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 .
Claims 1-9 are pending and examined below.
Priority
The instant application claims foreign priority 35 U.S.C. 119(a)-(d) to Chinese Patent Application No. CN202110454259.3 filed on April 26, 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is April 26, 2021.
Information Disclosure Statement
The information disclosure statement filed Aug. 30, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Claim Rejections - 35 USC § 102/103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, and 5-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated under, or in the alternative, under 35 U.S.C. 103 as being unpatentable over Wei Chiju et al. (CN 107446884, cited in the IDS filed on Oct. 20, 2023).
The claims are directed to engineered mitochondria formed by attaching exogenous cell membranes to outer membranes of exogenous mitochondria. All of the claims (1-9) are product-by-process claims, as they recite the product obtained using the steps recited. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (emphasis added). MPEP 2113.
Wei Chiju et al. teaches a cell membrane particle,, where the cell membrane particle encapsulates biomacromolecules and organelles, specifically the mitochondria; the cell membrane particle does not have a cell nucleus; the cell membrane particle encapsulates proteins and mitochondria and the particle can be used to treat aging and injured cells (Abstract).
Wei Chiju et al. does not teach that the cell membrane and mitochondria are exogenous. The specification does not define exogeneous. It does indicate that “exogenously obtained mitochondria can be autologous to the recipient’s cell. (paras. [0013], [0034]). As such, it is unclear how the product (an engineered mitochondria) can be distinguished from the fusion cell taught by Wei Chiju et al., as “exogenous mitochondria” are not distinguished by the claim as being from another organism, from another species, from a different, specific place. Rather, the claim recites the product “an engineered mitochondria” and everything else is directed to the details of how that product is formed. However, in the case of claims 1 and 3-8, it is unclear how, if at all, the recited preparation prepared in this manner would differ from the cell membrane protein taught by Wei Chiju et al., as the mitochondria have cell membranes attached to their outer membranes of the mitochondria. (Again, if the steps of claim 1 are followed and the product is examined, how is obtaining the cell membrane and the mitochondria exogenously going to result in an engineered mitochondria that has different characteristics than that produced by Wei Chiju et al.? With the claim not requiring anything other than the elements listed (mitochondria have cell membranes attached to their outer membranes of the mitochondria), the recited process does not appear to distinguish the product from that taught by Wei Chiju et al. It is therefore submitted that if the cell membrane wrapped mitochondrial particles are distinguishable, any aspects that are different are not patentably distinct, as the claims appear to recite a product that is the same or not patentably distinct from that taught by Wei Chiju et al.
With respect to claims 3, and 5-8, it is again unclear how the product would appear differently if the mitochondria were extracted from cells or tissue, as mitochondrial extraction kits exist and their goal is to prepare mitochondria that stay intact, which is the same kind of mitochondria that is taught by Wei Chiju et al.
Claim Rejections - 35 USC § 103
Claim(s) 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Wei Chiju et al. (CN 107446884, cited in the IDS filed on Oct. 20, 2023), as applied to claims 1, 3 and 5-8 above, and further in view of McCully et al (Clinical and Translational Med, 2016).
Wei Chiju et al. teach the particles are from human umbilical cord mesenchymal stem cells. (Abstract)
With respect to claims 2, McCulley et al. teach that transplantation in cardiac tissue (claim 4) is a helpful therapy during ischemia. (whole doc). With respect to claim 4, McCulley et al. teach that mitochondrial transplantation has been achieved in breast cancer cells. (pg. 10, “Mitochondrial transplantation in other organs”, 2nd para.).
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have used the method taught by Wei Chiju et al. to form cell membrane particles encapsulating biomacromolecules and organelles, specifically the mitochondria but to have substituted the cell type to both cardac cells and cancer cells as taught by McCully et al. because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Making this modification would have led to predictable results with a reasonable expectation of success because Wei Chiju et al. teach that the particles can be used therapeutically to target mitochondria to diseased or injured tissue and McCulley et al. teach that naked mitochondria can be used in these settings. Therefore, it would have been obvious to make the cell membrane organelle covered particles having mitochondria from these cells and to have tried using them as a therapeutic entity to see if having an encapsulated mitochondrial particle provides a better therapeutic effect than using naked mitochondria in the same situation.
Claim(s) 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wei Chiju et al. (CN 107446884, cited in the IDS filed on Oct. 20, 2023), as applied to claims 1, 3 and 5-8 above, and further in view of Oh et al. (Experimental Gerontology, 2020)
Wei Chiju et al. teach that their cell membrane particles are made using human cells. (Abstract)
Oh et al. teach that C57BL/6J mice provide a mouse model of age-related hearing loss. (pg. 2, “2.1 Mice and animal care”) and that the hearing loss they experience is at least partially due to mitochondrial DNA damage that accrues with age.
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have used the method taught by Wei Chiju et al. to form cell membrane particles encapsulating biomacromolecules and organelles, specifically the mitochondria but to have substituted the C57BL/6J mice as the organism to try to create a particle that could be used to treat age-related mitochondrial damage because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Making this modification would have led to predictable results with a reasonable expectation of success because Wei Chiju et al. teach that the particles can be used therapeutically to target mitochondria to diseased or injured tissue and Oh et al. teach that the mitochondria in aged mice are problematic and the C57B/6J mouse is a model for age related hearing loss. Therefore, it would have been obvious to make the cell membrane organelle covered particles having mitochondria in C57B/6J mice and to have tried using them as a therapeutic entity to see if having an encapsulated mitochondrial particle could restore the mitochondria in this model and treat the age-related hearing loss.
Conclusion
No claims are allowed.
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/TERESA E KNIGHT/ Primary Examiner, Art Unit 1634