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/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on July 9, 2026 is acknowledged. Claims 14-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 9, 2026.
Claim Objections
Claim 1 is objected to because of the following informalities: capitalization of the “Metal-Organic Framework” which is not a proper noun. Claims 2-4, 7-10 are also objected to for this reason.
Furthermore in claim 1, line 1, “, MOF,” should be “(MOF)”, and since “MOF” is not used in any other claims the abbreviation appears unnecessary. In the third-last line, a semicolon should follow the “pyromellitate”.
Appropriate corrections are required.
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 8-10 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.
Claim 8 recites a “[m]etal-[o]rganic [f]ramework comprising an inorganic part based on aluminum and an organic part based on polydentate ligand chosen from fumarate, …, pyromellitate, for use to immobilize an antigen, in a vaccine adjuvant, said antigen being immobilized at least within said” MOF. It is ambiguous whether the claim requires an antigen. First, the first line of claim 8 states the claim is drawn to an MOF, not a “composition” as in independent claim 1 comprising an MOF and an antigen. Second, said MOF is “for use to immobilize an antigen, in a vaccine adjuvant”, meaning the intended use of the MOF. However claim 8 also states “said antigen being immobilized at least within said” MOF, which indicates inclusion of the antigen within the MOF. Therefore it is ambiguous whether claim 8 is drawn to an MOF having aluminum and a polydentate ligand recited, or such an MOF that also comprises an antigen immobilized therein. None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
For the purposes of examination now this claim 8 is construed as either an MOF comprising an inorganic part based on aluminum and an organic part based on a recited polydentate ligand, or the MOF comprising an antigen immobilized therein.
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.
Claim(s) 8-10 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Kiener (US 20120167761).
Kiener teaches a pure Al-fumarate metal organic framework (MOF) (title; abstract; paras.0007-12, 0020-22, 0028, 0035, 0099 (storage) ; Examples 1-4). It further teaches using the porous MOF “for the uptake of at least one substance for the purposes of its storage, separation, controlled release, chemical reaction or as support” (para.0095). While Kiener does not expressly teach “for use to immobilize an antigen…” as in claim 8, it is noted that the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. MPEP § 2111.02. Because Kiener teaches using its MOF for “for the uptake of at least one substance for the purposes of its storage, …, controlled release, …or as support”, the skilled person would have recognized that Kiener’s aluminum-fumarate MOF would be capable of incorporating an antigen, which is not specified in claims 8-10.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kiener (US 2012/0167761) in view of Chong (Chong, G., et al., Bioengineering of nano metal-organic frameworks for cancer immunotherapy, Nano Res. 2020 Nov 23;14(5):1244–1259).
Kiener teaches a pure Al-fumarate metal organic framework (MOF) (title; abstract; paras.0007-12, 0020-22, 0028, 0035, 0099 (storage) ; Examples 1-4). It further teaches using the porous MOF “for the uptake of at least one substance for the purposes of its storage, separation, controlled release, chemical reaction or as support” (para.0095). The Al-fumarate MOFs comprise micropores which provide at least 1000 m2/g of surface area (paras.0045-47) and the Al-fumarate MOFs are crystalline (para.0012).
Kiener does not specifically teach an antigen immobilized within its Al-fumarate MOF as recited in claims 1, 5, and 6, or a further antigen as in claim 7.
Chong reviews applying nano metal-organic frameworks (nMOFs) for delivering cancer immunotherapy (see entire document including title; abstract; Scheme 1 and accompanying text). Chong teaches nMOFs utilizing Al3+ ions and fumarate ligands (p.1246 2.1 Components and synthesis of nMOFs). Suitable cargo vaccines include antigens such as ovalbumin (p.1249 rt.col.-p.1250). The nMOFs prepared with fumaric acid ester exhibited “[g]ood biocompatibility and biodegradability” (p.1247 Table 1), i.e., resorptive. antibodies” which is “highly favorable for inducing immune response” (p.1245 left col.).
Regarding claim 7, Chong discusses, “biofilms rich in outer-membrane antigens proteins can be wrapped on the surfaces of nMOFs to mediate immune escape and to protect the structural stability of nMOFs” (p.1247 left col.).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Kiener and Chong and devise Kiener’s Al-fumarate MOF to store antigens as recited in the instant claim(s). The skilled person would have been motivated to do so because Kiener teaches using its MOF for “for the uptake of at least one substance for the purposes of its storage, …, controlled release, …or as support”, and Chong teaches, “nMOFs with high porosity, large surface area and greater tunability possess high loading efficiency of immune-related biomolecules, such as nucleic acids, antigens,
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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