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 .
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 October 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicants’ election without traverse of Group I (Claims 1-13, 16, 31, and 34) and species of thermosensitive polymer (claim 8) in the reply filed on 8 May 2026 is acknowledged.
Status of Application
3. The instant application is a national stage entry of PCT/FI2022/050532 filed 16 August 2022. Claims 1-13, 16-19, 21-25, 27-31, and 33-34 are currently pending. Claims 14-15, 20, 26, and 32 are cancelled. Claims 9-10, 17-19, 21-25, 27-30, and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8 May 2026. Claims 1-8, 11-13, 16, 31, and 34 are examined on the merits within.
Claim Objections
4. Claim 11 is objected to because of the following informalities: “MOF framework” should instead recite “MOF” to avoid redundancy. Appropriate correction is required.
Claim Rejections – 35 U.S.C. 112(b)
5. 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.
6. Claims 2, 11, and 31 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.
7. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “nucleic acids, peptides, and proteins”, and the claim also recites “including mRNA, plasmids, enzymes, antibodies, and Cas9/sgRNA ribonucleoprotein complexes” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
8. Claim 11 recites the limitation "release of the biomolecules or loaded biomolecules" in line 4. There is insufficient antecedent basis for loaded biomolecules in the claim.
9. Claim 31 recites the limitation "the thermosensitive nanoparticles" in line 4. Although the claim recites nanoparticles, there is insufficient antecedent basis for thermosensitive nanoparticles in the claim.
Claim Rejections – 35 U.S.C. 102
10. 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.
11. Claim(s) 1-4, 12-13, 16, and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tolentino et al. (J. Mat. Chem B, 2020).
Regarding instant claims 1-4, 12-13, 16 and 34, Tolentino et al. disclose a nanomaterial consisting of a ZIF-8 metal organic framework (MOF) encapsulated within a DNA surfactant micelle assembly, referred to as a nucleic acid nanocapsule (NAN). See abstract. MOFs are well known for their ability to encapsulate a wide range of molecular cargo. Tolentino et al. investigate ways to broaden the chemical nature of the cargo that NAN can accommodate based on growing interest of achieving controlled delivery of plasmids, mRNA, and proteins. See Introduction, page 5627.
Thus the instant claims are anticipated by Tolentino et al.
12. Claim(s) 1-2, 4-8, 12-13, 16, 31, and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheng et al. (Advanced Functional Materials, 2020).
Cheng et al. teach a light triggered core shell nanosystem to boost antitumor immune response via controlled release of anti-PD-L1 antibodies. The nanosystem is constructed via integrating gold nanorods as a photothermal core and zeolitic imidazolate framework-8 (ZIF-8) as a shell for PD-L1 delivery and further PEGylating. See abstract. The resultant AZ-PP was tested to determine heating behavior. See page 3.
Thus the instant claims are anticipated by Cheng et al.
13. Claim(s) 1-2, 4-6, 11-13, 16, and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Advanced Materials, 2019).
Li et al. teach the delivery of plasmid DNA via zeolitic imidazole framwork-8 (ZIF-8) and Zif-8-polymer vectors. Through the use of polyethyleneimine capping agents the nanostructures exhibit enhanced loading capacity, better pH responsive release and stronger binding affinity to pDNA. See abstract.
Thus the instant claims are anticipated by Li et al.
Claim Rejections – 35 U.S.C. 103
14. 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.
15. Claim(s) 1-8, 12-13, 16, 31 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tolentino et al. (J. Mat. Chem B, 2020) in view of Cheng et al. (Advanced Functional Materials, 2020).
Tolentino et al. teach a nanomaterial consisting of a ZIF-8 metal organic framework (MOF) encapsulated within a DNA surfactant micelle assembly, referred to as a nucleic acid nanocapsule (NAN). See abstract. MOFs are well known for their ability to encapsulate a wide range of molecular cargo. Tolentino et al. investigate ways to broaden the chemical nature of the cargo that NAN can accommodate based on growing interest of achieving controlled delivery of plasmids, mRNA, and proteins. See Introduction, page 5627.
Tolentino et al. do not teach external stimuli.
Cheng et al. teach a light triggered core shell nanosystem to boost antitumor immune response via controlled release of anti-PD-L1 antibodies. The nanosystem is constructed via integrating gold nanorods as a photothermal core and zeolitic imidazolate framework-8 (ZIF-8) as a shell for PD-L1 delivery and further PEGylating. See abstract. The resultant AZ-PP was tested to determine heating behavior. See page 3.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use photothermal material with an biomacromolecule to control release of the active ingredient. It would have been obvious to add PEG to the zinc imidazolate since this is known to be effective with ZIF-8 and biomacromolecules desired for photosensitive and thermosensitive release.
16. Claim(s) 1-6, 11-13, 16, 31, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tolentino et al. (J. Mat. Chem B, 2020) in view of Li et al. (Advanced Materials, 2019).
Tolentino et al. teach a nanomaterial consisting of a ZIF-8 metal organic framework (MOF) encapsulated within a DNA surfactant micelle assembly, referred to as a nucleic acid nanocapsule (NAN). See abstract. MOFs are well known for their ability to encapsulate a wide range of molecular cargo. Tolentino et al. investigate ways to broaden the chemical nature of the cargo that NAN can accommodate based on growing interest of achieving controlled delivery of plasmids, mRNA, and proteins. See Introduction, page 5627.
Tolentino et al. do not teach positively charged polymers.
Li et al. teach the delivery of plasmid DNA via zeolitic imidazole framwork-8 (ZIF-8) and Zif-8-polymer vectors. Through the use of polyethyleneimine capping agents the nanostructures exhibit enhanced loading capacity, better pH responsive release and stronger binding affinity to pDNA. See abstract.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add polyethyleneimine to the nanomaterial of Tolentino et al. to enhance drug delivery. One would have been motivated, with a reasonable expectation of success, because Li et al. teach polyethyleneimine in combination with ZIF-8 enhances loading capacity, provides better pH responsive release and a stronger binding affinity of plasmid DNA.
Conclusion
17. No claims are allowed at this time.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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