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 .
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.
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 1 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (C.N. Patent Application Publication No. 114648504; hereinafter Zhu) in view of von Maltzahn et al. (U.S. Patent Application Publication No. 2017/0151287 A1; hereinafter Maltzahn). The rejections are mapped to the machine translation of CN 114648504.
Regarding claims 1 and 5, Zhu discloses an invention that claims an application of young blood plasma exosomes for the treatment of mitochondrial dysfunction caused by degenerative diseases of aging (Abstract). Zhu does not address utilizing exosomes for treating brain injuries associated with ferroptosis. However, Maltzahn discloses using “chondrisomes”, which are derived from mitochondria and encapsulated in exosomes, for the treatment of intracerebral hemorrhage (para. [0854]) and reducing ferroptosis (para. [239]). Maltzahn further discloses that the mitochondrial source can be the blood of healthy human volunteers (para. [0555]) and/or tissue from young donors (para. [0551]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the chondrisomes of Maltzahn with the plasma exosome generation/treatment protocol of Zhu. Maltzahn and Zhu disclose that damage and dysfunction of mitochondria are important factors in a range of human diseases and aging, respectively. Therefore, they both establish and provide motivation for generating a protocol that utilizes exosomes or chondrisomes derived from young blood and tissue donors as treatment options.
Regarding claims 2, 3 and 6, Zhu discloses a range of 18 – 40 years (p. 7, claim 2) old for the age of donors for the human plasma exosomes (p. 7, claim 3).
Regarding claim 4, Maltzahn discloses in Example 1-2a (para. [0946]), that human or mouse tissue can be used as a mitochondrial source for chondrisome production. Maltzahn further discloses (para. [1151]) injecting the chondrisomes (7.25 mg/kg) into the mice.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the concentration of the chondrisome composition injected into the mice of Maltzahn for incorporation into the exosome-derived treatment protocol of Zhu. Doing so would allow for the inventors to study the therapeutic potential of human-derived exosomes in a controlled animal model as motivation, before considering human trials.
Regarding claim 7, Zhu discloses an intravenous injection of the pharmaceutical composition into an organism (p. 5, Top of page).
Conclusion
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/WALTER JACKSON III/ Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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