upper amount exceeding 5 μg and 40 μg limited in claims 10 and 11. McCully et al. teach the mitochondria are isolated from animal tissue with a homogenization buffer and centrifugation to obtained a mitochondrial pellet (see Fig. 1, pg. 46-47).
What McCully et al. does not teach is the volume or concentration of the 51.8 x 10-12 to 51.8 g of mitochondria injected into the kidney. Nor do they specifically teach administering 15-40 μg of mitochondria. However this is a matter that could be met by routine optimization of the range of mitochondria administered (i.e. 51.8 x 10-12 to 51.8 g of mitochondria) at a concentration suitable for injection to the subject to treat ischemia/reperfusion injury in a kidney (MPEP 2144.05).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim Objections
Claims 2, and 5-8 are objected to for being free of the art but dependent from a rejected claim.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699