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 .
Election of Species
Applicant's election with traverse of Group Iin the reply filed on is acknowledged. The traversal is on the ground(s) that the groups share the common technical feature of isolated bioactive mitochondria coated with a layer of non-cytotoxic MOF. The examiner’s response is that this cannot be a special technical feature because it is not a common technical feature in the groups. Group I, for example, does not disclose isolated bioactive mitochondria coated with a layer of non-cytotoxic MOF, but instead isolated bioactive mitochondria with a generally coating layer of MOF that is not necessarily non-cytotoxic. Further, isolated bioactive mitochondria coated with a layer of non-cyctotoxic MOF cannot further be a special technical feature because it is not novel. Haddad (Design of a Functionalized Metal–Organic Framework System for Enhanced Targeted Delivery to Mitochondria,. J. Am. Chem. Soc. 2020, 142, 14, 6638–6648) teaches a functionalized, non-cytotoxic metal–organic framework (MOF) nanocarrier designed explicitly for targeting and encapsulating intracellular components, including bioactive materials targeted directly to the mitochondria (abstract; Results and Discussion). This is isolated bioactive mitochondria coated with a layer of non-cyctotoxic MOF.
The requirement is still deemed proper and is made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30-40 and 50-51 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is insufficient written description for what MOF are and are not considered “non-cytotoxic” within the meaning of “non-cytotoxic Metal Organic Framework (MOF).” There is no art recognized definition of what MOFs are and are not ““non-cytotoxic.” “Non-cytotoxic" when applied to metal-organic frameworks (MOFs) means different things depending on the testing method, dosage, and specific cellular properties being measured. A MOF is rarely universally non-cytotoxic; it is usually non-cytotoxic only within a specific threshold. Exceeding that specific concentration (often >50 to 100 µg/mL) turns the same framework toxic as it degrades and releases constituent metal ions or organic linkers into the cellular environment. A MOF is often labeled "non-cytotoxic" if specific in vitro assays, such as MTT or cell membrane integrity tests, show that cell survive and mtianing normal metabolic activity at a chosen, depending on the practioner, (not standard) concentration. For these reasons, the artisan would not accept that applicant had possession of the inventio at the time of filing.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31- 32, 34-36, 39, and 50 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 31 and its dependent claim 32, it’s unclear what standards or outcome needs to be accomplished in order to qualify for intracellular delivery and/or intracellular release of the mitochondria to be “improved” within the confines of the claimed invention.
Regarding claim 34, it’s unclear what “and any combinations thereof” refers to light, heat, magnetism” or to “by endogenous stimuli or by external stimuli.” Further regarding claim 39, it is unclear in what way Al is based on MOFs, MIL-53… and UiO67. Regarding claim 50, it’s unclear how new and under what conditions “freshly” isolated the mitochondria need to be and under to be considered “freshly” and “not freshly” within the confines of the claimed invention.
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 30-37, 39-40 and 40 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Haddad (Design of a Functionalized Metal–Organic Framework System for Enhanced Targeted Delivery to Mitochondria,. J. Am. Chem. Soc. 2020, 142, 14, 6638–6648. Haddad teaches a functionalized, non-cytotoxic metal–organic framework (MOF) nanocarrier designed explicitly for targeting and encapsulating intracellular components, including bioactive materials targeted directly to the mitochondria. Standard cell-encapsulation techniques using biocompatible Zeolitic Imidazolate Frameworks (e.g., ZIF-8) on living cells/organelles were well-established, and details the assembly of biocompatible MOFs to coat/interface natively with bioactive mitochondrial outer membranes to achieve intracellular therapeutic effects (Abstract; Results and Discussion). This is isolated bioactive mitochondria coated with a layer of non-cyctotoxic MOF. Regarding claim 33, Haddad teaches that the mitochondria provide a therapeutic effect and are loaded with cancer agents (a therapeutic) (Results and Discussion). Regarding claim 35, the composition comprises other substances of the structure (Results), which as there is no structural limitation to claim 35, is deemed to read on the claim.
Note and Comments
No prior art was found against claims 38 and 51.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
September 18, 2026
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