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
1. Applicant’s election without traverse of liposomes, cyclodextrin, and adamantane, in the reply filed on 12/02/2025 is acknowledged.
Claims 1-12 and 14-20 have been amended.
Claims 1-20 are pending and under consideration.
Claim Objections
2. Claim 1 should recite “the second part is a nanoparticle” (lines 3-4); and “the macrocyclic host molecule or guest molecule on the first cell is in correspondence with the guest molecule or macrocyclic host molecule on the nanoparticle (last two lines).
3. Claim 2 should recite “host molecule” in line 2.
4. Claim 3 should recite “a macrophage” in line 2.
5. Claim 4 should recite that the molar ratio is “1:10 to 10:1” in line 2.
6. Claim 5 should recite “the nanoparticle is a liposome” in lines 1-2.
Claim Rejections - 35 USC § 112(b)
7. 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.
8. Claim 13 is 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 13 recites the limitation "the PEG" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
9. 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.
10. Claims 1, 2, 6-8, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (Materials Letters, 2018, 221: 131-134).
Zhou et al. teach a mesenchymal stem cell (MSC) comprising on its surface cyclodextrin (CD) attached via DSPE-PEG and azobenzene-modified nanoparticles (Azo-NPs) bound to the MSC surface via host-guest interactions between CD and Azo. Thus, Zhou et al. teach a supramolecular cell-based carrier as recited in claims 1, 2, and 6. Zhou et al. teach obtaining the carrier by: (1) coupling CD to the PEG moiety of DSPE-PEG to obtain DSPE-PEG-CD; (2) incubating the MSCs with DSPE-PEG-CD for 30 min at 37 ºC to obtain CD-modified MSCs; and (3) mixing the CD-modified MSCs with the Azo-NPs for 30 min (claims 7, 8, 12, and 14) (see Abstract; p. 131-132; p. 133; p. 134, column 1; Supplemental Material, third page). It is noted that mixing for 30 min as taught by Zhou et al. anticipates the range ≥10 sec recited in claim 14.
Thus, Zhou et al. teach all claim limitations and anticipate the claimed invention.
Claim Rejections - 35 USC § 103
11. 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 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.
12. Claims 1-3, 5-9, 11-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al., in view of Choi et al. (Biomaterials, 2012, 33: 4195-4203).
The teachings of Zhou et al. are applied as above for claims 1, 2, 6-8, 12, and 14. Zhou et al. teach an MSC, not a macrophage (claims 3 and 9). Although Zhou et al. teach choosing MSCs because their ability to target tumors, Zhou et al. teach that macrophages are also suitable to be used as vehicles for nanoparticle-based DDS (see p. 131, column 1; p. 134, column 1, last paragraph). Furthermore, Zhou et al. teach that the supramolecular cell-based carrier is suitable for targeted drug delivery (see p. 134, column 1 last paragraph). Choi et al. teach that macrophages are capable of targeted drug delivery to tumors due to their ability to home to tumors; Choi et al. teach using macrophages for the delivery of liposomal doxorubicin (LP-Dox) to the tumors of a subject affected by cancer (see Abstract; p. 4196, column 1, last three paragraphs; last paragraph). Based on these teachings, one of skill in the art would have found obvious to modify Zhou et al. by replacing the MSC with a macrophage to achieve the predictable result of obtaining a composition capable of delivering therapeutic agents to tumors. One of skill in the art would have also found obvious to further modify the LP-Dox of Choi et al. with Azo and either attach the resultant Azo-LP-Dox to the macrophage via the host-guest interactions alongside Azo-NPs or replace the Azo-NPs with Azo-LP-Dox, with the reasonable expectation that doing so would result in a composition suitable to be used in cancer therapy (claim 5). By doing so, one of skill in the art would have practiced the method recited in claim 11 and would have obtained a drug carrying system as recited in claims 15-17, 19, and 20.
With respect Zhou et al. teach incubating for 30 min, not for more than 30 min as recited in claim 13. However, MPEP 2144.05 III A states that "[a] modification of a process parameter may be patentable if it ‘produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art." (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In this case, there is no evidence of a difference in kind or even degree when using an incubation time of more than 30 min instead of 30 min.
With respect to the DSPE-PEG-CD concentration range (claim 13), there is no evidence of record indicating that using the claimed 1µM-1mM range leads to unexpected results. One of skill in the art would have reasonably concluded that DSPE-PEG-CD concentration is a result effective variable with respect to Dox loading (and thus, therapy) and would have found obvious to optimize the composition for therapeutic effectiveness via varying the amount of DSPE-PEG-CD, which would have only entailed routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that the selection the claimed range was other than routine or that the results should be considered unexpected in any way as compared to the closest prior art (see MPEP 2144.05 II).
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
13. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. taken with Choi et al., in further view of Sun et al. (Chem. Commun., 2016, 52: 4602-4612).
The teachings of Zhou et al. and Choi et al. are applied as above for claims 1, 2, 5-9, 11-13, and 15-17. Zhou et al. and Choi et al. do not teach adamantane (ADA) (claims 4, 10, 18). However, it was known in the prior art that ADA and Azo are functional equivalents with respect to interacting with CD (see Sun et al., p. 4603, column 2, first full paragraph; p. 4606, column 2, last paragraph; p. 4607, paragraph bridging columns 1 and 2). One of skill in the art would have found obvious to replace Azo with adamantane to achieve the predictable result of obtaining a supramolecular cell-based carrier.
With respect to the ratio range recited in claim 4, there is no evidence of record indicating that using the claimed range leads to unexpected results. One of skill in the art would have reasonably concluded that the ratio is a result effective variable with respect to Dox loading (and thus, therapy) and would have found obvious to optimize the composition for therapeutic effectiveness via varying the ratio between CD and ADA, which would have only entailed routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that the selection the claimed range was other than routine or that the results should be considered unexpected in any way as compared to the closest prior art (see MPEP 2144.05 II).
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
14. No claim is allowed. No claim is free of prior art.
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/ILEANA POPA/Primary Examiner, Art Unit 1633