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 Group II (Claims 2 and 4-9; drawn to a method of thawing frozen platelets to obtain mitochondria) in the reply filed on October 23, 2025, is acknowledged.
Claims 1, 10-11, and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups I and III-IV), there being no allowable generic or linking claim.
DETAILED ACTION
The amended claims filed on October 23, 2025, have been acknowledged. Claims 3 and 12-13 were cancelled. Claims 1 and 6 were amended. In light of the Applicant’s elected invention, claims 1, 10-11, and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 2 and 4-9 are pending and examined on the merits.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).The applicant claims foreign priority from KR10-2020-0116297 filed on September 10, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received March 8, 2023. While a certified copy of the foreign patent application KR10-2020-0116297 is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
Information Disclosure Statement
The information disclosure statements (IDS) filed on March 15, 2023, June 25, 2024, and April 16, 2025, have been considered.
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 2 and 6-8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by United States Patent Application No. 2019/0048365 (Castora).
Regarding claim 2, as an initial matter, claim 2 uses consisting of (closed) language. Therefore, there cannot be steps between thawing, disrupting, and removing the lysate. However, Applicant’s specification identifies that multi-step processes can be used for disrupting the thawed platelets (physically disrupted using a vortex and/or a 27 G or 29G syringe (Example 1)) and for removing the lysate (After disruption of the platelets, the resultant was centrifuged at 2000 xg for 5 minutes. Then, the resulting supernatant was centrifuged at 12,000 xg for 10 minutes to obtain precipitated mitochondria). Therefore, multi-step processes for disrupting and removing are considered to fall within the broadest reasonable interpretation of the claims.
Castora teaches a method of isolating platelet-derived mitochondria comprising:
1.0 ml of suspended platelets is then aliquoted into smaller volumes and stored frozen at - 80° C. For storage of an aliquot at - 80° C , the aliquot is centrifuged at 1000 xg for 10 minutes . The supernatant is carefully removed, and the platelet pellet is frozen at - 80° C.
Then, in the next stage of the process, to isolate mitochondria from the purified human platelets, they use a combination of non-ionic detergent lysis and differential centrifugation. The process is disclosed as below (steps 1-2 in Example 8 are performed prior to freezing):
Disrupting the thawed platelets:
3 . Add 800 uL of Mitochondria Isolation Reagent A. Vortex at medium speed for 5 seconds and incubate tube on ice for exactly 2 minutes.
4 . Add 10 uL of Mitochondria Isolation Reagent B. Vortex at maximum speed for 5 seconds.
5 . Incubate tube on ice for 5 minutes, vortexing at maximum speed every minute.
6 . Add 800 uL of Mitochondria Isolation Reagent C. Invert tube several times to mix (do not vortex).
Removing the lysate excluding mitochondria by centrifugation:
7 . Centrifuge tube at 700xg for 10 minutes at 4°.
8 . Transfer the supernatant to a new microfuge tube and centrifuge at 12,000xg for 15 minutes at 4° C.
9 . To obtain a more purified fraction of mitochondria, with > 50 % reduction of lysosomal and peroxisomal contaminants, centrifuge at 3000xg for 15 minutes.
10 . Transfer the supernatant ( cytosol fraction ) to a new tube . The pellet contains the isolated mitochondria (Example 8).
Although Castora did not specifically identify thawing their frozen aliquots, this would be inherent in the process. Either Castora would thaw the frozen platelet pellet prior to adding the Mitochondria Isolation Reagent A or Castora would add the Mitochondria Isolation Reagent A to the frozen pellet. If Castora added the Mitochondria Isolation Reagent A to the frozen pellet, the pellet would have to thaw before the lysis buffer can disrupt (lyse) the platelet cells.
Regarding claim 6, Castora, as stated supra, teaches that they used centrifugation to remove the lysate excluding mitochondria (Example 8).
Regarding claim 7, Castora teaches that they collected blood from a subject before isolating the platelets and freezing them (Example 8).
Regarding claim 8, Castora, as stated supra, teaches that they froze the platelets at -80°C (Example 8).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No. 2019/0048365 (Castora) as applied to claim 2 above and further in view of Valeri et al. (Blood 43: 131-136. 1974).
Castora, as stated supra, is silent regarding the thaw step that is inherent within their method.
However, Feingold teaches that they preserved human platelets at -80°C before thawing them in a 37°C water bath for 1-2 minutes (abstract and page 131, paragraph 3-page 132, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Castora to thaw frozen platelets in a 37°C water bath for 1-2 minutes prior to disrupting the platelets as part of the method of Castora to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify the method of Castora to thaw frozen platelets in a 37°C water bath for 1-2 minutes with a reasonable expectation of success because Feingold and Castora freeze platelets at -80°C before thawing them and Feingold successfully reduces to practice that -80°C frozen platelets can be thawed in a 37°C water bath for 1-2 minutes. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No. 2019/0048365 (Castora) as applied to claim 2 above and further in view of Clarke et al. (The Journal of Cell Biology 160: 577–587. 2003) and United States Patent Application No. 2019/0374582 (Maltzahn).
Castora does not teach that they performed multiple freeze-thaw cycles before disrupting the platelets.
However, Clarke teaches that they subjected platelets to three cycles of freeze-thaw before disrupting the cells by passing them through a 25G needle ten times (page 586, column 2, paragraph 1).
Furthermore, Maltzahn teaches that mitochondria can be extracted from cells following three rounds of freeze/thaw (paragraph 0837).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Castora to have the platelets undergo three rounds of freeze-thaw before mechanically disrupting the cells by passing them through a 25G needle ten times, as identified by Clarke, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify the method of Castora to have the platelets undergo three rounds of freeze-thaw before mechanically disrupting the cells by passing them through a 25G needle ten times with a reasonable expectation of success because Clarke teaches that platelets can be disrupted by performing three rounds of freeze/thaw and then performing mechanical disruption of the platelets by passing them through a 25G needle ten times and Maltzahn teaches that mitochondria can be extracted from cells following three rounds of freeze/thaw. As such, it would have been obvious that platelet could undergo multiple rounds of freeze/thaw prior to mechanical disruption to extract mitochondria from platelets. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Conclusion
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/KEENAN A BATES/Examiner, Art Unit 1631